Physiomesh: Another Example of FDA’s Failure to Protect Consumers from Dangerous Products

The Ethicon Physiomesh hernia mesh is yet another implanted medical device that was pulled off the market because of higher than normal rates of revision surgeries and adverse effects. You would think that with all the rigorous research and testing that the U.S. Food & Drug Administration (FDA) requires, these kinds of issues would not be occurring.

But wait: Ethicon, maker of the Physiomesh product, was not required to provide any safety testing results, conduct clinical trials or longitudinal research studies of how the product held up over time when implanted before they were able to sell it. Sounds absurd, right? The FDA, which is the federal agency in charge of making sure that the food supply and pharmaceutical industry provides safe and effective products to U.S. consumers, allows medical device manufacturers to market untested medical devices if they can show that the product is similar to another product that has already received FDA approval.

What was Physiomesh allowed to make it to market at all?

Because Physiomesh was introduced to the market via the fast track approval through the FDA’s 510(k) process, the public was never made aware of the fact that the Physiomesh product is constructed using polypropylene, which the manufacturer has prohibited against being implanted into the human body. (Polypropylene is the same material used to make the defective transvaginal mesh devices that were recalled, costing the company millions in lawsuits.) Ethicon has coated the polypropylene mesh with an absorbable film coating designed to keep the product from adhering to the tissues inside the body. As this coating degrades the body absorbs the particles, which can cause allergic reactions and strain the kidneys, whose role is to process toxins in the body.

When a medical device comes to market through the 501(k) process, it cannot be marketed as if it were FDA approved; however, it can be marketed as “510(k) cleared.” Because Physiomesh is not FDA approved, the product is not protected from litigation by the medical devices act of 1976. This might be why the company voluntarily pulled Physiomesh from the market in May 2016.

Side effects of Ethicon’s Physiomesh

Some of the injuries that patients with Physiomesh implants have suffered from include:

• Adhesions
• Obstructions
• Infections
• Severe abdominal pain
• Inflammation
• Nerve damage
• Perforations
• Allergic reactions
• Kidney and liver abnormalities

Patients who have the Physiomesh implanted in their bodies after hernia repair surgery, have filed product liability lawsuits against Ethicon, which is a subsidiary of Johnson & Johnson, for alleged negligence in designing and manufacturing a defective product that is the direct cause of their injuries, and for failing to warn consumers about the dangerous side effects that often require patients to undergo painful and costly revision surgeries to have the defective mesh repaired or removed.

If you or a loved one is suffering in pain because of a defective hernia mesh implant, or if you have been injured by another type of defective medical device, we want to help. You are welcome to call an experienced South Carolina defective medical device attorney from McGowan, Hood, and Felder, LLC to help you get justice in the form of compensation for your injuries. Please phone 1-803-327-7800 or complete our contact form today to schedule a no-obligation consultation.