The FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review.
The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through its pre-market approval process for transvaginal POP procedures. The moves do not apply to mesh used in other indications, including stress urinary incontinence and abdominal POP repair, the FDA said.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said Dr. William Maisel, deputy science director & chief scientist for the agency’s Center for Devices & Radiological Health, said in prepared remarks. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
An estimated 100,000 product liability lawsuits have been filed in state and federal courts across the country against pelvic mesh makers, including Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon, Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR).
Companies that make pelvic mesh for transvaginal POP procedures have 30 months to file PMA applications with the FDA for devices already on the market. The agency warned about the risks of pelvic mesh in 2008 and 2011, but in 2014 refused to ban U.S. sales of the implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.