Transvaginal Surgical Mesh reclassified by FDA as High Risk (Class III)
On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued two final orders to both manufacturers and consumers intended to strengthen the requirements for surgical mesh used to repair pelvic organ prolapse (POP) transvaginally or through the vagina. In one order, the medical devices were reclassified from a class II (moderate risk) to a class III (high risk). The second order requires manufacturers to submit a premarket approval (PMA) application that supports the safety and effectiveness of surgical mesh used for the transvaginal repair of POP.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures.”
In recent years, the FDA has seen a significant increase in the number of complications arising from the use of surgical mesh for transvaginal POP repair. As a result, an advisory panel in 2011 recommended that more data was needed to establish device safety. Since then the FDA has taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.
In the two orders issues in January, the manufacturers have 30 months to submit a PMA for devices currently on the market. Manufacturers of new devices will be required to submit a PMA before marketing.
More information is available on the FDA website.
If you or a loved one has experienced serious injuries after receiving a transvaginal mesh implant, you may be entitled to compensation. Click HERE to learn more about important next steps.