Johnson & Johnson Ignored FDA Order to Stop Selling Mesh: When Will They Learn?

According to Bloomberg News, Johnson & Johnson continued to sell one of its vaginal mesh implants for nine months after the FDA told it to stop marketing the device.

In a letter on August 24, 2007, the FDA ordered J&J to halt the sales of its Gynecare Prolift device until the agency could determine whether the device was “substantially equivalent” to other products on the market. This order was due to the potentially “high risk for organ perforation” when mesh is implanted vaginally to support weakened pelvic tissue. After nine months of negotiating with J&J’s Ethicon unit, the FDA cleared the device in May 2008 without ordering sanctions.

This isn’t the first time J&J has put its profits before people. On March 23, 2012, we told you about how J&J chose to sell off its inventory of metal-on-metal hip implants instead of recalling them. Just a month before that, it was revealed that J&J sold the ASR Hip Resurfacing System overseas after it was rejected by the FDA.

J&J began selling the Prolift in 2005 without filing a new application after its own determination that it was substantially similar to the Gynemesh, a device, also sold by J&J, that was approved by the FDA. The FDA didn’t learn about Prolift until 2007. Both Prolift and Gynemesh are subjects of the nationwide transvaginal mesh litigation.

According to the FDA, 123 complaints were made about the Prolift from 2005 to May 15, 2008. Since then, a fivefold jump in deaths, injuries, or malfunctions tied to transvaginal mesh has been reported. In January, the FDA ordered J&J, Murray Hill, C.R. Bard, Inc., and other manufacturers to study organ damage and complications related to the products. On June 5, J&J said it will stop selling four vaginal mesh implants, including the Prolift.

Categories: Transvaginal Mesh