J & J’s Ethicon Ignores FDA’s Warnings to Stop Marketing Mesh Device
In August of 2007, the FDA sent Johnson & Johnson a letter stating that it needed to stop marketing and sales of Gynecare Prolift, a TVM device manufactured and sold by its Ethicon division. The FDA stated that it needed more information on 16 potential deficiencies with the product, and that it would decide whether the device should have been cleared using 510(k).
FDA concerns centered around organ perforation. The FDA clearly stated in this letter to Ethicon that continuing to market and sell this product would be a violation of the Federal Food, Drug, and Cosmetics Act, and as such could be punished by fine or sanction.
Johnson & Johnson failed to do as it was ordered by the FDA. Instead, while the FDA investigated the Gynecare Prolift, they continued to manufacture, market, and sell it. The product was eventually cleared by the FDA, but Johnson & Johnson suffered no fine, sanction, or reprimand.
Now, the Gynecare Prolift and a number of other Ethicon TVM products have been recalled. This 2007 incident is just another in a slew of examples of FDA conduct that falls short of protecting the public. Time and again, dangerous devices are cleared and put on the market, putting patients at risk. When drug companies and device manufacturers see the FDA fail to enforce any fines or sanctions on companies that have clearly violated their orders, it encourages other drug companies to follow suit and do the same. As in the case of TVM, thousands of women end up suffering irreparable harm, and it is the actions of these women that will finally hold the manufacturers responsible for their actions.
Have you or a loved one suffered serious side effects from TVM? If so, contact an attorney at Kirkendall Dwyer LLP today. We are experienced, compassionate, and can hold these device makers responsible for the injuries you have sustained. You deserve compensation; contact us today.