Ethicon Physiomesh Hernia Mesh Product Liability Lawsuits for Injuries and Revision Surgeries

By S. Randall Hood | May 24, 2017

Ethicon Physiomesh Hernia Mesh Product Liability Lawsuits for Injuries and Revision SurgeriesPhysiomesh is a product manufactured by Ethicon, a subsidiary of Johnson & Johnson, to be implanted into human bodies to repair hernias. The product was approved by the U.S. Food and Drug Administration (FDA) in April 2010 through the agency’s 510(k) process. This fast track that is the 510(k) process allows device manufacturers to skip all that “pesky” safety testing, if they can convince the FDA that their product is similar enough to another product that the FDA has already approved.

Not only has Ethicon managed to get a product to market that will be surgically implanted into the abdomen of live human beings without having done any longitudinal safety studies, or proving that the product does what it promises, but they constructed the product using polypropylene, a product which the manufacturer says is prohibited from permanent implantation in the human body. For their part, Ethicon sprayed a coating on the polypropylene mesh in an attempt to discourage the mesh from adhering to tissue, and protect the mesh from being broken down by the body.

Some of the injuries reported in patients who had Ethicon’s Physiomesh hernia mesh implanted include:

  • Infections
  • Perforation
  • Obstruction
  • Infection
  • Inflammation
  • Allergic reactions
  • Nerve damage
  • Pain
  • Adhesions

After higher than normal rates of revision surgery in patients that had been implanted with the Physiomesh product for hernia repair, Ethicon attributed the higher revision rates to a “multifactorial issue,” which means that they do not know what is causing the mesh to fail. In a field safety notice to health care providers in May 2016, Ethicon announced that it was taking the Physiomesh product off the market. The FDA has not provided any additional information about the Physiomesh recall on its website.

Now, some of the people who have suffered serious injuries after having had Physiomesh implanted as part of a hernia repair surgery have filed product liability lawsuits against Ethicon for the negligent design, manufacture and marketing of the product. Patients have suffered in severe pain, infections, abscesses, and other health problems which required revision surgery to remove the mesh and correct the problems it was causing in patients’ bodies.

If you or someone you care about has experienced complications from Ethicon Physiomesh or any other dangerous medical product, you are welcome to schedule a consultation with McGowan, Hood, and Felder, LLC. Our South Carolina defective device attorneys can help you get justice. You are invited to call 1-803-327-7800 or fill out our contact form today to have your case reviewed and your questions answered.

Posted in Medical Devices