The Food and Drug Administration (FDA) has ordered manufacturers of surgical mesh used to treat pelvic floor disorders to conduct three years of trials to determine just how dangerous their devices are and whether they provide any benefit over older methods of treatment. The order comes just months after the FDA began a safety review on the mesh after discovering a five-fold jump in deaths, injuries and malfunctions associated with the devices.
Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used to shore up pelvic organs that have dropped due to age, childbirth or obesity.
Problems may arise if the mesh erodes through the vaginal wall, which can cause excruciating pain and complications such as painful intercourse, infections, inability to sit or urinate without a catheter, and a return of incontinence or prolapse. Many of these conditions require multiple hospitalizations and surgeries to remove the mesh, and many women claim they have suffered permanent injury.
Thirty-one medical device companies make transvaginal mesh, of which Johnson & Johnson and C.R. Bard Inc. are the largest. All 31 companies received letters from the FDA notifying them that they would be required to conduct safety studies on their transvaginal mesh products. They have 30 days to respond to the order.
An estimated 300,000 transvaginal mesh devices were implanted in the United States in 2010. More than 650 lawsuits have been filed against manufacturers of the mesh from women who allege they have suffered injuries.
Transvaginal mesh is currently classified as a “moderate risk” medical device. The FDA advisory panel recommended that the devices be reclassified as “high risk,” which would require them to undergo more rigorous clinical tests before new mesh products are approved for sale in the United States. The FDA has yet to make a decision whether it will heed the panel’s advice.
Source: Business Week