SEPTEMBER 8, 2011 – About the only thing that the room full of injured patients, industry representatives, and surgeons could agree on at the first FDA hearing on synthetic surgical mesh was that more studies are needed on the safety and efficacy of the controversial medical device.
This was the first of a two-day expert panel to decide the fate of mesh to repair a woman’s pelvic floor was characterized by how little is known about the medical device.
Even with a lack of critical data, an estimated 75,000 surgeries were performed last year using the petroleum-based plastic mesh to repair a common condition known as pelvic organ prolapse or POP.
One hundred new pelvic mesh devices have been approved by the FDA’s Center for Devices and Radiological Health since 2002 with no requirements for scientific studies or clinical trials. At the same time adverse events have increased five- fold. Devastating side effects include mesh eroding through the vaginal wall, infection, pain and a recurrence of prolapse.
Mesh injured patient Janet Holt told the FDA panel she had the mesh come through her leg groin. She often cannot walk or sit. “We do not need further studies we have already done trials on women and I am one of them.”
Not all doctors supported mesh wholeheartedly. Dr. Debra Myers of the American Urogynecological Society said they do “not support the routine use of transvaginal mesh for prolapse, but there may be circumstances when it is appropriate.”
Dr. Denise Elser, a specialist in pelvic medicine at the University of Illinois said “Over all we don’t know enough about transvaginal mesh for prolapse repair. We need to balance the risk with the benefits to our patients.”
“Thoughtful placement of surgical mesh should be performed only by trained surgeons “and “should not be widespread” said Edward Varner, president of the Society of Gynecologic Surgeons.
The key question to be answered during this two-day meeting is whether transvaginal mesh, a Class II medical device should be reclassified as high risk or Class III.
The question was raised following the July 13th FDA advisory warning complications were “not rare” and that thousands of women had suffered complications. A July 29th Institute of Medicine report warned that the current process that approves mesh for marketing without safety and efficacy requirements, called 510(k) was “fatally flawed” and the process should be scraped. Under 510 (k) all a manufacturer must do is claim its device is “substantially equivalent” to others already on the market.
Panel members agreed they want more regulation and more guidelines for training doctors. The emergence of precut synthetic mesh “kits” aggressively marketed to doctors who do not regularly perform surgery are though to have added to the complication rate. Also missing from the equation is any formal follow up with patients and a registry of adverse events.
In the meantime injured patients have filed hundreds of lawsuits against leading manufacturers Johnson & Johnson and C. R. Bard Inc.
If mesh is reclassified to Class III Herb Lerner of the FDA told MDND devices currently on the market would stay and the agency would work with industry to be the “least burdensome” solution, allowing for a grace period before tighter post market requirements would take place.
The panel made up of academics, surgeons and patient/consumer reps will advise the FDA on how to proceed. The FDA does not have to follow the advice of its expert panel. #