Pelvic Reconstructive Surgery

Why do they not listen?

2011-07-14T12:33:00.000-07:00

It is now for more than 4 years that the webmaster of this blog is advocating safe alternatives for the repair of the damaged vaginal support structure.
I would like to bring this FDA news release to the attention of readers.

Remember: due to the varying results in Prolapse surgery, no procedure can be seen as the golden standard- all prolapse surgical procedures must at this stage being seen as "experimental". The main aim of human experimenting is that the "do no harm" principle must be adhered to- this is what this blog is all about. There is a third and safer alternative, namely defect specific repairs with minimal use of synthetic implants.

If your treating surgeon suggest that you should have synthetic meshes implanted, without suggesting alternatives which do not have a potential for permanently damaging your vaginal supports- remember even a 1% chance will be 100% for that person-, put as much as possible distance between you and him/her!

FDA NEWS RELEASE
For Immediate Release: July 13, 2011
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks
Agency says other options may expose women to less risk than transvaginal procedure.

The U.S. Food and Drug Administration today issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.
The safety communication also says that with the exposure to greater risk comes no evidence of greater clinical benefit such as improved quality of life.

Pelvic Organ Prolapse (POP) occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

Surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.

”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”

In 2010, there were at least 100,000 POP repairs that used surgical mesh. About 75,000 of these were transvaginal procedures.

The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. The reports don’t always differentiate between transvaginal and abdominal procedures.

The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.

The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.

FDA recommends that health care providers:

Recognize that in most cases, POP can be treated successfully without mesh;

Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;

Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and

Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

The FDA recommends that patients:

Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;

Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and

Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

The FDA also announced that an outside panel of experts in obstetrics and gynecology will meet on Sept. 8-9, 2011, to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence (SUI), a leakage of urine during physical activity. The panel will discuss the risk of transvaginal POP repair, clinical studies that may be necessary to address risks and benefits of this type of surgery, and the FDA’s interim recommendations for health care professionals and patients.

“Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for POP and SUI repair, including any changes that would improve our oversight,” Maisel said.

Today’s safety communication is limited to the transvaginal placement of mesh to repair POP. It does not address the safety and effectiveness of mesh used to treat SUI or mesh implanted abdominally.

For more information:

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

http://www.facebook.com/l/rAQBAd_OHAQCltLeJV4JeCzecogadh0KHzFE-qzyL-cimvw/www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

(webmasters' note:

It must be stressed that this warning involves vaginal placement of meshes- this mesh sheets is placed between the bladder wall and the vaginal wall in a natural space ( vesico-vaginal space) and the rectum and the vaginal wall (recto-vaginal space). The manufacturers of these meshes provide it in "mesh kits" which involves the use of needles which are used to "tension free" anchor the arms of the meshes to the side wall of the pelvis and through ligaments of the pelvis- so called "minimal invasive" procedures. Unfortunately do the use , and abuse, of these meshes involves vaginal surgery, and as a vaginal surgeon I must protest to this, for it gives vaginal surgery a bad name! Vaginal reconstructive surgery is an art which involves the reconstruction of the damaged vaginal support systems, utilizing the available natural tissue layers present and reconstructing normal vaginal support anatomy with the normal vaginal anatomy as template. Due to different factors, that will be discussed in this blog, this is not in all cases durable enough and do one need to supplement or augmenting the primary surgery with the use of implants, synthetic or biological. This must never take over the role of proper good surgical technique and expertise, as happens in the use of these mesh kits. An incompetant surgeon must never made to feel competant by the use of these.

have a look at other opinion maker's comments:

http://fvvo.be/archive/volume-3/number-3/editorial/pacemakers-are-not-vacuum-cleaners/

structured reconstruction surgery

2010-07-31T02:27:00.000-07:00

Declare the past, diagnose the present, foretell the future; practise these acts. As to diseases: make a habit of two things- to help, or at least do no harm.
Hippocrates; Epidemics, Bk I, sect XI

The two groups of patients most neglected in prolapse surgery are the very young women with prolapse and the patient who had a suboptimal result after prolapse surgery. The reason why any gynecologist is not keen to operate on the young woman with symptomatic prolapse is the awareness that the repair gives not only poor long term results, but also results in tissue damage.
The patient who had had previous surgery, with a suboptimal result, creates a dilemma for the surgeon: the footprint of the previous surgery makes assessing difficult, and the re-do surgery is difficult due to tissue scarring and removal of tissue with the primary surgery. Success in addressing the prolapse is also less guaranteed with repetitive surgery. The use of synthetic materials in the vaginal wall of a young patient is for obvious reasons not an option, and in a patient with suboptimal result a challenge for repeat surgery.
A more structured approach to prolapse repair can be a viable option for these two groups of patients. If the primary surgery is done on a structured manner the harm done to the young patient is minimal. The re-do of failed previous repairs can also be done in a structured constructive manner- be it by repairing the underlying pathology (in a side and site specific manner) and bolstering it with a collagen graft, or by bridging the gap left by the undo process with a non-cross linked bio graft. In this re-do group of patients one obviously needs to motivate why one did not do the primary surgery in a structured constructive way in the first instance.
The yardstick of successes and failures of surgical results, though, is not only the claiming of successful correcting the da- mage or defect, but also the ability to deal with the complications. With a focus on the suboptimal results, be it failing to correct what had been set out to be done, or causing damage -even if the defect had been corrected-, one comes across what can be called the undo re-do factor of surgery. Before the surgical correction of the defect can be done with a secondary procedure (re-do) the after effects of the primary surgery must be undone (undo). This factor is what in the end will be the surgical legacy or footprint of the surgeon.

Prolapse surgery of yesteryear is based on getting rid of the bulging vaginal wall- it is seen as a central bulge of the un- derlying organ into the non supportive vaginal wall. The bulge is directly folded back to take the underlying organ away from the vaginal cavity. In the resultant surgery, tissue –be it vaginal skin or even perfectly normal organs like the uterus- is being removed. The formation of scar tissue can be experienced as an advantage. The first attempt at surgery is usually the best chance of success. In this type of surgery no reference is made to seek out and repair the underlying pathology that leads to the prolapse- the symptom of the disease is treated and not the cause. Secondary corrective surgery is to be done against the background of tissue damage and scarred tissue. The undo factor is hampered by scar tissue formation and at times depleted tissue. Especially the re-do aspect of surgery is challenging – shall one do the same procedure again or shall it be an alterna- tive method?
No wonder that “innovative“ avenues of pelvic floor surgery are being explored. In most of these pelvic organ support is being created by the introduction into the pelvis of different kinds of grafts and mesh implants. The basis of these surgical procedures in the anterior vaginal wall is to release the anterior vaginal support from its lateral sidewall attachments to the white line and the attachments to the central cervical ring. An indirect support system is created by bridging the gap from white line to white line, posterior aspect of the pubic rami to interspinous space with a xenograft or mesh of synthetic materials. The procedures are simplified to make incompetent surgeons more competent. Unfortunately do this lead to an increasing number of reports of complications- in most cases leading to corrective surgery and even removal of the placed materials. The undo re-do factor- especially the undo part- in these cases is high leaving the patients worse off compared to what they had been before the primary surgery. To re-do one needs to follow a new avenue of surgery.

Recognition of normal anatomical landmarks, understanding the integration of normal anatomy and normal function and how it is influenced by the damage that is present with pelvic organ prolapse provides the basis of successful reconstruction surgery. Suboptimal results in the standard treatment modalities available must be compared, with an emphasis on the un- do/redo factors of each. This will show that an alternative could be to restore normal anatomy on a structured reconstructive way- especially if one realizes that it is never possible to reconstruct the vaginal supports in one operation only in all cases of prolapse. The primary surgery must allow for the laying down of building blocks that, if it does not result in full restoration of normal anatomy and function, at least can function as a foundation on which further surgery can be done. This will thus be an add-on rather than an undo/redo type of surgery in the patient with a suboptimal result.
This will set the stage for a more staged approach to reconstruction of the pelvic floor supports. An engineer will not build a bridge without laying the traffic still- we want to do that with still having the traffic present. With this approach it may be possible.

Could it be that our judgment is so clouded by industry and the input from them that we are blinded to see the obvious? It may be time to admit that the use of synthetic material- especially between the bladder and vagina- had been a surgical experiment that failed. We must look for better and fresher ideas.

This article is published here: http://www.pelviperineology.org/march_2010/pdf/pelviperineology_march_2010.pdf

IUGA 2009, Como

2009-06-29T10:47:00.000-07:00

IUGA 2009, Como came and went. In the world of the Uro-gynaecologist- or as some would prefer the pelvic organ reconstructive surgeon – the annual IUGA congress is the highlight of the year. This is a time where one recharges your knowledge- sometimes it is more a reassurance of one’s competence to practise.

Compared to previous IUGA congresses, IUGA 2009 was different. The programme was changed in many ways- the workshops were well planned and well attended, the main programme interlinked review lectures with the scientific programme- to such an extent that the lecture halls were still full on the last day! The overdose of industry seminars of the past was not there- the biggest plus point of IUGA 2009. Whereas the congresses of 2006 2007 and 2008 were dominated with all kinds of innovations on the different synthetic mesh kids, on this one, one needed to hunt to find any. The scientific programme was central and the rest more peripherally.

The feel of this congress was that a new era is dawning: the joy of the fantasy of mesh kits having the answers to all our problems is being replaced with the reality that the cracks in the wall are appearing. As time go by the synthetic meshes are giving rise to a new science: how to diagnose complications caused by them and how to rectify that. The focus had been in the past on the successes and failures to cure prolapse- now it is shifting to not only the failure rates, but also the harm done to those who had failures and more importantly, the long term complications even in those who had initial good results. The pendulum is still on the move.

No wonder that at this congress 5 workshops highlighted complication of synthetic meshes: how to diagnose, classify and treat them. This is to my mind going to be one of the main attractions in IUGA congresses to come. IUGA 2009 was the starting point. The last few drops in the synthetic mesh innovations bucket was a few introductions of, what someone called, the stamp size mesh kits. Increase the pore size, or decrease the mesh size- both leading to less and less mesh, until nothing remains. Those who (still) do not want to hear will, unfortunately, stay deaf, and those who do not want to see, blind.

One aspect of the IUGA 2009 experience which needs to be underlined is the video sessions. At this congress, in contrast to IUGA 2006 and 2007, these proved to be poorly attended. A pure organizational blunder- the EUGA was given the responsibility of having video sessions as part of their poorly advertised pre-congress meeting. The few videos accepted were more accepted on the base of the Names who subjected these than on the basis of content. Videos not accepted for this meeting were introduced as a “digital poster” session- some fantastic idea, but poorly advertised, if advertised at all. I am sure few attendees knew about this. Video with data was a new addition to the main programme, and well attended. Unfortunately the excluding criteria of not mentioning industry names or advertising was not adhered to in quite a few of these. Some videos were also of very poor quality. The vast majority of attendees to IUGA are experienced surgeons- they want to see other surgeons operate and compare. Videos of surgical procedures- it do not need to be “surgical innovations” all the time; a simple rerun of a well known procedure in the hands of an expert- is always good to watch.

A fantastic introduction to IUGA 2009 was the lunch with experts. To be able to speak with your heroes and idols at a congress is always one of the reasons why normal mortals attend. At IUGA 2009 this was possible, not only due to this lunch meeting, but also in between lectures. One of the responsibilities of being leaders in your field is that you must be available to your piers during meetings like this. This initiative by the organisers must be applauded.

Out of the perspective of someone who has English as a second language, I do want to make a suggestion to organisers of Congresses where the only language is English. At this congress, as in others, it came once again apparent the advantage speakers with English as first language have. The poor Greek, Italian, French speaker is at a distinct disadvantage: he has to put his message forward in the same time frame as his English/American colleague, has to answer questions –which he/she normally did not fully grasps- off the cuff under the same pressures as the English/American colleague. Is it possible to lend these people a hand? In the days leading up to an international congress like this a special workshop session can easily be arranged to coach interested speakers. I am certain a lot of good knowledge and new perspectives get lost due to the language barriers.

