The litigation surrounding Ethicon, Inc.’s allegedly defective Phyisomesh hernia products continues to grow.
According to court records, new Physiomesh lawsuits were filed just last week in the U.S. District Court, Southern District of New York, on behalf of three plaintiffs who suffered hernia recurrence and other complications, allegedly due to the falure of an Ethicon device. (Case No. 1:17-cv-06667, 1:17-cv-06681, 1:17-cv-06682).
Ethicon’s Physiomesh hernia patches are constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated with an absorbable film coating. The company claims that this unique, multilayer design helps the hernia mesh incorporate into the body and reduces inflammation.
Ethicon obtained regulatory clearance for its first Physiomesh products in 2010, via the U.S. Food & Drug Administration’s (FDA) 510(K) program, which allows a medical device to come to market without human clinical trials, as long as a manufacturer can demonstrate that it is “substantially equivalent” to another product previously approved by the agency.
Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the company said in an Urgent Field Safety Notice issued on May 25, 2016.
Ethicon has indicated it will not be returning Physiomesh Flexible Composite Mesh to the products.
According to the New York lawsuits, all three plaintiffs experienced severe abdominal pain and hernia recurrence after receiving Physiomesh during laparoscopic ventral hernia repair. During the plaintiff’s respective revision surgeries, the hernia mesh was found to have lost its integrity and pieces of the mesh had broken off and adhered to their bowels.
The complaints cite Ethicon’s decision to withdraw Physiomesh from the market in May 2016, noting that the company “never notified patients of potentially unacceptably high rates of complication and failure.”
The lawsuits also dispute claims that the polypropylene material used in Physiomesh is inert, and assert that “substantial body of scientific evidence shows that this mesh material is biologically incompatible with human tissue and promotes and immune response in a large subset of the population receiving Defendants’ Products.”
The complaints also claim that Ethicon was aware of the problems associated with Physiomesh, but did not act on this information.
Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federally-filed Physiomesh lawsuits in the U.S. District Court, Northern District of Georgia. The proceeding got underway last month, when it convened an Initial Conference on August 1st. Court records indicate that more than 100 Physiomesh lawsuits are now pending in the Northern District of Georgia.