Texas' attorney general is suing a Grapevine women's health clinic and six of its doctors for allegedly giving patients a non-FDA-approved birth control device.
Mirena is a hormone-releasing contraceptive that is placed in a woman's uterus. The U.S. version of the intrauterine device is FDA-approved, but the Canadian version is not.
"Because the IUDs were procured from a Canadian pharmacy rather than a licensed drug distributor, the products were not stored or transported through licensed distribution channels," Attorney General Greg Abbott's office said.
The clinic ordered the IUDs from Medisave, an online Canadian pharmacy, to save patients money. The Canadian version of Mirena costs patients without health insurance about U.S. $200, while the American versions costs about $700.
Dr. Angela Cope, the clinic's president, said the Canadian version of Mirena is just as safe as the American version.
"There is one plant in the entire world that makes the Mirena IUD, and that plant is located in Finland," she said. "So whether the Mirena IUD gets on an airplane and goes to Canada, or whether the Mirena IUD gets on an airplane and goes to America -- from a medical perspective, the IUD itself is exactly the same. The huge majority of patients are happy with their IUDs."
However, the Texas Department of State Health Services determined that the products are not identical to the FDA-approved versions, the lawsuit states.
Bayer, the manufacturer, sent a letter to U.S. health care professionals in May 2008 warning against the use of Mirena from other countries, the attorney general's office said. The letter also said the UIDs differ from county to country, including variations that affect insertion of the devices and patient care.
The Canadian version of Mirena comes with instructions in Scandinavian languages, but doctors referred to online English instructions.
The DSHS discovered that Women's Integrated Healthcare was selling the Canadian version of Mirena during a 2009 inspection. The clinic voluntarily stopped selling the devices in December 2009.
The Women's Integrated Healthcare has informed patients about the lawsuit, and the clinic said most patients have chosen to continue using Mirena. A couple of the clinic's doctors who personally have Mirena also continue to use it, the clinic said.
The attorney general is seeking a court order requiring the clinic to only purchase and sell FDA-approved IUDs that are labeled in English and civil penalties.