Why did the Food and Drug Administration approve the Ethicon hernia mesh, a dangerous medical device that is the subject of thousands of lawsuits and has been linked to at least three wrongful deaths?
The agency, which is supposedly a consumer safety watchdog, approved the Ethicon Physiomesh because it was “substantially similar” to the Prolift vaginal mesh, which was an existing product. Both these medical devices serve basically the same function and they are made from the same basic materials. The Ethicon hernia mesh does have a very thin protective coating, which was apparently enough to convince the FDA that the new product was safe. However, one would think that the Prolift’s history would have given the agency pause. So far, Johnson & Johnson has paid over $120 million in Prolift lawsuit settlements.