The U.S. Food & Drug Administration (FDA) has banned the sale of transvaginal mesh implants used to treat pelvic organ prolapse, concluding that their potential risks outweigh any purported benefits.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, said on Tuesday. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
Transvaginal mesh implants are indicated for the surgical repair of pelvic organ prolapse or stress urinary incontinence. Both conditions plague millions of women, frequently after childbirth.
The FDA began reviewing transvaginal mesh more than a decade ago, after thousands of patients reported painful and potentially permanent injuries, including:
Just three years later, the agency warned that complications following transvaginal mesh prolapse repair are not rare, a reversal of the position it took in 2008.
The FDA finally designated transvaginal mesh for prolapse surgery high-risk medical devices in 2016. Manufacturers that intended to continue marketing their implants were required to submit new applications to the agency. Most medical device makers chose to stop selling the devices.
Only Boston Scientific Corp. and Coloplast, Inc. submitted new applications , and both apparently failed to prove the long-term safety or benefit of their transvaginal mesh implants to the FDA’s satisfaction. They agency has ordered the companies to withdraw their products from the market within 10 days.
More than 100,000 women have sued transvaginal mesh manufacturers during the past decade, making litigation one of the largest mass torts in United States’ history. Boston Scientific and other device makers have agreed to pay more than $8 billion to settle claims.
The litigation involves transvaginal mesh for prolapse repair, as well as implants for stress urinary incontinence. While devices for incontinence have also injured thousands of women, the FDA ban does not extend to those implants.