gynecare mesh lawyer

Seeking Approval for Gynecare Mesh
Typically, before releasing a new product on the market, a company must apply for a review and approval from the FDA. Many times, they can opt for the so-called “fast track” 510(k) approval program, which requires only that the company show the new device to be significantly similar to one that’s already been approved.

J & J indicated that it based its decision not to apply for 510(k) approval for the Prolift vaginal mesh on the FDA’s guidance document entitled, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Since it’s up to companies to decide when to apply for approval, J & J decided that the new Gynecare Prolift was so similar to its previous product, the Gynemesh, that a new review was not necessary.

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