Ethicon Hernia Patch Lawsuit Filed Over Recalled Physiomesh Implant

According to allegations raised in a product liability lawsuit against Ethicon, complications from a recalled Physiomesh implant caused a Florida man to suffer a recurring hernia, pain and adhesion problems after the mesh recoiled, resulting in the need for revision surgery to remove the hernia patch.

David A. Sunter filed a complaint (PDF) against Johnson & Johnson and its Ethicon subsidiary in the U.S. District Court for the Middle District of Florida earlier this month, alleging that the Physiomesh hernia patch was defectively designed and that the manufacturers failed to adequately warn the medical community about the risk of problems.

Ethicon Physiomesh was introduced in March 2010, for use during hernia repair surgery. However, the implant has been plagued by reports of complications, including adhesions, perforations, infections, mesh erosion and the need for hernia revision surgery. After failing to identify the cause of these problems, an Ethicon hernia mesh recall was issued for certain Physiomesh products in May 2016. Although the action was classified as a “market withdrawal” in the United States, the manufacturer asked that all hospitals return unused implants and indicated that it will not be returning the device to the market.

Sunter indicates that he received a 25 x 15 cm Physiomesh Composite mesh during a laparoscopic hernia surgery in November 2015, to repair an incisional hernia. However, less than a year later, Sunter had to undergo additional surgery to remove the hernia patch due to complications. In October 2016, his surgeon found that the mesh had recoiled, resulting in recurrent hernia, pain and adhesion complications, resulting in a lawsuit being filed against the manufacturer for selling an unreasonably dangerous and defective product.

“When affixed to the body’s tissue, the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection, abscess formation and other complications,” Sunter’s lawsuit indicates. “The multi-layer coating provides a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”

The case joins a growing number of other Ethicon hernia patch lawsuits over Physiomesh, each raising similar claims that when the coating is disrupted or degrades, the uncovered polypropylene mesh can become adhered to organs and cause damage. Sunter indicates that neither he nor his doctor were informed of these risks.

Sunter presents claims against the manufacturer for strict product liability, defective design, failure to warn and negligence, seeking both compensatory and punitive damages, which are designed to punish the defendant for continuing to sell Physiomesh after learning that it was defective and unreasonably unsafe.