There are those who assumed the Physiomesh was actually recalled in the US due to its withdrawal from the US market.
However, there was never a formal recall. While there was a formal recall in at least one instance outside of the United States, that wasn’t the case in the US. While it has not been established if any issues with regard to Ethicon Physiomesh side effects might have qualified for formal recall under criteria maintained by the US Food and Drug Administration (FDA), Ethicon was nonetheless in a position to undertake a product withdrawal from the market – stopping the issuance of new product and extending refunds to hospitals and healthcare facilities willing to return unopened and unadulterated product to the manufacturer.
In spite of the lack of a formal recall in the US, Ethicon Physiomesh lawsuits have nonetheless rolled in based on a myriad of Ethicon Physiomesh complaints and adverse event reports with regard to failure of the mesh deemed at higher rates than competing products.
In an effort to illustrate some of the complaints plaintiffs are alleging, a lawyer with the Hollis Law Firm in Kansas City took to You Tube recently for a demonstration utilizing various packages of Ethicon Physiomesh.
The round mesh was found to be less-robust than the presenter expected it to be, as he was able to tear the mesh with his hands and fragment the mesh easily. Some adverse events reports noted that holes and tears had developed in the product, allowing for hernias to return.
Other adverse incident reports suggested that Physiomesh failed to remain at the deployment site, and migrated away from the hernia the mesh was meant to manage. The presenter explained the polypropylene mesh is coated with a product called Poliglecaprone on both sides – the reason for which is to help prevent the mesh from adhering to the bowel and other underlying organs, which can be problematic.
However, in spite of this coating the Physiomesh, in some patients, had nonetheless become bound with the bowel and / or intestine and the mesh had to be removed. In other cases, according to adverse event reports logged with the FDA, the double-sided coating of Poliglecaprone prevented the ultra-thin, lightweight mesh from adhering properly to the abdominal wall, which was the desired result for the mesh to properly control the hernia.
The result was migration away from the original deployment location to other areas of the abdomen where the mesh would have no useful purpose and, in some patients pose a risk for other adverse events.
There have also been allegations of issues pursuant with the packaging of Ethicon Physiomesh.
Surgical mesh is not new, having come into wider use in hernia repair and other applications for which laparoscopic surgery has been found to be less invasive, with reduced blood loss, reduced stress to the health care system, and to promote faster healing. Folded or rolled mesh would be inserted through a small incision then deployed via camera and remote instruments. While the technique is less invasive than traditional surgical procedures and has certain advantages, it has also proven problematic with the FDA actually recommending against use of mesh in some procedures.
The actual mesh material itself however, has evolved. And since mesh is not a new product per se, forthcoming incarnations of mesh have been introduced to the market through the FDA’s 510(k) Substantial Equivalence Clearance protocol, which allows for a manufacturer to skip the normal intensive testing usually required of new products in an effort to get the updated product to doctors and their patients sooner. Provided the incoming product is “substantially equivalent” to an existing product, the 510(k) Clearance is granted.
READ MORE ETHICON PHYSIOMESH LEGAL NEWS
Plaintiffs assert that Ethicon Physiomesh was not adequately tested, amongst other allegations.
Ethicon Physiomesh Flexible Composite Mesh was approved in April, 2010 by the FDA under 510(k) Clearance #K093932 and deemed as ‘Substantially Equivalent’ (SESE). There was no review by a third party…
Ethicon Physiomesh side effects lawsuits have been consolidated in multi-district litigation (In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, Case No. 1:17-md-02782 in US District Court, Northern District of Georgia.