Oklahoma City Personal Injury Lawyers

Busy Mom? Mirena IUD Birth Control Device? Time to Party!

I’ve heard of house parties to watch football games, promote political candidates, celebrate new babies and sell everything from Tupperware to cosmetics to home decor. But until recently, I had never heard of a house party to hawk birth control devices.

That’s how Bayer HealthCare Pharmaceuticals used to promote the Mirena IUD, which is now the focus of several hundred lawsuits brought by women who have experienced serious adverse health effects from using the Mirena birth control device.

Bayer evidently didn’t use the house party marketing strategy for long, perhaps because the U.S. Food and Drug Administration sent them a warning letter in December 2009. Bayer HealthCare Pharmaceuticals, a division of Bayer AG, a $48-billion-dollar German-based company, claims that it discontinued the parties earlier that year, before receiving the FDA letter.

At the “Mirena parties,” women heard a nurse practitioner describe how the Mirena IUD would make the world a better place for “busy moms.” The nurse practitioner/salesperson followed a script provided by Bayer that promised that women who used the Mirena IUD would “look and feel great” and enjoy improved sexual relations.

However, in several hundred lawsuits filed across the country, Mirena users allege a variety of harms and losses caused by the device, including:

  • Uterine perforation
  • Device migration away from the uterus to other parts of the body
  • Serious infections, including pelvic inflammatory disease, and
  • A long list of other adverse effects, including ectopic pregnancy, loss of pregnancy, infertility, abdominal pain, nausea, vomiting, bloating, heavy vaginal bleeding, ovarian cysts, chills, fever, loss of sex drive, migraines and acne.

Hasbrook & Hasbrook is investigating possible lawsuits on behalf of women in Oklahoma who have experienced adverse effects due to use of the Mirena IUD.

The FDA’s seven-page warning letter to Bayer is available in its entirety on the Internet (FDA Letter to Bayer re: Mirena). The letter said that the house party script “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”

The letter also informed Bayer that the FDA knew of no evidence that Mirena improved a woman’s “reconnections,” romance or intimacy, as claimed in the parties. The FDA also took exception to the promise that women who use Mirena are “looking and feeling great.” To the contrary, the FDA wrote:

“Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above. The experience of these side effects can prevent patients from ‘looking and feeling great.'”

The FDA chastised Bayer for failing to spell out the risks of using the Mirena IUD. The letter specified these risks:

  • pelvic inflammatory disease
  • ovarian cysts
  • irregular bleeding
  • amenorrhea
  • the risk of Mirena “embedding in, perforating or being expelled from the uterus”
  • increased risk of ectopic pregnancy
  • risk to an intrauterine pregnancy; should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility.

The letter said that 10% or more of users in clinical trials experience these “very common adverse reactions”: uterine/vaginal bleeding, including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea, and ovarian cysts.

Bayer’s Mirena house parties have gained notoriety as a textbook example of exploiting women. The Handbook of Feminist Research (2012, on p. 276) says that in a patriarchal society, woman “meeting together in communal, nonhierarchical groups” can have a powerful influence on women. The textbook them presents the Mirena parties as a prime example:

“Bayer Pharmaceuticals … appears to have exploited a version of the consciousness-raising group, using house parties for women … The house parties brought women together under the pretense of facilitating woman-to-woman conversations. A salesperson was secretly inserted in the group to influence attitudes and behavior, including passing along false information about the IUD’s supposed benefits.”

You wouldn’t necessarily expect good things from a website titled “Evil Slutopia,” a name which is apparently meant to be an ironic description of the “liberal, pro-choice, feminist, open-minded, strong-willed, outspoken, powerful women” who write for the site. Those women weighed in on the Mirena house party mess, writing:

“I know that moms/mom bloggers/women in general are smart, perfectly capable of making the best choices for themselves and their families … I’m just not sure that Bayer … agree[s] with me. If they did, wouldn’t they have written a script that was FDA-compliant and honest about the real benefits and risks of Mirena, and trusted women to weigh the pros and cons and make up their own minds? Giving women a free party is no substitute for respecting them enough to give them the truth.”

Very well said.

If you or someone you know has experienced adverse effects from using a Mirena IUD, get in touch with us for a free, confidential consultation. For more information about possible legal action, see: Mirena IUDs: Severe Side Effects; Lawsuit Critieria.