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Ethicon Physiomesh is a flexible, composite, macroporous, and partially absorbable mesh made of non-absorbable polypropylene by Johnson & Johnson. FDA approved the use of Ethicon Physiomesh in March 2010 for repair of hernias and other fascial deficiencies that require the addition of a strengthening or bridging material to obtain the desired surgical result. Hernia is a condition which occurs when an organ, intestine, and/or tissue squeezes through a hole or weak point in the surrounding muscle or connective tissue. The number of hernia repair operations performed every year in the USA is remarkable.
Despite the already existing mesh implants in the market, the sale of Ethicon Physiomesh increased after the FDA approval as it was promoted as a physiologically well-designed device, offering strong and comfortable healing and giving an exceptional intraoperative handling benefit. But within a few years, Ethicon globally recalled the Physiomesh after thoroughly considering the data which was revealed out of Hernia registries.
More than 1000 lawsuits have been filed as Ethicon Physiomesh was found to cause too many issues, increasing the rate of a recurrent hernia and repeat surgeries.
Serious Alleged Injuries include:
- Hernia recurrence
- Scar-like tissue that sticks tissues together (adhesion)
- Intestinal blockage
- Perforation (a hole in neighboring tissues or organs)
Ethicon Physiomesh Flexible Composite Mesh was approved by FDA on the basis of 510k process, in which human testing is not a mandate if manufacturers of medical devices can validate that their products are substantially equivalent to another legally marketed device. Ethicon stated that their product, Physiomesh, was substantially equivalent to their own product, Proceed, a hernia mesh. Later, in 2006, Ethicon recalled Proceed as the layers separating and exposing the underlying polypropylene mesh during a hernia repair procedure were increasing the risk adhesions and bowel fistulas in the operated patients. Following this, Physiomesh was also ultimately recalled in 2016.
Law Suits Allegation:
Personal injury cases in mass tort are expected to be filed against the manufacturers and marketers of Ethicon Physiomesh. As Ethicon has acknowledged and recalled their product with the assurance of not returning back to the market, these litigations have a chance of reaching a settlement at a faster rate.
Evidence to be looked for in potential cases:
- Usage of Hernia Mesh in Operative and Medical Records
- Identification details for Hernia Mesh Implant
- Indications for usage of Hernia Mesh in Medical Records
- Complications and their Treatment after Hernia Mesh Implant
Medical Record Review and Claim Validation of Hernia Mesh review should approximately take 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.