IUGA 2009 was a better experience to me personally, compared to the last one I attended in 2007- the fact that I did not bother to go to Taiwan in 2008 says it all.

My thanks and congrats to the Italian organisers.

Andri Nieuwoudt: IUGA 2009: Some perspectives from a neutral corner. International Urogynecology Journal: Volume 20, Issue 9 (2009), Page 1007.

Congresses of note

2008-07-23T11:34:00.000-07:00

Anyone interested in furthering his/her own knowledge in PelvicOrganReconstructiveSurgery, or who wants to share his/her knowledge and experience in the subject must take note of this congresses:

IUGA 2010 ICS 2010 meeting Toronto Canada

society of gynaecologic surgeons

Advanced Gynecology surgery: USA

Surgical Footprints, then and now.

2008-05-10T21:32:00.000-07:00

“Learning without thought is labour lost; thought without learning is perilous.”confucius

Looking down the timeline of vaginal reconstruction surgery, one probably need to start in 1909 when George White, a gynecologist from the rural United States, found that the reason for the anterior vaginal wall to prolapse is tears that happened in the support tissue of the bladder on its lateral attachments to the pelvic sidewalls. This para-vaginal tears -which propably occurs during preceding childbirth- could be reproduced by him by cutting through this collagen, with resultant anterior vaginal wall prolapse with a “cystocoel” forming. He rectified this by a simple side stitch through the vaginal wall, through the underlying tissue and onto the sidewall of the pelvis, thus pulling it upwards and the prolapsed bladder out of the vagina.

These outstanding findings were unfortunately overshadowed by the teachings of a more prominent member of the medical fraternity, Howard Kelly. Howard Kelly looked into the vagina, saw a bulge coming down in the midline on the anterior wall and named it after the organ which it must contain - a cystocoel - and rectified this bulge by folding the overlying central tissue between bladder and vaginal skin onto itself, thus augmenting the stretched tissue onto itself.

White saw the anterior vaginal wall as a prolapsed organ, Kelly saw it as a bladder prolapsing into the vagina. White wanted to re-build the support of the anterior vaginal wall, Kelly only focused on getting rid of the bulging bladder into the vagina.

These two pathogenetic and resultant treatment modalities are in total conflict with each other. On the one hand the pathogenesis is based on a mechanical tear happening on the attachment of the support tissue of the bladder to the pelvic sidewall, and the oposing view is based on a central stretching -later to be viewed as a "central defect"- of support tissue. In the first instant one needs to rectify the lateral defect, in the other one needs to fold the stretched tissue on itself, thus pushing the bladder upwards and out of the vagina.

Being the “father” of American Gynecology, Howard Kelly's teachings were adopted and George White’s did not get any attention.

This still persists in modern vaginal reconstructive surgery. The general teaching is that the inexperienced surgeon should only do this type of surgery - your first attempt at correcting prolapse is your best chance- and this is left to the inexperienced! The experienced is keeping himself busy with the "complex" repairs - a rather nice way to describe the failures!

The period from 1909- when White wrote his article- to 1914 -when Kelly introduced his teachings to the world- can be seen as the first sliding door opening where the wrong door probably was entered.

The second sliding door happened in the 1970’s and 1990’s with the rise of laparoscopic surgery, where the defects on the pelvic side walls were seen by Richardson and these “para-vaginal tears” were sutured by either open surgery or through the laparoscope. A few articles appeared with results, but with no standardized methodology and with no universal results. Before this could be universally tested, the sliding door opened in a different direction with the advent of Mesh kits whereby a bridge is put between the bladder and the vaginal wall stretching from sidewall to sidewall and cervix to symphysis pubis.

The ensuing mesh kits that came on the market were attractive due to the simplicity involved in the placing of these, and - to put it bluntly - incompetent surgeons found themselves suddenly looking rather competent! The focus changed from reconstruction of the defects present to constructing a support for the centrally prolapsed organ in the form of a bridge. The anterior wall was opened, the lateral attachments were severed from the sidewall of the pelvis (thus creating a bilateral defect) and the mesh was used as a permanent bridge to support the bladder.
With experiences of this type of graft over only weeks or months, products came on the market for general use, being basically untested in the pelvis. Debates ranged over the type of meshes to use for this bridge, with the lighter being put forward as the better and synthetic graphs as being superior to different biological grafts. In all these debates there was a total disregard for the normal anatomy and the deviation from this normality due to disruption in the collagen support.

Around the turn of the century everyone was also caught in the clamour of the TVT and TVT-O era. Add to this the marketing and involvement of big business, and what happened should have been expected.

The aspiring vaginal pelvic organ reconstruction surgeon is thus confronted in 2008 with basically two choices: either use the “classical” central bulge reducing methods as taught by Kelly, or follow the mesh bridge teachings of the “modern” pelvic organ reconstruction surgeons.
The followers of the “mesh kits” are honest enough to report failures and complications of these kits, with different types of “innovations” with each ensuing congress. The cracks in the wall are showing already in a relatively early stage.

What to do if, or shall I say when, complications appear, will be the new science of the future.

The aspiring surgeon has thus a choice between two evils.

In all this the sliding door leading towards the recognition of the pathology present and directly restoring that, is once again totally ignored.

Standing back from this, one only has to look at what needs to be done: one needs to know the anatomy, recognize what is the underlying cause of the central prolapse in the vaginal wall (mechanical defects with collagen degradation), and then follow the simple rules of proper reconstructive surgical techniques to rectify the defective anatomy. This had already been proposed by George White in 1909 and resurrected by others.

In teaching the aspiring surgeon these basic principles, we the teachers, will leave a less harmful trail. Only then one can follow the simple rule of “do no harm”.

The footprints laid down in the pelvis by childbirth and degeneration of collagen in the surrounding tissue is the reason for the prolapse. How this can be prevented is not clear. The surgical footprints laid down by the pelvic organ reconstruction surgeon, however, can be.

Our function is to see to that. We must be reconstructive surgeons, not destructive surgeons.

this editorial had been accepted for publication by the International Urogynecology Journal on 22 june 2008: the original publication is available
here

The footprint of a synthetic mesh in the pelvis: a report on experience with 48 cases

2008-04-11T22:52:00.000-07:00

7 July 2009:
As an introductory to this session I would like to present a videoclip of the procedure needed to remove the Anterior portion of the Total Prolift System.

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Anatomical Outcomes and Complications of the Total Vaginal Mesh (Prolift) Procedure for Pelvic Organ Prolapse

Synthetic mesh kits are wide employed in both the Netherlands and elsewhere, with a high incidence of Industry involvement- the main driving force is based unfortunately more on financial than proven medical safety and effectiveness. Re-operation rates is reported to be between 8, 5% (Diwadkar GB, et al, Obstet Gynecol. 2009; 113(2.1): 367-73) and 25% (Chris Mayer- abstract at IUGA 2009, Como).

In this report the experience of a peripheral gynaecologist is shared with the use of a polypropylene mesh kit, the Total Prolift System. It is an overview of experience gained in a rural hospital practise in the Netherlands- rural in the Netherlands means that the hospital is 120 km from the nearest Dutch teaching hospital. All the surgeries were done by the same surgeon (AJ Nieuwoudt) who had 26 years of experience in vaginal surgery. Training in the Prolift System was provided by Prof Jacquetin in Clermont-Ferrand. The surgical protocol followed in all cases was as laid down by Gynecare. A strict surgical auditing was prospectively followed, with interval communications with both the Dutch Pelvic floor workgroup and Gynecare. There was no financial involvement from industry.

The anatomical outcome with the placing- and assessment of complications experienced- of the Total Prolift System as first surgical choice in 48 consecutive patients with pelvic organ prolapse is reported. These procedures were done from the 1st of April 2005 to the 31st of January 2007, when the procedure was abolished for reasons that will become apparent.

The mean age of the patient population studied was 63yrs, with a variation between 31 and 78 yrs- only 5 cases were younger than 50yrs. 17 of the patients were sexually active. All patients had POPQ staging of the prolapse before surgery: 53% had at least stage 2 prolapse, and 47% stage 3 or more. 8 patients had previous prolapse surgery, with 2 incontinence surgery. 13 had a prior hysterectomy.

In the anterior compartment 90% had stage 2 prolapse (Aa=+2 – variation: -3 to +3 - Ba= +1.41 – variation: -3 to +6 – and C=-2). In the posterior compartment 90% also had stage 2 (Aa= 0 and Bp=+0.41). In the apical compartment 41% had stage 2, with 20% stage 3 – the mean for point C was +0,2.

The only noteworthy intra-operative complication was a ureter ligated with a haemostatic stitch on the bladder wall. The resultant ureter obstruction was diagnosed in the immediate post operative period. After vaginally removing the offending stitch in theatre, the obstruction was resolved- an IVP on 6 weeks confirmed no obstruction and no kidney damage. There were no bladder/or bowel intra-operative injuries.

2 cases of erosions were found on the 6 weeks assessment- one into the bladder- needing abdominal surgery- and one exposure (erosion through the suture line on the anterior vaginal wall). On 6 months 3 erosions presented- 2 on the posterior vaginal wall, and one on the anterior vaginal wall. The anterior vaginal wall erosion was in a sexually active patient and was away from the suture line scar. On 12 months a further 3 patients presented with erosions- all on the posterior wall on the perineum.

Follow-up of the patients were on 6 weeks, 6 months, 12 months, 24 months and 36 months

Patients were taken out of the study after a secondary procedure were done- this gives a 36 months availability for follow-up on 35 patients out of the initial 48. The secondary procedures will be alluded to later, but of note is that there is an accumulation of patients needing secondary surgery as time go by- after 36 months 25 out of 48 cases needed a form of secondary surgery, be it for poor results of prolapse repair or for correction of complications caused by the procedure.

Looking at results for the correction of prolapse, the poorest results were with apical support: on 6 weeks 8 cases had a bigger than grade 1 apical support failure (mean point C= -1, 68). One case had a posterior compartment prolapse greater than grade 2.

On 6 months symptomatic prolapse were present in 10% of cases (n=5). 10 cases had stage 2 or greater apical prolapse- representing 22% of cases operated on (C varied from -8 to +4). At this early stage 5 cases needed secondary surgery for apical prolapse (3 vaginal hysterectomies and 2 vault suspensions).

At 12 months 15% had in the anterior compartment a greater than stage 1 prolapse. 11 cases (33%) had an apical compartment prolapse, necessitating 5 vaginal hysterectomies and 9 vault suspensions. A further 4 (17%) had an apical prolapse on 24 months follow-up, necessitating in 2 cases vaginal hysterectomies and 3 vault suspensions.

If successful surgery for prolapse is defined as being a leading edge stage 0 or less than stage 1, the following results emerged:

The tendency was an ever increasing prolapse in the treated compartment, ending with only 48,7% having successful surgical cure after 24 months.

Looking at which compartment that did the worse, it is obvious that the apical compartment is the offending compartment in nearly all cases with stage 2 or greater prolapse:

Focusing on secondary procedures needed, a clear picture comes to the fore: after 12 months 5 out of 39 cases were done, which increased to a total of 13 out of 36 (24 months) and 25 out of 35 (after 36 months).

The specific procedures are listed- note that after 36 months a total of 12 out of a possible 35 patients with uteruses needed a secondary hysterectomy to treat the apical prolapse. In 11 cases the anterior mesh were removed, necessitating a total re-do of the anterior wall support. These cases all had shrinkage of the anterior mesh, resulting in pain, either spontaneous or with intercourse:

Looking at the mean time interval between primary and secondary surgery, it became apparent that there is a delay of more than a year in most procedures. Even the two cases which needed a TVT-O due to de novo stress incontinence needed it after 25 and 30 months.

According to the Dindo classification of surgical complications, secondary surgery can be seen as a grade 3b complication: in 25 out of 48 studied a grade 3b complication was noted.

A special category of complication was noted, namely mesh shrinkage.Defining shrinkage as shortening of more than 50% of the distal to proximal distance, after 6 months 45 out of 46 the anterior portion of the Total Prolift System fullfilled the criterium. If one focus only on those that showed pain, whether spontaneous or with intercourse, 16 were present after 24 months- of these 14 required removal of the mesh. This was an acumilating effect.

