Lawsuit Over Mirena IUD Imported From Canada Filed By Texas A.G.

The state of Texas has filed a lawsuit against a women’s healthcare clinic for allegedly using Mirena IUD birth control devices that were illegally obtained from Canada. 

Texas Attorney General Greg Abbott filed a deceptive acts and practices lawsuit over Mirena (pdf) against the Women’s Integrated Healthcare clinic in Grapevine, Texas, for providing women with versions of the Intra Uterine Device (IUD) that were acquired from an on-line Canadian pharmacy. The lawsuit accuses the clinic of causing confusion and misunderstanding among patients who believed that the Mirena IUDs were the same as those sold in the U.S.

The clinic claims that there is no difference between the IUDs sold in the U.S. and those sold in Canada. In a press release, clinic officials say they have stopped providing the birth control devices and that the only effect of the lawsuit will be to prevent women the clinic serves from obtaining affordable birth control.

In May 2008, Bayer sent out a “Dear Healthcare Professional” letter (pdf) warning U.S. doctors not to buy foreign versions of the Mirena IUD for use in the U.S. The company said that it understands that there is a price difference between those sold abroad and those sold in the U.S., where it is generally more expensive.

“[T]he foreign product is not FDA approved, and use of a foreign product raises important patient care and legal considerations,” Bayer warned doctors throughout the United States. “We are writing now to make sure that you are aware of these issues and to caution you against using the foreign product.”

Bayer further warned that the products may have passed through a number of countries before being shipped to the U.S. and there is no guarantee that the products are not counterfeits, have been properly stored and protected, and said that there are product differences from country to country that can affect insertion and “appropriate post-insertion monitoring and patient care.”

The FDA followed up with a similar Mirena import alert in July 2010, which says that the practice of importing the Mirena IUD began in Rhode Island and spread to other states. The FDA also warned that devices acquired abroad could be fakes, tampered with or manufactured with different specifications.

“Unapproved products bring a lot of unknowns into the equation,” said Kathleen Anderson, an FDA compliance officer. “An Internet ad may claim to sell IUDs made in Canada, but there’s no way to be sure. They might have been made anywhere in the world and in unsanitary or undesirable conditions.”

The Mirena IUD was approved by FDA in 2000 as a birth control device. In addition to placement as to prevent sperm and egg contact, it also releases the progestin levonorgestrel to futher prevent pregnancy.

A number of women have reported experiencing potentially serious problems with Mirena IUDs, including perforation of the uterine wall, migration of the IUD, infections, ectopic pregnancies (where the egg grows outside the uterus) and an increased risk of pelvic inflammatory disease.