FDA Strengthens Safety Requirements for Transvaginal Mesh Products
The U.S. Food and Drug Administration (“FDA”) has issued tighter regulations for surgical transvaginal mesh products that are designed to address pelvic organ prolapse, which is a condition that occurs when the pelvic floor is no longer able to support a woman’s pelvic organs. The surgical mesh is intended to strengthen the pelvic floor and wall, and to help keep the pelvic organs in place. The devices have been used for several decades in surgeries to treat pelvic organ prolapse and the stress urinary incontinence that results from the condition.
Common issues associated with the devices surfaced around 2002, involving devices implanted through the vaginal canal as opposed to through the abdomen. The method of implantation through the vaginal wall was touted as a more efficient way to implant the device that required less healing time and resulted in a smaller incision. According to the FDA, however, the veracity of these claims has not been proven.