Congress Questions the FDA’s 510(k) Process

In the wake of approximately 600 lawsuits, each of which allege that the surgical application of transvaginal mesh was responsible for severe injuries, medical device manufacturers are facing the repercussions of their previous neglect for public safety. However, the blame has not been placed solely on the shoulders of industry leaders. Recent complaints indicate that the medical device approval process, regulated by the U.S. Food and Drug Administration (FDA), is equally responsible for the introduction of dangerous devices to the U.S. market. Subsequently, Congress has been pushing for an overhaul of the current 510(k) approval process.

According to 510(k) Clearances identified in the FDA’s Food, Drug and Cosmetic Act, medical device manufacturers are required to notify agency officials of their intent to market a medical device at least 90 days in advance. This allows the FDA to determine whether the device is substantially equivalent to a device already placed on the market. Accordingly, if a new device displays the same propensity for safety and effectiveness as one already on the market, it is deemed safe for interstate commerce.

However, concerns regarding the 35-year-old 510(k) system have been acknowledged in a number of recent lawsuits. Johnson & Johnson (J&J), an industry leader in medical device production, is in the middle of a lawsuit that claims a woman was injured by a transvaginal mesh device that was substantially similar to Boston Scientific’s ProteGen, a transvaginal mesh device removed from the market over ten years ago because of safety concerns. Unfortunately, the FDA continued approving similar J&J devices after ProteGen was pulled from the market, even after similar devices were removed from the market because of safety concerns.

Actions taken by the FDA, under regulations cited in the current 510(k) process, demonstrated a gross neglect for public safety. As a result, Congress believes that the current plan needs to be revised in order to protect consumers from any further outbreaks of adverse events. According to Amy Allina, a policy director at the National Women’s Health Network, “The chain of approvals that began with Boston Scientific’s device highlight a key flaw in the 510(k) process.” In a recent interview, Allina concurred that the system is flawed, stating “if a first iteration is recalled, they don’t necessarily look at the second, third or fourth things that are based on that.”

As of January 2011, the FDA released a report that acknowledged significant concern about the use of recalled predicates, saying that such a practice could “put patients at risk.” Accordingly, the FDA stated that it would consider 25 changes to the current 510(k) system as early as this year, including stricter guidelines on what products can be cited to back new devices. Approximately 7 months later, the U.S. Institute of Medicine warned of the risks associated with clearing medical devices based on older products. About 29 percent of devices cleared through 510(k) are no longer on the market.

Do I Have a Transvaginal Mesh Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in transvaginal mesh lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by transvaginal mesh, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.