How the 501(K) Approval Process Led to Thousands of Claims
Many people who have procedures done using medical devices assume that those devices are safe because they have been approved by the Food and Drug Administration (FDA). Unfortunately, the circumstances surrounding the approval of transvaginal mesh products, and the subsequent recall or withdrawal from the market of many of those products, proves that FDA approval is far from a guarantee of safety. One of the big issues is that the FDA has a fast-tracked approval process called the 501(K) clearance process.
Under the 501(K) clearance process, a medical device can be approved for sale with limited or even no premarket testing on humans. How is this possible? The device is approved because medical device manufacturers claim it is substantially similar to existing devices already approved on the market. Unfortunately, this “existing device” could be a product that itself is not safe, that has led to thousands of adverse event reports or that has even been recalled voluntarily. This happened with many transvaginal mesh products, which left thousands of women experiencing severe pain, discomfort during intercourse, vaginal scarring, infections and perforated organs. If you are one of the many women who suffered complications due to vaginal mesh, you need to understand your rights. Carey, Danis & Lowe can represent you.
FDA 501(K) Approval and Transvaginal Mesh
Boston Scientific was the first medical device manufacturer who brought a transvaginal mesh product to market using the 501(K) clearance process. In 1996, Boston Scientific obtained approval of its ProtoGen vaginal sling based on an earlier approval (#K851086) of Ethicon’s Mersilene Mesh.
Four other devices were then approved based on the ProtoGen including the Tension Free Transvaginal Taping Device (TVT), the TriAngle Sling, the In-Sling, and the Mentor Suspended Sling. More manufacturers, including Ethicon (a Johnson & Johnson subsidiary) and C.R. Bard also began coming out with their own vaginal mesh products, with virtually all devices getting 501(K) approval.
Unfortunately, just a few short years after initial approval, Boston Scientific submitted a letter to the Food and Drug Administration on January 22, 1999. The letter indicted the intent to institute a voluntary recall of the ProtoGen because of complications patients were facing. The ProtoGen was removed from the market, and Boston Scientific subsequently settled 738 lawsuits arising from the defective medical device. The transvaginal mesh market was thriving by this time, though, and thousands more patients would go on to be injured both by devices that were later recalled as well as by transvaginal mesh products that remain on the market to this day.
In St. Louis, victims injured by mesh products manufactured by Boston Scientific, Ethicon (Johnson & Johnson), C.R. Bard, American Medical Systems and other mesh manufacturers can pursue a transvaginal mesh claims in St. Louis with the help of an injury lawyer from Carey, Danis & Lowe.
To learn more, please download our free How The 510(K) Approval Process Led To Thousands Of Vaginal Mesh Claims here.