More Mirena Lawsuits Expected with New Study

New York, NYBayer announced a 33 percent rise in Mirena IUD sales worldwide between 2010 and 2013, making it the drug company’s most popular model. But three recent studies may affect Mirena as a moneymaker in the future.

One study showed that the risk of Mirena perforations is low - about 1 per 1,000 insertions. Out of 61,000 women included in the study, 81 of the women experienced uterine perforations.

The American College of Obstetrics & Gynecology recently published a study in the “Green Journal” that involved 5,000 women who were implanted with the Mirena. Over three years, 10 percent of the devices were expelled.

And a third study, also published in the Green Journal, is most alarming. The study shows a link between Mirena and breast cancer after examining information from over 93,000 women between the ages of 30 and 49 who used IUDs that release levonorgestrel. The researchers found 1,542 breast cancer cases, indicating a 20 percent risk of breast cancer among IUD users, including Mirena.

According to Vogue magazine (February 2015), Planned Parenthood saw a 75 percent spike in use among its patients from 2008 to 2012. “There has been a real explosion in interest in IUDs over the past five years,” says Stephanie Teal, M.D., a professor of obstetrics and gynecology at the University of Colorado. And American OB-GYNs are three times as likely to choose an IUD for themselves as any other form of birth control, according to a 2013 poll published in the journal of the American College of Obstetricians and Gynecologists.

Meanwhile, more Mirena lawsuits are being filed. By mid-January, 1,624 claims had been filed in Bergen County Superior Court. The lawsuits claim that Bayer failed to adequately warn about complications that may follow implantation of the Mirena IUD (In Re: Mirena Litigation; Case No. 297) as well as serious complications caused by Mirena, including uterine perforations, ectopic pregnancies, organ damage and infertility. Also last month, court documents show that 1,160 Mirena lawsuits have been centralized for pretrial proceedings (In re: Mirena IUD Products Liability Litigation, MDL No. 2434).

And just to make sure Mirena sales do not decline, Bayer announced on February 23, 2015 that, through its ARCH (Access and Resources for Contraceptive Health) patient assistant program, it will provide Mirena to “low-income women who meet eligibility criteria.” Will Bayer also pay medical bills for these low-income women if they suffer Mirena complications?