“My doctor reassured me that a TVM sling was the way to go and I wouldn’t have any complications,” says Shirley. “I later found out that I had the implant just a few months after the FDA ordered the mesh makers to look more closely at the risks associated with these devices.” And about six months before that, the FDA warned the medical community and the public that transvaginal placement of surgical mesh to treat pelvic organ prolapse may carry more risks than other surgical options, without any evidence of greater benefit. “How could my doctor not have known about the FDA warnings? I’ve been in pain for six years,” says Shirley.
Shirley filed a complaint against the mesh manufacturer because it led her doctor to believe their device was safe. “If I was aware of the FDA warnings, of course I would never have allowed the implant. So my complaint, along with pain and suffering, is that I wasn’t properly warned. And neither was my doctor. Obviously he wouldn’t have advised the mesh to treat my prolapse had he known. He told me that he doesn’t have enough time in the day to read every FDA warning. But he does have time to listen to transvaginal mesh sales reps.”
Almost ten years ago Linda (not her real name) was implanted with a transvaginal mesh bladder sling to treat incontinence. Her urologist sold her on the new “mini sling” that purportedly had less risk of complications and was the “latest in technology”. Less than a week after surgery Linda was in his office, requesting that he take it out.
“He told me not to worry and assured me that the surgery was a success,” says Linda. “I asked him how it could be a success when I am in so much pain. He said the pain wasn’t coming from the mesh but from my gallbladder because I am elderly.” Linda was 55 years old when she had the surgery. She complained to her primary doctor about the mesh but he sided with the urologist. Linda was more than frustrated. She had nowhere to turn because her insurance wouldn’t cover a second opinion by another urologist.
READ MORE TRANSVAGINAL MESH LEGAL NEWS
As of November 2014, more than 65,000 transvaginal mesh lawsuits had been filed against a number of manufacturers, including C.R. Bard, Ethicon (a Johnson & Johnson subsidiary), American Medical Systems and Boston Scientific.