These Are Recent RECALLS.
Are you or a loved one experiencing complications due to a hernia implant or procedure? People are starting to speak up and are filing claims against their injuries. It’s time to take action. You may be entitled to financial compensation. Get the Answers you need.
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Kugel Hernia Patch
Dec. 22, 2005
Kugel patches are synthetic, made from a double layer of monofilament polypropylene. Designed to be used in minimally invasive laparoscopic procedures, the Kugel patch is folded for insertion before it’s deployed in the body cavity with the help of a “memory recoil ring” that springs the patch open to its full shape and size.
C-QUR Hernia Patch
August 9, 2013
C-QUR product is made of polyethylene plastic and coated with Omega-3 fatty acid fish oil. The FDA announced Atrium recalled thousands of units of C-QUR V Patch, TacShield, Edge and standard C-QUR Patches because the fish-oil coating on them could stick to the packaging and peel off.
First Trial Set for 2018
Physiomesh is known to be ‘Unreasonably Dangerous’
Ethicon will defend against claims that its hernia patch caused serious injuries in a trial slated to begin in 2018, according to court documents. The trial is the first Ethicon will face over its Physiomesh Flexible Composite Mesh. The plaintiff, Matthew Huff, was one of the first to file a lawsuit after Ethicon pulled the product from the market in 2016. According to the company, it stopped selling the product because of higher rates of hernia recurrence and re-operation compared to similar products. Ethicon issued a voluntary recall in Europe and other countries, but only a “market withdrawal” in the U.S. as we told you earlier. Read the full story here.
Physiomesh & Proceed Hernia Mesh
Physiomesh is made of polypropylene laminated with poliglecaprone. Proceed is made of polypropylene with one side coated in oxidized regenerated cellulose (ORC). The ORC layer is bioabsorbable and separates from underlying tissue and organs.
Physiomesh Hernia Patch
Ethicon is facing several lawsuits from people who were injured by Physiomesh product. It was pulled off the market in the United States after studies found higher rates of hernia recurrence and revision surgery. The FDA did not announce a recall. Ethicon recalled Physiomesh in Europe and Australia, but the same action was called a “market withdrawal” in the U.S.
International Recall For Ethicon
Ethicon recalled its Physiomesh outside of the U.S. in Europe and Australia, meanwhile the same action was called a “market withdrawal” in the U.S., which is why the FDA did not make any announcements to warn patients. According to an Urgent Field Safety Notice to surgeons on May 25, Ethicon recalled Physiomesh after analyzing unpublished data from two large independent hernia registries in Germany and Denmark. The studies showed Physiomesh had higher rates of hernias returning and needing another surgery (called “recurrence and re-operation”) compared to similar types of hernia mesh for laparoscopic ventral hernia repairs. Ethicon blamed the complications on multiple factors, including possible “product characteristics, operative and patient factors,” but decided to remove it from the market rather than fix the issues. Ethicon said the “voluntary recall has been communicated to the U.S. Food and Drug Administration (FDA).” The FDA classified the action as a market withdrawal rather than a recall. To learn about some complications being reported with claims, be sure to head over here.