On September 8 and 9, 2011, the Food & Drug Administration will convene a panel of experts to provide advice to the Agency with regard its regulation of gynecological medical devices. The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will focus on evaluating the safety and effectiveness of transvaginal surgical mesh which is widely utilized to treat women who suffer pelvic organ prolapse.
For more than a decade there has been serious concerns about the safety of these devices and whether they have been over-utilized in treating women who have suffered a dropped bladder or other organ prolapse. More than a decade ago, there was litigation over the ProteGen bladder sling, a device that was actually used as a predicate device for the summary approval of newer mesh products that are currently on the market, yet the products continued to be approved by government regulators and aggressively marketed to surgeons and their patients.
The Food & Drug Administration first sounded the alarm about these mesh products in October of 2008 with the publication of a Safety Alert informing physicians that the FDA had, at that time, received more than 1,000 reports of complications associated with use of the mesh in surgeries for pelvic organ prolapse and stress urinary incontinence. At that time, physicians were encouraged to seek specialized training for implantation of the mesh products and to be hyper-vigilant in monitoring patients with potential complications, including: bowel perforation, bladder perforation, blood vessel perforation, vaginal scarring, erosion of the mesh through the vagina, chronic infections, pelvic pain, and dyspareunia. Unfortunately, most patients did not receive this important safety information, and many physicians were either unaware of the FDA alert or were unable to appreciate its significance amidst lots of contrary information regarding the properties of the vaginal mesh, the questionable regulatory history behind many of the products that had been approved for sale, and the spotty safety history of these devices. The medical literature, as is so often the case, did not provide clear information on the true safety profile of the products, because it had become polluted with far too many “puff pieces” masquerading as scientific research. Also, despite more than a decade of implanting products in women, very little was known about the long-term complications, safety, or advisability of using these products in the pelvic region.
On July 13, 2011, the FDA again issued a safety alert to both patients and healthcare providers. This time, the Agency indicated that its concerns about the safety of the product has increased since the October of 2008 safety alert, and that adverse event reports and other data indicated that serious complications stemming from implantation of the mesh are far more common than had been previously understood or disclosed to patients. From January of 2008 through December of 2010, the FDA received nearly 2,900 adverse event reports for serious complications associated with the use of transvaginal mesh in surgeries for pelvic organ prolapse (POP) as well as stress urinary incontinence (SUI). In addition to the organ perforation, infections, dyspareunia, and mesh erosion noted earlier, the more recent adverse event report data also indicated that patients were suffering a recurrence of their pelvic organ prolapse, neuro-muscular problems, vaginal scarring or shrinkage, and emotional problems.
This data led the FDA to conduct a more thorough review of the safety profile of the devices from 1996 through 2011, which was quite illuminating. The Food & Drug Administration concluded that the mesh used in the pelvis posed patients to risks not noted with the use of mesh in other parts of the body; that there was no evidence to substantiate that use of transvaginal mesh (especially in apical or posterior repairs) provided any benefit over traditional surgical methods which do not utilize mesh; and that the benefits, if any, of use of the mesh in an anterior repair pale in comparison to the risks associated with the medical devices. In essence, there is no reason why these products should be implanted in women.
Hopefully, the Advisory Committee that meets next month will also agree, and support the FDA in efforts to limit or ban use of these products. While this would be good news for future patients, it will be little solace to the tens of thousands of women who have had needless suffering over the past 15 years due to medical devices that should have been withdrawn years ago or, better yet, never sold at all.