Tell the FDA: Ban Mesh!
The FDA is taking comments until July 30 on proposed orders to reclassify certain types of surgical mesh from medium risk (class II) to high risk (class III) medical devices, and require premarket approval for some devices.
While they are improvements, the proposed actions stop far short of what is needed. Corporations will still be able to sell most mesh implants without conducting any safety studies. Sign on to our comment on the proposed order and let the FDA know debilitating, untested vaginal mesh implants need to be taken off the market, today.
Here's our comment in full:
July 31, 2014
Margaret A. Hamburg, M.D.
Commissioner, Food and Drug Administration
Department of Health and Human Services
Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiologic Health
Food and Drug Administration
Department of Health and Human Services
Re: Docket No. FDA-2014-N-0297 (Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation).
Dear Drs. Hamburg and Shuren:
We respectfully request that pursuant to 21 U.S.C. §§ 360f and 360h, and 21 C.F.R. §§10.30, 810 and 895, the FDA immediately ban the marketing of non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP), and order all manufacturers of these products to recall them immediately.
Sadly, this is not the first time this request has been made.
Three years ago, on August 11, 2011, Public Citizen made a similar request, filing a lengthy petition that explained that the devices offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh; and that there have been high rates of serious complications, many of which require additional surgical intervention and some of which result in permanent life-altering harm, therefore presenting an “unreasonable and substantial risk of illness or injury,” the standard for the FDA to institute proceedings to ban a device.
In the intervening three years since Public Citizen raised this issue, tens of thousands of additional American women have been injured. As the FDA itself has documented, reports of adverse events surrounding implantation of pelvic mesh are legion. As of 2013, more than 85,000 individual lawsuits were filed against mesh manufacturers as a result of these injuries.
State government officials are increasingly concerned about this issue. The consumer protection division of the Texas attorney general’s office has been leading a nationwide probe into whether Johnson & Johnson, one of the leading manufacturers of pelvic mesh, has violated laws related to the advertising, marketing, promotion, sale and distribution of surgical mesh. Texas Attorney General Greg Abbott has demanded documents from the company related to safety and research as well as details about financial and other incentives paid to doctors and representatives selling mesh products.
The harm caused by pelvic mesh extends well beyond the United States. Just last month, the Scottish Health Secretary ordered the suspension of surgical mesh operations for POP pending a safety audit.
While the FDA’s issuance of a proposed order to reclassify surgical mesh for the treatment of POP as a “high-risk” Class III medical device that requires premarket approval is appropriate, it simply does not offer adequate protection to women.
Given the number and severity of adverse reactions to pelvic mesh, the FDA should not leave this dangerous product on the market while studying its safety and effectiveness. Instead, manufacturers and companies should be barred from marketing and selling surgical mesh to treat POP.
American women already have waited far too long for the FDA to act.
We Are Mesh Survivors Coalition,
Corporate Action Network,
< You! >