The NWHN’s statement on the FDA ordering manufacturers of surgical mesh to stop selling devices for uterine prolapse

Contact: Evita Almassi, ealmassi@nwhn.org

Telephone: (202) 682-6240

 

The following statement can be attributed to Cynthia A. Pearson, Executive Director of the National Women’s Health Network.

Washington, D.C. — Today, the U.S. Food and Drug Administration ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S.

The National Women’s Health Network has a long history of raising concerns to the FDA asking them to reclassify surgical mesh for pelvic organ prolapse (POP) repair from a Class II to Class III medical device.

In 2016, the FDA reclassified transvaginal mesh used to repair pelvic organ prolapse (POP) as a Class III device—the highest risk category—in response to over 20,000 adverse event reports during a three-year period alone. The NWHN actively fought for the change, which should have also required manufacturers to submit thorough, randomized safety and effectiveness studies before new mesh products could go on the market.

On February 12, Executive Director Cynthia Pearson testified at the FDA on the dangers posed to women by relying on post-market surveillance instead of treating transvaginal mesh like a true Class III device. She stated, “The FDA decision [in 2016] to allow manufacturers to use post-market surveillance studies for pre-market approval may seem fair to companies that began clinical studies sometime between 2011 and 2016, but it is not fair to women who deserve the information from high-quality, controlled PMA studies.”

Pearson praised today’s announcement, saying: “Women deserve the highest standard of scientific evidence. Women with pelvic organ prolapse deserve treatments that work. The FDA’s decision that surgical mesh has not been shown to help clears the way for doctors and researchers to figure out what does, in fact, work.”

We applaud the FDA for listening to our advice and the concerns of thousands of women. They have acted to protect women’s health.  The NWHN calls on the FDA to always stand up for women and protect their safety.

 

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