Johnson & Johnson’s Ethicon Physiomesh Open Flexible Composite Mesh Device is designed for the repair of fascial defects, primarily hernias. An increasing amount of complications have been reported following hernia repair procedures. This product was withdrawn from the European and Australian market in 2016.
Physiomesh Voluntary Recall
Ethicon issued a voluntary recall of the Physiomesh in May of 2016 after an analysis of data found increased hernia reoperation rates following use of the Physiomesh. Ethicon said within this voluntary recall statement that “the recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Within this statement, healthcare advisors were advised to stop using the Physiomesh product. This voluntary recall was shared with the FDA and the European Competent Authorities.
The Physiomesh is Similar to the Proceed Device
The Physiomesh was approved by the FDA without human testing merely because it was based on an earlier product, the Proceed. The Proceed was recalled in 2006 over concerns of its effectiveness after many reported cases of complications following the application of the Proceed mesh. After improvements and testing, the Proceed reentered the market.
The FDA’s 510(k) approval process allows clearance of devices that are deemed equivalent in effectiveness and safety to other approved products, resulting in the approval of the Physiomesh. Despite a 20% failure rate of the Physiomesh being reported by the Society of American Gastrointestinal and Endoscopic Surgeons, this is why the Physiomesh was FDA-approved.
Contact Us for a Physiomesh Settlement Review
Have you or a loved one suffered recurrent hernia surgeries after use of Physiomesh? Jason J. Joy & Associates, P.L.L.C. has the experience needed to fight for all kinds of mass tort medical claims, including the Physiomesh lawsuit. Contact one of our attorneys as soon as possible to discuss your potential case.
You can also learn more here about the Physiomesh voluntary recall: