FDA Makes Major Announcement Halting Sales of Medical Device Pelvic Mesh
On April 16, the Food and Drug Administration (FDA) made a significant announcement concerning the medical device known as the pelvic mesh. Specifically, the FDA ordered all medical device companies still selling the product to stop sales and distribution throughout the United States.
The product was manufactured and has been used since the 1970s in order to treat weak pelvic muscles that can cause urinary incontinence and other issues with the bladder, uterus, and other organs. However, according to allegations made by some plaintiffs in mesh-related litigation, the product also lead to significant complications, such as bleeding, dislodging, inflammation, infection, and pain after being implanted in patients’ vaginal walls. A number of women reportedly had to undergo a second surgery in order to repair the damage from its implantation because, according to some sources, the small mush devices have a complication rate of 5 to 15 percent. Disputes over the product have gone on for more than a decade; involving thousands of complaints of serious injuries and approximately 80 deaths.
FDA Claims
According to reports, the FDA invited pelvic mesh manufacturers to submit information indicating that the devices were safe and more effective than alternatives, such as surgery, starting in 2016. However, according to the FDA, the relevant companies failed to meet this burden of proof; Specifically, the FDA claims that the companies failed to submit the proper evidence indicating that the devices were safer and more effective than surgery to repair pelvic organ prolapse.
Projected Impact Of This One Announcement
This litigation ranks as one of the largest mass tort cases in United States history in terms of the number of corporate defendants and settlement totals. The FDA’s announcement, alone, is expected to significantly affect the two companies that still primarily sell the product, including Coloplast and Boston Scientific, as well as verdicts against previous manufacturers of the devices, such as Johnson & Johnson. As of now, manufacturer such as Boston Scientific and Johnson & Johnson are paying approximately $8 billion to resolve approximately 100,000 claims.
The companies now have 10 days to come up with a plan for how to withdraw devices from the market. Still, at this time, there is no indication that the FDA has extended the decision to include mesh devices used for treatment of certain urinary conditions, such as stress incontinence. Companies that manufacture devices have indicated that approximately 50 percent of women will suffer from pelvic organ prolapse because these products are no longer available. Transvaginal mesh products count for approximately 25 million in sales per company, where, between 2010 and 2017, sales in the United States alone total approximately $600 million.
Contact Our Texas Defective Medical Device Attorneys to Find Out More
A number of medical device manufacturers and other companies are currently involved in state and federal litigation fighting to defend themselves against products like the pelvic mesh that the FDA previously approved. If you are defending against a claim such as this, contact our Brownsville defective medical device attorneys at Colvin, Saenz, Rodriguez & Kennamer, L.L.P. today to find out how we can help.
Resource:
nytimes.com/2019/04/16/health/vaginal-pelvic-mesh-fda.html
