The U.S. Food and Drug Administration’s (FDA) oversight of transvaginal mesh products culminated with an emergency order to remove all transvaginally placed prolapse devices from the market in April 2019, with restrictions escalating for years prior to the order, and more than 100,000 cases overall.
By October 2023, defendants had paid $525 million to compensate plaintiffs implanted with vaginal mesh devices to repair pelvic organ prolapse (POP). The courts anticipate a total of $550 million to ultimately be distributed to plaintiffs, with 95 percent of the cases now settled or dismissed.
Surgeons began using surgical mesh to repair hernias in the 1950s. Gynecologists began repairing abdominal tears related to POP in the 1970s and using mesh for transvaginal repairs of POP beginning in the 1990s. The FDA in 2002 cleared the first transvaginal mesh device to repair POP as a Class II device. Class II is reserved for devices which pose moderate risks to patients. About 12.5 percent of all women will undergo POP-repair surgery during their lifetime, although the use of transvaginal mesh devices for the procedure had already declined since the FDA began issuing warnings about safety concerns.
When the last transvaginal mesh prolapse products were removed from the stream of commerce in 2019, the FDA found that the manufacturers, Boston Scientific and Coloplast, failed to show the products were safe and effective, which was a mandatory standard after the FDA reclassified them to a high-risk Class III in 2016. To market Class III products in the U.S., the manufacturers had to receive market approval after undergoing stringent review and submitting a premarket approval (PMA) application. They failed to do this, prompting the FDA to issue the withdrawal from the market order.
July 2011. After consumer complaints and numerous adverse events, the FDA released an FDA Safety Communication with new recommendations for using surgical mesh for transvaginal prolapse repair.
September 2011. The Obstetrics and Gynecology Devices Panel advised the FDA about the pitfalls and benefits transvaginal mesh offers when used for POP repair. After the meeting, 522 orders were issued to 34 transvaginal surgical mesh manufacturers, requiring that they complete post market surveillance studies to establish safety and efficacy. Most manufacturers abandoned transvaginal mesh repair for POP as a result.
January 2016. Transvaginal surgical mesh manufacturers were dealt another blow when the FDA reclassified mesh devices from moderate to the highest Class III. To keep their products on the market, remaining manufacturers were subject to the most scrutinized path to device approval and required to file premarket approval applications.
July 2018. Premarket approval applications for transvaginal mesh devices used to repair POP were due by July 5, 2018. The manufacturers that submitted applications were permitted to continue to sell their products while the FDA reviewed the PMAs and those that did not submit PMAs had to withdraw their products.
February 2019. An advisory committee at the behest of the FDA was asked to provide scientific and clinical evidence about the benefits, risks, safety, and effectiveness of using transvaginal mesh. The committee also made recommendations about physician training to use the mesh and how to identify women who would be appropriate patients to receive the procedure.
After transvaginal prolapse mesh was withdrawn from the market in 2019, the FDA released a statement that it is committed to improving women’s health, and the safety and effectiveness of all medical devices, including those used to treat pelvic floor issues. Unfortunately, many women have already experienced pain and suffering from transvaginal mesh erosion.