FDA Decision on Pelvic Prolapse Repair Mesh Sets Back Women’s Health
Written by Dr. Andrew Siegel
Recently the U.S. Food and Drug Administration (FDA) ordered the manufacturers of all remaining surgical mesh products for trans-vaginal repair of pelvic organ prolapse (Boston Scientific and Coloplast) to stop selling and distributing their products in the USA immediately. According to the FDA, the manufacturers in their premarket applications failed to provide reasonable assurance that the benefits of the products outweighed their risks, compared with trans-vaginal surgical tissue repair without mesh. The inaccessibility of these products will severely hamper treatment options for many women with pelvic organ prolapse and is a genuine disservice to the female population and a blow to women’s health, which has otherwise made major strides forward in the last few decades.
Clearly, the issue is NOT the mesh, which is a synthetic material—polypropylene—that has been used safely and effectively for years as a suture material and for virtually all hernia repairs. Rather, the issues are threefold—inappropriate manufacturing company marketing, inexperienced surgeon implanters, and our “ambulance-chasing” financially-motivated legal culture.
For years, the manufacturers of these mesh products—many of which ultimately removed themselves from the mesh business—assertively marketed these mesh products in “weekend” courses to surgeons (who were not surgically trained to perform these procedures). These inexperienced physicians then became avid mesh implanters and often engendered complications in the patients whom they implanted, setting the scene for law firms to aggressively advertise and seek clients for litigation.
Sadly, there is excellent scientific data to support the safety and efficacy of vaginal mesh when done in properly selected patients by skilled pelvic surgeons. Millions of such vaginal mesh surgeries have been performed successfully with minimal complications by pelvic surgeons with training in a subspecialty of urology and gynecology—female pelvic medicine and reconstructive surgery. This requires several years of specialty fellowship training after completion of urology or gynecology residency and a second board examination in addition to board certification in urology or gynecology, thus most in this subspecialty are dual board certified.
Why mesh in the first place?
Why use a synthetic material when native tissues can be used? The answer lies in the nature of pelvic organ prolapse. Analogous to a hernia, pelvic organ prolapse is a weakness in connective tissue support allowing a pelvic organ (often the bladder) to pooch down into the vagina and at times outside the vagina, causing an annoying bulge, pressure and often difficulties with urination. The mesh principle is using a structurally sound material instead of a patient’s defective connective tissues (that has already failed) to rebuild support. If a brick wall collapses because of structural issues, would one use the same bricks to rebuild the wall? Clearly the answer is no. This is why polypropylene mesh is used in the vast majority of hernia repairs: hardy structural support is needed to compensate for the native connective tissue defect.
The mesh principle: For anatomic defects, using weakened/defective native tissues for a structural repair often causes failures.
In the properly selected patient operated on with the appropriate surgical technique by the experienced surgeon, the results of vaginal mesh repairs have been extraordinarily gratifying and nothing short of a paradigm shift from the native tissue repair era. This procedure passes muster and the “MDSW” test—meaning I would readily encourage my mother, daughter, sister or wife to undergo the procedure if the situation called for it.
When performed by a skilled pelvic surgeon, the likelihood of cure or vast improvement is very high. Meshes are strong, supple and durable and the procedure itself is relatively simple, minimally-invasive and amenable to doing on an outpatient basis. When patients are seen several years after a mesh repair, their pelvic exams typically reveal restored anatomy with remarkable preservation of vaginal length, axis, caliber and depth.
Meshes act as a scaffold for tissue in-growth and ultimately should become fully incorporated by the body. I think of the meshes in a similar way to backyard chain-link fences that have in-growth of ivy. Meshes examined microscopically years after implantation demonstrate a dense growth of blood vessels and collagen in and around the mesh.
When mesh is used for bladder repair, there is rarely any need for trimming of the vaginal wall, which maintains vaginal dimensions as opposed to the native tissue repairs, which often demand some trimming of vaginal wall with alteration of vaginal anatomy. Another advantage of the mesh repair is that if there is some uterine prolapse accompanying the dropped bladder, the base of the mesh can be anchored to the cervix and thus provide support to the uterus as well as the bladder, potentially avoiding a hysterectomy.
The bottom line is that mesh repairs for pelvic organ prolapse have been revolutionary in terms of the quality and longevity of results—a true game-changer. They represent a dramatic evolution in the field of female urology and urological gynecology, offering a vast improvement in comparison to the pre-mesh era.
That said, they are not without complications, but the complication rates should be reasonably low under the circumstances of proper patient selection, a skilled and experienced surgeon performing the procedure, proper surgical technique, and proper patient preparation. Three factors are integral to proper mesh integration: mesh factors, patient factors and surgeon factors.
The gold standard mesh is a piece of large-pored, elastic, monofilament polypropylene—any other synthetic can result in integration issues. This is the standard for sling surgery as well, and time has proved this to be the best synthetic mesh.
Patient considerations are very important as risk factors for integration problems include the following: compromised or poor-quality vaginal tissues, diabetes, patients on steroids, immune-compromised patients, radiated tissues, and tobacco users.
Foremost, a well-trained, experienced surgeon should be the one doing the mesh implantation. It is sensible to check if your surgeon is specialized, and if not, at least has significant clinical experience doing mesh procedures. It is particularly important that the surgeon performing the mesh implant is capable of taking care of any of the small percentage of complications that may arise and are most often quite manageable.
Again, many of the problems that have occurred are not intrinsic to the mesh itself, but are potentially avoidable issues that have to do with either the surgical technique used to implant the mesh or to patient selection. Rather than addressing these issues, the FDA has chosen to throw out the proverbial “baby with the bath water,” leaving in the wake of this short-sighted decision many female patients who will needlessly suffer.