Ethicon has withdrawn the Physiomesh Composite Mesh hernia patch after two studies found higher rates of hernias re-opening (called “recurrence”) and additional surgery compared to similar products.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Physiomesh induced injury cases in all 50 states. If you or somebody you know had hernia recurrence or surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is Physiomesh?
Physiomesh is hernia patch that is made from flexible, non-absorbable polypropylene (plastic) filaments that are woven into a fabric. The patch is laminated between two layers of Monocryl (poliglecaprone), which is intended to have anti-inflammatory or anti-adhesion benefits.
FDA Approved Without Clinical Trials
Physiomesh has been on the market in the United States since March 2010. The FDA approved it with a 510(k) application, which allowed it on the market without new safety studies because it was “similar” to other types of hernia mesh on the market.
Physiomesh Pulled Off Market Due to Revision Surgery Risk
In May 2016, Johnson & Johnson issued a voluntary global market withdrawal for its Ethicon Physiomesh® Flexible Composite Mesh due to an increased risk of side effects. Two large studies in Germany and Denmark found higher rates of hernia recurrence and re-operation compared to similar products that are used in laparoscopic ventral hernia repair, according to an Urgent Field Safety Notice (PDF) to surgeons.
Lawsuit Blames Physiomesh Failure on Coating
Physiomesh has a unique coating. The mesh is laminated between two layers of Monocryl (polyglecaprone), which are supposed to prevent or minimize adhesions and inflammation. Instead, lawyers say the coating on Physiomesh is not bio-compatible and sometimes triggers major complications.
In a lawsuit (PDF) filed in December 2016, lawyers for a woman who needed revision surgery say the coating on Physiomesh “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.
Physiomesh Lawsuit Filed in Florida
In September 2016, a lawsuit (PDF) was filed against Ethicon by a woman from Florida who required surgery to remove Physiomesh that grew into her intestines and caused serious health problems. Click here to read more.
Physiomesh Lawsuit Set for Trial in 2018
The first Physiomesh trial date is set for January 22, 2018 before Judge J. Phil Gilbert. The plaintiff was diagnosed with an infection in and around the mesh, causing two abscesses and an intestinal fistula. He required surgery and continues to suffer health problems. The lawsuit (PDF) was filed on April 1, 2016 in the U.S. District Court for the Southern District of Illinois — In Re: Matthew Huff v. Ethicon, Inc. — Case No. 3:16-cv-00368.
Complications of Hernia Mesh
- Infection
- Chronic pain
- Hernia recurrence
- Adhesion (scar-like tissue that sticks tissue together)
- Intestinal blockage
- Mesh migration
- Mesh shrinkage (contraction)
- Surgery
What is a Ventral Hernia?
Physiomesh is used to repair ventral hernias, which occur when internal organs squeeze through a hole or weak spot at the site of a previous surgical incision. Ventral hernias can occur weeks, months, or even years after a surgery. Small ones can be repaired with a few stitches. Large and complex hernias often require major reconstructive surgery on the abdominal wall.
Hernia Patch Surgery
Every year, surgeons perform about 100,000 to 150,000 ventral hernia repairs in the United States. The operations can be minimally-invasive (“laparoscopic”) or open. It is very common for surgeons to stitch a mesh patch over the hernia to strengthen the abdominal wall. Hernia mesh is often used to reinforce the abdominal wall and prevent the hernia from re-opening (called recurrence). The problem is that some types of mesh are better at preventing recurrence than others. Another problem is that mesh increases the risk of rare but serious long-term side effects.
Do I have a Physiomesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting Physiomesh induced injury cases in all 50 states. If you or somebody you know had hernia recurrence or surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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