Back in December 2009, the FDA requested that Bayer discontinue a promotional program for Mirena, an intrauterine form of birth control. In a letter written to Bayer’s Associate Director of Advertising and Promotions, the FDA stated that the program misbranded Mirena in violation of FDA regulations and the Federal Food, Drug, and Cosmetic Act. Specifically the FDA’s letter mentioned that Bayer’s advertisement for Mirena:
- Overstated the efficacy of Mirena;
- Presented unsubstantiated claims;
- Minimized the risks of using Mirena; and
- Included misleading presentations regarding Mirena.
Bayer’s Mirena IUD Promotional Campaign
Bayer’s promo for Mirena, entitled “Mirena Simple Style Statements Program,” was designed as a live presentation targeting a consumer audience of “busy moms.” The program was staged in a variety of intimate settings, such as a consumer’s home or private restaurant party, where women were invited to learn about Mirena birth control. It included an interactive Q&A session with a series of statements which, according to the FDA, indicated that Mirena can increase intimacy and help women reconnect with their partners. The recurring theme within the presentation was that Mirena can improve the romantic relationships of women who use the device, while helping them “look and feel great.”
FDA Says Bayer Overstated Mirena Efficacy & Downplayed Risks
In contrast to the messaging within Bayer’s Mirena ad, the FDA said that clinical studies of the contraceptive device told a much different story. While the ad suggested that Mirena ramps up intimacy, the FDA noted that at least 5% of clinical trial patients actually reported decreases in libido with Mirena-use. The FDA stated that Mirena caused adverse reactions, such as uterine and vaginal bleeding, heavy bleeding, and ovarian cysts, in a very common frequency (less than 10%) of clinical trial patients. Other reported Mirena side effects include headache, pelvic pain, nervousness, nausea and depression which, according to the FDA, could negatively affect a woman’s mood or feelings about being intimate and prevent her from “looking and feeling great.”
The FDA also addressed the risk presentation portion of the ad, saying that Bayer did not sufficiently communicate all of the health risks associated with Mirena, such as an increased susceptibility to pelvic infections. The ad also failed to convey that a woman may lose her baby or her fertility in the off-chance that she does become pregnant while using the device.