Ethicon Responds to Canadian TV Investigation on Mesh

Image from CTV-TV Canada

Mesh Medical Device News Desk, September 30, 2017 ~ Johnson & Johnson and its Ethicon division that makes medical devices rarely speaks for the record in defense of its pelvic mesh products.

However, the healthcare giant is speaking about a Canadian Television report that criticizes the company for its family of polypropylene (PP) pelvic and hernia meshes. CTV, Canadian Television and its W5 unit, continues its close-up look at the pelvic mesh controversy.

After producing similar stories in 2013 and again in 2016 (See coverage here), Avis Favaro, Medical Correspondent and producer Elizabeth St. Philip has produced Mesh Misery, a two-part investigation on mesh usage in Canada.

In Part One, Favaro talks to mother of two, Chrissy Brajcic. Within hours of her surgical implant of a polypropylene

Reporter Avis Favaro, CTV

(PP) plastic mesh sling, she knew something was wrong. The pain got worse and worse and soon she couldn’t urinate at all.

After more than one year, it took a surgeon five hours to extract pieces of mesh from her pelvis. Brajcic continues to endure chronic infections that have her hospitalized almost monthly, as well as pain from nerve damage.

Being sold on the device, Brajcic was told the "problem mesh" had been taken off the market, this was a “different” mesh, not the one the subject of many lawsuits she asked about.

Chrissy Brajcic, Canadian mesh implant sufferer

She is one of thousands of women in Canada who have filed product liability lawsuits against Ethicon, the Johnson & Johnson (J&J) subsidiary that makes the mesh implants. More than 120,000 lawsuits have been filed against seven mesh makers in the states (55,500 against J&J), as well as thousands around the globe.

The same questions that surround PP pelvic mesh are being asked of the PP hernia mesh that is used in nearly a million surgeries a year.

Hernia mesh patient, Keith Richter, CTV News

Patient Keith Richter, 26-year-old says he “can’t do s***” after his hernia implant with a PP mesh made by C.R. Bard, he tells Favaro as he tears up.

The Canadian Urological Association still supports the use of mesh to treat SUI but not pelvic organ prolapse (POP), except in some circumstances. Many physicians continue to believe that PP pelvic and hernia mesh does not cause pain and that the complication rate is 1-2%. Others say the complication rate can range as high as 30%.

Dr. John Morrison of Chatham, Ontario, Canada is a surgeon who believes in patients in pain. He is interviewed by CTV.

“They feel nobody will listen to them, thay are passed from one professional to another,” he says he hears constantly. He’s seen mesh erode into neighboring tissue, the spermatic cord, vas deferens, erode into the rectum, for example, where it can nick the bowel and cause deadly sepsis.

Dr. Vladimir Iakovlev

Dr. Vladamir Iakovlev, of St. Michaels Hospital is the director of Cytopathology. He was also an expert in the case of Egneyhem v. Boston Scientific in Miami where he showed jurors some specimens under the electron microscope that he has removed from patients experiencing complications. More than half of the specimens are bunched up, and harden, however in some patients it does not. No one knows why.

Mesh degrades, becomes brittle, and can migrate. Dr. Iakovlev says, and he believes a study is needed to follow patients for at least ten years to get the true complication rate.

Dr. Colleen McDonald, Urogyn Toronto

Dr Colleen McDonald, a urogynecologist from Toronto, implants and removes mesh. She would have mesh, she tells Favaro.

In her only criticism, she says the companies producing these devices were targeting the generalist doctors and inviting them to do 3-4 day courses to learn how to implant mesh. You can't learn that in four days, she says. It’s given mesh a bad name. In the right hands, mesh can be used successfully, she says.

Here are Parts 1 & 2 of CTV’s Mesh Misery.

Stats from Canada: Approximately 25,000 surgeries to treat stress urinary incontinence every year in Canada, 90% with mesh

100,000 hernia repairs with over 90% done with mesh.

Statement from Ethicon

In response to W5's investigation, here is a statement issued Saturday, September 30, from Ethicon, a subsidiary of Johnson & Johnson:

“We empathize with all women suffering from stress urinary incontinence, a condition that can be serious and debilitating. Pelvic mesh devices have helped millions of women suffering from stress urinary

incontinence. There are limited treatment choices for women with stress urinary incontinence seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment. Ethicon is confident in the positive impact our pelvic mesh products have had on the vast majority of women who have chosen this treatment option. In addition, the evidence shows that Ethicon acted appropriately and responsibly in the research, development and marketing of its TVT device for the treatment of stress urinary incontinence.”

Despite repeated requests, C. R. Bard, Inc. did not provide comment.