Hernia Mesh Explantation Required Following Ethicon Physiomesh Failures, Lawsuit Alleges

According to allegations raised in a product liability lawsuit filed by a Florida woman who required hernia mesh explantation surgery less than a year after Ethicon Physiomesh was implanted in her body, design defects associated with the recalled patch make it unreasonably susceptible to severe complications and failure following hernia repair surgery.

The complaint (PDF) was filed by Sheri Ann James and her husband, Alfred George James, in the U.S. District Court for the Middle District of Florida on June 30, naming Johnson & Johnson and it’s Ethicon, Inc. subsidiary as defendants.

James indicates that she underwent two separate hernia surgeries where Ethicon Physiomesh was used. In May 2012, a 15cm by 25cm patch of Physiomesh was implanted to repair a multiple anterior abdominal wall recurrent incisional hernia. After experiencing pelvic pain, urinary frequency and a fistula, she underwent another procedure in December 2012, for lysis of adhesions, laparoscopic removal of her bladder from the hernia and abdominal wall, and a mesh repair of the abdominal wall hernia. That procedure required another 10cm by 15cm Physiomesh patch.

In July 2013, James had another procedure to repair the recurrent hernia during which some of the Physiomesh had to be removed. Her doctors indicate she may have to undergo additional procedures due to adhesions and scarification.

“The Physiomesh implanted in Plaintiff Sheri James failed to reasonably perform as intended. The mesh failed, caused serious injury including formation of fluid and infection around the mesh, and required that the mesh be removed by and through another serious invasive surgery,” the lawsuit states. “Plaintiff Sheri James’ severe adverse reaction, and the necessity for surgical removal of the Physiomesh, directly and proximately resulted from the defective and dangerous condition of the product and Defendants’ defective and inadequate warnings about the risks associated with the product, and the frequency, severity and duration of such risks.”

The case joins a growing number Ethicon Physiomesh failure lawsuits, each raising similar allegations that the hernia mesh was defectively designed, posing an unreasonable risk for consumers.

In June 2016, Ethicon recalled Physiomesh products from the market worldwide, due to a high rate of problems and revisions among individuals who had the patch implanted, since the manufacturer was unable to identify or correct the underlying cause of the complications.

Although the action was classified as a “market withdrawal” in the United States, Ethicon asked hospitals to return all unused implants and indicated that it does not intend to return the product to the market.

Given the similar questions of fact and law presented in cases pending throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to establish coordinated pretrial proceedings in the federal court system, transferring all cases filed nationwide to U.S. District Judge Richard Story in the Northern District of Georgia to reduce duplicative discovery, avoid contradictory pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

As hernia mesh lawyers continuing to review and file additional lawsuits in the coming weeks and months, it is expected that several thousand complaints will be included in the MDL proceedings.