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Mesh implants have been used since the 1950s to treat abdominal hernias. In the 1970s, gynecologists began recutting surgical mesh for treatment of POP and, in the 1990s, SUI. Seeing an untapped market, manufacturers began to manufacture surgical mesh specifically designed to support pelvic organs. Medical device companies created kits that included equipment to aid doctors in placing and securing the mesh transvaginally. A kit for SUI treatment was first approved by the FDA in 1996, while the first POP mesh kit received approval in 2004. The kits were generally marketed directly to gynecologists instead of to surgeons.
One advantage to transvaginal implantation is that the procedure is less invasive and less complicated than other surgeries to correct POP and SUI, generally requiring only a small incision in the shape of the implant.
In 2010, according to manufacturer data provided to the FDA, approximately 100,000 women had surgical mesh implanted to correct POP; 3 out of 4 of those mesh procedures were transvaginal. That same year, roughly 260,000 women had surgery for SUI. More than 4 out of 5 of those procedures involved transvaginal mesh.
Types of Transvaginal Mesh
The FDA identifies several different types of urogynecologic surgical mesh, characterized by the type of material, usually synthetic, from which they are manufactured. Synthetic meshes may come in the form of knitted mesh or non-knitted sheets. The type of mesh a doctor recommends will depend on each patient’s unique circumstances, including age, severity of the prolapse and symptoms, which organs are involved, level of sexual activity, and desire to have children.
Non-absorbable synthetic: These surgical mesh implants are designed to provide permanent reinforcement to the pelvic organ in question. Most non-absorbable synthetic mesh is made from polypropylene. This is the most common type of surgical mesh.
Absorbable synthetic: Absorbable synthetic surgical mesh (e.g. polycaprolactone or poly (lactic-co-glycolic) acid) is designed to break down over time and be absorbed by the surrounding tissue. They are intended to provide support during the regrowth of tissue.
Biologic: Surgical mesh may also be made of animal tissue (usually from pigs or cows), processed and disinfected so that it may be safely implanted. Biologic mesh implants are absorbable.
Composite: Surgical mesh may incorporate a combination of absorbable and non-absorbable materials. The first transvaginal mesh implant approved by the FDA, Boston Scientific Corporation’s ProteGen, was a composite of synthetic mesh coated with bovine collagen.
Uses of Transvaginal Mesh
Urogynecologic surgical mesh is primarily used to help treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The mesh design differs based on which condition it is meant to correct, and is shaped to fit the specific organ it will support.
POP is a condition wherein the tissue and muscle of the pelvic area is stretched or weakened to the point where it can no longer support some or all of a person’s pelvic organs in their normal position. This leads to a “drop,” or prolapse, of one or more of the organs, most commonly the bladder.
Pelvic Organ Prolapse (POP)
POP is a condition wherein the tissue and muscle of the pelvic area is stretched or weakened to the point where it can no longer support some or all of a person’s pelvic organs in their normal position. This leads to a “drop,” or prolapse, of one or more of the organs, most commonly the bladder. Other pelvic organs that can prolapse include the vagina, cervix, uterus, urethra, and rectum.
A number of routine events can cause sufficient weakness or damage to pelvic muscle or tissue to lead to POP, most commonly childbirth. A hysterectomy or simply aging are also common factors. Some women may also be genetically predisposed. It’s important to remember that, while as many as 50% of women will experience some degree of POP in their lifetime, only around 2% exhibit symptoms, and most won’t require surgery. A variety of nonsurgical treatments may ease or correct the condition.
Symptoms of POP may include sexual problems, urinary incontinence, pain and discomfort.
Stress Urinary Incontinence (SUI)
Women with SUI experience urinary leakage during moments of heightened abdominal stress caused by physical activity, such as exercise or a laugh, cough or sneeze. Similar to POP, the muscles of the pelvic floor weaken enough that the area where the bladder and urethra connect descend temporarily during bursts of activity, which can interfere with proper urethral function. The sphincter controlling the urethra may also weaken enough that it cannot properly control the flow of urine.
Mesh implants designed to treat SUI generally take the form of a bladder sling.
FDA 510(k) Approval of Mesh
Urogynecologic surgical mesh is categorized as a Class II medical device, meaning it is subject to the FDA’s 510(k) clearance program, which does not require clinical trials for medical implants if a manufacturer can demonstrate sufficient similarity–known as substantial equivalence–to an existing device. Substantial equivalence is meant to enable companies to bypass a lengthy approval process when updating existing devices.
However well intentioned, the flaws in the 510(k) process are obvious. Any problems in the clearance of an initial (predicate) device, which often itself does not undergo long-term clinical trials, can be passed down to subsequent devices. Postmarket testing can also be difficult, because a device can, and often is, modified before testing is completed.
Moreover, the concept of substantial equivalence can be interpreted loosely: a device may be found to be similar to an existing device that doesn’t actually perform the same function. Such was the case with Boston Scientific Corporation’s ProteGen sling.
Boston Scientific Corporation’s ProteGen
The ProteGen sling, released in 1996, was the first SUI transvaginal mesh implant cleared by the FDA. It was designed to hang between the pelvic bones and provide support for the bladder.
Under the 510(k) program, the device was cleared for use based on a 90-day study of rats, and the use of the same type of mesh for cardiovascular grafts. At the time of its release, it had never been implanted in a human vagina. The material involved, polyester fabric coated with bovine collagen, had never been tested for urologic applications.
BSC rushed to have the device approved prior to April 1997’s American Urological Association conference. In its first year on the market the ProteGen approached $1 million in sales, but reports of severe side effects that manifested between 4 and 9 months of implantation quickly began to reach the FDA. BSC was forced to recall the device in January 1999, at which point the FDA declared the device defective and misbranded.
