Women living in this fast-paced, instant information age are seeking quick fixes and simple solutions to problems. So in 2000 when the pharmaceutical company Bayer introduced the birth control Mirena, an intrauterine device (IUD) inserted directly into the uterus to prevent pregnancy, as part of its “Simple Style” program targeted toward busy moms, the new birth control choice became an instant hit. The pharmaceutical company continues to market the IUD with the tagline “Keep Life Simple” and upon its release claimed the device would not only serve as a birth control method but also increase libido and make women “look and feel great”.
Bayer’s multi-million dollar advertising campaign of its IUD directly to the consumer helped create a surge in the use of IUD’s in the United States. In 2009, the use of IUDs implanted in American women using birth control had doubled in just two years (about 7.5 percent of all American women using birth control had IUDs.)
The tactical marketing plan received much attention from the Food and Drug Administration (FDA) after it was found that many of the statements in the “Simple Style” program were found to be more flashy than truthful. The program tended to also downplay the side effects of Mirena. These side effects may include:
- Uterine perforations
- Ectopic pregnancy (a pregnancy in which the fetus grows outside the uterus)
- Intrauterine pregnancy (a pregnancy with Mirena in place)
- Group A streptococcal sepsis
- Pelvic inflammatory disease (PID)
- Embedment of the device in the uterine wall
- Perforation of the uterine wall or cervix
- Infertility, abscesses, erosion of adjacent areas such as the vagina
The FDA issued an official warning to Bayer in 2009 for overstating the effectiveness of Mirena, while minimizing the risks associated with it. The German pharmaceutical giant had already received a similar warning, along with a large fine, from the FDA regarding how it advertised Yasmin and Yaz products, other birth control products. A fax from The Department of Health & Human Services, the umbrella organization of the FDA, to Fadwa Almanakly, the associate director of advertising and promotions for Bayer, states that FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed the script for the live consumer-directed program entitled “Mirena Simple Style Statements Program.”
The DDMAC found that statements directly from the “Simple Style” program misled women. For example, according to the fax, the “Simple Style” script included the following statements: “Do you ever feel so overwhelmed by your schedule that intimacy is much more of a ‘to do’ on a list than a desire?” and “One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don’t have to think about every day, such as the intrauterine contraceptive, Mirena.” The DDMAC concluded that these statements, and several others in the script, indicated that the use of Mirena will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. The fax warning goes on to say that these claims misleadingly overstate the proven efficacy of Mirena. The DDMAC noted that Mirena does in fact not involve a daily routine, but they are not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance or intimacy with their partners. In fact, 5 percent of clinical trial patients reported decreased libido as a side effect of Mirena use.
Also included in the warning from the FDA to Bayer, was a concern that the “Simple Style” program was also leading women to believe that Mirena can help patients “look and feel great” by stating during the program that “…figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding a birth control that is compatible with your busy lifestyle.” In the warning, the FDA stated that it is not aware of any evidence suggesting that women who use Mirena look or feel great. It goes on to state that patients using Mirena may experience various side effects such as: irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness and acne. These side effects may thus keep women from “looking and feeling great.”
In the warning, the FDA states that Bayer’s claims that Mirena improves quality of life, such as intimacy or romance increases, or claims that Mirena help women look or feel better, must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. The FDA asked Bayer that if it does have substantial evidence to prove these claims, that they submit them to the FDA for further review.
There are now several lawsuits against Bayer for its false and misleading statements concerning the Mirena IUD. These suits allege claims similar to those concluded by the FDA’s warning in 2009. The pending lawsuits allege Mirena-using women suffered serious and permanent physical injuries, including sexual issues. The plaintiffs also claim that Bayer misrepresented the drug in its marketing campaign and never failed to divulge the harmful side effects.
The lawyers at Nolan Law Group are equipped to handle cases involving injuries from the usage of Mirena. We are currently evaluating Mirena IUD cases. If you or someone you know has suffered after using Mirena, please Contact Us or call 312-630-4000.