The State of Texas has filed a lawsuit against a womenÃ¢â‚¬â„¢s clinic in Grapevine Texas. The WomenÃ¢â‚¬â„¢s Integrated Healthcare Clinic, according to Texas officials, has been using the Mirena IUD for pregnancy prevention but has been obtaining them from Canada. The lawsuit title says it all: Ã¢â‚¬Å“Deceptive acts and practices,Ã¢â‚¬Â and cite an incident where the clinic was inspected and found with the foreign-made devices that Ã¢â‚¬Å“were not identical to FDA-approved IUDÃ¢â‚¬â„¢s.Ã¢â‚¬Â Clinic providers were not informing women of the use of these cross-border products and clinics across the country have been warned by the Food and Drug Administration multiple times to only use U.S. obtained IUDÃ¢â‚¬â„¢s.
An IUD, or intrauterine device can be designed to work a variety of ways but are used to prevent pregnancy by releasing hormones directly into the uterine wall and creating an environment that is not ideal for pregnancy to occur. Approved for placement that can last up to 5 years, the Mirena IUD has been a highly popular alternative for many women who simply do not wish to take a pill and still want effective long-term contraception. With any IUD, and as is the case with Mirena, there are risks from use including perforation of the uterine wall, infection, and ectopic pregnancy (a pregnancy that implants outside the uterus, usually in the fallopian tubes).
The cause for concern with this particular case stems from fears that the Mirena IUDÃ¢â‚¬â„¢s that are obtained from outside the country cannot be guaranteed safe. There are no promises of proper manufacturing, storage, or safety specifications. In fact, there are concerns that some could be completely counterfeit–and there would be some very angry new mothers in the world when they became pregnant as a result. The FDA fears that Canadian IUDÃ¢â‚¬â„¢s may not have even been made there and could have passed through a variety of countries before stopping there for distribution–and no one is sure exactly how well they were made.
Since 2008 the FDA has been releasing a variety of different warnings to healthcare providers across the country to ensure the use of locally made Mirena IUDÃ¢â‚¬â„¢s. Despite these warnings it seems that many are not following the recommendations. Potentially serious side effects have been reported with use of the Mirena IUD including those discussed earlier and others like pelvic inflammatory disease and IUDÃ¢â‚¬â„¢s that displace and move–causing damage to adjacent tissues. In a letter released by Bayer they stated,
Ã¢â‚¬Å“The foreign product is not FDA approved and use of a foreign product raises important patient care and legal considerations. We are writing to make sure that you are aware of these issues and to caution you against using the foreign product.Ã¢â‚¬Â
Logically, one can assume that this womens clinic chose these particular IUDÃ¢â‚¬â„¢s because of the cost. IUDÃ¢â‚¬â„¢s can cost several hundred dollars and in clinics that are serving the less fortunate, the facility is often absorbing the majority of the cost–so trying to cut corners could have evolved into the use of these unapproved devices.