On May 25, 2016, Ethicon, a Johnson and Johnson subsidiary, recalled its Physiomesh flexible composite mesh (for laparoscopic use) from the global market. This Physiomesh is a flexible composite mesh used for hernia repair by reinforcing the abdominal wall and preventing the hernia from re-opening. Ethicon recalled the product following the release of unpublished data from two separate independent European hernia registries. The studies suggest that the recurrence/reoperation rates after laparoscopic ventral hernia repair using the Ethicon Physiomesh composite mesh were higher when compared to other similar hernia meshes. Ethicon Physiomesh was also shown to fail earlier than competitors in the market.
Physiomesh, made of polypropylene, was found to break down in structure causing the layers of the mesh to separate, leaving the polypropylene exposed. This breakdown in structure causes the hernia to recur or causes other serious bacterial infections at the site of surgery, potentially making additional surgeries necessary. Some common symptoms of Physiomesh failure include problems such as: bacterial infections, internal organ damage, chills, fever, pain and swelling at the site of surgery, fluid filled abscesses in the abdomen, and perforation of blood vessels.
Ethicon issued a field safety notice stating that it believes the higher rates of recurrence/reoperation to be a multifactorial issue; however it still has not been able to characterize the issue. Ethicon noted these issues could possibly be product characteristics or operative and patient factors. However, Ethicon is unable to identify ways for doctors to prevent hernia recurrences and complications due to use of the Physiomesh. Thus, Ethicon has indicated it will not be returning the Physiomesh Flexible Composite to the market.
Physiomesh was approved under 510(k) clearance April 9, 2010, by the U.S. Food and Drug Administration (FDA). This process does not require clinical trials for safety and efficacy. This program allowed Ethicon to skip many pre-market studies and research by demonstrating that the Physiomesh was “substantially equivalent” to another product that was already approved by the FDA. Ethicon used its own Proceed mesh device as its substantially equivalent device to fast-track the process.
Ethicon denies that the product was actually recalled, but maintains the stance that they merely “voluntarily withdrew” the Physiomesh after the independent studies were released. In June 2012, Ethicon also removed four transvaginal meshes from the market claiming “business reasons” as the motive for recall. These transvaginal mesh products were also made from polypropylene.
There are at least three Physiomesh cases already filed nationwide. These cases claim severe reactions to the Physiomesh including severe infections, abscesses, intestinal fistula, abdominal pain, diminished bowel obstruction, and the Physiomesh pulling away from the abdominal wall leading to additional surgeries.
To find out which mesh was used during their laparoscopic surgery patients should ask their doctor or hospital for an operative reports and/or device tags. If you suffered complications after hernia surgery using Physiomesh, contact Melissa Prickett, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Melissa.Prickett@BeasleyAllen.com.
Sources: Swiss Medic, FDA, Lawyers & Settlements
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