Conclusion:

A few conclusions can be drawn from this study:

In the author’s experience with 48 cases, poor anatomical outcomes were found with the use of the Total Prolift System in treating pelvic organ prolapse. This is especially true where the apical support is concerned.
Significant complications were encountered; especially long term complications were a worrying feature. These needed a high incidence of secondary corrective surgery. The delayed feature of the onset of complications predict that the real incidence of complications is still to be seen.
Shrinkage- also a delayed feature- of specially the anterior mesh is a serious complication. The only successful treatment there-of is removal of the mesh and a re-do of the prolapse surgery. This has a significant influence,not only on the morbidity, but also on the quality of live.

The use of synthetic meshes, especially in the anterior compartment, but also as a means of support to the apical aspect of the vagina cannot be supported.

The above had been presented by Andri Nieuwoudt at the 34 th Annual meeting of the International Uro-Gynaecology Assosiation on the 18th of June 2009 in Como , Italy.

Vaginal Reconstructive surgery: What surgical footprint to leave behind.

2007-08-29T00:29:00.000-07:00

"No man ever steps in the same river twice, for it's not the same river and he's not the same man." (Heraclitus)

In the revolution of Vaginal Reconstructive Surgery new techniques come and go. The basic choices are to either stay with the known "classical" anterior colporrhaphy- with all its known defects and ethical issues- or to implant synthetic meshes between the bladder and the vaginal cavity.

To the author both these surgical footprints are not acceptable. On the one hand destructive surgery is the basis of the quest to rid the patient of her bulge with the classical operation,while on the other hand own experience showed that the implanting of a synthetic mesh (n=70) between two cavities leads to shrinkage in 100% of cases after 12 months, with resultant risks of support failure, and even more important, erosions and dyspareunia.

Both these techniques are a disgrace to our profession and can not be condemned in strong enough terms!

There is an alternative footprint: reconstructing the damaged anatomy to as near as possible to the original state, without doing your patient harm. To induce the body to reconstruct its own weakened collagen is the ultimate goal of reconstructive surgery.

With this one leave a surgical footprint behind which follows the rule of do no harm- a footprint that can be a foundation to build on if the result of the surgery is suboptimal: this is the basis of the future of vaginal organ reconstructive surgery.

In the following chapters the author is going to allow the reader to enters his world of pelvic organ reconstructive surgery.

For interested Vaginal Reconstructive Surgeons the following DVD's are available on visiting the unit at Terneuzen:

1. Primary Vaginal Sidewall Specific Repair (VSSR)

2. Suboptimal Results: Removal of Anterior Prolift

3. Suboptimal Results: VSSR after previous Classical Repair

4. Suboptimal Results: Vaginal Hysterectomy and vaginal Topplasty after previous VSSR and Post Prolift.

5. Suboptimal results after Ant Post Prolift: Vaginoplasty.

Vaginal Side Specific Repair (VSSR)

2007-07-16T07:39:00.000-07:00

"The reasonable man adapts himself to the world. The unreasonable one persists in trying to adapt the world to himself. Therefore, all progress depends on the unreasonable man.” (George Bernard Shaw)

Collapse of the vaginal support of the underlining organs is due to, at times interlinking, mechanical and biochemical factors. The mechanical damage to the support systems is usually associated with childbirth, with the biochemical factor an usually secondary occurrence years later when the surrounding collagen tissue undergoes degenerative changes.

The surgical approach of the pelvic organ reconstructive surgeon must be focused on surgical improvement of this collapse and do not only include repair of the mechanical damage but must also include improvement of the accompanying collagen weakness.

Understanding the pathogenesis of the damage childbirth causes help in creating the type of surgery necessary to rectify the wrong:
Damage of the anterior vaginal wall is due to the manoeuvres of the presenting part of the foetus as it encounters the resistance of the pelvic floor. This includes engagement, flexion (if it is a head) and internal rotation. The strain put on the supportive collagen tissue of the bladder is greatest on the side of the face; here is the greatest arch of rotation and movement. With the more common LOA position of the head it’s therefore not surprising to find the damage on the right -para-vaginally- in the vicinity of the ishial spines and on the transverse aspect just distal from the peri-cervical ring.

The focus of the vaginal repair done for the collapsed anterior wall must be to strengthen this weakened side supports of the bladder at or near the ischial spines and just proximal to the peri-cervical ring.

The existence of a "central" defect is questioned, as it is difficult to pathogenically explain its occurrence.

The traction direction on the side supports of a patient with prolapse is from lateral to medial; this direction of pull must be reversed.

Exactly this is done with the vaginal para-vaginal side specific repair (VSSR) by tying the torn side supports back onto the white line - focusing on the area at or near the ishial spines - plus re-attaching the inferior border of the vesico-vaginal “septum” onto the peri-cervical ring. (Compare this approach with the classical repairs where the focus of the repair is centrally, increasing the tension on the already weakened sides).

As a bonus the weakened surrounding collagen can be strengthened by bolstering the repair with a remodelling biomesh. This will act thus as a "band-aid" to the primary surgery.The resultant strengthening of the repair will come from the ingrowth of new collagen.
Compare this with the use of meshes where it is used to act as a primary support for the bladder - a bridging effect.

The Anterior VSSR in steps:

The procedure is preferably done under a spinal anaesthesia. The use of a Lone Star is essential for proper dissection and is indispensiable:- the traction - counter traction thus provided ensure success of the sharp dissection.

Vaginal paravaginal repair slideshow
if you click on "view" above,one can have a full screen presentation

1. The vaginal wall is incised with a knife between two Kocher tissue forceps after a mixture of water and adrenaline is injected. The cervix is stabilised onto the Lone Star retractor with a single hook fixed on the internal side of the anterior cervical lip.

2. With sharp dissection the vaginal skin is peeled off from the underlying vesico-vaginal tissue. This dissection is done with the scissors in a push and spread way directing towards the para-vesical space, as superficial to the vaginal skin as possible.

The veins that are exposed are cauterised with a high power cuatery (60+) thus creating a “flame thrower” effect.

3. When the lateral borders of the dissection field reach the inferior border of the pubic rami, the attention is directed to the central attachment of the bladder and the cervix, between the bladder pillars. This attachment is loosened with sharp dissection in the midline in the same fashion as one does with a vaginal hysterectomy before entering into the vesico-uterine cul de sac. A Maxon O suture on a HGU-46 taper needle ( Tyco serial number 6455-61)is placed on the dissected anterior surface of the cervix and the suture -with the needle still attached- is pulled and anchored onto the Lone Star retractor, pulling the uterus inferiorly. The hook is removed from the endocervix.

4. As the dissection proceed under the inferior pubic rami, progress is made by gentley sweeping the bladder from the sidewall of the pelvis with the surgeons’ finger, thus displacing the ureter and bladder centrally. This sweeping movement is on the sidewall on the inner aspect of the obturator fascia, directing the movement from above to below. The dissection is directed towards the Ischial spines and, when reached, one usually encounters the paravaginal defect running from the spines upwards along the white line towards the Symphasis pubis. If no weakening of the lateral attachments of the vesico-vaginal septum, or a defect, is found, one can follow the attachment of the said septum along the inferior border of the white line from ischial spines to symphasis pubis.

5. Through the window created between the bladder pillar below and the pubo-urethral ligaments above, one can identify the lateral aspect of the bladder if a defect is present, or is created.

The presence of fat is confirmation of this - the vaginal wall does not have fat! On the inner aspect of the obturator fascia the white line can usually clearly be felt, running from the ischial spines below to the inner surface of the symphisis pubis.

6. With a Boudijk (or Navratil Breisky) retractor (preferably a narrow one) the bladder is pulled medially. This enables one to place the lateral stitches on the obturator fascia.

7. A 10 x 20 swab is put into the para-vaginal space and removed directly before the stitches are placed- this provides local pressure and controls any venous bleeding.

8. Stitch A and B: The first two stitches (Maxon O on a HGU-46 taper needle) are placed near the ischial spine and one centimetre above the spine on the white line.

9. The double needle holder technique make the placing easier: beginning on the left side of the patient first (if right handed; begin on the right side if left-handed), to enable one to swing the needle from top to bottom as it pierces the obturator fascia, with the Boudijk or Breisky retractor pulling the bladder pillars medially and downwards - thus protecting the bladder and pulling the ureters out of harm’s way.

This placing is best guided by first feeling with the index finger of the free hand where the Ischial spine is and then directing in a blind fashion the needle towards this point. With the first stitch in place, the second can be placed by pulling the suture to the contra lateral side at a 45% angle upwards or downwards. This depends on whether the first placed stitch is near enough to the ischail spine so that the second one can either be placed inferior or superior to the first one.

By pulling on the stitch one can also feel the white line as it comes under tension.
10. The third stitch (Stitch C) is placed halfway between the symphisis pubis and the top of the above two stitches on the obturator fascia.

The last stitch (Stitch D) is put through the Pubo-urethral ligament (PUL). Placing of this is easier if the needle is on the needle holder in a “cat’s claw” fashion.

For both these superficial placed stitches it is recommended to use an O delayed absorbable material (example monofilament polyglyconate) also on a HGU-46 taper needle- TYCO. The author prefers to use Maxon O (serial number 6455-61)

• After placing of the stitches a 10x20 swab is again placed into the para-vesicle space.
• The needle is not removed from the suture material, neither is a knot thrown. It is useful to clamp the different stitches with different types of forceps on the outside to enable one to differentiate the sutures once placed from each other.

11. The side specific repair is done with stitches A an B:
• After removal of the swab a Boudijk (or Breisky) retractor is placed on the bladder pillars, pulling it downwards and away from the sidewall. With controlled removal and suction on the tip of the retractor, one can identify the area where the septum and lateral bladder wall meets -in this edge the needle of first stitch A and then stitch B is hooked from lateral to medial. This is put not deeper than 0.5 mm as the ureter is about 1cm from the edge in the bladder pillar. (This manoeuvre is easier if one grab the septal edge with a small kocher and pull it downwards).

• Tying Stitch A first and then Stitch B before doing the other side make the procedure easier on the contra lateral side.

• If needed a lateral plication can be done: with a medial bite of either stitch A or B the bladder can be plicated in a lateral to medial direction, bringing the bladder base under more tension. This type of secondary stitching can also control bleeders.

Once these four stitches are tied, the high transverse defect becomes apparent:

this can now be closed by tying the inferior border of the septum down onto the cervix, or onto the utero-sacrals if a hysterectomy was done (the “site” specific part of the repair)

12. If needed or deemed necessary, the repair can be bolstered with a suitable
remodelling biomesh material in the following way:
• A 10x7 piece of mesh is prepared.

• The mesh is secured to the side wall and onto the PUL and cervix by using the previously placed stitches (A,B,C,D and the cervical stitch).

By not tying the central stitch -cervical- and stitch B -on both sides- one can plicate the mesh sideways and around the cervix- thus creating a cervical ring- with these as they are tied secondary. The author did this to strengthen the central area. This plication also pull the biomesh into tension, which will enhance the secondary collagen reaction.

initially the author used Ti-Cron for all sutures, but the Ti-Cron tends to erode through the vaginal skin, and in one instance into the bladder: this was replaced by the use of Maxon. The key to success of this procedure lies in the use of the Lone Star retractor, the use of the HGU-46 needle and the double needle holder technique of side wall suture placing.

13. A trans urethral catheter is placed and the vagina is tightly packed. Both the vaginal plug and the catheter are removed after 24 or 48 hours.

This technique was initiated by Richard Reid in 2006 and modified in Ziekenhuis Zeeuws Vlaanderen in Terneuzen ,The Netherlands. Regular hands-on workshops are conducted in Ziekenhuis Zeeuws Vlaanderen by the author.
We are greatfull for the support given to us by Dr Reid. His vision led to a new mindset in treating the patient with POP.

