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New Devices and Medical Advances

Letter written by Dr. Murphy in 2008 predicting mesh related class action lawsuits:

Pelvic Health & Childbirth was published already in 2003. During the years since then there have been significant developments in the recognition and treatment of pelvic floor disorders, especially incontinence and pelvic organ prolapse.

Also, the topic of incontinence and prolapse has become a bit less of a “taboo” topic.  Although not a dinner conversation topic, women are more likely today to bring this problem to their physicians’ attention than even a few years ago. There have even been attempts made by the media to “normalize” the discussion. Even so, I continue to find it amazing that so many women have never heard the term “prolapse” and many women have never even heard of possibility of long term pelvic damage related to childbirth. The possibility that her most secret, female organs might simply drop out, exposed to the entire world to see if she were naked, is still a complete and utter shock to many women. Knowledge, or at least awareness of urinary incontinence is becoming more common, but anal incontinence is also something that doesn’t register in women’s minds when they are pregnant and considering their delivery. Anal and fecal incontinence however, can be disasters for afflicted women and is very difficult to treat.

Although there are some new experimental treatments for anal incontinence and urinary incontinence, the treatment of genital prolapse has really taken off in the last five years. Since we published our book, companies have started to realize what an epidemic there is out there of women with prolapse. These companies have spent millions of dollars developing new surgical treatments and more millions on marketing. Part of the problem I am going to point out in this document is that more effort and attention is going into getting the products into the marketplace and promoting their particular product, than supporting the scientific studies proving its value and more importantly, its safety.  Since there is no money to be made from preventative measures, there is also little support for research in this area. The experience with the treatment of urinary incontinence has set the stage and although we’ve been remarkably successful in this area, the automatic application of ideas that work for incontinence is  a dangerous leap of faith when it comes to prolapse. Until the end of the nineteen nineties, the surgical treatment of urinary incontinence involved either a major operation that was quite successful, or minor ones that didn’t work all that well or for very long. The gold standard operation was the Burch operation (which I described in detail in my  book). This operation involved a laparotomy and a lengthy recovery. The operation, although effective, often resulted in prolonged voiding dysfunction (difficulty voiding) afterwards and also had frequent after-effects of increasing an existing tendency (or sometimes initiating it) of prolapse of the posterior compartment. This involves descent (prolapse) of the back wall of the vagina, leading to rectocele or enterocele with all the symptoms associated with that.

The alternative surgical options involved various types of needles suspensions or vaginal surgical procedures. In spite of rosy prognoses given by surgeons to their patients, these procedures simply didn’t work very well. If they worked at all, it was usually short-lived. This is part of the reason many women believe today that prolapse and incontinence surgery lasts only a short while.

The introduction of TVT (Tension Free Vaginal Tape) changed all this. Suddenly we as surgeons had available a relatively simple, easy to insert prosthetic sling that worked! Not only is the surgical procedure relatively minor, is usually done under local anaesthesia and has a very quick recovery, but the results are at the very least similar (and many will argue superior) to the old gold standard. So successful has this one procedure become in a few short years that the procedure that has been done for more than forty years is done so seldom today that many of our residents never get to see one. The success of this revolutionary treatment of urinary incontinence with the introduction of a synthetic prosthetic has opened a virtual can of worms. Suddenly every major and even minor medical device company, realizing the enormous market out there, had to bring to market their own device. These devices differ in mesh properties and surgical technique and many of them have not been properly studied. Claiming “significant similarity” to the original TVT however, they circumvent what little regulatory control there is and the next thing that happens is that I have to defend my decision not to switch to the latest “miracle”, to an anxious and zealous company representative.

Realizing the even greater untapped market in prolapsers, the companies extended the basic premise of the TVT (insertion of a synthetic mesh) to the eventual complete wrapping of the vagina, bladder and rectum in synthetic or biological mesh (I will explain the difference between these two later).  Although meshes have been used in specific and severe cases of prolapse for a long time, their usage have been restricted by complications, cost and lack of good long term data. With the overnight success of TVT however, the actual practice of pelvic reconstructive surgery world wide would make one believe that such data is no longer a prerequisite for general introduction of a medical device – sometimes even in very young women.

