Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the U.S. Food & Drug Administration (FDA) to halt sales of the unapproved product.
As we’ve reported previously, Johnson & Johnson’s Ethicon unit introduced the Gynecare ProLift transvaginal mesh product in 2005, under the assumption that, because it was so similar to another device already on the market, FDA approval was not needed. But when the FDA learned in 2007 of the existence of the device, it informed Johnson & Johnson that it would need to submit a 510(k) approval application in order to continue marketing Gynecare Prolift.
In a letter dated August 24, 2007, the FDA told Johnson & Johnson to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market, according to Bloomberg. “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval. Doing so, the letter stated, would be a violation of the Federal Food, Drug and Cosmetic Act. The letter also cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.
The FDA finally approved Gynecare Prolift nine months after issuing the letter. But between August 2007 and its May 2008 approval, Gynecare Prolift remained on the market. The FDA did not sanction Johnson & Johnson for failing to heed its warning that sales of the device be halted, Bloomberg said. An FDA spokesperson told Bloomberg that no sanctions were ordered because the agency determined that the company applied its guidance in good faith and it “promptly complied” when the FDA required a new application.
A Johnson & Johnson spokesperson told Bloomberg that the August 2007 letter from the FDA was “only one part of an extended dialogue with FDA in 2007-08, and it is out of context.”
An attorney representing women in transvaginal mesh lawsuits against Johnson & Johnson told Bloomberg the episode raises concerns about the FDA’s ability to protect the public from dangerous medical device.
“Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.”
According to Bloomberg, Johnson & Johnson faces 1,400 lawsuits by women who claim Gynecare Prolift caused organ perforation, pain, scarring and nerve damage. Their cases could get a boost following revelations about the product’s approval history.
Earlier this month, Johnson & Johnson revealed in court papers that it would stop marketing Gynecare Prolift and three other transvaginal mesh lawsuits by 2013. The company has maintained that the decision was not made because of safety concern surrounding the product.
Gynecare Prolift and similar products are used in the surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Last July, the FDA said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh products made by Johnson & Johnson and other companies from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
Like Gynecare Prolift, most transvaginal mesh products used in POP and SUI repair were approved through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing if it can be shown a product is similar in design to a previously-approved device. However, the FDA is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair, and has asked the makers of such devices to conduct safety studies of the products