Thousands of women who had a vaginal mesh or bladder sling implanted to treat pelvic organ prolapse have experienced severe internal injuries, urinary problems and other complications as a result of problems with the medical devices, which may actually provide no real benefit over other methods of treating pelvic organ prolapse.…
Johnson & Johnson and Ethicon have agreed to pay 41 states nearly $117 million to settle charges of deceptive marketing and defrauding state health care systems over the safety and effectiveness of vaginal mesh products.…
Johnson & Johnson faces more than 100,000 lawsuits over problems with its products, which may cost up to $50 billion to settle.…
Two new studies provide more evidence that vaginal mesh carry few, if any, benefits, and that there is little which can be done to improve them.…
A vaginal mesh lawsuit indicates Boston Scientific mesh devices caused severe injuries, complications and the need for surgery.…
Johnson & Johnson has reached a $9.9 million settlement agreement to resolve a lawsuit by the state of Washington claiming it endangered women by failing to warn about the risks of vaginal mesh products.…
The FDA has banned the sale and distribution of transvaginal mesh products in the United States, saying they cannot guarantee the devices are safe or effective for women.…
A Pennsylvania jury has awarded $41 million to a woman who suffered multiple vaginal mesh failures after being implanted with products from Ethicon, a subsidiary of Johnson & Johnson.…
The FDA will hold an advisory meeting in February to help determine the future use of transvaginal mesh in the U.S., given the high risk of complications and the low level of benefits they provide.…
The FDA is considering changes to its highly criticized 510(k) medical device approval program.…
