National Consumers League

FDA acts to protect women’s health

Nissa Shaffi

Last April, the U.S. Food and Drug Administration (FDA) issued a ban on all sales of pelvic surgical mesh products after determining that the manufacturers, Boston Scientific and Coloplast, failed to “demonstrate [a] reasonable assurance of safety and effectiveness.”

The ban comes on the heels of a 2016 reclassification of the product by the FDA, resulting in a class III (high-risk) designation. As a result, the manufacturers were required to undergo meticulous review and obtain premarket approval by the FDA in order to continue sales of their products in the United States.

A surgical mesh is a medical device used to treat urogynecological or pelvic organ issues. Most commonly, surgical mesh has been used to treat pelvic organ prolapse (POP). POP is a type of pelvic floor disorder that occurs when the muscles and tissues supporting pelvic organs become weakened–often resulting in urinary incontinence typically seen as a result of childbirth or advanced age.

A transvaginal surgical mesh is intended to provide additional support to the pelvic floor muscles to reinforce a weakened vaginal wall for treatment of POP. A urethral sling surgical mesh is supposed to provide support to the urethra or bladder to address urinary incontinence. Surgical mesh comes in two forms: synthetic and animal derived. Synthetic surgical mesh remains in the body indefinitely and acts as a permanent implant. Animal derived mesh, made from the intestine or skin of pig or cow, are absorbable and lose durability over time.

The most frequent complications from these devices include vaginal scarring, mesh erosion, increased risk of infection, and painful urination. Nearly 10 million women worldwide have received mesh implants, with about 10 to 15 percent of these women suffering from complications. Following the ban, there are currently no FDA-approved pelvic surgical mesh products available for sale in the United States.

The FDA advises that women who have already received a transvaginal mesh for the surgical repair of POP should continue their routine follow-up care with their provider and need not take any additional action if they are satisfied with their procedure. Patients should notify their provider if they experience any adverse reactions, such as bleeding or pain, following the procedure.

Given the grave injury these devices have caused in women patients, the National Consumers League questions how they ever received FDA approval in the first place. Nevertheless, banning the devices now is better than keeping them on the market. We must expect better from our healthcare regulators. Thankfully, we now have stronger safety standards that have brought an immediate halt to the sale of these unsafe medical devices.

To read the FDA’s full report on transvaginal mesh, click here.

NCL Health Policy Intern Alexa Beeson contributed to this blog.