2007-07-03T01:15:00.001-07:00

Clinical teaching session at ZiekenHuis DeHonte Zeeuws Vlaanderen The Netherlands

2007-01-22T10:19:00.000-08:00

Adress: Wielingenlaan 2 - 4535PA TERNEUZEN - Netherlands - +31 115 688000

ZorgSaam Hospital, with 421 beds, reunions all common disciplines under one roof and collaborates very closely together with other specialized units within the country as well as with the neighbouring Belgium.

Ziekenhuis Zeeuws Vlaanderen has developed into a vibrant Vaginal Reconstructive surgical training centre where an international panel of visiting pelvic surgeons are at times permitted to demonstrate operative techniques. This program has grown into a valuable Regional Training Centre, where delegates can gain practical experience in an ongoing fashion the new ‘defect-specific’ methods of prolapse repair.

Dr. Nieuwoudt welcomes you for an interesting teaching day in his theatre. The theatre session is done on a 6 weekly basis and consist of a full day in theatre. The orevious afternoon a seminar will be held where different aspects of the surgery is highlighted with the assistance of DVD's.
Please note that, in order to assist Dr. Nieuwoudt a Hepatitis Vacination as well as an MRSA Swap Test not older then 10 days is mandatory.

The course is accredited for 12 CME points by the Dutch Society of Obstets and Gyneacology (NVOG).

Organisation:
• 4 Participants can assist per day.
• Please plan your travel arrangements so that you can present yourself at the hospital at 7:30 am. The Seminar starts at 13:00 on the previous day, if you want to attend that too.
dates for 2009 are:
22,23 January
5,6 March
16,17 April (fully booked)
28,29 May
9,10 July
3,4 September.
In case you need assistance in doing your travel arrangements please contact your local COOK representative.

Traveldetails:

• By plane:
Best is to fly into Brussels International or Charleroi or Antwerp. From there you can take a train or a rental car. Distance to Terneuzen is approx 100 km(Brussel) or 58km (Antwerp)
Please note that if you come from Manchester or London (City) it is possible to fly to Antwerpen, with resultant less traveling time: www.flyvlm.com
• By car: Upon arrival in Terneuzen please follow the signs leading to Ziekenhuis De Honte.
• By rail: Take the train to Gent Sint Pieters , and then continue with a taxi (ca. 40 min)
• Trains with direction to Gent are leaving every hour from international airport on the platform on level -1. Costs approx 20 €. From Charleroi you go to Brussels’ midi train station by bus and then to Gent Sint Pieters station.
• Arrival by Eurostar: You arrive at Brussels’ Midi (South,or Zuid) station. Take a national train to Gent Sint Pieters station: there is two trains that go, one is a Intercity (IC) that take about 27 minutes, the other is the milkrun, that take longer! Remember that your Eurostar ticket is good for travelling to any station in Belgium also!

Hotel:
Golden Tulip Hotel L’Escaut
Room rate € 130,00
e-mail:info@goldentulip-lescaut.nl
Internet: http://www.goldentulip-lescaut.nl/
Adresse: Scheldekade 65
4531 Terneuzen/NL
+31 115 694855

About Terneuzen

Terneuzen, a community in the south west of the Netherlands with approx 55.000 inhabitants owns the 3rd biggest harbour within the country and is the biggest community within the state of Zeeland. The 43km long Zeecanal Gent-Terneuzen connects the city with Gent in Belgium. Terneuzen prides itself for being the birthplace of the flying dutchman.

Welcome to Terneuzen and have an enriching training.

All funds derived from the workshops in Terneuzen is directed into the Hospital administration and used solely for the purpose of advancement of the service provided by the Pelvicfloor service at Ziekenhuis Zeeuws Vlaanderen

Important discoveries..and not so important ones!

2006-11-24T23:14:00.001-08:00

1794 May 8

Antoine Laurent Lavoisier is beheaded in the early days of the French Revolution. It was Lavoisier who had discovered oxygen.

It is said that he had told his friends that he would start blinking as the guillotine blade fell and they were to to see how long his eyes carried on blinked after his head was severed.............

The result was some 15 seconds!

IUGA 2007

2006-11-24T23:14:00.000-08:00

some people are wise, some are otherwise!

14 June 2007
Once again a year has passed since the last IUGA meeting (September 2006 in Athens). On the same basis as with the previous meetings the structure of IUGA 2007 in Cancun, Mexico consisted of pre-congress “workshops”- this time nearly 30- stretching over 2 half days, to be followed by two and a halfday of congress- the business part.

This meant that we had a choice: attend any 2 of the 30! As can be expected each “workshop” had a grand total of least plus minus 6 to 20 attendees- hardly a good feeding ground for the seminar form of these “workshops”.

As was the case last year I came to this meeting totally biased in what I do and how I tackle the problem of pelvic reconstructive surgery in the patient with prolapse:
The way I see it one has only a few alternatives: you plicate the hell out of the bulge, you try to find what went wrong and re-suture the damage or you loosen all attachments and hook a pre-made kit of synthetic material- or if you want to, with a kit with some or other biologic material- behind the bladder and hang it onto the bony pelvis. In the last case one feel like adding: “and starting to pray”!

At the pre-congress workshop THE NAMES preached his or her own preferences: this was from doing nothing, to using all kind of toys. The terms synthetic meshes and biological grafts were used loosely. At times one could predict with quite accuracy which industry sponsored whom. And once again THE LEADERS were not too shy to promote!

With this as the breeding ground it ended in a choice between plicating and tying synthetic meshes all over the pelvis - with one NAME from Australia telling us how dangerous the synthetic meshes are and how he is occupied to take them out: please rather plicate!

Nice progress from last year wouldn’t you say?

No wonder one of the LADIES asked : “should we not take the Marshall- Marchetties, and the Manchester procedures off the rack, and reintroduce them!”

In between, a lonely “workshop” banned to an across the street hotel tried to tell an audience of 10 mostly Spanish speaking attendees that the third alternative could be to not re-invent the wheel, but learn from the experiences of the general surgeons, and to follow the rules of the hernia principles.

To most the biological grafts were all the same and no mention is made of the biological grafts with remodeling capacity available that induce the body to heal itself. Why should that be?

I am also perplexed by the stated opinion that the one arm of any study of any new product must include plications- an operation that do not work, is based on the wrong assumption that the prolapsed is due to stretching ( or if you want a “central” defect), do harm to the patient’s vagina, and to use the words in an editorial “is on tenuous ethical grounds”! One elderly NAME explained to me that although the operation stated is unethically the American College ( RULERS?) expect that it must be included in studies! I would rather include a placebo do nothing “operation” or put a pessary in, than do an operation which I believe is unethical in the placebo arm!
Even worse: and it is expected that this is the operation that must be taught by us, the masters, to the uro-gyneacologists of the future.

Robert Frost said:
“I shall be telling this with a sigh, somewhere ages and ages hence: two roads diverged in the wood, and I – I took the one less travelled by. And that has made all the difference.”

Maybe that is the reason why I still am looking for reasons to believe THE NAMES.

Today the Congress really starts!

Friday, 15 June 2007: 18:00

With a bit of uneasiness I can look back now on two days of IUGA 2007 congress experience. To be honest is it extremely difficult to say that I gain by this experience. The advantage of having had the experience of IUGA 2005 and IUGA 2006 place one in the position of comparing them- and that is my problem.

Either the standards were too high in the previous congresses, or the previous congresses depleted the pool of Urogyneacological knowledge. In the last case one should think that we should meet less frequently that once a year. My wife keep on telling me that our subject consists of only a anterior wall, a posterior wall and the vaginal top! To my mind this cannot be true.

The answer must be the low standard one.

I attended meticulously all sessions available and ended up in the wrong rooms- somewhere else better material must be presented than the lot that I am listening to.

The “state of the art“ lectures lead basically nowhere- with the exclusion of tomorrow’s for I have not heard them yet!- , the industry driven symposiums were just that: industry driven, the meeting sessions came up with little bits of information – that is if you were lucky enough to find the place and topic on the confusing program-, and the video sessions were disasters. Most of the times technical support was poor.

This afternoon I was totally embarrassed by the early afternoon video session: the 2 of the 5 videos that were able to be shown made one thankful that the others could not be shown. I should think that someone somewhere in the corridors of power look at the videos beforehand and screen the quality. This either had not been done or there had been a shortfall of available material. The worse to me was that at the end of a nightmarish two hours the NAME sitting in front did not apologize to the attendees about this. In other words to us the message was: this is OK as far as IUGA is concerned. One of the attendees, I must admit though, did get a bit of comment out of one of them regarding the wrong message of one of the videos.

Suffice to say that I did not attend the later scheduled video session. I have a bad feeling about this for the video sessions always were the highlights of the previous IUGA sessions.

Even the memorial lecture by the past LEADER was clouded by the noise he made at the back of the lecture hall at the end of his oration in total disregard to the small people around him when a little man was trying to deliver his little presentation. Last year the history of urogyne went without mentioning of George White, this year it was the same.

I am serious if I say that if this is the quality I would seriously have to reassess my association with this association. It at times felt as if it was the Urogyneacological Society of Zimbabwe’s annual congress.
Come on: we can do better!

Please don’t get me wrong: all was not entirely negative. Most of the scientific presentations were of good to excellent quality, as were most of the posters. This were unfortunately on a plate that was difficult to digest. The composition of the program was impossible to understand. It was not possible to go from one meeting to another due to bad synchronization of talks and presentations, with the result that you stay with one meeting - ending up with this feeling of wanting to be else.

The ability to rub shoulders with peers in the corridors is always a good way of exchanging ideas. The most irritating part of these, as with all meetings, were that one talk to a NAME who keep on looking over your or his shoulder to see if someone more important than you are not passing by, that is if the NAME is not excusing himself for he is on his way to some or other bigger than you happening. Few realize their responsibility to their subject and peers: these are the only time that the small guy out of not-so-important-hospitals has to improve his/hers direct knowledge.

And I think maybe they can sometime learn from this little person’s experience.

Even more irritating is the maybe to be name that struggle to let himself/herself be seen or heard; they usually trailed the NAME and suck up to him.

These interactions between NAME, name and little person were at this meeting not different from other meetings.

Let my summarize my personal observations:
1. The organization of this IUGA meeting was terrible and not up to international (or third world country, for that matter: Zimbabwe could have done better) standard. The less said over this the better.
2. The venue was supposed to be in Mexico, but Cancun- although nice and beautiful- is not Mexico; it have the same touristy look and feel as any other tourist trap in the world. For us Africans visa requirements make traveling to these spots extremely difficult: me and my wife were nearly jailed on our way here in the US of A because of visas that were not right (this is a tale for another day).
3. The scientific papers were good, but one had a difficult time to find those that you want to attend- once again a organizational fault.
4. The state of the art speakers were bad.
5. To my mind did the main message of the future of pelvic organ reconstructive surgery not came through: there is biological support systems for the repair of the damaged pelvis that can help the body to heal itself. The message was rather: go back to the techniques of the past- although shown to be ineffective and dangerous, at least we know what we’ve got-, with a mixed (and to my mind at times dangerous) message over the use of synthetic meshes ( to satisfy the industries for where else will all the money come from to drive the congress).
6. The dominance of industry will always be a problem.
7. The ever present bad command of the English language by some speakers need to be addressed. This is getting in the way of communicating the messages, which I am certain are present.

And tonight is “Gala dinner” night and tomorrow the closing ceremony- I do not have to attend these to know that THE LEADERS and THE NAMES are going to tell each other how wonderful the Cancun experience had been. They who are here basically to do networking and leaving as soon as their bit are done and who do not see the need to sit through it all as we do; they know enough and we not.

Maybe if the BIG men listen the next one in Taiwan will be better, or shall we have the same? Ask me next year.

Mr NAME, mr LEADER; This little guy do not think that what you created here is the worth to leave his patients for a week and travel 11 hours at great expense to himself, just for this. You can do better, no, you need to do better.

Surgical Options in Vaginal Prolapsed Pelvic Organ Reconstruction

2006-11-24T23:13:00.000-08:00

The “classical” prolapse surgical techniques in common use in Europe, and elsewhere in the world, do not follow this ground rule. The main aim is to get rid of the bulge!

