New details on Johnson & Johnson’s (NYSE:JNJ) marketing of its controversial transvaginal mesh implants are again in the spotlight as unsealed documents suggest that the healthcare giant sold the devices for an additional 9 months after the FDA deemed the products adulterated and asked J&J to pull them off the shelves.
J&J’s Ethicon division brought the original Prolift device to market in March 2005, based on the safety and effectiveness of an existing device, the Gynemesh PS, which won FDA clearance in 2002, spokesman Matthew Johnson told MassDevice.com in an email last month.
Prolift did not go through FDA review channels until 2007 when the federal watchdog agency noticed the device on a submission for a different product, the Prolift+M.
"During FDA’s review of Ethicon’s 510(k) submission for Prolift+M in 2007, FDA requested, and Ethicon provided, documentation of Ethicon’s assessment of Prolift as a change to Gynemesh PS that did not require a new 510(k) under FDA’s ‘Guidance on When to Submit a 510(k) for a Change to an Existing Device,’" Johnson told us.
Newly released communications between the agency and the company suggest that the FDA ordered J&J to halt sales on the Prolift device until the company had provided "adequate information," Bloomberg reported.
"If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it," Adam Slater, an attorney suing on behalf of 150 women, told the news service. "It’s egregious that J&J was selling the device without clearance."
"The letter referenced by Bloomberg in their recent story was only one part of an extended dialogue with FDA in 2007-2008, and it is referenced out of context," Johnson told MassDevice.com today. "The agency did not take any compliance actions in this situation because such steps are not typically taken when the FDA determines that a company relied in good faith on agency guidance."
The Prolift won FDA clearance in May 2008 after 9 months of discussions with Ethicon about proper labeling and potential issues associated with the device. The agency didn’t apply any penalties because it determined that J&J’s acted in good faith and cooperated with the agency’s demands.
Misgivings about the company’s path to the market may harm the company’s case as it moves forward with a clutch of patient lawsuits claiming that the company’s transvaginal mesh products did more harm than good.
The mesh hullabaloo stems from a July report by the FDA’s Obstetrics & Gynecology Devices Panel. The group recommended bumping the devices, which are used to treat pelvic organ prolapse, into a higher risk category given rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.
"Ethicon remains committed to vigorously defending all product liability lawsuits concerning the use of our pelvic mesh products," Johnson told us. "Numerous clinical studies suggest that when combined with proper surgical technique, surgical mesh can improve patient outcomes, and Ethicon’s devices are among the most studied devices on the market for this condition."