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FDA 510(k) Approval Process & Patient Safety (Transvaginal Mesh)

fdaThough the 510(k) approval process used by the U.S. Food & Drug Administration (FDA) to quickly and efficiently clear medical devices similar to already approved products has its benefits, the process does present hazards to patient health and safety, since it is less stringent about clinical trials. For example, if a medical device manufacturer already received FDA approval for a certain product, some companies have been known to redesign that original product in a small way, and bypass the requirement of conducting clinical trials, since the new, slightly modified product is considered similar to the original product.

This process of winning approval without proof of consumer safety is the topic of a recently published article on the New York Times Well blog. As discussed in the article, after gaining FDA approval, a medical device manufacturer can alter their product for what appears to be an unlimited number of times without having to reapply for approval.

Over time, accounting for all of the modifications, it is highly likely that the original product would no longer be similar to the modified product. In such a case as this, a clinical trial is imperative in gaining a better understanding of whether the modified product is still as safe to use as the original.

Through submitting their modified transvaginal mesh products through the 510(k) approval process, Johnson & Johnson (J&J) was able to send to market a number of products that have since been the subject of thousands of lawsuits filed across the U.S.

J&J submitted a 510(k) application for the Gynecare Prolift mesh, and received approval in May 2008. According to a Bloomberg article published in March 2012, the FDA cleared the Prolift mesh because, in their 510(k) application, J&J supplied evidence that the Prolift was as safe to use as the original mesh product, Gynemesh.

Though the evidence said otherwise, the Gynecare Prolift mesh has been blamed for debilitating injuries sustained by thousands of women due to mesh erosion. For some women, these transvaginal mesh injuries have permanently changed their lives.

Carey Danis & Lowe Can Help

Carey Danis & Lowe is a national law firm based in St. Louis that has a team of dedicated defective medical device lawyers who represent women who have been injured by transvaginal mesh. If you have been injured by transvaginal mesh, explore your legal options and compensation eligibility with Carey Danis & Lowe today.

Contact Carey Danis & Lowe by phone at 800.721.2519, or by completing one of our confidential personal injury claim forms.