In this conquest, new anatomical structures are developed, present anatomical organs are mutilated, and new lines of pull directions are designed. Thus taking over a new godlike role! There was success in the conquest, but in others failures left the patient with a mutilated pelvis, with a resultant new attempt at rectifying the bulge with a repetition of the initial attack! Let us call this option POR option A.

To improve results tissue graph techniques were designed to supplement the defective area weakness, either from surrounding tissues (incorporating muscle for instance in areas where it normally are not found) or from distant body areas. These gave poor results with, once again, mutilation of the prolapsed area.

Keeping the above “do no harm” effect in mind and hoping to obtain at least the same results in reconstructing the damaged pelvis, a paradigm shift is to my mind necessary.

1. With the normal anatomy (and the functional anatomy) as a template the pelvic organ reconstruction surgeon can repair in the true sense of the word!

2. Knowing what the pathogenesis was in damaging the pelvis, especially with childbirth, will also support the resultant rectifying surgery.

3. Using proper surgical dissection techniques flow from this, with a resultant lesser risk for intra operative complications.

4. Adhering to the basic surgical principles of hernia surgery can diminish failure rates.

5. Do not use any technique that mutilate the pelvic organs, and remove redundant tissue, if really necessary, with care.

6. The use of graphs must be highly individualized.

Pointers in decision making can be age of the patient, the type of defect and the area in the pelvis where the tissue needs to be used.

A protocol for the type of pelvic reconstructive surgery is possible.

This pelvic organ reconstructive (POR) protocol will be dependant on the following options:

1. POR option B:

Site specific repair, the so-called vaginal paravaginal repair (VPVR), using only native tissue of the patient: repairing the damaged tissue directly.
A new approach is to augment or strengthen this with a Side Specific repair: the endopelvic fascia is sutured on both sides to the obturator fascia, following the ATFP as a guide.

2. POR option C:
Above is done and by using an overlay of a second generation Xenograph the tension is decreased on the tissue supporting the hernia repair

3. POR option D:

Using a synthetic graph to decrease tension on the tissue surrounding the hernia.

With this there is no PORoB done.

In the following of the options from PORo B thru PORoC to PORo D, the risk, especially long-term, may be increasing ( “do no harm effect!”), but with possibly a better long-term success rate.

The young patient can qualify for PORoB, or C, with the sexually inactive older lady, or possibly a patient with a faillure after previous surgery, for PORoD

With the necessary individualization based on above, the correct procedure can be done on the correct patient, with less harm to the patient, especially if the procedure did not give the optimal desired effect.

Only the future will give the answers.

extra reading

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We must dare to think 'unthinkable' thoughts. We must learn to explore all the options and possibilities that confront us in a complex and rapidly changing world. We must learn to welcome and not to fear the voices of dissent. We must dare to think about 'unthinkable things' because when things become unthinkable, thinking stops and action becomes mindless.
~ James William Fulbright

The Flagpole concept

2006-08-15T02:05:00.000-07:00

In putting my thoughts on repairing the prolapsed vagina and also taking into account the pros and cons of available options ( VPVR, VPVR with biomesh augmentation and VPVR with synthetic mesh augmentation) into perspective the concept of the flagpole came to mind.
This came from Richard Reid where he wants the support system of the vaginal top to be as solid as possible ( the flagpole), but the supports needed for the anterior wall as mobile as possible ( the flag).
This whole concept bring a combination of treatment options for the vaginal prolapse into being: the solid support of the vaginal top can be provided by the synthetic meshes ( post prolift fits nicely into this) and the mobility of the anterior wall can be gaurantied by the use of a biomesh augmentation ( SurgiSIS or SymphaSIS fits the label).

The slideshow will fill in the detailes:

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This concept are currently tested in Ziekenhuis Zeeuws Vlaanderen, Terneuzen, The Netherlands.

Any comments or thoughts are welcome.

Concepts of PelvicOrganReconstructive Surgery

2006-07-08T22:42:00.000-07:00

Whether to use a biomaterial:
Until very recently, gynaecologists had not kept pace with the concept of either bolstering a sutured repair or of bridging a fascial defect with mesh. However, the potential benefit of reinforcing pelvic floor defects using a biomaterial implant is self evident, particularly given the poor performance of ‘suture-only’ repair techniques. The advantages given by the biomeshes can put the pelvic organ reconstructive surgeon ahead of the pack - my prediction is that the general surgeons will not be long in realising that to correct the collagen deficit can form the basis of a scientific repair of the hernia.
The choice of the type of mesh or biomesh must greatly be influenced by the defective collagen structures surrounding the herniated vaginal wall: rectifying the “wrong” in the tissue defects must clearly include improving the collagen content of the surrounding tissues.

Winds of change are blowing, but not always in the right direction!
The trend began with laparoscopic mesh sacrocolpopexy, but has been greatly extended by heavy marketing of commercially available minimal access devices (“kits”). Current surgical practice in many pelvic floor clinics around the world now amounts to little more than implanting quite large sheets of polypropylene mesh, either with a laparoscope or with a trans-gluteal or trans-obturator needle device ─ despite a the lack of clinical safety data, and the absence of any compelling clinical evidence that the use of synthetic mesh improves either anatomic or functional outcome.
This paradigm shift has been fuelled largely by two arguments: the well recognized superiority of prosthetic hernioplasty over non-augmented suture repairs, and the stellar track record of “tension free” mid-urethral tapes. Nonetheless, it is surprising that there has been such a pronounced swing to an unproven method, particularly given the worrisome anecdotes of mesh misadventure, which now seem to abound.

It has been said that “the regional gynaecological clinics specialise in putting in these mesh buttresses, while tertiary referral units now specialise in the enormously difficult task of taking them out”.

The basis of the synthetic meshes’ success is dependent on the permanent presence of “supporting” material and the inflammatory reaction it gives, with resultant scar tissue formation- both reasons not to use it in the tissue layers surrounded by hollow viscus!
This alone is enough reason not to use synthetic meshes and to use second generation biomeshes.

How best to insert the biomaterial:
It is a long established surgical principle that placing alloplastic material in close approximation to a hollow viscus (bladder, rectum) is hazardous. Surgical prudence might also question the wisdom of having relatively inexperienced gynaecologists insert mesh into the pelvic sidewall with needle devices, when they have not been trained to dissect these areas at open surgery. Given the limited safety data relating to trans-gluteal or trans-obturator mesh insertion, there is justified concern that these ‘minimally invasive’ techniques may not be ‘minimally harmful’ ones!

The other question is whether to operate via the vaginal or the abdominal route. For the surgeon with advanced vaginal skills, exposure of the fascial defects and access to the retroperitoneal spaces is easily accomplished from below. The hernia can be corrected from the side of the herniation on the site of the herniation.
Despite the trend towards endoscopic surgery in recent years, there is also little justification for repairing prolapse via a laparoscopic approach.

The Need for Change in Treatment Strategies
The basis of traditional anterior and posterior “repairs” is to remove a central diamond of vaginal wall overlying the central bulge, and then plicate the medial “fascia” (which is, in reality, just the muscularis layer of the vagina). This process inevitably creates a central plate of non-specific scar tissue, which generally relieves symptoms and hides the bulge for a time.

From the biomechanical perspective, midline fascial plication makes no attempt to define or repair the true fascial defect. Rather, plicating the loose tissue towards the midline actually increases the strain on the un-repaired paravaginal defects, or if done with the VPVR, on the repaired defects[7]. Hence, it should surprise no-one that anatomic failure rates are high and that durability of symptomatic bulge control is unreliable.

Given the enormous economic costs of pelvic floor surgery, gynaecologists must come up with a more mechanically appropriate method of prolapse repair, or face cost controls from third party payers.

‘Suture-only’ vaginal paravaginal repair or uterosacral colpopexy repairs the true fascial defects, using connective tissue that is often beginning to weaken secondary to an acquired collagen defect. Results can be better than with plication-type repairs, but failure to address the collagen defect is an unremedied source of failure.

Augmentation materials, used in a tension-free manner, would thus appear to be as appropriate for prolapse repair as for hernia surgery. However, one should be wary of placing a permanent mesh and inducing inflammatory scarring in close proximity to a hollow viscus. Synthetic mesh that works well for TVT mid-urethral slings or abdominal sacrocolpopexies may be erosive and painful if placed in a more dynamic part of the vaginal wall.

The limitations of operating with surgical kits should also be kept in mind. Optimal paravaginal repair requires the ability to individualise (according to each patient’s defects and age) and to tension the suspensory hammock in all directions. Conversely, mesh placed with “surgical kits” has a limited range of adjustment, and can only be tensioned in a side-to-side direction.
Hence, bulge recurrence can occur above or below the transverse margins of the synthetic implants, or creating a phenomenon called a meshoma by Amid [8]; nonfixation, insufficient fixation, or insufficient dissection to make adequate room for the prosthesis can lead to folding and wrinkling of the mesh, a process that continues until the mesh is wadded up into a ball, causing pain or bulging on both sides of the ball.

In my own series of Prolift implants this happened with especially the anterior prolifts after 12 months. This shrinkage of polypropoline meshes can be as much as 30-50% of their original size as soon as after four weeks![9].

If tissue augmentation is needed, use of a remodelling second generation biomesh (SIS or InteXen) offers excellent repair strength and is virtually morbidity-free.

In summary, what can be achieved at surgery ranges from reliable anatomic restoration, to non-physiological distortion. Pelvic reconstructive surgery is presently undergoing a revolutionary change.

What course you take is up to you:
· You can either stay in the “comfort” of what you are doing with POP surgery or you can step into the future.
· You can treat the prolapsed vaginal wall as a bulge that is in need of camouflage, or you can visualise it as a herniation needing a ‘site-specific’ repair.
· You can try to strengthen this support defect use weakened, collagen-deficient tissue, or you can utilise an appropriate augmentation material.
· You can augment with synthetic mesh, applied with a “one-size-fits-all” surgical kit, or you can individualise your repair depending on the type of prolapsed and the patient’s age.
· You can implant synthetic meshes which can be morbid and difficult to remove, or you can essentially avoid such problems with modern tissue engineering technology.

Further reading:

1. Robinson Dudley, Anders Kate, Cardoso Linda, Bidmead John(2007). Outcome measures in urogynecology: The clinicians’perspective. Int Urologynecol J 18: 273-279
2. Pelusi G, busacchi P,demaria F and Rinaldi AM(1990).The use of the kelly plication for the prevention and treatment of genuine stress urinary incontinence in patients undergoing surgery for genital prolapse. Int Urogynecol J 1 196-199
3. Weber AM,Walters MD,Piedmonte MR. Ballard LA (2001). Anterior Colporrhaphy: a randomized trail of three surgical techniques.. Am J of Obstet 7 gynecol 185(6): 1299-1306.
4. H D E Atkinson, S G Nicol, S Purkayastha, and S Paterson-Brown,(2004) Surgical management of inguinal hernia: retrospective cohort study in southeastern Scotland, 1985-2001. BMJ. 2004 December 4; 329(7478): 1315–1316.
5. Raphael Rosch, Uwe Klinge, Zhongyi Si, Karsten Junge, Bernd Klosterhalfen and Volker Schumpelick .(2002) A role for the collagen I/III and MMP-1/-13 genes in primary inguinal hernia? BMC Medical Genetics 2002, 3:2
6. Lin et al, (2007). Changes in the extracellular matrix in the anterior vagina of women with or without prolapsed. Int Urogynecol J 18:43-48
7. Morse N,O’Dell KK,Howard AF, Baker SP, Aronson MP, Young SB (2007). Midline anterior repairs alone vs anterior repair plus vaginal paravaginal repair: a comparison of anatomic and quality of life outcomes. Int Urogynecol J (2007) 18:245-249.
8. Parviz K. Amid (2004). New Phenomenon Causing Chronic Pain After Prosthetic Repair of Abdominal Wall Hernias Arch Surg. 2004;139:1297-1298
9. Klinge U,Klosterhalfen B, Muller M ottinger AP, Schumpelick V.(1998)Shrinking of polypropylene mesh in vivo: an experimental study in dogs. Eur J Surg. 1998 Dec;164(12):965

edited by R Reid

Primum Non Nocere

2006-07-08T22:41:00.000-07:00

IUGA 2006: Athene 6-9 September 2006

If you attend a world congress you go with a few preset ideas: you would like to test your own quality of medical practise against that of your peers and if you pass that first hurdle, you would like to increase your knowledge.

