FDA Proposes Stricter Safety Rules for Pelvic Mesh
Adverse events cause concern
The FDA has issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and would require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate the treatment’s safety and effectiveness.
POP occurs when the internal structures that support the pelvic organs, such as the bladder, uterus, and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort; disruption of their sexual, urinary, and defecatory functions; and an overall reduction in their quality of life.
“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 William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”
Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Many mesh products come in kits that include instruments specifically designed to aid in the insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in these kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).
Beginning in January 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.
In September 2011, the FDA’s Obstetrics and Gynecology Devices Advisory Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMA applications.
In July 2011, the FDA provided an updated safety communication regarding serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the FDA also released a review of adverse events associated with urogynecologic surgical mesh adverse events, and summarized peer-reviewed scientific literature that identified serious safety and effectiveness concerns. The FDA had previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an October 2008 Public Health Notification.
Surgical mesh indicated for surgical treatments of SUI, for abdominal POP repair with mesh, for hernia repair, and for other non-urogynecologic indications are not part of the FDA’s proposed order.
Source: FDA; April 29, 2014.