When it comes to promoting a new drug or medical device, drug makers can get creative. But when they overstep the lines, the Food and Drug Administration (FDA) steps in to point out the error of their ways.
Such is the case with drug maker Bayer. In 2009, the company partnered with the social media site Mom Central. The plan was to organize in-home events designed to promote the use of the company’s Mirena IUD. The small, flexible, T-shaped device is inserted into the cervix where it releases a small amount of hormone to prevent pregnancy as well as reduce excessive menstrual flow.
At these parties, a Bayer representative would talk to the gathering of women and tout the romantic – and convenient – benefits of such a device, such as not having to stop foreplay to slip on a condom, not having to take a daily pill, and – for some women – enjoying lighter and less frequent periods.
Only three parties involving about 80 women were held before the FDA became Bayer’s party pooper. The agency criticized Bayer for minimizing the risks associated with the intrauterine device.
Women across the country have complained of Mirena side effects. These include the device perforating tissue and organs, migration of the device to other parts of the body, pelvic inflammatory disease, and ectopic pregnancy. In many cases, surgeries have been required to remove the device and some women have had to undergo hysterectomies.
Several lawsuits have been filed against Bayer alleging the company did not adequately warn women of the Mirena side effects. Bayer, however, continues to fight these claims despite mounting evidence from women who say they have been injured by the device.