Understanding The Dangers Of The Ethicon Physiomesh
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.
One-third of the drugs that receive an okay from the FDA later have safety problems, and the Trump administration may try to relax approval regulations.
The Expedited Approval Process
New devices which are able to be marketed and sold in the United States and are “substantially equivalent” to existing products are eligible for waivers under Section 510(k). The FDA defines this phrase very broadly, so many new medical devices and drugs are fast-tracked for approval.
The regulation makes some sense, since drugs and devices that have already been closely examined arguably do not need such a thorough second look. Needless to say, device and drug makers use the 510(k) loophole at every possible opportunity, since it drastically reduces the cost of development and allows the company to start selling the medicine or gadget more quickly.
But the problem is that the FDA assumes that the comparative drug or device is safe, and given the agency’s track record, that is a rather dubious assumption.
Hernia Mesh Dangers
In 2016, Ethicon voluntarily recalled the Physiomesh with very little explanation, other than “product characteristics, operative and patient factors.”
The mesh was designed for hernia surgery patients. But almost immediately after this Johnson & Johnson division began selling the hernia mesh, patients began reporting serious side effects, including:
- Serious and even life-threatening infections,
- Internal organ damage, and
- Hernia recurrence.
Due to these and other side effects, hernia mesh patients had little choice but to undergo emergency removal surgery. But the device is not easy to remove, because the mesh particles often adhere to internal organs and other tissue.
Because of the known risks, hernia mesh patients who experience vomiting, fever, pain, redness, or any other signs of infection should probably assume that the Physiomesh is the cause and immediately seek medical treatment.
The Ethicon Physiomesh often causes serious side effects. For a free consultation with an experienced defective medical device lawyer in Glasgow, contact Attorney Gary S. Logsdon. Our main office is conveniently located in Brownsville.