October 2, 2014Prolene Mesh 300

 

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

 

Dear Drs. Hamburg and Shuren,

We, the supporters and members of the We Are Mesh Survivors Coalition, respectfully request that pursuant to 21 C.F.R. §§ 10.30, the FDA immediately reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP) as a Class III ‘high risk’ device. We understand that the FDA is currently reviewing a proposal to reclassify mesh for that treatment, and we request that the proposal be adopted promptly.

We wish to supplement that existing request by respectfully requesting that the FDA also reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of stress urinary incontinence (SUI) as a Class III ‘high risk’ device.

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.

The FDA reports that from January 1, 2008 through September 30, 2011, it received 1,876 reports of complications associated with surgical mesh devices used to repair SUI.

As reported by the FDA, the most common complications reported through Medical Device Reports (MDRs) for surgical mesh slings for SUI repair, in descending order of frequency, include: pain, mesh erosion through the vagina, infection, urinary problems, recurrent incontinence, pain during intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems, and vaginal scarring.

We fully support 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.

Given the number and severity of adverse reactions to pelvic mesh, the FDA should immediately reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP) as a Class III ‘high risk’ device and consider similar action for non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of stress urinary incontinence (SUI).

Class III designations will prevent more American women from being injured by these devices. Thank you for working to protect the health of American women.

Sincerely,

We Are Mesh Survivors Coalition and the following individuals:

 

George Sheldon, AG Candidate Florida

Jane Akre, Editor, Mesh News Desk

Pamela Wise, Mesh Survivor

Elizabeth Way, Mesh Survivor

Robert Fish, son of mesh-injured woman