As a defective medical device attorney, I’ve read with growing alarm about the problems with certain vaginal mesh products. These are medical devices used in surgery for women who have suffered prolapse of pelvic organs such as the uterus; the mesh helps keep the organs in place, alleviating symptoms like urinary incontinence. The mesh products are relatively new, however, and studies have begun showing that transvaginal mesh products are associated with serious complications that threaten patients’ lives or cause significant pain. As a result, lawsuits have arisen all over the country, alleging that mesh manufacturers knew or should have known about the serious risks. Now, Bloomberg News reported March 21, it has emerged that Johnson & Johnson, maker of the Gynecare Prolift device, actually sold the device without FDA approval.
It is illegal to sell new medical devices in the U.S. without FDA approval, unless they are substantially similar to devices that are already approved. FDA approval includes testing in human subjects designed to make regulators and doctors feel comfortable with the safety of the product. Johnson & Johnson failed to get that approval because it believed the Gynecare Prolift was similar enough to an approved product. However, the FDA didn’t know of the Prolift’s existence until 2007 — three years after it went into the market — when Johnson & Johnson applied for FDA approval of a related product. The FDA required the medical device company to submit a late application for approval after it learned of the problem, and both devices were eventually approved. However, selling an unapproved device could also lead to warning letters, seizure of the product, fines or a court injunction forbidding more sales.
Vaginal mesh devices, including those from other manufacturers, have been in the news because they’re responsible for a flood of reports of injury to the FDA. Last summer, that agency issued a report finding a fivefold (five times as many) jump in deaths, injuries or malfunctions related to vaginal mesh products. An FDA advisory panel later recommended that vaginal mesh be put in the “high risk” category of devices that require testing in humans. Earlier this year, it required certain manufacturers to study complications of those products. These include erosion of the mesh through the vagina and shrinkage of the mesh, both of which can cause severe pain, infection, painful intercourse and irritation to male sexual partners. In addition, mesh shrinkage can cause the vagina to tighten or shorten. These criticisms apply to all brands, but Johnson & Johnson alone is facing more than 550 lawsuits over the Prolift.
As a dangerous medical device lawyer, I suspect more lawsuits may be on their way when patients and their attorneys hear about Johnson & Johnson’s apparent decision to ignore the well-known FDA approval process. Though politicians and patient advocates have sometimes said the lengthy approval process is slow and often unnecessary, it’s also designed to protect the public. When manufacturers choose to ignore it, or find ways to limit it or withhold information, they’re putting their patients at risk. Indeed, the number of vaginal mesh complaints the FDA has received appear to show the risks of end-running around FDA approval. As a medical device liability attorney, I look forward to hearing how they do in court.
Carey, Danis & Lowe represents clients across the United States who have been seriously injured by a medical device or pharmaceutical they trusted. To tell us your story and discuss your legal options, call us for a free consultation at 1-877-678-3400 or send us a message online.
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