Ethicon Physiomesh Recall
Ethicon's Global Market Withdrawal: Hernia Mesh Recall Information
In May of 2016, following the release of two European hernia studies, Ethicon issued a global market withdrawal of its Physiomesh Flexible Composite Mesh patches. Essentially the equivalent of a hernia mesh recall, the global market withdrawal was a voluntary action taken on the part of Ethicon to eliminate the defective product from markets worldwide. While implantation of the device is considered permanent and irreversible, surgeons were directed to promptly halt the use of any ventral hernia Physiomesh patch kits they had on hand. Essentially, this action indicates Ethicon deems Physiomesh dangers to outweigh its potential benefits. Unsafe for general use, Ethicon hernia mesh is no longer being sold.
Prone to failure and deemed to be unsafe, Ethicon hernia mesh is no longer being sold.
Serious Hernia Mesh Side Effects Prompt Market Removal
The two European studies, which originated from Denmark and German hernia registries, revealed an alarming trend: Patients that were implanted with Ethicon Physiomesh suffered far higher rates of side effects and hernia recurrence than patients who were implanted with a similar product during the same procedure, laparoscopic repair of a ventral hernia. Specifically, Ethicon Physiomesh has been found to cause severe internal injuries, organ perforation and damage, and ongoing abdominal infection.
The Ethicon Physiomesh warning cited nonspecific causes of the product's high failure rates: The company referred to a “multifactorial issue” possibly related to “product characteristics, operative and patient factors”. In other words, Ethicon suggests that the problem with Physiomesh can be traced to the product itself, to the implantation operation, and/or to particular details about the patient. Having pulled the product permanently from global markets, it is unlikely that Ethicon will ever specify the particular defects that cause Physiomesh problems.
Hernia Mesh Pulled After Six Years on the Market
Ethicon received FDA approval through the controversial 510k method, a fast track approval process that allows products that are substantially similar to another approved product to gain approval quickly. The 510k process does not require human testing; only animal tests were conducted in the premarket trials of Physiomesh. Ethicon cited another of its synthetic mesh products, Proceed, in order to achieve fast approval of Physiomesh hernia patches. Proceed was also recalled at one time for problems with adherence and organ damage.
Thousands of American consumers agreed to the implantation of Physiomesh, under the assumption the product had been tested for safety. Now we know Ethicon hernia mesh was never tested for the particular application of abdominal implantation. Contrary to product developers' hopes, the polypropylene fibers that make up Physiomesh are not compatible with abdominal tissues.
Physiomesh was approved and sold without being tested for implantation in the abdomen.
Surgeons Warned of Hernia Mesh Risks
In the warning letter to surgeons and physicians, Ethicon advised surgeons and physicians to halt the use of Physiomesh hernia patch kits in their possession. The company advised that patients already implanted with the device be monitored for Physiomesh side effects on an ongoing basis. Early signs of problems from Physiomesh include pain, fever, redness of the abdominal skin, and other indications of infection.
Hernia Mesh Lawsuits
Persons and the family members of persons who were harmed as a result of Ethicon brand hernia mesh may be eligible for meaningful compensation through filing an Ethicon hernia mesh lawsuit. Physiomesh lawsuits pursue justice on behalf of individual consumers who were harmed by the carelessness of a large corporation.
National Physiomesh Lawyers
When American families are hurt by the negligence of a large company, our Physiomesh attorneys handling product liability claims are committed to pursuing justice no matter how complex the case. Working on a contingency basis, these hernia mesh lawyers charge no legal fees unless they win on your behalf.