The U.S. Food and Drug Administration recently announced two proposals to reclassify transvaginal mesh. This response is due to serious health risks linked to transvaginal mesh repair following pelvic organ prolapse (POP). If proposals are finalized, it would reclassify transvaginal mesh from a moderate-risk device (class II) to a high-risk one (class III). Upon approval, manufacturers must submit a pre-market approval application to the FDA for evaluating device effectiveness as well as safety.
FDA Announces Intention to Reclassify Transvaginal Mesh As “High Risk” Device
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said Dr. William Maisel. Dr. Maisel currently serves deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health.
Why Reclassify Transvaginal Mesh Now? How Was It Initially Approved?
According to the Wall Street Journal, many transvaginal mesh kits received FDA approval through the 510(k) process. This program approves any device substantially similar to others already on the market without clinical trials. The process is frequently criticized for approving new devices without proper safety testing. Further, the FDA is investigating serious transvaginal mesh complication reports. Possible adverse events include shrinking as well as device migration throughout the body. Migration or perforation injuries may be severe and cause chronic pain.
In addition, the FDA will review surgical mesh kit instruments provided separately from TVM implants. The FDA proposes to reclassify urogynecologic surgical instrumentation from low-risk (class I) to moderate-risk devices (class II).
What You Can Do
Women who suffer major transvaginal mesh complications may qualify for a cash settlement. To see if you have an eligible claim, fill out your free TVM claim review form today. After submitting your information, an experienced attorney in your area will contact you to discuss your compensation options.