A man has filed a hernia repair mesh lawsuit after his two pieces of Physiomesh allegedly caused him severe injuries.

Plaintiff Clemens G. underwent hernia repair surgery in February 2012. His surgeon allegedly used two pieces of Physiomesh, a type of hernia repair mesh made by Ethicon, a subsidiary of Johnson & Johnson. Clemens claims that after the mesh failed, he was forced to undergo another surgery in March 2013 “to repair the hernia that the Physiomesh was initially implanted to treat.”

Hernia mesh products are intended to strengthen hernia repairs, making the need for additional surgeries less likely. Physiomesh is one such product.

Hernia Mesh: Layers of Complications

Physiomesh is made of five layers. Two layers of polyglecaprone-25 (Monocryl) film cover two underlying layers of polydioxanone film, which coat the polypropylene mesh. Ethicon claimed the multi-layer coating was intended to prevent or reduce the possibilities of adhesions and inflammation.

The hernia repair mesh lawsuit contends that the multi-layer coating allows bacteria to breed, causing infection that the body is unable to fight because of the impermeable coating.

The lawsuit also alleges the multiple layers cause excessive inflammation and the material contracts, erodes, and is rejected by the body. As a result, the body can experience hindered wound healing, rejection, nerve damage, tissue damage, tissue death, abscess formations, and other complications per the complaint.

Physiomesh markets the multi-layer design as a barrier against adhesion to any internal organs. According to the hernia repair mesh lawsuit, the outer layers were designed to degrade over time, eventually leaving the plain polypropylene mesh in contact with organs and tissues.

However “[t]he degradation of this multi-layer coating caused or exacerbated an intense inflammatory and foreign body reaction,” says the hernia mesh repair complaint, which goes on to allege the mesh is susceptible to adhesion, bowel perforation and other injuries.

Hernia Repair Mesh Quietly Pulled from Market

Physiomesh costs significantly more than competitive products because of the multi-layered coating, although patients received no benefits from the design, and allegedly incur increased risks of complications due to the design that promotes the degradation of several of the product’s layers.

In May 2016, Ethicon and Johnson & Johnson issued voluntary recall in other countries that included language indicating patients who had received Physiomesh should continue to be followed. No such notice was sent in the United States, where Physiomesh allegedly was removed from the market and sales stopped. The market withdrawal in the U.S. did not alert health care facilities, doctors or patients that Physiomesh patients should continue to be monitored for potential complications.

The hernia repair mesh lawsuit alleges the company knew Physiomesh patients continued to be at risk for adverse problems because Ethicon directed overseas doctors to continue monitoring their patients.

In his complaint, Clemens says he “has suffered and will continue to suffer physical pain and mental anguish” even after the Physiomesh was removed.

The Hernia Repair Mesh Lawsuit is Case No. 3:18-cv-09710-MAS-TJB, in the U.S. District Court for the District of New Jersey, Trenton Division.