FDA Issues Proposed Orders to Reclassify Transvaginal Mesh to a High-Risk Device
On April 29, 2014, the FDA issued an immediate release notifying the public of its issuance of two proposed orders to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP). If these orders are finalized, these orders will reclassify transvaginal mesh products from a moderate-risk device (Class II) to a high-risk device (Class III), thus requiring manufacturers to submit a premarket approval (PMA) application for the FDA to evaluate safety and effectiveness.
William Maisel, M.D., M.P.H. and Deputy Director of Science and Chief Scientist at the FDA’s Center for Devices and Radiological Health, said that “[t]he 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.” Maisel added, “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.”
Transvaginal mesh products (commonly referred to as pelvic mesh, vaginal mesh, or bladder slings) are medical devices that are surgically implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). As a result of childbirth, hysterectomy, or menopause, a woman’s uterus, bladder or rectum may slip out of place due to weakened muscles or ligaments. As a result of these organs “dropping,” increased stress is placed on the woman’s vagina, causing pain and discomfort, as well as urinary incontinence in some cases. Although this is a sensitive condition, it impacts millions of women nationwide.
According to the most recent report released by the Judicial Panel on Multidistrict Litigation (JPML), over 30,000 transvaginal mesh lawsuits are pending in federal courts – and the number of cases continues to grow. Complications alleged to be associated with these transvaginal mesh products, include but are not limited to, erosion or perforation of the mesh product, pelvic or vaginal pain, dyspareunia, infection, urinary or bowel problems, mesh shrinkage or contraction, mesh migration and neuromuscular problems. Other alleged complications that women suffer from the use of transvaginal mesh include invasive surgeries, as well as costly and painful medical procedures, to remove the mesh and/or repair damage. Because the vaginal mesh/sling products are designed and placed with the intention of remaining in a woman permanently, they can be very difficult to remove and may require multiple surgeries.
On October 20, 2008, the FDA released a Public Health Notification concerning “Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence”. The purpose of this notification was to alert healthcare professionals that the FDA had received over 1,000 reports of complications associated with the mesh products. On July 13, 2011, the FDA released another FDA Safety Communication to health care professionals and patients involving the transvaginal mesh products placed for Pelvic Organ Prolapse. This updated Safety Communication states, “serious complications associated with surgical mesh for transvaginal repair of POP are not rare…Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
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