Johnson Johnson s Ethicon subsidiary first received approval to market its Physiomesh Flexible Composite Mesh products in March 2010. However, the product has been plagued by problems following laparoscopic hernia repair surgery.
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 required 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 fascial deficiencies. The product is composed of a nonabsorbable, 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. An additional dyed polydioxanone film marker has been added for orientation purposes.
Ethicon Physiomesh Hernia Repair Problems
After obtaining approval to 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.
As individuals underwent hernia surgery where Ethicon Physiomesh was implanted, a higher-than-expected number of problems after laparoscopic ventral hernia repair were reported, typically involving hernia recurrence and re-operation to remove the hernia mesh. Many individuals have also experienced hernia surgery complications with infections, wound problems and severe abdominal pain.
In May 2016, an Ethicon Physiomesh Flexible Composite Mesh recall was announced by the manufacturer, which was classified by U.S. regulatory officials as a Market Withdrawal . The high rates of problems with Ethicon Physiomesh hernia patches could be caused by a number of factors, according to the urgent field safety notice, including issues with the design of the hernia repair mesh, instructions provided to physicians and patient selection.
Since Ethicon was unable to fully characterize the factors or issue further instructions to surgeons that may have reduced the hernia recurrence rate, the manufacturer decided to recall Physiomesh products from the Composite Mesh line.
However, many individuals have already been left with severe and permanent injuries following hernia repair, and may be at risk of future complications. As a result, financial compensation or Ethicon Physiomesh settlements may be available through a product liability lawsuit.
It appears that Ethicon knew or could have discovered problems with the Physiomesh hernia repair products much earlier. If warnings or better instructions had been provided to physicians about the Physiomesh risks, many individuals could have avoided severe and debilitating problems.
Hernia Mesh Lawsuits
In addition to cases for Ethicon Physiomesh problems, lawyers at Saiontz Kirk, P.A. are also reviewing potential Atrium C-Qur hernia mesh lawsuits. as well as other unreasonably dangerous and defective hernia repair products.
It is not necessary to know the exact product used during your hernia surgery. as free case evaluations are provided to help determine if you or a loved one may be entitled to a hernia mesh settlement.
To request a free consultation and case evaluation with the lawyers at Saiontz Kirk, P.A. complete the form below and provide information about injuries suffered from Ethicon Physiomesh.
Our law firm can also be reached toll free at 1-800-522-0102 .
During the case evaluation, Saiontz Kirk, P.A. will review the circumstances surrounding the injury and help determine whether financial compensation or a Ethicon Physiomesh settlement may be available. You will have an opportunity to speak with a lawyer and review any questions or concerns before moving forward with a case.
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