Remarkably, many transvaginal mesh implants on the market today can trace their approval directly to the ProteGen.
Mentor’s ObTape Vaginal Sling
Mentor’s ObTape vaginal sling was cleared four years after the ProteGen’s recall. It was cleared based on its purported similarity to Johnson & Johnson’s Tension Free Vaginal Tape System and American Medical Systems’ Sparc Sling System; Johnson & Johnson’s product used the ProteGen as a predicate. (Mentor is now owned by Johnson & Johnson.) On approval, Mentor pivoted, and began to market the ObTape based on the uniqueness of its features.
Mentor’s marketing proved accurate, as there indeed turned out to be important differences between the ObTape and the products it was purportedly identical to. Notably, the mesh used in the ObTape proved insufficiently porous to allow the proper growth of capillaries and tissue. That prevented the device from being fully integrated into the tissue it was meant to support, which in turn led to a wide range of complications.
Complications of Transvaginal Mesh
Transvaginal mesh has been shown to have a variety of side effects. Patient factors such as cigarette use and obesity may increase the likelihood of complications, which include:
- Pain, including painful sexual intercourse (known as dyspareunia)
- Urinary and bowel problems, including discharge
- Bowel, bladder and blood vessel perforations caused by surgical error or by the mesh itself
- Erosion of the mesh. This is the most common reported side effect for POP patients, affecting approximately 10% of patients within a year of implantation, according to numerous studies. Pieces of eroded may also poke through the vaginal wall. Erosion can require multiple revision surgeries and may leave patients with fragments of the mesh permanently embedded in their organs. One surgeon likened the procedure to extricate eroded mesh to trying to remove rebar from a sidewalk without damaging the concrete.
Many patients report that the side effects of transvaginal mesh are severe enough to significantly impact their quality of life.
Testifying before the FDA’s advisory panel in September of 2011, Dr. Michael Thomas Margolis argued that the concept of transvaginal surgical implantation is essentially untenable, because the presence of natural bacterias in the vagina makes sterile implantation impossible.
Concerns About Surgical Sterility
Testifying before the FDA’s advisory panel in September of 2011, Dr. Michael Thomas Margolis argued that the concept of transvaginal surgical implantation is essentially untenable, because the presence of natural bacterias in the vagina makes sterile implantation impossible. Most mesh erosions, according to Dr. Margolis, are induced by infection.
Seven deaths allegedly related to transvaginal mesh POP repairs were reported to the FDA between 2008 and 2010.
Before electing to undergo transvaginal surgical mesh implantation to treat POP or SUI, patients should be aware that a variety of alternative treatments exist.
Surgery to repair POP or SUI will not necessarily involve a mesh implant. Burch urethropexy is a surgical procedure that utilizes sutures to provide support to pelvic organs. It is, however, more complicated and invasive than mesh implantation, and some studies have demonstrated low long-term success rates. One study, which examined 66 women who underwent the procedure to correct SUI, found high rates of suture erosion. Half the women in the sample required revision surgery while less than a third reported that their condition improved.
Sacrocolpopexy is considered the “gold standard” in treatment of POP by many surgeons. Most commonly used in the case of vaginal vault prolapse, it, too, involves the implantation of a small piece of mesh to support pelvic organs. Surgery, however, is performed through incisions in the abdomen rather than the vagina.
There are two disadvantages to sacrocolpopexy to treat POP. The conventional form is significantly more invasive than transvaginal implantation, and can involve a recovery time of six weeks or more.
Minimally invasive laparoscopic (keyhole-incision and camera-assisted) and robot-assisted approaches exist as an alternative to standard abdominal sacrocolpopexy, but they are more expensive because of the specialized equipment involved. Nonetheless, the long-term success of sacrocolpopexy is found to be as high as 90 percent, according to some studies.
Additionally, a number of nonsurgical treatments may provide relief from POP and SUI, including:
Pelvic floor exercises (Kegels): In some cases, exercising the pelvic muscles can strengthen the pelvic floor sufficiently to provide support for prolapsed pelvic organs.
Pessary: A pessary is a removable device that can be nonsurgically inserted into the vagina to provide support for pelvic organs.
Transurethral bulking agents: Though not always permanent, the area around the urethra may be thickened with the help of collagen injections, helping to control urine flow.
Behavioral modification: Patients with SUI may find that behavioral modification can help them successfully avoid actions that lead to urinary leakage.
FDA and Surgical Mesh Studies
In 2012, in light of ongoing reports of harmful side effects and device failure, the FDA ordered manufacturers of urogynecologic surgical mesh to conduct postmarket studies evaluating the devices’ effectiveness. By 2013, 95 postmarket study orders had been delivered to 34 manufacturers of surgical mesh for POP, while 14 study orders had been delivered to 7 manufacturers of mini-slings designed for SUI.
The FDA released a communication in 2011, stating that serious side effects to surgical mesh for transvaginal repair are “not rare.” The alert also suggested that the mesh is not discernibly more effective at treating POP and SUI than alternative forms of treatment.
Transvaginal Mesh Recalls and Withdrawals
In addition to the ProteGen, Johnson & Johnson’s Ethicon division withdrew four models of its own transvaginal mesh in 2012: the Gynecare TVT Secur system, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M. Ethicon denied that the withdrawal was due to safety concerns, instead blaming market factors.
More than 50,000 lawsuits have been leveled at manufacturers of surgical mesh. Many observers believe that liability is relatively clear, and expect the majority of the suits to settle out of court.
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