This delegate had the following as the basis of his pre-congress perspectives as far as the reconstruction of the damaged female pelvis is concerned:
The primary basis of choosing an option for pelvic reconstructive surgery is that, whatever you do, you must do no harm.
What are these options? Using the hammer of vaginal surgery, one has four nails (options) to choose from:
Option A for getting rid of the bulge would be to plicate the “endo-pelvic fascia” . This is the classical method used since 1913 as advocated by Howard A Kelly.
Options B, C and D have as a basis a site specific approach. The difference being that in Option C a biomesh is put between the bladder and the vaginal skin, and in option D a synthetic mesh. The only synthetic mesh used by me is Prolift from Gynecare.
Options C and D can be seen as “ side specific” repairs.

In my daily practise plications is seen as an un-anatomical operation in which tissue are permanently damaged and scarred, with a proven high failure rate. If one has to re-operate on these, the patient will be at a distinct disadvantage. Option A is thus never done, not even in conjunction with the other options.

Option B is done only in the very young patient, and Option D is kept for the elderly women who is no longer sexually active , and who is not going to start with this activity in the foreseeable future.

The vast majority will fall under Option C. The only biomesh used by me is the second generation biomeshes, Surgisis or Symphasis, because of their distinct tissue engineering properties.

The damage in the pelvis is reconstructed with the normal anatomy as a guide.

Athens: IUGA 2006 - covering the bare essentials

IUGA 2006 in Athens consisted of different sub-settings :
1. Review sessions were the basis of the pre-congress workshops. These were summary sessions of the past, present and future of the subject matter.
2. Scientific and poster sessions in which studies were presented.
3. “State of the art” lectures by prominent figures in the field.
4. Seminars presented by industry on their different products.
5. Meetings of the societies and committees.

The most satisfaction to this delegate came from the pre-congress “ workshops" during which the opinions were unbiased and presented as reviews on different aspects. The state of the art lectures will also fall under this heading. The scientific meetings, although a necessity, gave me at times the feeling that I probably could have learned more if I attended the meeting next door.

The seminars where the industry backed their products were the most disappointing. Biased opinions were given by “big names” who were supposed to be unbiased. I really do not think that people in leading positions in our societies should participate as speakers on these forums. It degrade their positions and also their names.

A few catch phrases were created. The most rewarding were the statement by Mark Slack in which he referred to high and low volume surgeons in reference to results and complications of operations. Hispareunia also come to mind – meaning the pain and discomfort of the male during intercourse due to the presence of an eroded mesh in the vagina!

The scientific meetings and workshops, including the state of art lectures, had one common lesson: we do not know enough to introduce synthetic meshes into the vagina to re-enforce the walls. The good that it does is not proven and the harm it can do is unknown. More studies are needed. The moment you feel convinced that you should stay away from these new products, an industry driven session was on the agenda to highlight the advantages and safety of these products!

Sober messages were that new is not always better (the Boeing 747 from the 1970`s is still flying, the Concord not!)- Eureka experiences from Archimedian times did not always end in changes for good. One must stay critical before you change your present day practises.

Bad surgical results are due to three factors: the patient herself change with time, techniques differ from surgeon to surgeon, and even from procedure to procedure, and surgeons differ in acumen ( “low and high volume surgeons”- Mark Slack).
In a quest to improve results a drive is on towards reliance on graphs and use of different approaches (via the obturator fossa). These may make the surgeon more “competent”, but it may be at the cost of the patient!
Looking back on past experiences, it can take 10 to 15 years for a specific bad technique before it loses popularity! We need to self-regulate, else we will be regulated! (Chris Maher).
The situation does came to a point where someone even stated that there are two kinds of gynaecologists: one who put meshes in, and those who take it out: you choose which one you would like to be! (Sultan). This obviously is where one will end if meshes are being used indiscriminately.

In his talk about the past, present and future of urogynaecology, Mickey Karram gave an overview of the masters of the past. In the mirror image one realises that in the past new technologies were embraced indiscriminately and bad ones were stopped with extreme reluctance. Maybe it was because we did not talk about our failures and complications, or knowledge was poor as far as pathogenesis and anatomy were concerned. To his mind the future must depend on scientific credibility, ethical issues, training and certification before new techniques were integrated.

I must say that I came out of that lecture with a bid of confusion. A pointer to me was that he named Kelly without alluding to George R White: a typical sliding door of the past where the wrong direction was taken - a good example of embracing wrong techniques and reluctance to stop harmful practises! It is nice to control everyone with certifications etc, but down this road the individual’s inventiveness may be lost.

The war on the type of synthetic mesh is apparently over, the war on what type of biomesh to be used has begun. Interference of industry, with resultant clinging to types that is not good, clouded to my mind this congress. The crossed linked biomeshes is behaving like an allograph (Deprest) and this is enough reason not to use them. If the answer lies in the non-crossed linked ones with their new tissue engineering properties, time will tel. It looks promising though, and follows the golden rule of do no harm.

We are at this stage confronted with a lot of issues, but the biggest could be that we do not even know exactly what to call ourselves. Urogynaecology is not good enough - it was a way of including the bladder into the field of the gynaecologist. The expanding of the field into reconstructing the damaged pelvic organs included the anterior and posterior vaginal walls, and thus the bladder, vagina and the rectum. In fending off the urologists, plastic surgeons and general surgeons from our domain - the vagina - we need to do a lot of rethinking. Stress incontinence was a prominent issue in the life of the uro-gynaecologist of yesteryear, today it is only one of the functional defects of the damaged pelvis. Exit the prominence given to bladder function on the agendas of IUGA meetings of the past. In IUGA 2006 mention of rectal function and functional defects came to the fore, and in future meetings this will be given it’s rightful place. To my mind vaginal surgery as the prominent route of treatment of the damaged pelvis should have more prominence.

Unfortunately did the IUGA 2006 not help to clarify matters: it defined to me the problems, but there was not enough solutions. The influx of industry into deciding how we should treat the patient (as was seen during the rise of oestrogen therapy in the late 90´s) has arrived. This is deeply disturbing. We need them, but then as supporters of science and not as rulers of science.

If one practise with the motto of Primum Non Nocere (do no harm to the patient) we must be certain in which direction one should go with this.

To what extent did IUGA 2006 influence my practise? In general probably not a lot. Knowing that one at times sees and hears only what you want to see and hear, I must admit that support for my chosen direction did come through.

Pelvic Reconstruction Workshop: Terneuzen 12/13 September 2006

2006-07-08T01:49:00.000-07:00

12 and 13 September 2006: Live demonstration of Vaginal Paravaginal Repair by Dr Richard Reid in Terneuzen , The Netherlands :

With the sudden influx into pelvic organ reconstructive surgical techniques of different meshes and different techniques of repairing the damaged pelvis, one needs to stay objective.

The revolution of pelvic organ reconstruction is based on:

1. The best access to the damaged pelvis is via the vaginal route

2.Solid knowledge of pelvic functional anatomy , knowledge of the pathogenesis of the processes that lead to the damaging of the pelvic organ support systems and precise surgical techniques form the mainstay of any pelvic reconstructive surgery

3. The use of any implant material must be highly individualized, with the "do no harm" principle given a high priority. Special knowledge of tissue engineered products (TEP's) is esssential in deciding on specific materials.

4. The primary consern of the pelvic reconstruction surgeon is repairing the damaged pelvis in a site specific way, and not only treating the prolapsed organ.

Following the IUGA congress in Athens, dr Reid stopped on his way to the USA in Terneuzen on the 12th and 13th September 2006.
During the 13 th a full day session in theatre was conducted with CC TV live coverage. Attendees was able to communicate with him while he operate on 2 patients.

Anterior and posterior vaginal wall reconstructions ( with the techniques as discussed at the recent seminar in London) was done on both.

It was a pleasure to welcome gynaecologists from Great Brittain, Belgium, Germany, South Africa and the Neterlands to Terneuzen, Zeeuws Vlaanderen and the Netherlands.

The Programme was:
Venue: Hotel L'Escaut Terneuzen
12 september 2006:

14:00 to 17:00: The place of Vaginal Paravaginal Repair in Pelvic Reconstructive surgery: an interactive discussion and video demonstrations.

Introduction: Hospital Director

Perspectives on Vaginal PelvicOrganReconstructive Surgery :Andri Nieuwoudt
The patogenesis of Pelvic Organ Prolapse: Richard Reid
The effect of childbirth on the Pelvic Support Anatomy :Charles Reyneke

The science governing hernia repair and the use of biomaterials : Richard Reid
Repairing the anterior compartment: Richard Reid
Repairing the posterior compartment and perineum: Richard Reid

18:00: Dinner

13 september 2006: venue: Ziekenhuis Zeeuws Vlaanderen; Locatie De Honte

08:00 to 10:00 : Case reports of the patients that are due to be operated on: techniques of pre-operative assesments and pre-and postoperative care.

10:00 to 17:00 : Live theatre sessions with a lunch break.

17:00 Closing remarks.

The meeting was made possible due to the support and sponsorship of Stichting Zorgsaam and the directors of Ziekenhuis Zeeuws Vlaanderen.

Cook sponsored induviduals to attend and also the dinner.

Due to the enthusiasm of the deligates and especially dr Reid this meetings was a success. The central location of Terneuzen in Europe made the venue a good choice. Emphasis in the future is going to be vaginal surgery and the repair of the damaged pelvic organs in the young patient.

See you all back in Terneuzen on the 4 of July 2007.

A summary of the procedings will be posted in the foreseeable future.

Accomodation: Hotel L'Escaut

The Route to Terneuzen:

where is Terneuzen?

By Car:

Routes to Ziekenhuis Zeeuws Vlaanderen, Location De Honte:

Route description in English

Route Im Deutch

Arriving by AIR:

The nearest airport is Brussel International Airport at Saventum, Brussels (85km).

Schiphol airport, Amsterdam, is 200 km away (two and a half hour by road or public transport) I would advise against the use of this airport: too busy and too long traveling time to Terneuzen.

It is thus advised that if you arrive by air to use Brussel Int Airport , or Brussel South Int Airport at Charleroi ( Ryanair)

From Charleroi to Brussel Midi (South or Zuid) station look here

At Brussel international Airport you can get a taxi to Terneuzen: cost will be about 100 euro or 75 pounds, one way.

A better and quicker alternative is to go by train to Gent Sint Pieters station ( 1 hour, direct), and take a taxi from there to Terneuzen.

Look here for the train schedules in Belgium: Belgium train schedules

( type in "Bruxelles-Int-Airport"and "Gent-Sint-Pieters")

Brussel airport train station

Arrival by Eurostar:

You arrive at Brussel Midi (South,or Zuid) station. Take a national train to Gent Sint Pieters station: there is two trains that go, one is a Intercity (IC) that take about 27 minutes, the other is the milkrun, that take longer!

Remember that your Eurostar ticket is good for traveling to any station in Belgium also!

Look here for the train schedules in Belgium: Belgium train schedules

( type in " Bruxelles-Midi" and "Gent-Sint-Pieters")

VPVR in Pictures

2006-07-05T01:01:00.000-07:00

Congress news

2006-05-11T00:03:00.000-07:00

Dates to Diarize: 25- 28 June 2007: next WIPS in London(after this seminar a vaginal surgical workshop on the 4, 5th July 2007 will be held in Terneuzen, The Netherlands)

London : 2-5 June2006 :
Workshop in Advanced Vaginal Pelvic Reconstructive Surgery

“Behold the turtle. He makes progress only when he sticks his neck out.”
~ James Bryant Conant

In the attendance of 72 gynaecologists from Great Brittian, The Netherlands, Germany and Italy a very successful workshop was held under the guidance of Dr Richard Reid, Proff Carl Zimmermann and S.Robert Kovack.

