WASHINGTON – Drug and medical device maker Endo International says it will pay $830 million to resolve roughly 20,000 personal lawsuits from patients who say they were injured by the company’s vaginal mesh implants.
The Irish company said in a statement Wednesday that the settlement is subject to a number of conditions and is not an admission of liability.
Tens of thousands of women have sued Endo and other device makers over mesh used to repair pelvic collapse in women. Mesh implants were initially pitched to doctors as an improvement over surgery, but the Food and Drug Administration has concluded they carry a higher risk of side effects including pain, bleeding and infection.
On Tuesday, the FDA proposed regulating vaginal mesh repair products as “high-risk” medical devices, subject to stricter safety requirements.