Lena Keeton contracted a deadly flesh-eating bacteria following surgery in 2001 to implant a synthetic mesh bladder sling to treat her occasional incontinence, and has since endured 17 surgeries and ongoing medical problems as a result of the mesh. Now Keeton, who spits her time between Austin, Texas, and Miami Beach, Fla., was in Washington, D.C., last week lobbying federal officials to strengthen oversight of medical devices such as surgical mesh.
The Food and Drug Administration (FDA) recently issued a warning to patients about complications with the mesh when used transvaginally to treat pelvic floor disorders, including incontinence and pelvic organ prolapse. While more problems were associated with the mesh when used for the repair of pelvic organ prolapse, a high number of complications were also associated with its use for incontinence.
The FDA then charged an advisory panel to review complaints about the devices. The panel opted not to recommend banning the devices, recommending instead that the they go through rigorous testing before similar products are allowed on the market.
Transvaginal mesh is considered a moderate-risk medical device, and can be approved by the FDA through an expedited process that requires no clinical testing if there are similar devices already on the market. More than 90 percent of moderate-risk medical devices do not require proof that they have been clinically tested and found safe and effective to be cleared by the FDA.
Medical device companies argue that the accelerated process allows thousands of medical devices onto the market in a timely manner and that most of these devices are safe. However, in 2009, FDA records showed nearly 5,000 people died due to problems associated with various medical devices.
The FDA recently announced that it is proposing to increase fees for medical device manufacturers, and that this increase would go to hire more staff to oversee the approval process of new moderate-risk medical devices. This, they hope, will help keep the process timely while ensuring greater safety.