Ethicon Physiomesh appears to be an unreasonably dangerous and defective hernia mesh product, which has been linked to reports of high failure rates and the frequent need for revision surgery.
In May 2016, Ethicon removed certain Physiomesh products from the market, after failing to identify a cause of the problems.
The hernia mesh lawyers at Saiontz & Kirk, P.A. are reviewing cases for individuals worldwide.
And it is not necessary to know whether Ethicon Physiomesh was used during your hernia repair.
The financial compensation may be available through Ethicon Physiomesh lawsuits for individuals who experienced complications like:
- Bowel Adhesions, Bowel Perforation and Organ Perforation
- Mesh Erosion Or Failure
- Hernia Revision Surgery
- Abdominal Pain
- There are no charges unless a recovery is obtained.
Johnson & Johnson’s Ethicon subsidiary first received approval to market its Physiomesh Flexible Composite Mesh products in March 2010.
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Ethicon Physiomesh was introduced under the FDA’s controversial 510K fast-track approval process, meaning that the manufacturer only had to demonstrate that it was “substantially equivalent” to a previously approved hernia mesh system.
As a result, the manufacturer was not essential to conduct thorough testing or research to establish whether users may face an unreasonable risk of problems following Physiomesh hernia repair.
In its FDA application, Ethicon described Physiomesh as “a sterile, low profile, flexible composite mesh designed for the repair of hernias and other facial deficiencies.”
The product is composed of a no absorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films.
An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh. The polypropylene component is constructed of knitted filaments of extruded polypropylene.
Ethicon Physiomesh Hernia Repair Problems
After obtaining approval to the market and sell the product, Ethicon Physiomesh was widely adopted within the medical community amid aggressive marketing by the manufacturer, which attempted to promote the hernia mesh as superior to other hernia repair products.