Transvaginal mesh and the FDA's 501(k) program: double trouble

In this month’s issue of Trial magazine, the American Association for Justice exposes important health concerns surrounding transvaginal mesh, a device surgically implanted to reinforce damaged or weakened pelvic walls caused by stress urinary incontinence (SUI) or pelvic organ prolapse (POP).

In 1996, the Food and Drug Administration approved Boston Scientific Corp.’s ProteGen mesh to treat stress urinary incontinence, which MedlinePlus defines as accidentally urinating while working out, coughing, sneezing, or laughing due to weakened pelvic walls. Johnson & Johnson’s Gynecare TVT mesh was approved two years later and as of 2010, more than 168 surgical mesh implants were approved. This was largely due to the FDA’s special approval process known as the 510(k) program, which classifies certain devices, such as surgical mesh, into low or moderate risk categories.

The 510(k) program was introduced in the late 1970s when Congress passed the Medical Device Amendments, which defined the steps the FDA has to follow in order to approve devices. Manufacturers are granted permission to begin selling their device without the need to conduct clinical studies as long as there is a similar device on the market and provided the manufacturer gives the FDA 90 days’ notice.

Due to such a lenient approval process, surgical mesh made its way into more than 300,000 surgeries as of 2010. However, the implants have been shown to cause more harm than good, leading to thousands of lawsuits against Johnson & Johnson, Ethicon, and other manufacturers.

Several reports say the devices lower a woman’s quality of life due to infection, bleeding, urinary problems, mesh contractions, organ perforation, and mesh erosion through the vagina. Because the implants are meant to be permanent, women need to go through extensive and numerous surgeries to find and remove the mesh.

In 2011, the FDA issued a notification stating that the number of reported complications is not rare and that they have not seen evidence to prove that surgical mesh is more effective than alternatives in treating stress urinary incontinence and pelvic organ prolapse.

The American College of Obstetricians and Gynecologists says that surgical mesh should be further tested for safety and used only as an experiment in clinical trials until its safety is proven.

The FDA’s 510(k) approval process continues to cause controversy among critics who some feel the program should be eliminated altogether. What do you think? Should companies be able to sell medical devices that are kind of like something else another company is selling? Or do you think they should have to prove the merits of their own product before selling it? Express your opinions in the comment section below.