A class action lawsuit has been filed in Canada on behalf of patients who were allegedly harmed by Ethicon, Inc.’s Physiomesh Flexible Composite Mesh products. The hernia patches named in the complaint were pulled from the global market last year, after data indicated the devices were associated with a high rate of complications when used in laparoscopic ventral hernia repair.
According to CTV News, as many as 30,000 Canadians may have received Physiomesh Flexible Composite Mesh during hernia repair surgery. The class action complaint charges that the hernia patch suffers from design defects that cause the mesh to contract, tear, or migrate. Plaintiffs are alleged to have suffered from perforations, abscesses, adhesions, infections and other complications that require revision surgery to remove the mesh.
“The pain is always there,” plaintiff Colleen Copland told CTV News. “It feels like my insides are going to explode.”
“If I cough or sneeze I have to hold my stomach. It is a horrible pain, to be honest,” the 34-year-old added.
Copland received Physiomesh Flexible Composite Mesh during hernia surgery in February 2016. The hernia patch has since stretched, leading to recurrence. Copland is currently awaiting a second surgery to remove the mesh.
Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh in May 2016, after unpublished data from two European hernia registries suggested the products were associated with higher average recurrence and revision rates in laparoscopic ventral hernia repair versus comparable meshes. Ethicon was unable to determine the cause of this issue, but noted that it could be due to product characteristics, as well as operative and patient factors.
Ethicon’s action has also sparked litigation in the U.S. On March 9th, plaintiffs pursuing Physiomesh lawsuits in federal courts around the nation asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all federally-filed cases before a single judge in the U.S. District Court, Middle District of Florida. The petition noted that there were at least 18 Physiomesh claims pending in federal courts in Florida, Colorado, Illinois, Georgia, Massachusetts, South Carolina, Oklahoma and New Jersey.
Plaintiffs point out that more than 330,000 Physiomesh devices were sold worldwide since the patches were brought to market in 2010, and assert that approximately 50%of those products were sold in the U.S. They predict that hundreds of additional hernia mesh lawsuits involving Physiomesh products will be filed in the future, and contend that centralization of the federal docket will promote judicial efficiency and preserve the resources of the courts, parties and witness involved in the litigation.