Johnson & Johnson pulled Physiomesh Composite Mesh off the market after studies found higher rates of hernias re-opening (called “recurrence”) and requiring another surgery.
Need a Texas Physiomesh Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a hernia patch complication, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Physiomesh Hernia Patch Pulled Off U.S. Market
In May 2016, Johnson & Johnson issued a global market withdrawal for all lots of Ethicon Physiomesh® Flexible Composite Mesh after two large studies found a higher risk of hernia recurrence and re-operation. It was recalled in Europe and Australia, but not in the U.S., which is why the FDA did not issue safety warnings.
Physiomesh Trials Set for 2018
A lawsuit (PDF) filed by a man who was seriously injured by Physiomesh has been set for trial on January 22, 2018. The case was filed by Matthew Huff, a man who developed an infection in and around the mesh. He required surgery to treat two abscesses and an intestinal fistula, and continues to suffer complications — In Re: Matthew Huff v. Ethicon, Inc. — Case No. 3:16-cv-00368.
What is Physiomesh?
Physiomesh Flexible Composite Mesh is a type of hernia mesh. It is made of flexible, non-absorbable polypropylene (plastic) filaments that are knitted into a fabric and laminated. It was approved by the FDA in March 2010 with a 510(k) application, which means it was allowed on the market without new safety studies because it was “equivalent” to other hernia patches.
Physiomesh and Hernia Surgery
Physiomesh is primarily used to repair ventral hernias, which occur when internal organs squeeze through a hole or weak spot in muscles in the abdominal wall. The complications may include
- Chronic pain
- Hernia recurrence
- Scar-like tissue that sticks tissue together (adhesion)
- Intestinal blockage
- Mesh migration
- Mesh shrinkage (contraction)
What is the problem?
On May 25, Ethicon issued an Urgent Field Safety Notice (PDF) to surgeons and blamed the problem on a number of factors. An analysis of two large independent studies in Germany and Denmark found higher rates of recurrence and re-operation after laparoscopic ventral hernia repair using Ethicon Physiomesh Composite Mesh compared to the average rate for similar products.
Is the Coating on Physiomesh Safe?
Physiomesh is a patch that is laminated between two layers of Monocryl (polyglecaprone). The coating is supposed to reduce inflammation and help prevent adhesions (scar-tissue). Instead, a growing number of lawsuits blame the coating on Physiomesh for causing major complications.
Lawsuit Blames Coating on Physiomesh Complications
One lawsuit (PDF) was filed in December 2016 by a woman who needed revision surgery less than 4 months after Physiomesh was implanted in her body. Her lawyers say the coating is not bio-compatible and it “prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response.” Click here to read more.
What is a Ventral Hernia?
Ventral hernias occurs at the site of a previous surgical incision. They are sometimes called “incisional hernias.” They can occur weeks, months, or even years after surgery and vary in size from small to very large and complex.
Depending on the size, repair varies from a few stitches to major reconstruction of the abdominal wall using large pieces of mesh. When the operation fails and the hernia reopens, it is called recurrence. Any subsequent repairs are much less likely to succeed.
Approximately 100,000 to 150,000 ventral hernias repairs are performed every year in the United States. In most cases, a mesh patch is stitched onto the weak spot to prevent recurrences.
Need a Physiomesh Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Physiomesh lawyers for a free lawsuit review.