Ethicon Physiomesh Lawsuit
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In June 2016, the medical device company, Ethicon, issued a voluntary recall of Physiomesh hernia mesh patches after two scientific studies revealed that the mesh increased the likelihood of hernia recurrence and corrective surgery.
About Physiomesh Hernia Patch
Physiomesh hernia patches are used to repair abdominal hernias. They are made from polypropylene, or plastic, filaments woven into a fabric and laminated between two layers of Monocryl, which is meant to separate the mesh from internal organs. Polypropylene can cause severe injuries if it attaches to patient’s body parts.
Physiomesh contains less polypropylene than other mesh products, increasing the risk of the mesh tearing apart and harming patients.
Common complications of Physiomesh include:
- Bowel obstructions
- Abdominal pain
- Injuries to internal organs
- Erosion of mesh
- Protrusion of the mesh
- Recurrence of hernias
Victims who have experienced complications after having a Physiomesh implanted may be able to file a Physiomesh lawsuit to obtain compensation for their damages. Our skilled defective medical device attorneys are committed to holding manufacturers accountable for producing dangerous products.
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Ethicon Issues Urgent Field Safety Notice
The U.S. Food and Drug Administration (FDA) approved Physiomesh in April 2010. However, the approval was issued under the 510(k) program, allowing Ethicon to avoid rigorous research and safety studies because the device was said to be similar to others already on the market.
Just six years later in May 2016, Ethicon, a subsidiary of Johnson & Johnson, issued an Urgent Field Safety Notice voluntarily recalling all Physiomesh products due to increased risks of side effects revealed in multiple studies.
The recall was a global withdrawal from the market through which Ethicon admitted Physiomesh complications may be associated with specific characteristics of the device.
Evidence of Physiomesh Dangers
The FDA has received approximately 650 adverse event reports about these patches since they were approved. Several studies have also shown that Physiomesh hernia patches have a higher risk of injury and other complications.
A study from March 2016, compared Physiomesh to Ventralight patches. Researchers found that 20 percent of patients experienced hernia recurrence, while none of the patients with Ventralight patches experienced this.
Another study from June 2016, found that many patients implanted with Physiomesh experienced hernia recurrence no matter what technique doctors used to implant the patches.
Finally, a study from August 2016, revealed that Physiomesh resulted in less tissue integration than two other composite hernia mesh products. In other words, Physiomesh did a poorer job of repairing hernias than the other two products. Researchers also found Physiomesh caused more seromas.
Current Ethicon Physiomesh Lawsuits
Ethicon is currently facing multiple lawsuits from patients who suffered injuries after being implanted with Physiomesh patches to repair abdominal hernias.
- The first Physiomesh lawsuit was filed in Illinois in April 2016. The plaintiff claims he suffered an infection that caused two abscesses and an intestinal fistula.
- A Florida woman sued Ethicon in September 2016, alleging Physiomesh grew into her intestines, requiring her to have corrective surgery to remove the mesh.
- Another Physiomesh lawsuit was filed in Massachusetts by a man who claims the mesh caused loops in his bowel.
Many more Ethicon Physiomesh lawsuits could follow given the high number of people implanted with these patches, approximately 300,000 according to an estimate from November 2016.
What to Do If You Were Injured by a Physiomesh Patch
If you have suffered severe injuries from a Physiomesh patch or had to have corrective surgery to replace one of these patches, you may be entitled to compensation for medical expenses, physical pain, mental suffering and more.
Our accomplished team can help you determine if you have grounds to file a Physiomesh lawsuit. If you do, we will guide you through the entire legal process and help you obtain the medical records and other evidence necessary to build your case. Our attorneys are committed to holding manufacturers accountable for producing and marketing dangerous devices that cause severe injuries.