Pharmaceutical

Tennessee Man Sues Ethicon Over Physiomesh

physiomesh Tennessee Man Sues Ethicon Over PhysiomeshA Tennessee man filed a lawsuit against Johnson & Johnson’s Ethicon over his implanted Physiomesh hernia repair mesh device, claiming it failed and injured him.

According to the complaint, on July 8, 2013, Robert Burdge went to Baptist Memorial Hospital in Collierville, Tennessee, to have an incisional hernia repaired. He was implanted with a Physiomesh device as treatment.

However, on Dec. 29, 2014, Burdge returned to the same hospital for repair of the hernia mesh, which ruptured. He was laparoscopically implanted with a larger Physiomesh device.

On Sept. 12, 2016, Burdge was back in the hospital to repair the hernia mesh once again, this time with major deformation of the mesh. The invasive surgery lasted two hours. Doctors found that the previous mesh had not only failed, but the hernia had also worsened with “extensive adhesions,” creating a medical mess, the complaint alleges.

Through the process, Burdge has gone from an independent working man to a sufferer of chronic pain, which has limited his daily activities as well as his ability to work. He is now on consistent treatment for his debilitating pain, and has been warned that future surgeries are likely.

Burdge’s lawsuit against Ethicon challenges the company’s claim that Physiomesh is “a safe and effective product for hernia repair,” and accuses the company of failure to warn of its dangers.

According to the lawsuit, the design of Physiomesh “is not used in any other hernia repair product sold in the United States.” It is made up of five distinct layers: two layers of polyglecaprone-25 (“Monocryl”) film, which covers to underlying layers of polydioxanone (“PDS”) film, which coats the middle layer of polypropylene mesh.

Ethicon’s marketing of Physiomesh says the product will “prevent or minimize adhesion and inflammation and to facilitate incorporation of the mesh into the body.”

“Instead, the multi-layer coating prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response,” the lawsuit states, “resulting in an adverse tissue reaction including migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic tissue and improper healing.”

The suit also points out that the multi-layer coating makes the device impermeable, which prevents fluid escape and promotes the buildup of bacteria, infection and abscess formation.

The lawsuit adds, “The polypropylene mesh used in the Physiomesh device was insufficient in strength to withstand the internal forces of the abdomen after implantation, which made the device susceptible to rupture and/or deformation, as occurred with the Physiomesh implanted in Mr. Burdge.”