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Saturday, July 08, 2006

Concepts of PelvicOrganReconstructive Surgery

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

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Primum Non Nocere

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

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")

    Wednesday, July 05, 2006

    VPVR in Pictures