Commercials tout the Mirena-brand intrauterine device as one of the easiest long-term birth control devices on the market.
That's how one North Texas woman felt about her IUD — until the day she heard from her doctor's office, Women's Integrated Healthcare in Grapevine.
"The first thing she said to me was, 'The Mirena that I had inserted a year-and-a-half previous was purchased in Canada,'" said the patient, who prefers to remain anonymous. "When she told me that, I thought, 'That's wrong; that's really wrong to do that and potentially cause harm.'"
An FDA-approved Mirena IUD in the United States costs about $700 wholesale to physicians. But on the Internet, IUDs imported from Canada can be purchased for as little as $200.
Women's Integrated Healthcare charged the patient News 8 spoke to more than $1,800 for inserting the bargain-priced Canadian product.
"From the billing, it looks like they billed the insurance company full price — as if the product has been bought in the USA at the United States price," said Randy Moore, an attorney who represents the patient. "I call that insurance fraud."
"I think it is a matter of greed," said the woman who Moore represents. "And I'm just dismayed... very dismayed."
The Texas attorney general's office calls the actions of Women's Integrated Healthcare "illegal" and a violation of the Texas Deceptive Trade Practices Act and the Texas Health and Safety Code, according to a suit filed Thursday in Tarrant County.
"Using an off-label product has no benefit to the patient," Moore said. "The only people who benefit from it is the doctor who makes more money."
In an interview with News 8, Dr. Angela Cope, one of six Women's Integrated Healthcare physicians being sued by the attorney general, says physician profit is not why her office purchased bargain IUDs online.
"Our uninsured patients and patients with very large deductibles simply were not able to afford the American pricing scheme of the Mirena IUD," Dr. Cope explained.
Dr. Cope claims her office gave deep discounts to those patients. She adds that an attorney they consulted about implanting the Canadian version of the Mirena device assured them it was legal.
And Dr. Cope insists the Canadian version is safe for patients.
"Mirena is a registered trademarked product. It is produced in a single plant. That plant is in Finland. And from Finland, it is distributed worldwide," Dr. Cope said. "From a medical perspective, the IUD itself is exactly the same. It's a misnomer to say a Canadian IUD versus an American IUD. And you know really a Canadian uterus is not any different than an American uterus."
Dr. Cope admits that she — like every gynecologist in the country this summer — recieved an FDA alert warning not to use these unapproved IUDs because of concerns about "effectiveness and safety — as well as the potential for fraud and counterfeiting."
The physician said she has stopped providing the Canadian devices to patients.
Women's Integrated Healthcare also sent letters to more than 40 patients, telling them they had implanted unapproved IUDs without their consent.
According to the AG's office, Women's Integrated Healthcare purchased nearly 500 of the Canadian IUDs.
Dr. Cope said her clinic is not the only one to implant these potentially illegal birth control devices
"I think there are OB/GYNs across the Metroplex and across the nation that have used Mirena IUDs imported from Canada," she said.
The Women's Integrated Healthcare patient interviewed by News 8 believes women do have a right to know what product is being placed in their bodies.
"It's just a complete betrayal of confidence," she said.