With litigation against the makers of Physiomesh mounting in the United States, a group of Canadian hernia surgery patients has launched a class-action lawsuit over allegations that they weren’t adequately warned of the dangers of Physiomesh.
The patients are blaming Ethicon, a subsidiary of Johnson & Johnson, for the severe pain they experienced after getting their hernias repaired using the Physiomesh Flexible Composite Mesh.
“I think there should be more testing on these products and not so quick to get them onto the market if they’re not ready,” Colleen Copland, one of the complainants who filed the class-action lawsuit against Ethicon, said to CTV News.
Physiomesh is a flexible mesh made from polypropylene designed to repair hernias by providing support to the weakened part of the abdominal wall. The goal of hernia mesh devices is to help decrease the likelihood of recurrence and revision surgery, but Physiomesh was found to have the opposite effect.
Copland had surgery in February 2016 to repair a hernia in her abdomen. Doctors used Physiomesh in the repair, but the mesh did work properly. According to Copland, the mesh stretched out and caused her hernia to recur, resulting in more pain than ever.
“The pain is always there,” Copland told CTV News. “It feels like my insides are going to explode.”
Just a few months after her surgery, she learned that all Physiomesh products were recalled and removed from the market.
Health Canada Recalls Physiomesh in June 2016
A few months after Physiomesh was approved for use in the United States by the U.S. Food and Drug Administration, it was made available on the Canadian market in September 2010.
In the following years, issues plagued patients who were implanted with the mesh, ultimately leading Health Canada to issue a recall for the product in June 2016. Data from two independent hernia registries revealed a higher than average rate of recurrence and reoperation in patients implanted with the mesh compared to those using other meshes.
According to Mass Device, Ethicon attributed the higher rates to a “multifactorial issue.” However, the company was unable to characterize all the factors contributing to higher rates and removed the product from the global market.
“Ethicon recognizes the voluntary product recall of the Ethicon Physiomesh composite mesh may be disruptive to your facility and apologizes for any inconvenience this may cause,” the company wrote in a letter to healthcare providers notifying them of the recall in May 2016.
Thousands May Be Implanted with Defective Physiomesh
According to CTV News, the class action’s statement of claim says that plaintiffs allege there is a defect in the design of Physiomesh causing it “to contract, tear, or migrate, leading to such injuries as perforations, abscess and adhesion formations, infections, and the need for further surgery.”
Jaqueline Deschenes, another complainant in the class-action lawsuit, told CTV News that she is also suffering from ongoing pain ever since her hernia was repaired with Physiomesh. Her surgeon told her that the device was not good and that it wasn’t being used anymore.
Even though Deschenes had the mesh removed in January 2015, she still experiences pain that feels “like a mass” inside her at all times.
Only a few have come forward claiming injuries but as many as 30,000 Canadians may be implanted with the device.
“It is our understanding that there are more people out there and there’s probably more people that are experiencing these kinds of side effects,” Jill McCartney, a lawyer representing the plaintiffs, said to CTV news.
Physiomesh Lawsuits Progressing in US Courts
Dozens of lawsuits have already been filed in courts across the United States making similar claims as the complainants in the Canadian class-action suit.
At least 18 cases are currently pending in federal courts. In March, plaintiffs in some of those cases filed a motion to the U.S. Judicial Panel on Multidistrict Litigation to consolidate all the cases into a single docket for judicial efficiency. Plaintiffs are awaiting a decision from the panel.
Cases continue to be filed in the United States every month.
In a lawsuit filed Feb. 2 by Connie Franklin in the U.S. District Court for the Middle District of Georgia, Ethicon and Johnson & Johnson were criticized for marketing Physiomesh as safe and effective when it was actually unsafe and defectively designed. Franklin is suing for negligence and a failure to warn, among other charges.