Patients in Canada who have suffered side effects from Physiomesh Flexible Composite Mesh have launched a class-action lawsuit against Ethicon and Johnson & Johnson over claims it was defectively designed.
Ethicon’s Physiomesh has been the subject of countless lawsuits in the United States, and now Canadien patients are speaking out about their experiences with the now-recalled device.
The hernia mesh product was approved for the Canadian market in September 2010, and is designed to repair hernias by strengthening the weakened part of the abdominal wall. In June 2016, Health Canada issued a recall of Physiomesh “following an analysis of unpublished data from two large independent hernia registries.”
The data from two European hernia registries indicated higher than average recurrence and reoperation rates than comparable meshes. According to Mass Device, Ethicon said the higher revision rates were due to a “multifactorial issue,” which possibly includes “product characteristics, operative and patient factors” but could not pinpoint the cause.
“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” according to a letter Ethicon sent to healthcare providers in May 2016. “Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”
Canadian Patients Point to a ‘Design Defect’ in Physiomesh
A number of patients who have had hernias repaired using Physiomesh in Canada have come forward claiming that the mesh was defective. According to the class action’s statement of claim, that defect can make the mesh contract, tear or migrate, creating issues for patients including perforations, infections and revision surgery.
Two complainants came forward and spoke to CTV News about their experiences with the mesh. Colleen Copland said that doctors used the mesh on a hole in her abdomen during routine hernia surgery. Since then, the 34-year-old’s mesh has caused a hernia recurrence and severe pain.
“The pain is always there,” she told CTV News. “It feels like my insides are going to explode.”
She had her surgery in February 2016 and learned a few months later that the product had been recalled and withdrawn from the market. Her pain persists, however.
“If I cough or sneeze I have to hold my stomach,” she added. “It is a horrible pain, to be honest.”
Jaqueline Deschenes suffered similar symptoms after her hernia surgery with Physiomesh. She eventually had the mesh removed in January 2015, but she told CTV News that the pain has never left.
The two joined the class-action lawsuit against Ethicon over claims that the company failed to warn patients of side effects and did not ensure its safety. As many as 30,000 Canadians may have received the Physiomesh implant.
“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,” lawyer Jill McCartney, who is representing plaintiffs, told CTV News.
Physiomesh Lawsuits Also Pending in US
Physiomesh was approved in the United States months before it was approved in Canada and was never formally recalled by the U.S. Food and Drug Administration. Instead, Ethicon simply withdrew the device from the market.
Dozens of cases are currently working their way through the court system in the United States. Earlier this month, plaintiffs filed a request to the U.S. Judicial Panel on Multidistrict Litigation to consolidate 18 pending federal cases into a single docket.
Plaintiffs in those cases made similar claims that a defect in the design of Physiomesh caused complications after surgery, including recurrence, obstruction of the bowels and revision surgery.
The panel has yet to make a decision on the request but cases continue to be filed in courts around the country related to Physiomesh.