J&J Neglected to Adhere to FDA Sanctions

Medical device manufacturers have become all too familiar with the scrutiny that coincides with their controversial products. However, none may be more accustomed to the criticism that follows the release of medical devices than that of Johnson & Johnson (J&J). As the current industry leader in medical device production, J&J has seen an influx of opposition regarding the safety and efficacy of several products. However, their most recent transgression has witnessed that opposition turn to distain. Subsequently, J&J has been accused of selling a vaginal mesh implant for nine months after U.S. regulators told them to stop marketing the devices in question.

As one of their most prominent medical devices, the Gynecare Prolift vaginal mesh system was specifically designed to assist in the treatment of compromised or weakened pelvic tissue. The mesh was intended to act as a reinforcement to damaged tissue while it was healing. However, transvaginal mesh devices from every manufacturer became synonymous with injury, leading to the current controversy burdening our federal regulatory agencies.

In the wake of the current transvaginal mesh controversy, J&J continued to both market and produce the Gynecare Prolift vaginal mesh system, even after officials at the U.S. Food and Drug Administration (FDA) ordered them not to. In a letter addressed to J&J in August of 2007, officials at the FDA requested the medical device manufacturer to halt the sales of Gynecare Prolift systems until the devices were considered to be “substantially equivalent” to other products on the market. The FDA acknowledged, in their letter, that their reasoning for the temporary moratorium on sales was due to their “potential high risk for organ perforation.” The company faces more than 1,400 transvaginal mesh lawsuits by women who said the mesh caused organ perforation, pain, scarring and nerve damage.

In addition to halting sales of the Gynecare Prolift system, the FDA letter addressed that J&J “may not market this device until you (they) have provided adequate information” regarding 16 potential discrepancies on the safety and efficacy of these products. Furthermore, the FDA told the New Jersey-based company that “if you (they) market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”

Disregarding the letter, J&J continued to market Gynecare Prolift systems for an additional nine months without complying to the requests by the FDA. Subsequently, the agencies failure to take additional steps in sanctioning J&J for their neglect to adhere to FDA regulations raises questions about their regulatory effectiveness. Many consumers are concerned that the FDA is unable to protect them from dangerous products. According to representatives in pending litigation, “Companies know the FDA has little enforcement ability and scarce resources.”

Complicating the already volatile situation, is “the industry’s ability to shrug off FDA enforcement,” said Erik Gordon, a business professor at the University of Michigan. “If companies can get away with selling products they aren’t supposed to sell, the FDA is a sheriff packing a water pistol.

In response to the growing concern over allegedly dangerous devices being allowed into the U.S. market, the Senate plans to vote on a bill that will increases funding for reviews and the FDA’s power to order safety studies after a product is cleared.

In a recent turn of events, J&J has acknowledged that they will soon stop selling select vaginal mesh implants like the Gynecare Prolift system. J&J spokesman, Matthew Johnson, announced that the company has already asked the FDA for permission to discontinue the sales of four such products within the next 120 days. According to their discontinuation strategy, J&J will be halting the sales of several products on a region-by-region basis over the next three to nine months. Included in the discontinuation are Gynecare Prolift Pelvic Floor Repair Systems, Gynecare TVT Secur Systems and Gynecare Prosima Pelvic Floor Repair Systems.

According to Matthew Johnson, “This is not a recall; it’s a global discontinuation.” Johnson then continued to elaborate on the current discontinuation, suggesting that the products were being removed from the market largely due to negative publicity, not because of the 1,000 pending transvaginal mesh lawsuits.