Yesterday’s announcement that the FDA is requiring clinical trials of vaginal mesh used for pelvic organ prolapse is good news for women! Until yesterday, women who were told by their physicians that their condition should be treated by implanting surgical mesh into the vagina had no reliable information about the risk of this procedure, because the necessary studies were never done. The National Women’s Health Network has been a leader on this issue and we are proud that the FDA listened to our concerns to reclassify surgical mesh for pelvic organ prolapse (POP) repair from a Class II to Class III medical device.
The first mesh device received a Class II (moderate-risk) designation in 2002 from the FDA, meaning that no pre-market data was required. Since then, thousands of women have experienced painful and disabling outcomes after having these devices implanted; from 2011-2014, the FDA received over 20,000 adverse event reports for surgical mesh for POP repair alone. Studying the devices to find out whether women are better off after treatment is essential, and we applaud the FDA for taking this step to protect women’s health. We encourage manufacturers to enroll a diverse group of women in their studies, including age and race, so that all women are well-represented and will have access to the vital information they need.
Despite the cause for celebration, there is still more work to be done to make sure vaginal mesh is safe and effective for women to use. We’re disappointed that the FDA’s announcement did not mention requiring premarket approval (PMA) studies for transvaginal mesh used for stress urinary incontinence (SUI). Although this condition is different than POP, the treatment also exposes women to known and unknown risks associated with the device. POP and SUI are different from each other, and both are drastically different from abdominal hernias, the original condition surgical mesh was intended to treat. Just because surgical mesh is safe and effective when used for hernia repair doesn’t mean that it is equally safe and effective for use in the vagina.
Reclassifying transvaginal mesh as a Class III device and requiring robust clinical trials with long-term follow-up is the right thing to do. Manufacturers need to accept responsibility for testing their products in women and do so prior to marketing or selling them. It’s about time that the FDA finally required manufacturers to study transvaginal mesh in women and we applaud their efforts to ensure the safety of this device for women who may use it.