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Woman sues over medical device

Says vaginal implant causes constant pain

By: Aldo Santin

Posted: 10/1/2012 1:00 AM | Last Modified: 10/18/2012 4:14 PM | Updates

A Winnipeg woman is suing the manufacturers of a medical device for $5 million, alleging the device implanted in her 10 years ago is defective and deteriorating inside her body but can't be removed.

The woman is one of dozens of women across Canada and the United States who are suing manufacturers of a device known as a transvaginal mesh -- originally promoted as a simple, safe solution to incontinence but has since turned into a nightmare.

The device was originally designed to contain hernias but never tested for placement in vaginas. The device has buried itself in the vaginal tissue and doctors are unable to remove it.

The woman says she is in constant pain, intimacy is painful and unbearable, and she suffers from anxiety, depression and incontinence.

"It's a complete nightmare," lawyer Paul Miller, of the Toronto firm Will Davidson LLP, said of the woman's situation.

The woman is suing Covidien and Tyco Healthcare Group Canada ULC, asking the court to award her $5 million in punitive and aggravated damages, and unspecified general and special damages.

The allegations have not been proven in court. Statements of defence have not been filed.

Miller said the woman did not want to be interviewed.

Along with the two companies named in the the woman suit, Miller said he represents about 130 women suing other medical-device manufacturers, including Johnson & Johnson and American Medical Systems. He said there are about 40 manufacturers worldwide who make a transvaginal mesh similar to the one implanted in the woman.

Miller said the mesh is made of polypropylene, which is made from waste petroleum byproducts.

After being used for hernia applications, Miller said it was then adapted, without testing, for pelvic and uterus insertions.

Miller said the polypropylene was inert and stable when used for hernias, but breaks down when inserted in the uterus. He said the device can't be removed because it grows into the tissue, even as it's deteriorating.

"The mesh is eroding through the vaginal wall," Miller said. "Sex is impossible for women because the pain is too severe. We have a number of clients whose partners have been cut by the mesh during intercourse.

"We have (clients) who've had the mesh erode and migrate through their bodies and have perforated their bladder or bowel."

In her statement of claim, the woman said she has "experienced significant physical, psychological and emotional pain and suffering, undergone surgeries and hospitalizations, and has sustained permanent and debilitating injuries."

The woman states she has "been unable to participate in employment, athletic, recreational, social and household activities... and unable to work due to pain and complications."

No date has been set for the trial.

aldo.santin@freepress.mb.ca

Republished from the Winnipeg Free Press print edition October 1, 2012 B4