FDA Completely Shuts Down Sales Of Pelvic Mesh After Years Of Complaints, Lawsuits Over Safety Concerns
Litigation over pelvic mesh, also called transvaginal mesh, ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Advocates have been trying to persuade the FDA for years about the dangers of the product.
The New York Times:
F.D.A. Halts U.S. Sales Of Pelvic Mesh, Citing Safety Concerns For Women
The Food and Drug Administration on Tuesday ordered the two remaining medical device companies selling surgical mesh for the repair of pelvic organ prolapse to stop all sales and distribution in the United States. It is the most stringent action the F.D.A. has taken in the lengthy legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area. (Kaplan and Goldstein, 4/16)
The Washington Post:
FDA Orders Manufacturers To Halt Sales Of Vaginal Mesh Used In Many Pelvic Procedures
The FDA action specifically affects surgical mesh used for the transvaginal repair of pelvic organ prolapse, which occurs when the muscles and tissues supporting the uterus, bladder or rectum become weak or loose. That can allow organs to drop or press into the vagina. The regulatory action does not apply to mesh used for other conditions, such as hernias or stress urinary incontinence. (McGinley, 4/16)
The Wall Street Journal:
FDA Orders Makers Of Women’s Surgical Mesh To Stop Selling The Products
Transvaginal mesh is used to treat a condition called pelvic organ prolapse, in which organs like the bladder, uterus and others sag into the vaginal area. It is estimated that about one in eight women has surgery in her lifetime to treat the condition. The condition can be treated with conventional surgery that uses a woman’s own tissue. But some surgeons have maintained that the synthetic mesh product can lead to a more permanent repair. Mesh products also are used in hernia repair and urinary incontinence treatment, but these uses carry a lesser risk in the view of surgeons and they remain on the market. (Burton and Nakrosis, 4/17)
The Associated Press:
US Halts Sales Of Pelvic Mesh Tied To Injuries In Women
Tens of thousands of lawsuits have been filed against mesh manufacturers by women who have reported pain, bleeding and infection tied to the devices. In some cases, the mesh can shift out of place, puncturing internal organs or the abdomen wall. Those problems sometimes require multiple surgeries to remove or reposition the mesh. Starting in the 1990s, gynecologists adapted surgical mesh to treat pelvic collapse in women, which can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary issues. The FDA first approved the mesh specifically for that use in 2002 and manufacturers promoted mesh as a way to speed patients' recovery time compared to surgery with stitches. (Perrone, 4/16)
Bloomberg:
FDA Halts Vaginal Mesh Sales; Boston Scientific Shares Fall
Boston Scientific, based in Marlborough, Massachusetts, decried the decision and said it would work with the agency to determine the company’s next steps. “We are deeply disappointed by the FDA’s decision,” said Kelly Leadem, a company spokeswoman. “The inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” she said. (Cortez and Feeley, 4/16)
