January 28, 2016 — Johnson & Johnson will pay $120 million to settle 2,000-3,000 lawsuits involving vaginal mesh, in the first big settlement out of nearly 45,000 lawsuits pending against the company.
Bloomberg reports that the average payouts will vary depending on the strength of each case.
This is the first time Johnson & Johnson and its Ethicon subsidiary have agreed to a large-scale settlement. The company has resolved only a handful of cases until now.
The settlement came just weeks after a Philadelphia jury ordered Ethicon to pay $12.5 million to Patricia Hammons, a woman who needed multiple surgeries after her Prolift mesh implant perforated her bladder.
The Ethicon Prolift was pulled off the market in June 2012, just months after the FDA ordered the company to conduct new studies to investigate its safety.
Earlier this month, the FDA reclassified vaginal mesh for the repair of pelvic organ prolapse (POP) as a Class III (“high-risk”) medical device. The agency also strengthened pre-market approval requirements.
The moves follow a series of warnings about the dangers of vaginal mesh, including erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, urinary problems, recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.
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