Some of these developments have been significant steps forward, benefiting many women. Unfortunately, some of the newer treatments that have been introduced, especially surgical techniques, have been rushed into clinical practice without thorough validation. The result is that many women will be harmed before some of these techniques and treatments are eventually recognized for the experiments that they are and abandoned. I have been telling some of my colleagues that I fully expect a major class action lawsuit to be launched within the next ten years, with thousands of defendants claiming major harm has been caused to their health by greedy device manufacturers and their ever so willing physician lackeys who were mostly looking at their wallets when implanting permanent devices into women with the full realization that they have no idea whether these devices are safe over the long term or what the long term harmful effects might be. When implanted into a young woman, one has to consider the effects of these devices over many decades in a body part that is not a static singular “thing”, but a functional, dynamic marvel of body functions: storage and elimination of waste products, weight bearing of the pelvic and abdominal organs as well as regular sexual function and in some cases, childbearing and delivery. Negative influence on even one of these areas could significantly, sometimes devastatingly, alter someone’s life.

The device manufacturers are falling over themselves to bring new devices (mostly mesh prosthetics) to market and have legions of lawyers, administrators and physician and scientific “experts” advising the governmental agencies who are supposed to protect the public, that their latest iteration is in some way unique and better, but also similar enough to what’s already on the market – in fact so similar that they don’t need to do any research or studies to prove their device’s safety. The logic behind this schizophrenic control mechanism boggles the mind. Instead of increasing the burden of proof on device manufacturers to prove that their products are safe before accepting their general implementation, a US Supreme Court ruling is apparently going to make it more difficult for plaintiffs to sue the manufacturers of medical devices that have been granted approval by federal regulators (The Economist; February, 2008). The problem here is not the Court ruling. I for one despise the culture of litigation that terrorizes physicians to become demoralized and either quit medicine (obstetrical practice in particular), or practice defensive medicine in a way that distorts the medical care available to the population. The problem is that the regulators have not done their jobs or are unable to do it, therefore creating a situation where real risk exists to consumers of health care, in this instance the medical device recipient. Denying legal means in this situation will be a travesty.

 The result of this lax regulatory oversight is no effective control, with dozens of prosthetics classified as “similar” to previously admitted devices being introduced into clinical practice every year. The fact is that NONE of these have any proven safety record, except for the original TVT device. In that case years of trial and error, pre-ceded by significant animal research and then post market ongoing studies have confirmed that the TVT procedure is a good procedure for urinary incontinence.  It is a minor operation; it has a quick recovery and is remarkably effective. Although there are risks and some of these can be serious, the incidence is low. The incidence of mesh erosion specifically is quite low and in most instances can be dealt with relatively easily. More about this later.

After regulatory approval for a device manufacturer to launch a specific product, the company typically relies on their specialist representatives to persuade surgeons to use their product. These representatives come from varied backgrounds, some of them highly educated and some not. A scientific background is not a prerequisite for the job. The representatives are given training and instruction on the devices they have the responsibility for and are then sent out, much like young Mormon men, to hit the road and preach the gospel of their device. They use whatever contacts already exist, cold call surgeons or come to the operating rooms of hospitals where they can meet the potential surgeon customers. Then the sale begins.

One of the telling features of this game is the fact that the academic physicians in the field in question are not the primary targets of the companies. Community physicians and surgeons with large practices suffer the main assault, usually willingly. The upside to them involve a free lunch or dinner talk here and there, a trip to another part of the country for the training (with a nice honorarium to offset lost remuneration for the time spent) and the sales pitch of “better” and “simpler” – which translates to “easier”, “quicker” and therefore “more” procedures and more money. In the meantime academic physicians are trying to juggle their own financial situation with the dilemma of whether introducing new procedures are ethically justified before complete scientific validation, which is per definition their whole reason for existence and the reason for their university appointments in the first place. Throw into the mix competition with the community high rollers who are less bound by perceived restraints of such scientific data as well as having much less departmental or board oversight and who only need to believe that they can perform the procedures without major immediate complications and the stakes increase.

