Bloomberg Businessweek recently reported that medical device maker Johnson & Johnson failed to follow the orders of the U.S. Food and Drug Administration (FDA) to stop sales of its Gynecare Prolift surgical mesh product putting thousands of women at risk for serious injury.
Documents recently made public indicate that the FDA informed Johnson & Johnson in August 2007 that its Gynecare Prolift surgical mesh device had not been approved for market and cited the “potential high risk for organ perforation” when the mesh was inserted vaginally to support weakened pelvic tissue. The letter from the FDA went further and advised that marketing of the Gynecare Prolift device was to be immediately stopped until approval was granted.
It was later discovered that while the FDA negotiated the approval of the Gynecare Prolift device with the Ethicon unit of Johnson & Johnson, the manufacturer never stopped marketing the product. These negotiations lasted nine months before approval of the device was granted in May 2008 putting thousands of women at risk of injury.
Johnson & Johnson chose to start selling the Gynecare Prolift in 2005 based on the company’s own determination that this device was substantially similar to its Gynemesh product, which was another device that was already approved by the FDA. The FDA did not learn of the Gynecare Prolift device until it received an application for the approval of another device, the Prolift+M which cited it. It was at that time that the FDA ordered Johnson & Johnson to stop marketing the Gynecare Prolift until adequate information regarding the device could be obtained.
Thousands of women who have had surgical mesh devices implanted transvaginally have filed reports with FDA complaining of serious injury. The complaints include severe pelvic pain, organ perforation, painful intercourse, urinary problems, and serious infection. These women have also filed lawsuits against Johnson & Johnson and other manufacturers of surgical mesh devices. As a result of the number of reports filed, the FDA has reclassified these devices and is now requiring manufacturers to provide additional testing of these devices to adhere to stronger safety guidelines.