Over a four day period Pelvic Reconstructive Surgery came under the spotlight as never before in Europe. A full day session was done on the anatomical considerations necessary for successful vaginal surgery, followed by sessions on the pathogenesis of structural damage to the female pelvis, especially with a focus on the birthing process. With this as a backdrop the surgical techniques as applied to pelvic floor damage reparation was discussed in detail.
For two days delegates was treated to videos and interactive discussions on different techniques as applied to pelvic organ prolaps restoration, with native tissue repair as primary requirement and the judicious use of especially biomesh materials to support tissue repair.

The main take home message for this delicate is that

1. Pelvic floor surgery as been taught by my teachers, and their teachers, did not follow the basic principles of anatomic damage repair: pelvic organ mutilation techniques to repair the damaged pelvic floor were done and taught by them re-inventing the female anatomy! The main focus of taught techniques are based on “ treating the bulge”: it is ignoring the underlying problem that leads to the prolaps and focus only on rectifying the prolaps. Treating only symptoms and not the pathology thus.

2. The first commandment of pelvic organ prolaps should be based on a solid knowledge of pelvic organ support system anatomy, recognition of the forces present in damaging the pelvic organ supports, especially during childbirth, and the techniques necessary to repair these supports by restoring the normal anatomy. Any operation done for restoration of pelvic organ prolaps should be guided by this simple principle.

3. The preferred route of Pelvic floor surgery is the vaginal route.

4. The high failure rate in the surgical techniques using only host tissue, especially if the tissue is being put under tension, can only being prevented if one keep the repaired area tension free, and if necessary one need to bridge tissue with graft tissue. Using the hernia repair principles as laid down by our surgical colleagues is paramount to our surgery’s outcome prediction.

5. If a graft are necessary the “do no harm” principle is paramount. In following this one will rarely need to use synthetic meshes. Synthetic meshes as being used in hernia repairs are being put into gaps that are between non dynamic spaces. In the pelvis the gaps are between dynamic hollow organs and the long-term risk of damage to the bladder, vagina and rectum is not known, especially if the time index is 10 years or more. In following the “do no harm” principle one need to individualize, keeping in mind the tissue engineering advantages provided by the second generation biomeshes, and the area into which one need to put the mesh support.

Dr Reid will visit Terneuzen on 12 and 13 September 2006: live demonstrations of two operations will be done. Demonstrations of VPVR and use of Biomesh, plus injection of bulking agent as a support for rectal sphincter repair will be done. Any interested parties can contact the webmaster for full detailes.
email

where is Terneuzen?

An abstract of one of the talks at the Seminar:

HERNIA PRINCIPLES: WHAT GENERAL SURGEONS CAN TEACH US ABOUT PROLAPSE REPAIR

The Hernia Hypothesis
Gynaecologists are beginning to articulate that prolapse is a form of hernia. I want to explore the implications of that possibility in a little more detail.

Hernia is the protrusion of an internal organ (usually small bowel) through the muscular wall of the body cavity, usually occurring at a site of natural weakness.

The pathogenesis of hernia has two components.
A mechanical event: namely, a ‘site-specific’ tear in the transversalis fascia, and

A metabolic event: namely, secondary (acquired) degenerative weakness in the connective tissue adjacent to the initial tear. Such degeneration in collagen quality inevitably occurs when ligaments not involved in continuous remodelling under the influence of body forces.

Likewise, prolapse is the protrusion of an organ (uterus, bladder or bowel) through the vaginal fibromuscularis, usually at a site of childbirth injury. It is also has mechanical and metabolic components.
The mechanical event is a group of ‘site-specific’ tears in the endopelvic fascia, and
The metabolic is an acquired collagen weakness in the endopelvic fascia. Connective tissue that is not exposed to the continuing remodelling forces (as occurs in a functioning suspensory hammock) display abnormal levels of lytic protease enzymes. Collagen turnover, as indicated by matrix metalloproteinase (MMP) activity is up to four times higher in prolapse tissue (Jackson et al. Lancet 1996.347:1658-61. Moali et al. Obstet Gynecol. 2005. 106 :953-63. Phillips et al. BJOG. 2006. 113: 39-46).

General surgeons have been able to reduce the failure rate for inguinal hernia to about 2%. The main vehicle of this success has been an adherence to a group of rules called the “Hernia Principles”.

We postulate then that these same “Hernia Principles” will help gynaecologists to improve prolapse repair outcomes.

The History of Hernia & Prolapse Surgery

1. Ancient Times:
As long ago as 400 BC, hernia and prolapse were well described, notably by Hippocrates in ancient Greece and Celsus in ancient Rome. However, the pathogenesis was not understood, and nobody envisaged an effective surgical cure for either problem. Physicians had nothing but ineffective medical and occasional primitive operations for the next 1800 years, from the time of Hippocrates to the beginning of Elizabeth I’s reign. Such as the cast iron girdle excavated from an archaeological site at Llandough in Wales. In this same era, women with prolapse were managed by being suspended upside down or by wearing a half pomegranate in the vagina as a pessary. Pessaries were later made from gold & silver, then from rubber.

Basically, nothing much changed until the end of the Dark Ages.

2. The Herniology Era:
The second era began during the Renaissance of the 16th and 17th centuries, when interest in hernia revived and some isolated (but notable) advances were made.
The first step on the road to modern hernia surgery was taken in 1559 by a Balkan surgeon called Kasper Stromagyi, who successfully treated a strangulated hernia by incising the skin, ligating the hernia sac at the external ring and then sacrificing the testicle. The wound healed by secondary intension and the patient survived.
140 years later, a German surgeon called Purman treated a second strangulated hernia by similar low ligation of the sac of the external ring. However, Purman spared the testicle, rather than sacrificing it.

These two insights led to sporadic attempts to manage hernia by various attempts to cicatrize the roof of the inguinal canal, typically by burning the aponeurosis of the external oblique with either acid or with hot cautery. As one would expect, the results were absolutely miserable.
The most important advance in the concept of thickening the fascia overlying the hernia bulge came in the mid Victorian era, when another German surgeon called Vinzenz von Czerny treated hernia by suture reinforcement of the roof of the inguinal canal (without having to incise the external oblique aponeurosis and enter the canal itself).

Thus the surgical technique of plication was born and flourished amongst hernia surgeons for a decade or so. However it was abandoned about 10 years later, because general surgeons found that plication had something like a 90% recurrence and 7% septic mortality rate.

By comparison, the concept of plicating the cystocoele was conceived of by Sims just after the American Civil War; however, very little actual treatment of prolapse occurred until a publication by Howard Kelly from Johns Hopkins in the early 1900’s.

Looking at the timelines, it is disappointing that gynaecologists embraced plication of prolapse a quarter of a century after general surgeons had abandoned the technique as being a palliative (not a curative) operation.

Although known to be unreliable, many gynaecologists had kept right on plicating and seem undaunted by the non-curative nature of this surgery.

3. The Era of Anatomic Discovery:
The third era of hernia surgery was driven by the anatomic discoveries of the 18th and 19th centuries. In 1804, Astley Cooper reported that hernia arose secondary to a tearing of the transversalis fascia. Cooper further showed that there were two sites of tearing.
Firstly, there were intrinsic tears within the main body of the transversalis fascia, and
Secondly, the entire fascia transversalis was often avulsed from its normal skeletal attachment to the inguinal ligament and suprapubic ramus.
The net effect of these tears was to disrupt the floor of the inguinal canal.

In this regard, hernia is obviously analogous to prolapse ─ which also has tears within the intrinsic fascia and avulsions from the arcus tendineus in the pelvic sidewall.
Following Cooper’s discovery that tears in fascia transversalis disrupted the floor of the inguinal canal, surgeons now had a valid understanding of the mechanical factors underlying hernia formation. However, they were unable to exploit this knowledge, because any attempt to enter the inguinal canal was beset with surgical misadventure.
Gynaecologists, however, made no progress during this era.

4. The Era of Suture Repair under Tension:
The fourth era of hernia surgery began in 1887, when Geordio Bassini described how ‘site-specific’ tears in investing fascia could be identified and repaired. Bassini’s essential principle was to suture the conjoint tendon and transversalis fascia under tension to the inguinal ligament. Modern hernia surgery had now begun.

Looking at the timelines, hernia surgeons now understood the mechanical aspects of hernia pathogenesis, and had developed a curative operation (with an operative success rate of about 65%). Hernia repair by suturing native tissues under tension held sway for 100 years, from 1887 to the mid 1980s. That is to say, from the time of the steam locomotive to the time of the Voyager space shuttle. During this time, about 70 technique variations on Bassini’s original were described, and operative success rate slowly rose to about 90%.

By comparison, the concept of doing a ‘‘site-specific’’ fascial repair to the avulsed endopelvic fascia as a means of obtaining lasting prolapse repair had been described in the early 1909 by George White. However, gynaecologists were misled by Howard Kelly from Johns Hopkins, into accepting both an erroneous theory and an ineffective treatment for cystocoele and rectocoele. It is disappointing that Kelly’s error occurred some 25 years after surgeons had abandoned palliative plication in favour of a curative repair of the fascia transversalis.

Anterior and posterior vaginal colporrhaphy began on a large scale in the 1920’s, when surgeons like Victor Bonney and Wilfred Shaw returned from World War I.

Richardson re-introduction a mechanically analogous operation for prolapse repair in 1976.

Beginning in the 1990's ,the concept of paravaginal repair is now become widely accepted in North America.

In contrast, European and UK gynaecologists have broadly speaking not embraced Richardson’s concept of paravaginal repair. While there is still a dearth of comparative studies, it is hoped that analogy to the experience gleaned from hernia repair will spur more thought on this issue.

5. The Era of Tension-Free Repair with Mesh:
The era of tension-free mesh repair began with a report by Lichtenstein and Amid in 1984. Nylon darning techniques had been used for recurrent hernias since World War II; this progressed to the use of a patch of woven synthetic mesh by the 1960s. However, the jump to using a mesh overlay for primary hernia was a serendipitous one, when surgeons at a Los Angeles hernia clinic discovered that an open mesh onlay technique greatly reduced postoperative pain (that was mainly due to suture line tension), thereby speeding up the return to normal activity. Surprisingly, this simple and rapid mesh repair method broke through a previously irreducible recurrence barrier, failure rate falling from 10% for ‘suture-only’ operations to <2%>% for tension-free mesh repairs. The reason for these superb results was that using mesh covered both the initial fascial defect and reinforced any weak adjacent tissue. The Lichtenstein open mesh procedure rapidly became the world-wide gold standard.

Looking at the timelines, by 1984, general surgeons had developed an operative technique that resolved both the mechanical and metabolic components of hernia pathogenesis.
By comparison, most gynaecologists were still following Kelly’s erroneous theories on pathogenesis, and were still treating cystocoele and rectocoele by the palliative plication method described by von Czerny in 1877. That is to say, gynaecologists still misunderstood the true mechanical lesion, and remained generally unaware of the secondary metabolic factors that fuel the failure of suture-only prolapse repair.

In car racing terms, prolapse surgeons were now two laps behind!

Some ground was made up in 1982, when Cullen Richardson re-introduced paravaginal repair. However, Richardson’s operation was only a robust Bassini-type tensioned suture repair using native tissue. His advocacy of paravaginal repair (as an alternative to plication) was the equivalent to Bassini’s innovations in 1887. Contemporaneously with Richardson’s pioneering insight, general surgeons were quickly abandoning suture-only repairs, in favour of the Lichtenstein prosthetic hernioplasty.

In other words, gynaecologists following Richardson’s lead were now only one lap behind.

To put this another way, general surgeons have been doing tension-free mesh repairs since the time of Ronald Reagan; gynaecologists began tentatively looking at using mesh in prolapse repair in the years spanning George W. Bush’s first term to his second term.

This timeline also shows a 12 to 15 year lag period in gynaecologists beginning to explore tension-free mesh repairs, despite the fact that general surgeons abandoned repair hernias by native tissue brought down under tension.. They also gave up external oblique aponeurosis plication more than 125years ago. Unlike hernia, the principles governing rational tension-free repair of prolapse have not yet been worked out or agreed upon.