Medical technologies are advancing at breathtaking pace and no one wants to be left behind and become a perceived dinosaur in their field. It is exciting to be on the forefront. The rapid introduction of these prosthetic devices however has created an untenable situation where dinosaur status is almost guaranteed for anyone wishing to wait for scientific validation before adopting.

Worldwide the situation differs from country to country, with more or less ability for companies to bribe surgeons.  Let’s call a spade a spade. I’ve been flabbergasted to find out that the ENTIRE contingent of a certain country’s (I prefer not to name the country) surgeons attending the International Urogynecological Association’s annual meetings for the last few years have been flown to the meetings (Paris, Athens...) and put up in hotels completely at  company expense. Even the language reflects the reality.  “I’m WITH Gynecare” or “I’m with American Medical Systems” are commonly heard remarks. This situation is illegal in North America and I suspect Europe as well.   However, let’s not kid ourselves. If I currently practiced in that particular country and was offered an opportunity to go to Paris for a conference – all expenses paid, my moral objections would probably disappear before I can say “Huh?”.  Human nature being what it is, one can easily kid yourself that you will still have the freedom of choice after your return. The truth is however that this is a very naive view. Almost all surgeons thus sponsored, will end up using that particular company’s product, at least for a while. Invited speakers usually get their way paid and rightly so, but for mere attendees to be put in such a morally untenable situation is a real conundrum. The problem is obviously compounded by economic and financial realities, in that many surgeons from third world countries will not be able to attend these conferences otherwise. The fact is however that most of the sponsored surgeons mentioned as an example here  are in private community practice in a relatively rich country. The companies know what they are doing.

I might sound overly harsh in my criticisms. I’m telling it as it is however, without pointing fingers at certain groups of physicians or even appointing blame to representatives. It’s the nature of the business and the companies are in the business of!  I’ve been in community practice myself. I know exactly the stress and competition of such an environment and the drive to better oneself. You want to believe. If the new procedure is easier as well, so much the better and if it might just prove to be equally good or better than what came before -well the incentive is irresistible. The thought will be something like the following: “Let the academic physicians sort out the long term answers – I don’t have the time, resources, ability or inclination”. Now that I’m in joint academic and private practice however, I know the dirty secret: The academic physicians don’t have any of the above either, if for different reasons perhaps.

In contrast to the TVT procedure, where a thin strip of synthetic polypropylene mesh has been implanted in a very specific place, surgeons of many backgrounds are now implanting large pieces and different types of meshes into women in a cookie cutter way just like the company taught them and with less foresight than before, when each woman was an individual and her surgical procedure as well. In many cases surgeons who have never before done prolapse or incontinence surgery have suddenly found the perceived “holy grail” of prolapse repair and have started slapping these prosthetics in left, right and center. The reason is that the device manufacturers have spent a significant time and effort on trying to make things easy for the surgeons. Not only have they put more design effort into surgeon comfort than long-term effects for the patients, but they also spend millions of dollars flying physicians all over the world to fancy places for training.  This training usually consists of a morning of didactic lectures, after which either a dry lab or cadaver lab session ensues. This means that the prospective company customers are given the opportunity to “play” with the devices on various tissues and even perform the surgery on cadavers. The next step is usually a short preceptorship where a noted “expert” (usually defined as someone who has inserted a few dozen of these devices without a known reputation for having killed anyone in the process) holds the prospective’s hand for the first few cases. After this – whalaa – you’re an expert and the company will do anything in their power to help you overcome any and all obstacles in finding willing and suitable candidates for the procedure. This help might include arguments to take to your hospital board, copies of publications on the study and cutthroat bargaining with the hospital purchasing department. Although the “scientific” publications they almost universally have available are not very scientific at all, the average community surgeon is not educated in reading scientific  papers with lot of understanding and anyway they don’t have the time. The reason I say these publications are not scientific is that most of the papers the companies push on their overworked, tired and somewhat hapless physician audience consist only of a case series of a few patients. Most are descriptive studies and almost none are properly randomised prospective trials, which are the hallmarks of good science in medicine. With this I’m not saying that the aforementioned type of study doesn’t have a place. I’ve been involved in many such studies in the past and present. The problem is that such pseudoscientific papers are sold to undereducated scientific physicians as proof of a particular mesh or device’s safety and effectiveness, when in fact it proves no such thing. These studies prove only one thing – that more research is required before any pronouncement can be made on the subject under trial and certainly before we can run around inserting PERMANENT devices into untold thousands of women. It is almost unbelievable that the governmental organizations responsible for monitoring and regulating public safety are so completely negligent in this respect. Contrast this situation to that of drug regulations. For a pharmaceutical company to bring a new drug to market is an almost unachievable goal. It involves years and years of preclinical trials and untold millions of dollars after which all relevant scientific facts are properly looked at. Human trials are only allowed under strict control and tight regulations. Drugs are withdrawn from the market for reasons that are sometimes difficult to understand – five people developed this or that complication on drug A, a few individuals died after taking drug B even though it is often by no means certain that it was in fact the drug under investigation that caused the complications in the first place.

