Men and women who have who have been harmed by Johnson & Johnson’s Ethicon Physiomesh or C-QUR manufactured by Atrium Medical (later acquired by Getinge Group/Maquet) may now qualify for compensation for side effects such as adhesions, lack of ingrowth, bowel obstruction, pain, abscess, hernia recurrence, infections, seromas, migration and shinking, curling, bunching and twisting.
Pelvic mesh is used generally in a tension free placement over the defect and ideally results in healthy tissue ingrowth. The mesh can be implanted laproscopically or via open procedure. The Physiomesh mesh was designed for laproscopic procedures and later introduced mesh for open procedures.
The pelvic mesh has been used in three main types of procedures – for femoral repairs (mostly women, post childbirth), ventral repairs, which include umbilical/epigastric and incisional hernia condition, and inguinal repairs.
January 11, 2017 – A new lawsuit has been filed against Ethicon, Inc., by a Florida woman who blames her serious health complications on the company’s Physiomesh Hernia Patch.
According to the complaint, Sarah Ann Gilman underwent laparoscopic ventral hernia repair surgery in February 2016 using 15 x 20 cm Physiomesh Composite mesh. After experiencing serious complications from the allegedly defective mesh, she was forced to undergo revision surgery whereby abdominal bulge, recurrent hernia, and adhesion complications were found.
The lawsuit alleges “Physiomesh was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design. As a result of the defective design and/or manufacture of the Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation/ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complications.”
Read the full complaint here.
Certain Physiomesh devices were withdrawn from the global market by Ethicon in May 2016 after unpublished data was found documenting higher than average hernia recurrence and revision surgery rates after laparoscopic ventral hernia repair procedures.
The first Physiomesh lawsuit was filed on April 1, 2016, in the U.S. District Court, Southern District of Illinois, and is scheduled for trial in January, 2018. The lawsuit was filed by a man who was hospitalized with serious complications after receiving the Physiomesh hernia patch in 2013. He was found to have an intestinal fistula and two abdominal abscesses.
Three types of mesh presently exist, very in line with the products seen in transvaginal mesh. Synthetic mesh (often polypropolene or polyester material with no other additional material), biologic mesh (human, pig or cow skin or tissue with no other additives) and composite mesh (a combination of the synthetic and biologic mesh products).
More than 12 manufacturers are producing mesh, including those at issue in the current litigation. The market share of C-QUR has been estimated at about 10-15%, while Physiomesh may have had a 20-25% market share.
In composite mesh scenarios the mesh is used in the intraperitoneal space with one side of the mesh against the body’s bowels, intestines, etc., while the other side rests against the abdominal wall. The idea is that the side coated in biologic material will prevent adhesions from forming between the mesh and the intestines/bowels, while the synthetic side rests against the abdominal wall and is tacked into place.
C-QUR mesh is coated with Omega 3 (or fish oil) on one side and polypropolene on the other. Physiomesh mesh combines a coating of several biologic materials with polypropolene.
C-QUR mesh was approved in March of 2006, but did not gain popularity or significant market share until 2010. Because of the complications, C-QUR started to lose market share in 2013. Presently, the C-QUR mesh is still on the market.
Physiomesh mesh was approved in April 2010, but did not come to market until October of 2010. J&J/Ethicon voluntarily withdrew Physiomesh mesh from the market in May 2016.
The products involved limited study – lab, animal, or clinical trials. The studies that were performed were unfavorable for both products. Animal studies in the Physiomesh mesh involved 100% adverse event rates for adhesions, shrinkage of the mesh, migration of the fixation devices, etc.
Ethicon blamed the design of the study for the poor outcome and the results were buried.
In the clinical studies post-market, at least one Physiomesh study was terminated as a result of the poor outcomes.
C-QUR suffered from similar stumbling blocks. C-QUR was the subject of many FDA action and warning letters about the manufacturing process and was subjected to several regulatory infractions and fines. Similar clinical outcomes occurred in the C-QUR study and resulted in a terminated study. As of today, the C-QUR pelvic mesh products are still being sold.
The injuries suffered by patients of both products included adverse events stemming from the pelvic mesh such as adhesions, lack of ingrowth, bowel obstruction, pain, abscess, hernia recurrence and seromas (fluid collection under the skin). Physiomesh also involved a significant number of infection problems. This was likely a result of the Omega-3 biologic element of their product. Some allergic reactions to the biologic materials may also factor.
Some of the issues developed as a result of the mesh shrinking, bunching, twisting and curling when the abdominal wall is deflated post-operatively. Other problems involve lack of absorption of the biologic material and subsequent failure to achieve healthy tissue ingrowth. The issue of porosity and much of the science in the pelvic mesh cases will mirror transvaginal mesh.
The current litigation is not against all manufacturers of this barrier mesh in the same vein as transvaginal mesh, but the potential to see other issues with other manufacturers is not unlikely.
An MDL has recently been formed in the District of New Hampshire with Judge Susan McCafferty (a first time MDL judge) in the C-QUR. It was unclear how many cases have been or will be consolidated in this federal litigation. A couple dozen claims have also been filed in state court.
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