Pharmaceutical

Physiomesh MDL established

physiomesh Physiomesh MDL establishedA hearing was held May 25, 2017 on plaintiffs’ request to create a new multidistrict litigation (MDL) for Physiomesh, against Physiomesh makers Ethicon and Johnson & Johnson. On June 2, the Judicial Panel on Multidistrict Litigation ordered that the cases should be combined in MDL No. 2782. The cases will be consolidated in the Northern District of Georgia under Judge Richard W. Story.

According to Mass Tort Nexus, at least 330,000 Physiomesh hernia repair devices have been sold around the world. It is believed that half of them were sold in the U.S. There are currently 18 complaints pending in nine federal district courts, and hundreds more are expected to arise.

Physiomesh is unlike any other hernia mesh repair device in the world because of its five distinct layers. It is usually inserted laparoscopically. Two of the device’s layers are made up of a polydioxanone (PDS) film, which is then covered by polyglecaprone-25 film, known as Monocryl. Both films coat a layer of mesh made of polypropylene.

The several layers of film was marketed as a way to reduce adhesion and prevent inflammation. The makers also claimed the film layers assisted in the mesh’s fixation into the abdomen. Many patients, however, claim the film layers interfere with proper incorporation of the mesh and encourage infection as well as other complications.

Claimants say the polypropylene material also is unable to withstand normal pressure and forces on the abdomen, which can lead to additional hernia through the mesh device. Many have complained of their hernia returning, or the mesh itself rupturing or deforming.

In May of 2016, Physiomesh was withdrawn from the market due to a high rate of failure.

The lawsuits accuse Ethicon and Johnson & Johnson of failing to provide adequate warnings and instructions about the potential dangers of the Physiomesh device. Many patients claim they have endured serious injuries, some of them permanent, with additional surgeries required to repair the failed device.