Now compare this situation again with our surgical device market: Company A manages to persuade the FDA, Health Canada or related organizations world-wide that they have a relatively safe and effective device. They obtain permission to launch the device into their market after only a few small human studies have shown some effectiveness and not too many deaths or major complications. Physicians in that market fall all over themselves to “get onboard” and start offering the procedure to their patients for fear of falling behind and losing their referral base to the sexy surgery offered down the road. The only training they get might include a single conference or a weekend course before they sing the benefits of this new procedure to their patients. Of course now the physician further down the street also has to jump onboard quickly and so on. As I mentioned before, many of these physicians and surgeons have never before offered surgical treatment for the conditions they now suddenly overnight became experts on. It gets worse! In many cases certain surgeons have never even treated these conditions before! I’m talking here of Urologists and general Gynecologists who didn’t do prolapse surgery prior to finding the “gift” of an easy “kit” surgery, offered by a sexy representative of the company, competing with the sexy representatives of the other companies for his/her attention, favour and business. If seduction, flattery or thinly veiled bribery don’t work (see discussion on travel to conferences), there’s always the reality of the pocketbook! If I can do two of these new quick procedures in the time of one of the older procedures I’ve been doing for years and years... Of course it is nice to argue that you’re helping twice as many patients, but at this stage of the game that line of thinking is self delusional and insincere, even if the conflict of interest is not recognized for the unethical or naive behaviour it is. For how can you argue that you will be helping these patients if you have no scientific validity to your decision making paradigm? The problem is that many fall for the lazy pseudoscience fed to them by the sexy salespersons with their designer suits and glossy brochures. No doubt many of these reps are sincere and honest people. I have met many very dedicated and passionate people in this field who will never knowingly misrepresent something they believe to be harmful. Unfortunately most of them are thoroughly indoctrinated by their particular company’s scientists, engineers, administrators and unfortunately – their physician “experts” that their particular product is the next thing to sliced bread and will be the last say on the matter – except of course if their own company comes up with something even better – which usually means it will be packaged more elaborately and will of course be more expensive.

