The U.S.Food and Drug Administration has moved to strengthen regulations on vaginal mesh, a controversial medical device used to treat pelvic organ prolapse, a condition that can occur after childbirth as a result of weakened pelvic muscles.
Following reports of thousands of injuries related to the devices, FDA issued two orders this week: It reclassified the devices from Class II, generally considered to be a moderate-risk, to Class III, considered high-risk. Additionally, the agency will now require vaginal mesh manufacturers to submit “a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of” pelvic organ prolapse.
From the FDA statement:
The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal 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 postmarket surveillance measures.”
Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. The FDA has since taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.
Manufacturers of surgical mesh to treat POP transvaginally will have 30 months, as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.
Prolapse occurs when pelvic muscles become stretched, torn or weakened, making it difficult to support the bladder, bowel or uterus; these organs can then drop and bulge into the vagina.
“While not a life-threatening condition, women with POP often experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate,” according to the FDA.
This week’s move follows a series of actions by the FDA warning of potential dangers of vaginal mesh. Notably, the agency’s latest orders relates specifically to transvaginal surgery for prolapse, and not other conditions, such as stress urinary incontinence, which has also been treated with vaginal mesh.
For reaction, I reached out to several doctors and a woman who suffered from complications related to vaginal mesh.
Amy Gezon, who testified before an FDA advisory panel about her experience back in 2011, sent me this email: “I am disappointed that the FDA did not reclassify mesh kits for the treatment of [stress urinary incontinence]. The apparent disregard of the serious complications experienced by myself and countless other women is truly disheartening.” Continue reading