The mss of the meshes- is there a way forward?

The debate on the pro’s and cons of synthetic implants in the resent press needs to be look at in the right context. One can only make sense out of the perfect storm if you realize a few facts:

1. The prolapsed vaginal wall is a symptom of an underlying disease. In itself is it not a diagnosis. Treatment should be directed at the disease and not the symptom.

2. “ All cystocoels are not the same” – patients needs to be clustered in groups that can be compared with one another. The different defects in the vaginal wall support system must be identified and surgical procedures for each need to be compared accordingly. The same apply to tissue reaction of different age groups- to compare a 29 year olds’ response to surgery with that of an eighty year old is impossible.

3. Due to different factors uniquely to pelvic surgery (e.g. poor tissue quality, intra-abdominal pressure effects on suture lines, absent tissue, scar tissue formation, etc.) one needs to realize that not all pathology will be able to be corrected at one sitting alone. Suboptimal results can be expected in some patients. Staged surgery is a real possibility. The surgical footprint done in primary surgery must never have the potential of permanent irreversible damage.

4. The role of implants should be to play a supportive role in pelvic floor surgery and not a primarily role. This supportive role will lay down the requirements –be it temporary or permanent support- that need to be fulfilled by the material to be used.

5. Reconstructive surgery is reconstruction of normal anatomy, and not creation of new “ innovative” anatomy. There is a reason why ligaments run into specific directions in the pelvis. For the same reason is there not place in normal anatomy for ligaments to follow non-traction lines e.g. from the peri-cervical ring to the sacro- spinous ligament.

In this Eureka moment a paradigm shift of the mind allows the eyes to see what it had previously been blind to. The vaginal wall topography takes on a new meaning. The presence and absence of the rugae tells what lies beneath, the lateral sulci on the anterior wall predict what lies beneath, the position of the cervix in the vaginal apex has its’ own tale, and the dimples on the lateral fornixes where the cardinal ligaments takes its’ origin from the vaginal wall provide information about the integrity of the cardinal-utero-sacral ligament complex.

By looking beyond the prolapsed vaginal wall to the underlying defect, one realizes what needs to be done. Rectifying the wrong by treating the disease and not the symptom will involves doing defect specific surgery and not covering the prolapsed wall with a blanket.

This is reconstructive surgery and not surgery with a potential of destruction

Why do they not listen?

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

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

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

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.

“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

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:

1. 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.
2. 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.
3. 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.