FDA Proposes New Orders Targeting "Clear Risks" With Vaginal Mesh
Identifying what it calls “clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse” (POP), the U.S. Food and Drug Administration recently issued two new proposed orders to address those risks in order to ensure “more safe and effective products.” If those orders are finalized, the FDA would reclassify surgical mesh from a moderate-risk device (class II) to a high-risk device (class III) and would require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness prior to marketing of such devices.
POP is caused when bodily structures that hold in place pelvic organs like the bladder, uterus, and bowel become so weak, stretched, or broken that the organs drop from their normal positions and bulge (or prolapse) into the vagina. This can create extreme pelvic discomfort for women with POP, as well as disrupt sexual, urinary, and bowel functions and reduce their overall quality of life.
Surgical mesh is a medical product that was intended to provide additional support when repairing weakened or damaged tissue. However, the FDA has identified serious health complications associated with the use of transvaginal surgical mesh to repair POP. In particular, the FDA’s review found that the use of mesh in transvaginal POP repair introduces risks that are not present in traditional non-mesh surgery for POP repair, and that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair, which can be debilitating for some women, and in some cases even multiple surgeries will not resolve the complication. Mesh shrinkage is another risk of transvaginal POP repair, which is associated with vaginal shortening, tightening, and pain. Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful intercourse, or an inability to engage in sexual intercourse.
The FDA issued the proposed orders on April 29, 2014 and will take comments on them for 90 days.