I have often sat back in my office chair listening to yet another representative telling me how great their particular mesh or prosthetic is and wondered whether I’m the only one perceiving the delicious irony of the moment. Here is a highly educated person trying to SELL a product to me as a significant benefit to patients with quality of life problems (versus life-threatening ones) without ANY scientific justification or backup regarding the long term safety. I have on occasion become irritated by the naive and uneducated righteousness of said enthusiasts telling me of yet ANOTHER new mesh – maybe the third such pitch in a week - and their indignation when I state that I have not the slightest intension of even trying it out.  “Just try it”, is usually one of the opening ploys.  The irony is that these reps have a secret, but very powerful weapon. This weapon is used with stealthy effectiveness and always coyly, never overtly. The threat is always however, just below the verbal threshold. It is – of course – the threat of competition, of being relegated to dinosaur status, of being left behind, stripped of the academic or surgical “expertness” status cultivated and built over years and years of being the fallback referral recipient of other physicians in your area and endless hours operating on difficult cases others don’t want to touch. The perception created is that “they” are jumping onboard like flying fish attracted to navigation lights in the Caribbean and that you’d better too. To the uninitiated this might sound naive, alarmist and even ridiculous. Believe me however, this is the reality of medical practice in the US, Canada and many other countries. The situation is compounded by competition between academic centers and peripheral hospitals where community physicians and surgeons work under much more benign administrations and usually have more say in what they want to do in clinical practice. I’ve worked in both situations and I know exactly how the game works.

It is no great surprise that many new surgical devices are often first introduced successfully in the more general smaller centres. This certainly is the case in incontinence and prolapse surgery. Most community surgeons are concerned about the following things, not necessarily in this order:

  • Safety
  • Effectiveness
  • Financial reward for performing the procedure
  • The fun factor of new technological toys

The issue of scientific validity is not dealt with in any consistent manner.  A consistent interpretation and evaluation of scientific merit necessitates a scientific “review” after all and this is beyond the capability of these small centres. Thus, what happens in the real world is that while the academic colleagues at the university centres struggle with the above questions, the factors of competition, finances and public pressure in some cases conspire to persuade these surgeons that they are doing the right thing to cut to the chase.

Many of the “experts” I have met through my years of attending company sponsored education sessions have involved community surgeons who have been first onboard. Having built up a repertoire of a certain number of cases, followed haphazardly but often not in a systematic and really scientific manner, they now talk the talk, sometimes condescendingly and even occasionally berating more tardy converts. I have also met very sincere individuals who openly admit the flaws of this whole situation. Their argument often goes something like this: “Somebody had to be first. Better me than ....someone else...”. Although the first part of the statement is true, the inherent arrogance of this stand is sometimes lost to them.

I also know a few individuals (who will remain nameless), who are surgical “Johns”. They jump into bed with the one company after the other; this year presenting lectures at international conferences for company X and sometimes not two years later you will find them presenting and gloating for company Y at the same annual conference. Always first onboard with every procedure and device, they rack up some experience performing the procedures before anyone else, thereby assuring a continuously goggling audience hanging onto their every word, year after year, not even realizing the pathetic hypocrisy of what they are doing. Self proclaimed “teachers of surgeons”, they do rack up impressive numbers in short order and in fact, some of them have made very significant contributions to the scientific literature. Being able to do this in a private practice scenario is quite impressive, but without industry backup, it will all come to a grinding halt. In some more sincere moments, sometimes helped by a few cocktails, some of these individuals have admitted to me that ... “remember that company X’s procedure...well we stopped doing it because we’ve been seeing all these complications one and two years later...”.  Of course, now being in year one or two of company B’s procedure, they are the golden boys for the moment, again; with a different hat.

Practice realities differ from country to country.  In Canada, where I practice, the systemic and financial disincentives to producing scientific research publications are so great that it is remarkable that anything gets published at all.

In contrast to the above are the Luddites, those hardy soles who reject every new invention until scientifically proven to be the better. Unfortunately in this field that means that they will not introduce any new procedure or device in their working lifetimes, for such is the burden of proof when it comes to implanting prosthetics into relatively healthy people’s bodies.

So – what is the answer?  Are we to reject every potential new development? Of course not.

I would like to stress a few principles I think are very important in this regard:

  • Caveat emptor
  • Individualizing the choice of procedure depending on patient specific factors.
  • New procedures and devices should be regulated more strictly and their introduction should be governed by the need for implementing them under the guidance of research protocols.

I would be interested in feedback.

Yours sincerely

Magnus Murphy

August; 2008