A New Jersey jury is recommending Johnson & Johnson and its subsidiary Ethicon pay a South Dakota woman $3.35 million for failing to warn her doctor of the serious risks associated with the companies’ transvaginal mesh device. The verdict was the first among about 1,800 transvaginal mesh lawsuits pending in New Jersey against Ethicon and Johnson & Johnson, and could impact not only the verdicts in those cases but in thousands more lawsuits filed against manufacturers of other transvaginal mesh devices.
The verdict was made in a lawsuit that alleged the companies’ Gyncare Prolift mesh was defective and caused serious injury to patients, including the plaintiff in that case, Linda Gross. The South Dakota woman had the mesh implanted in 2006 to treat urinary incontinence and pelvic organ prolapse.
The mesh is inserted vaginally to hold up organs that have dropped due to childbirth, age, or obesity. Gross, a nurse, said the device caused problems including mesh erosion, scar tissue buildup, and inflammation. She had 18 surgeries to repair the damage caused by the device.
Gross soon learned that she was not the only person to experience serious adverse reactions to the device. In 2011, the Food and Drug Administration (FDA) issued a Safety Communication that complications with transvaginal mesh are severe and frequent, and that it had received 2,874 reports of injury, death or malfunctions associated with the devices.
The FDA cited complications such as mesh erosion through the urethra, vaginal wall, bowel and bladder; bleeding; urinary tract, vaginal, and deep tissue infections; and chronic pain. The agency also noted that some women had to undergo numerous surgeries to remove the device, and many have not fully recovered.
Last June, after numerous transvaginal mesh lawsuits were filed against Johnson & Johnson and Ethicon, the companies announced they were no longer making the device.
Source: NBC News