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FDA Letter Shows that J&J Sold Gynecare Prolift Without Approval

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According to recently released court documents, Johnson & Johnson (J&J) continued to sell the Gynecare Prolift vaginal mesh implant after the FDA told the company to halt sales in August 2007.

The Gynecare Prolift mesh is the subject of thousands of lawsuits filed by women claiming injuries like mesh erosion, bleeding, infections, pain, and scarring. In 2011, the FDA warned that such complications with transvaginal mesh implants were not rare, and often involved multiple corrective surgeries that may not completely resolve any issues.

FDA Letter Told J&J to Halt Sales

The FDA reportedly sent a letter to J&J on August 24, 2007, telling them to halt sales of the Gynecare Prolift. Recently, the letter was made public as part of a legal request in vaginal mesh litigation.

J&J started selling the Prolift in 2005. J&J determined on their own that the device was so similar to their other mesh product, Gynemesh, that they didn't need to apply for FDA approval. The FDA disagreed with this conclusion, and required a new application. The agency expressed concern that the product could potentially increase the risk of organ perforation. J&J complied by filing the application, but continued to sell the product despite instructions from the FDA not to do so until the issue had been resolved.

The Gynecare Prolift is a surgical mesh device placed inside the pelvis to restore organ support for women with pelvic organ prolapse – a condition in which the pelvic muscles become too weakened or stretched to fully support organs like the bladder, bowel, and uterus. The mesh is intended to help keep the organs in their correct positions, but post-marketing reports linked the device to complications like infections, erosion of the mesh into the vagina, and urinary problems.

J&J Withdraws the Gynecare Prolift from the Market

J&J stated in an email that the August 2007 letter was one part of a long dialogue with the FDA, and that its contents have been taken out of context. The company stated that its actions were consistent with FDA regulations.

The FDA went on to clear the device in May 2008, after nine months of negotiations with J&J's subsidiary, Ethicon. Today, J&J faces thousands of lawsuits filed by women who claim serious injuries from Prolift vaginal mesh.

Interestingly enough, Ethicon announced in early June that it plans to stop sales on four of its Gynecare vaginal mesh implants, including the Gynecare Prolift. In a letter to U.S. District Judge Joseph R. Goodwin, J&J stated that it had asked the FDA for approval to stop commercializing the devices, requesting 120 days to end sales. The company added that they are discontinuing sales of vaginal mesh products worldwide, but they are not implementing a recall.