Johnson & Johnson's ($JNJ) sordid vaginal mesh implant saga continues, as Bloomberg reports that the company continued to sell Gynecare Prolift for 9 months after the FDA ordered the company to pull the product and address safety concerns.
In a 2007 letter unearthed by Bloomberg, the agency warned J&J that failure to yank the urinary incontinence-treating device would constitute a breach of law, but that didn't stop company from selling the implants. The agency eventually cleared Prolift 9 months later.
A company spokesman told the news service that the letter is "out of context." But attorneys representing the more than 1,400 women who say Prolift caused scarring, pain, nerve damage and organ perforation contend it's just more evidence that J&J deliberately dodged safety regulations in pursuit of profit.
And the FDA isn't coming out unscathed, either. The agency didn't sanction J&J for those 9 unregulated months of Prolift sales, and the regulators previously declined to punish the company for the three years it marketed the mesh without proper approval, determining on its own that Prolift was substantially equivalent to earlier techs. One lawyer suing the company said the agency lacks the necessary power and resources to enforce the proper safety measures, allowing companies to put patients at risk.
J&J has agreed to stop selling four of its vaginal meshes, including Prolift, but is not conducting a recall and says the decision has nothing to do with safety concerns, citing changing market conditions instead.
- read the Bloomberg story