When Eric Hagen was implanted with Ethicon’s Physiomesh device to help repair a hernia at Dartmouth General Hospital in Nova Scotia in 2012, he had no idea how unbearable his pain would become around seven years later.
“I can’t describe it today in words how much it hurt. I didn’t think anything could hurt that much,” the Nova Scotia resident told CBC News this week.
The 86-year-old is just one of what some experts are estimating thousands of Canadians who will suffer complications from Physiomesh.
Hagen recounted his story to the Canadian news outlet about how the surgeon had told him to use the mesh back in 2012 because it was the “new thing.”
Ethicon, which is a subsidiary of Johnson & Johnson, was granted approval to sell Physiomesh by the U.S. Food and Drug Administration (FDA) in 2010. Later that year, it was approved for use in Canada.
For Hagen, his experience was positive with no issues until one morning in March when he was talking to a neighbor on his property.
“All at once it just hit me, and I was to my knees,” he said.
He also told CBC News that the pain has been so severe and unexpected that he’s no longer able to look after himself.
“I’m worried I’m not going to be able to look after myself. Right now, I can’t look after myself,” he said.
Hundred of Physiomesh Lawsuits Filed Across North America
Hundreds of patients who allege injuries related to Physiomesh have filed lawsuits in the United States and more recently Canada.
In fact, Hagen’s story in CBC News comes just days after the U.S. Judicial Panel on Multidistrict Litigation (JPML) granted a request from plaintiffs to consolidate all similar cases related to Physiomesh pending in federal courts across the United States into a single docket.
“All of the actions share common factual questions arising out of allegations that defects in defendants’ Physiomesh hernia mesh can lead to complications when implanted in patients, including herniation through the mesh, recurrent hernia formation and/or rupture, and deformation of the mesh,” the June 2 transfer order says.
Patients in Canada have also filed a class-action lawsuit against Ethicon over complications that arose after implantation with Physiomesh.
“What happens is, we allege, is that it triggers major complications,” said Jane McCartney, a lawyer with a law firm in Canada who is applying to certify a class-action lawsuit. “It moves, and then people have mesh that’s either pulled apart or moved, and isn’t doing the job it was put in to do.”
A complainant who is part of the class-action suit in Canada spoke to CTV News in March about her experience with the synthetic hernia mesh product.
“The pain is always there,” 34-year-old Colleen Copland told reporter Karolyn Coorsh. “It feels like my insides are going to explode.”
Copland had the mesh implanted to repair a hole in her abdomen following routine hernia surgery. The mesh has since stretched out and led to a recurrence of her hernia along with severe pain.
“If I cough or sneeze I have to hold my stomach,” she continued. “It is a horrible pain, to be honest.”
Physiomesh Victim Says Patients ‘Should Be Alerted’
Although Physiomesh was removed from the market in 2012 after a higher than average rate of failure and later recalled by Health Canada, Hagen was never informed that the mesh implanted in his body was potentially defective.
“They should be alerted, so they’re forewarned,” he told CBC News.
Wait times to see a surgeon in Canada can take anywhere between one and eight months, according to a health care wait times site in Nova Scotia. The office Hagen has been referred to will not take new appointments until August.
For those patients who know they have been implanted with Physiomesh, physicians say there is not much you can do until a problem arises.
“Unfortunately, there is not a whole lot to do for patients that have it, and my advice for patients is to leave it alone and if they have any problems with it, then it will have to be dealt with at that time,” Dr. John Morrison, a surgeon who specializes in mesh removal in Canada, said to CTV News in March.
Dr. Alex Mitchell, head of surgery at the Dartmouth General Hospital, told CBC News that he used Physiomesh frequently to repair hernias because it was easy to put in and seemed comfortable to patients. He says people with no symptoms should not be alarmed.
“If you’ve had a hernia repair with mesh and you are well, don’t panic,” Mitchell said.
Those with symptoms should consult their family doctor and those with symptoms in the United States should also submit official reports to the FDA.
Although Hagen could take part in the class-action lawsuit against Ethicon over failing to warn of dangers and making a defective product, he said he has no plans to join the lawsuit at this time.