6. The Era of Laparoscopic Hernia Repair:
About a decade after the Lichtenstein open mesh repair was introduced, surgeons began approaching hernias through the laparoscope. The initial method, which was an intraperitoneal onlay of mesh, violated the “Hernia Principles” as they had been discovered to that point, and had an unduly high failure rate. However, this error was soon rectified, and there are now two endoscopic methods which do satisfy the “Hernia Principles”. One is called transabdominal pre-peritoneal (TAPP) and the other is a totally extra-peritoneal (TEP) repair. Several randomized controlled trials have shown that the open and endoscopic procedures are comparable. Laparoscopic methods have a slightly higher recurrence rate and are somewhat more expensive, for the benefit of about one day earlier return to full activity.

By either technique, general surgeons have brought failure rates down to about 2% for primary hernia and perhaps 5% for recurrent hernia. Relative to prolapse, endoscopy has certainly helped gynaecologists to visualize the existence and location of the little understood ‘site-specific’ defects on the pelvic sidewall. However, durability of laparoscopic paravaginal repair probably falls short of an open APVR.

The Hernia Principles

Let us now look at the Hernia Principles – what they are and how they developed over the 135 years in which surgeons have operated electively.

In the pre- Listerian era, doing elective surgery on non-incarcerated hernias was basically too painful without anaesthesia and too risky in the days before Lister.

The first of these obstacles was resolved by the introduction of anaesthesia in the mid 1840s.
Wells and Morton were two Boston dentists. Wells had used nitrous oxide and Morton used ether. Morton gave the first anaesthesia in Massachusetts General Hospital in 1846.
A year later, J Y Simpson and John Snow (who is ‘the father of epidemiology’ and the person who solved many of the mysteries surrounding cholera), began using anaesthesia in the United Kingdom.

Despite the quite rapid spread of anaesthetic techniques, surgery was basically reserved for emergencies such as amputations, strangulated hernias or obstetric problems. In the pre-antibiotic era, fear of sepsis precluded elective surgery, as illustrated by the fact that there were only 333 operations at Massachusetts General Hospital in the 20 years proceeding the years of general anaesthesia.

Despite the success of anaesthesia, the problem of sepsis remained unresolved. Post operative septic mortality was about 50%, basically because the only hernias that were operated on were those that were strangulated, thus presenting a contaminating field.

The second of these obstacles was resolved by the introduction of antiseptic surgery in the 1870s. Pasteur’s discovery of microbes rationalized medical understanding of sepsis, and Joseph Lister’s invention of an aerosolizing carbolic acid spray that covered the operative field with a fine antiseptic mist dramatically reduced infection rates. With the combination of anaesthesia and antisepsis, the modern era of elective surgery was born. Hernia was one of the first targets of Victorian surgeons. In contrast, prolapse surgery remained a rarity.

First Principle: Avoid Wound Infection.
Over the years, hernia surgery had been dogged by infection, arising initially because operation was usually reserved for incarcerated cases, meaning that surgery was often done in a contaminated field. Even in elective cases, despite the value of carbolic acid spray (and later of aseptic technique), opening the inguinal canal seemed to be a very infection prone operation before antibiotics. In response, the first of the ‘Hernia Principles’ concentrated on how to minimize infection risk through optimal tissue handling.
Important strategies were:
gentle sharp dissection,
use of fine suture,
no mass pedicle ligation and
the strict avoidance of haematoma or seroma.

Subsequent generations of surgeons have learned much of their dissection techniques from hernia repair.

By comparison, many gynaecologists doing prolapse repair are still guilty of blunt dissection with rough tissue handling, mass pedicle ligation, often secured with coarse suture and casual haemostasis with undue reliance on packing. All of this favours microbial colonization of the healed wound and a consequent reduction in the strength in the final repair.

Second Principle: Protect Repair from Intra-abdominal Pressure.
The second principle, which also evolved during the pre-Listerian era, came from the knowledge that the hernia repair had to be protected from intra-abdominal forces. In the pre Victorian era, this was approached by ligating the hernial sac at the external ring.
Later, Bassini and others evolved more secure techniques that involved:
ligating the sac at the internal ring.
narrowing the internal and/or external rings, and
perhaps sacrificing the testicle.

In prolapse surgery, the gynaecological equivalent of this second hernia principle is that we also ligate enterocoele sacs (although perhaps with mesh use, this might not be necessary). Other examples of shielding prolapse repair from abdominal forces are:
uterosacral ligament plication and cul de sac obliteration,
combining prolapse repair with hysterectomy or even colpocleisis,
re-establishing a “hockey stick” vaginal axis, and
narrowing a widened urogenital hiatus.

Third Principle: Repair Tears in Investing Fascia.
Following the work of Bassini, the evolving “Hernia Principles” were extended to include the concept that it is mandatory to repair any mechanical tear in the transversalis fascia. This invariably led to suture line tension. Why is tension such a problem in the Bassini repair? The reason is that it sews together structures that do not normally approximate (ie, the conjoint tendon & fascia transversalis are sewn to the inguinal/Cooper’s ligaments). In consequence, there is pronounced postoperative pain, blood supply is often poor and the approximated structures can pull apart before healing is complete. Hence, the third principle dealt with how to effectively repair the torn investing fascia without exacerbating these healing problems.

Dictates of this principle are that:
the surgeon must sew identical tissue within the same layer,
using interrupted stitches of permanent suture,
without undue suture line tension in any direction.

Basically, placing any kind of suture line in the pelvic fascia produces wound tension regardless of how well the operation is done. However, in doing suture-only repairs, the surgeon must limit the amount of tension created. It is only since the availability of the mesh, 100 years after Bassini’s tensioned repair, that surgeons can avoid wound tension entirely.

The gynaecologic equivalent of the third “Hernia Principle” is the repair of ‘‘site-specific’’ tears within the endopelvic fascia. For example, a high transverse defect, where the pubocervical fascia has separated from the pericervical ring. Obviously, pulling together ill defined “white stuff”, under tension, and constricting the vaginal canal violates these principles. This is an issue that gynaecology as a profession must address.

Fourth Principle: Re-anchor Back onto Skeleton.
The fourth “Hernia Principle” is another legacy of the Bassini’s landmark advances. In addition to repairing the tears within fascia transversalis, Bassini also bolstered the defect by stitching a ‘triple layer’ (which included fascia transversalis) back onto the inguinal ligament. Subsequent surgeons have sometimes used Cooper’s ligament instead of inguinal ligament. No true agreement exists. Both are still used today. By and large the issue has been largely by-passed by the coming of the tension-free prosthetic hernioplasty era.

Gynaecologic equivalents of the fourth principle in prolapse repair are:
Sewing an avulsed lateral margin of pubocervical or rectovaginal fascia back onto the parietal fascia of obturator internus or levator ani muscle. That is to say, repair of a paravaginal defect is really an adherence to the fourth principle, and repair of a superior defect is really an adherence to the third principle.

Likewise, any some form of colpopexy that re-anchors the vaginal vault back onto the uterosacral ligaments, the sacrospinous ligaments or the sacral promontory is another example of Bassini’s fourth “Hernia Principle”.

Obviously, when a gynaecologist purports to “getting good tissue out laterally”, he is not satisfying this hernia repair principle.

Fifth Principle: Tension- Free Mesh Repair.
The fifth “Hernia Principle” evolved in more recent times, following the introduction of tension-free mesh repair. Recurrence rate of Bassini’s original repair was about 35%; a variety of technique modifications in the first half of the 20th century reduced this failure rate to about 10%. This 10% failure proved an impenetrable barrier, irrespective of surgical skill or precise technique. That is, of course, because the fascial edges being sewn together have a metabolic weakness in their collagen composition, for which some kind of tissue augmentation is the only possible remedy.

The use of mesh in tension-free hernia repairs is now quite well defined:

The mesh must suit the surgical site and the adjacent tissues. In groin hernia, most surgeons prefer low weight, macroporous, monofilament, polypropylene meshes. That is to say, an Amid type 1 mesh.

The mesh must be anchored with interrupted monofilament (not braided) sutures, to prevent subsequent inflammatory reaction from wrinkling the implant into a troublesome mass.

The mesh must also suit the surgical objectives. Is the surgeon trying to reinforce a lateral strut (in which case his repair will only face static forces), or is he trying to bridge a gap between two struts (in which case his repair will be subjected to dynamic forces).

Is the mesh protected from contact with any nearby hollow viscus?

Finally, modern surgeons have learnt that the mesh must be shaped to be tension-free when the patient is ambulatory, not just when they are lying prone on the theatre table.

Broadly speaking, this involves keeping the mesh loose (to allow for subsequent contracture), and creating a slight bowl-like curvature within the mesh.

In prolapse, the concept of tension-free mesh repair appears to be equally valid, and I have no doubts personally that it will one day become the norm. However, the principles of mesh use in prolapse are still evolving. I would point out that “the vagina is not the abdomen”, and we cannot ignore these obvious differences.

Abdominal hernias occur in robust collagenous fascia, that lies deep beneath three layers of striated muscle. Moreover, the hernia site is separated from the hollow viscera by the peritoneal membrane and pre-peritoneal fat.

Conversely, prolapse represents a tear in fragile fibrovascular areola tissue, covered only by a thin layer of mucous membrane and lying in close proximity to a hollow viscus. Obviously, vaginal tissues will not tolerate the kind of abrasive tissues reaction that is relatively harmless in the groin.

While there is much debate to be had yet, it is broadly speaking my opinion that biodegradable meshes with remodelling properties are probably preferable to permanent implants.

writen by Dr Richard Reid, Eastpoint Towers,Suite 607, 180 Oceanst, Double Bay, NSW 2028, Australia.

What is the Surgical Options:

2005-11-09T04:22:00.000-08:00

In the surgical repair of the damaged pelvis a few ground rules apply:
the most important of these is surely that no further damage must be done, especially if the surgical results are suboptimal - the so-called “ do no harm” effect.

The “standard” prolapse surgical techniques in common use in Europe, and elsewhere in the world, did not follow this ground rule. The main aim was to get rid of the bulge!
In this conquest, new anatomical structures were developed, present anatomical organs were mutilated, and new lines of pull directions were designed , taking over a new godlike role!
There was success in the conquest, but in others failures left the patient with a mutilated pelvis, with a resultant new attempt at rectifying the bulge with a repetition of the initial attack!
Tissue graph techniques were designed to supplement the defective area weakness, either from surrounding tissues ( incorporating muscle for instance in areas where it normally are not found) or from distant body areas. These gave poor results with , once again, mutilation of the prolapsed area.

Keeping the above “do no harm” effect in mind and hoping to obtain at least the same results in reconstructing the damaged pelvis, a paradigm shift is to my mind necessary.
Based on a solid knowledge of the anatomy of the pelvis, especially keeping in mind the functional anatomy, the pelvic reconstruction surgeon should be able to understand the damage present in the pelvis. Knowing what the pathogenesis were in damaging the pelvis, especially with childbirth, will also support the resultant rectifying surgery. Using proper surgical dissection techniques flow from this, with a resultant lesser risk for intra operative complications. Adhering to the basic surgical principles of hernia surgery will diminish failure rates. Do not use any technique that mutilate the pelvic organs, and remove redundant tissue, if really necessary, with care. The use of graphs must be highly individualized.
Pointers in decision making can be age of the patient, the type of defect and the area in the pelvis where the tissue needs to be used.

A protocol for the type of pelvic reconstructive surgery is possible. This pelvic organ reconstructive (POR) protocol will be dependant on the following options:

1. POR option A:
Site specific repair, the so-called vaginal paravaginal repair (VPVR), using only native tissue of the patient: repairing the damaged tissue directly.

2. POR option B:
Using of a second generation Xenograph to decrease the tension on the tissue surrounding the hernia.

3. POR option C:
Using a synthetic graph to decrease tension on the tissue surrounding the hernia.

In the folowing of the options from PORo A thru PORoB to PORo C, the risk, especially long-term, may be increasing ( “do no harm effect!”), but with possibly a better long-term success rate.

With the necessary individualisation based on above, the correct procedure can be done on the correct patient, with less harm to the patient, especially if the procedure did not give the optimal desired effect.

Only the future will give the answers.

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