A product liability lawsuit filed by a North Dakota man alleges that there are serious design problems with an Ethicon surgical mesh product, which caused severe and life-threatening health complications after it was used during an umbilical hernia repair, ultimately resulting in the need for revision surgery to remove the defective patch from his body.

The complaint (PDF) was filed this month by Ronald P. Keller in the U.S. District Court for the District of North Dakota, indicating that Physiomesh Flexible Composite Mesh manufactured and sold by Johnson & Johnson and it’s Ethicon subsidiary was not reasonably safe for use in hernia repair.

Keller underwent laparoscopic surgery for an umbilical hernia repair in November 2010, at which time the Ethicon Physiomesh surgical mesh was implanted in his body. Following the procedure, he indicates that his condition became steadily worse, resulting in hospitalization for a small bowel obstruction in May 2011.

As a result of that complication, Keller required additional surgery, at which time the doctor noted a “massive amount” of adhesions, and had to remove a portion of Keller’s small intestine in an attempt to relieve the bowel obstruction.

Unfortunately, the surgery did not resolve Keller’s problems, as he indicates that he continued to experience severe pain and other complications. In September 2014, a CT scan revealed adhesions to the Ethicon surgical mesh in his lower abdomen, requiring an exploratory laparotomy.

In September 2015, Keller indicates he was again hospitalized due to problems with the Ethicon Physiomesh, which had to be removed during a lengthy procedure where areas of the surgical mesh that had adhered to his small intestine had to be “meticulously cut off.” Keller then had to undergo an open incisional ventral hernia repair due to the complications.

“The Physiomesh implanted in Plaintiff Ronald Keller failed to reasonably perform as intended. The mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the Physiomesh was initially implanted to treat,” the lawsuit states. “Plaintiff Ronald Keller’s 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 defective and inadequate warnings by Defendants J&J and Ethicon about the risks associated with the product, and the frequency, severity and duration of such risks.”

The case joins a growing number of Ethicon Physiomesh lawsuits filed in recent months, each involving similar allegations on behalf of individuals who received the surgical mesh following a hernia repair in recent years.

The Ethicon Physiomesh was introduced in March 2010, but was recalled from the market last year amid a large number of reports involving complications with the hernia surgery mesh, often resulting in the need for risky and painful surgical procedures to remove the product after it became entangled with internal organs.

After failing to identify the cause of these hernia repair problems, the manufacturer decided to remove the product from the market worldwide in May 2016. The Ethicon hernia mesh recall was classified as a “market withdrawal” in the United States, but all hospitals were asked to return unused implants and the manufacturer does not intend to return the product to the market.

As hernia mesh lawyers continue to review and file a number of lawsuits for individuals nationwide who had the Ethicon surgical mesh implanted, a motion was filed last month with U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to transfer all Physiomesh cases to the Middle District of Florida for coordinated discovery pretrial proceedings. The panel is expected to consider oral arguments on the motion during an upcoming hearing session scheduled for May 25, in San Antonio, Texas.

Tags: Ethicon, Hernia, Hernia Mesh, Johnson & Johnson, Physiomesh