Winnipeg woman 'traumatized' by decade of pain after surgical mesh splits apart, lawsuit alleges

A Winnipeg woman is suing Johnson & Johnson after more than a decade of pain she alleges was caused by one of the medical giant's surgical mesh products splitting apart and becoming embedded in her organs and tissues.

The woman, 57, got the mesh made by Ethicon, a Johnson & Johnson trademark after a partial hysterectomy in 2008, according to a statement of claim filed in Manitoba's Court of King's Bench on March 15.

At that time, she was suffering from general pain and diagnosed with fibromyalgia and depression, but still worked full-time and had an active life, the lawsuit says.

However, after the hysterectomy, her pain got worse.

For more than a decade, she saw her family doctor and a variety of specialists, spent time in the emergency room and had numerous scans and tests done, but no one could figure out the cause, the filing alleges.

Meanwhile, she developed stomach issues and had trouble sleeping, and her mental health deteriorated.

By 2020, the pain was affectingevery part of the woman's life, including causingher to miss work and preventing her from being physically or socially active, the lawsuit says.

"At times, the pain was so significant that she could not sleep, laugh, cough or sit upright in a chair for longer than five minutes without significant discomfort," the court filing says.

In 2021, the woman had her gallbladder removed in the hopes of relieving somepain but it continued getting worse.

Later that year, an exploratory surgery revealed the Ethicon mesh put inside her over a decade earlier "had eroded, split apart and/or disintegrated," becoming affixed to her bowels and resulting in serious infection throughout her body, the filing alleges.

"Her experience has left her traumatized," the lawsuit says.

No statementof defence hasbeen filed. None of the allegations in the lawsuit have been proven in court.

Mesh scrutiny

Ryan Carbain, a spokesperson for Johnson & Johnson, said the company's pelvic mesh products are safe.

"We will always empathize with any patient who has had complications as the result of a medical procedure, but our pelvic mesh products are recognized as safe and effective treatments for patients suffering from severe prolapse and stress urinary incontinence," Carbain said in an email.

The company's mesh products have come under scrutiny before. In 2012, Ethicon withdrew four used to treat women's pelvic organ problemsfollowing injury claims and lawsuits. The company said the decision was based on commercial viability and not related to safety or efficacy.

In 2016, Ethicon also voluntarily withdrew Physiomesh, which was used after hernia repairs. The company said that decision came after it discovered the product was responsible for more failures and repair operations than other meshes on the market.

A class-action case that started in Australia in 2017 argued the company's vaginal mesh implants caused them devastating pain, ravaged their bodies and, in some cases, ruined their lives.

Life-saving procedure

After discovering the mesh throughout the woman's body, doctors did an emergency surgery to remove as much as possible out of fear she would become septic, putting her life at risk.

As part of that life-saving procedure, they also put a temporary ileostomy bag inside the woman which "psychologically devastated" her, the lawsuit says.An ileostomy bag collects intestinal matter from the small intestine through an opening made in the abdomen.

The bag stayed in place for five months before being removed. During that time, the woman had limited mobility and needed at-home care. The bag also caused enzyme acid burns on her stomach, and the seal would often break, leaking excrement over her body.

She also had another surgery around that time, thoughher abdominal and pelvic pain continued sometimes dull and aching, and other times"significant, stabbing and completely debilitating," the lawsuitsays.

The woman had two more surgeries in 2022, including an open abdominal surgery where damaged parts of her bowel and one-third of her rectum were removed. She was also advised the significant amount of scar tissue inside her would make it dangerous to do more surgeries.

A colon test later that year found her pelvic floor nerves were no longer connected "as a result of the disintegration of the mesh and/or the various surgeries required as a result," the lawsuit alleges.

Continued pain

The woman continues to suffer from varying degrees of abdominal pain, bowel issues and bladder incontinence. She also continues to see specialists and has been unable to return to work, the court filing says.

The suit alleges Johnson & Johnson breached the duty of care it owed the woman, and that the company's conduct "was high-handed, improper and valued profits over the health of patients."

It also alleges the company introduced the mesh before it had been properly tested and failed to warn the public of its potential harm.