Ethicon Physiomesh Flexible Composite Mesh is a mesh patch used in hernia repair. In May 2016, this product was withdrawn from the market, after data from two European registries suggested that the Physiomesh Flexible Composite Mesh device was associated with higher rates of revision compared to other meshes following laparoscopic ventral hernia repair. Another Physiomesh device, Open Flexible Composite Mesh, was not involved in the action, but became the subject of a lawsuit in April 2016.
Physiomesh Flexible Composite Mesh is made from flexible, non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated. The hernia patch is used to repair ventral hernias, which occur at the site of a previous surgical incision. Physiomesh is used to reinforce the abdominal wall and prevent the hernia from re-opening.
The Physiomesh Flexible Composite Mesh product was cleared for sale by the U.S. Food & Drug Administration (FDA) in April 2012, via its 510(k) clearance program. This program does not require that a device be subject to human clinical trials as long as the manufacturer can demonstrate that it is “substantially equivalent” to a predicate product that was already approved by the agency.
Ethicon, Inc. cited its Proceed mesh as one of the predicates for the original Physiomesh product. In 2005, Ethicon issued a recall for the Proceed mesh device because of an issue that caused the layers of the mesh to separate, leaving the polypropylene exposed. This could lead to an increased risk of adhesions and bowl fistulization.
In October 2014, the FDA cleared another 510(k) application for a second Physiomesh product, Open Flexible Composite Mesh.
In May 2016, Ethicon announced that it had decided to withdraw Physiomesh Flexible Composite Mesh from the global market after an analysis of unpublished data from German and Danish hernia registries indicated that the hernia patch was associated with higher rates of recurrence and revision versus comparable meshes after laparoscopic ventral hernia repair.
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the company’s notice state.
The action only involved Ethicon Physiomesh devices included in the Flexible Composite Mesh line, and did not extend to any Physiomesh Open Flexible Composite Mesh products.
Ethicon indicated that it would not be returning the Physiomesh Flexible Composite Mesh product to the global market.
While it was not named in the May 2016 action, a lawsuit filed in the U.S. District Court, Southern District of Illinois, the previous month asserted that the Ethicon Physiomesh Flexible Composite Mesh device is defective, unreasonably dangerous and not suitable for its intended use. The complaint was brought on behalf of a man who received the hernia patch in 2013 to treat an abdominal wall hernia. He began experiencing severe abdominal pain in July 2015, as well as fever, nausea, chills and redness on the skin of his abdomen. He claims that his hernia mesh had become infected, resulting in two abdominal abscesses and an intestinal fistula.
A docket entry posted by the Court indicates that the case will go to trial on January 22, 2018.
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