Advisory Panel Backs FDA Plan for More Transvaginal Mesh Studies
Advisors to the FDA appear to support the agency’s plan to require more stringent pre-market testing of vaginal mesh products, despite urging from consumer activists for the pelvic organ prolapse (POP) treatment devices to be removed from the market altogether.
Yesterday was the first of a two-day meeting by the FDA’s Obstetrics and Gynecological Devices panel to discuss growing concerns over the health risks of vaginal mesh products.
The meetings continue today, but the panel already appeared to be heavily in support of an FDA plan to reclassify all vaginal mesh as Class III devices, so that medical device makers cannot fast-track approval of the devices and will have to do detailed clinical trials before being allowed to put them on the market. However, that plan would allow existing products to remain on the market.
The pelvic organ prolapse surgical mesh products, which are implanted through the vagina, are currently considered a Class II medical device, which means that manufacturers can apply for approval through the FDA’s 510(k) approval process. That process only requires that a manufacturer show that the device is “substantially equivalent” to an existing device on the market, without requiring preclinical testing.
Some lines of surgical mesh date back to before the current market approval requirements, which means that in some cases they have never actually been tested, but have just been piggybacking on the approval of untested products that were grandfathered into the current regulatory scheme decades ago.
The panel also agreed with the FDA’s plans to conduct post-marketing studies on vaginal mesh products, and the FDA said that the devices already on the market can stay, despite calls from consumer advocates for all vaginal mesh to be removed from the market.
Officials from Public Citizen called for a ban on all non-absorbable surgical mesh for transvaginal POP repair, and petitioned the FDA last month for a vaginal mesh recall to be issued.
Public Citizen pointed out that even the FDA has found that there appears to be no medical or health benefit for women who have vaginal mesh POP surgery when compared to more traditional, safer, methods of treatment.
“Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable,” Dr. Michael A. Carome, Public Citizen’s deputy director of health research, testified.
The vaginal mesh products, which are sometimes referred to as a bladder sling or transvaginal surgical mesh, are designed to support organs that have begun to fall in older women or women who have had children, to prevent them from pressing on the bladder and vagina. The products are sold by a number of different companies, including Ethicon, C.R. Bard, American Medical Systems (AMS), Boston Scientific and others. They are made of non-absorbable synthetic material that is permanently implanted using small incisions as an alternative to other methods of treating pelvic organ prolapse.
The FDA issued a warning in July that the products were associated with a growing number of reports of vaginal mesh problems after use to repair pelvic organ prolapse, including erosion of the mesh into the vagina, pain, bleeding, organ perforation, recurrence of POP and other complications after surgery. The agency also indicated at that time that available evidence failed to establish any health benefit for women who receive a transvaginal mesh, as opposed to more traditional forms of pelvic organ prolapse repair.
Despite the growing number of reports in recent years involving transvaginal mesh failing and causing women to experience problems, an estimated 75,000 women undergo the surgical procedures each year.
While the recommendations of FDA advisory panels are not binding on the agency, they are usually a major factor in the agency’s decision-making process about what regulatory steps, if any, should be taken.