Physiomesh is a surgical mesh product used to help repair ventral hernias, or the bulging of an organ or tissue through an abdominal opening usually at the site of a previous surgical incision. The mesh is made out of flexible plastic called non-absorbable polypropylene woven into a fabric.
Sometimes surgeries cause a weakening in the abdominal wall weeks, months, or even years after the procedure. When this occurs, organs or tissues like the stomach or intestines can push through an opening in the weak abdominal wall. To help repair the weakened abdominal wall, surgeons can place hernia mesh like Physiomesh to strengthen the abdominal wall and prevent further hernias.
The U.S. Food and Drug Administration (FDA) approved the mesh in 2010 through the controversial 510(k) pathway, which allowed Physiomesh onto the market without the standard rigorous trials required for medical device approval. Unfortunately, two large studies have since found Physiomesh has much higher rates of hernia recurrence and re-operation than other similar hernia mesh products.
Physiomesh can cause serious complications including:
On May 25, 2016, the makers of Physiomesh, Ethicon Inc. (a subsidiary of Johnson & Johnson), voluntarily recalled the device because of its high rate of complications. Unfortunately for patients already implanted with the mesh, Ethicon could not provide guidance to surgeons on how to correct complications. The success of preventing hernia recurrence in patients greatly decreases with each surgery and implantation of hernia mesh. Patients implanted with the defective mesh are running out of options to treat their hernias.
Every year, surgeons perform anywhere between 100,000 and 150,000 ventral hernia repair procedures in the United States. While some of these surgeries can be minimally invasive, many require hernia mesh like Physiomesh. The widespread use and failure of the mesh has led to lawsuits filed against its manufacturer by patients harmed by the device.
While several Physiomesh lawsuits are pending in courts across the country, the first trial is set for January 22, 2018 in the U.S. District Court for the Southern District of Illinois. The plaintiff in the case suffered an infection around his Physiomesh patch causing him to develop two abscesses and an intestinal fistula, or opening in the intestines. The plaintiff not only required additional surgery, but hecontinues to suffer from serious health issues. While this case moves toward its trial date, it is anticipated that many more Physiomesh lawsuits will be filed.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.