Ethicon Physiomesh Caused Failed Hernia Repair, Lawsuit Alleges

A product liability lawsuit filed against Johnson & Johnson and it’s Ethicon subsidiary claims that problems with the design of Physiomesh resulted in bowel adhesions and failed hernia repair surgeries. 

The complaint (PDF) was filed by Lizzey Annett in the U.S. District Court for the Eastern District of Texas last week, indicating that the Ethicon Physiomesh hernia patch has numerous defects that create an unreasonable risk of dangerous injuries, side effects and severe complications.

Annett underwent surgery in July 2014, at which time a 20cm by 25 cm Physiomesh patch was implanted to treat an incisional hernia. Following the procedure, she developed an enlarging bulge that was determined to be a recurrent hernia.

During a second abdominal hernia repair surgery in February 2015, a 15cm by 20cm Physiomesh patch was implanted, but that hernia repair failed as well.

“Unfortunately, Ms. Annett’s condition did not improve but steadily worsened after the February 2015 procedure,” the lawsuit states. “Due to chronic pain and suspected recurrent hernia, Plaintiff again presented for CT scan, which demonstrated evidence of recurrent incisional hernia.”

A third procedure was performed in October 2016, involving robotic surgery. At that time, the surgeon discovered the Physiomesh had caused dense, small bowel adhesions, which led to the procedure being aborted in favor of open laparotomy. The surgeon conducted revision surgery, but was not able to remove all of the Physiomesh material. The surgeon also had to conduct two small bowel resections and deal with the adhesions.

According the lawsuit, the surgeon determined that the Physiomesh failed following hernia repair, causing Annett severe pain and suffering.

Ethicon Physiomesh was introduced in 2010, featuring a unique design with a total of five distinct layers. The hernia patch contains two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS), which in turn coat a polypropylene mesh.

While the multi-layer coating was marketed and promoted as a means to prevent adhesion and inflammation, as well as facilitate incorporation of the mesh into the body, it has actually been linked to a high rate of intense inflammatory and chronic foreign body response, leading to issues.

An Ethicon Physiomesh recall was issued for certain products in May 2016, after the manufacturer failed to identify fix for the large number of adverse events reported worldwide. While 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.

Annett’s case joins a growing number of Ethicon Physiomesh lawsuits filed in recent months, each involving similar allegations on behalf of individuals who received the hernia patch in recent years. Over the coming weeks and months, it is widely expected that the manufacturer will face hundreds, if not thousands, of cases brought nationwide.