The U.S. Food and Drug Administration this week issued an order for new safety studies on surgical mesh implants, which are often implanted in women to repair weakened or damaged tissue and to provide support in cases of pelvic organ prolapse (POP). The surgical mesh can also be used to help women suffering stress urinary incontinence.
The FDA’s order for new studies came after the regulatory agency received more than 1,500 reports of complications related to the surgical mesh, including erosion and infection.
U.S. health regulators also announced they may reclassify the devices, listing them in a higher-risk category. A reclassification would mean that manufacturers of the devices, such as Johnson and Johnson, and Boston Scientific, would need to conduct clinical studies in people prior to receiving FDA approval.
In 2010 alone, approximately 75,000 women have received surgical mesh repairs for pelvic organ prolapse, and more than 200,000 received transvaginal repairs for stress urinary incontinence.
Surgical mesh has been used for decades as a means by which to repair abdominal hernias. However, physicians only began to use the mesh for POP procedures back in the 1990’s and doing so has since become quite popular.