New Bayer IUD Approved Despite Mirena Lawsuits

Despite lawsuits piling up against Bayer Pharmaceutical by women who have experienced serious side effects from using the company’s birth control intrauterine device (IUD), Mirena, the Food and Drug Administration (FDA) recently approved another IUD made by Bayer.

In January, the FDA approved Skyla, a low-dose hormone IUD designed to prevent pregnancy and manufactured by Bayer. Skyla is the first IUD approved for usage in the United States in 12 years. Skyla was launched for usage in the U.S. in February. Mirena was approved by the FDA in 2000.

Mirena and Skyla are similar products, both T-shaped polyethylene devices that release diminishing amounts of progestin over time to prevent pregnancy. The main difference is that Mirena is designed to remain inserted in a woman’s uterus for five years, while Skyla is approved for only three years. Also, Bayer is marketing Skyla toward younger women who have not had children previously; Mirena is marketed toward moms.

The FDA approval comes as over 40 lawsuits are pending against Bayer from women across the United States who have suffered serious problems during usage of Mirena. Most of the lawsuits claim the device migrated from the uterus, sometimes perforating other organs or the uterus itself. These injuries caused major health problems and sometimes required surgery, according to the lawsuits. Women have also complained of ectopic pregnancies, pelvic inflammatory disease (PID) and even infertility following usage of Mirena.

The Mirena lawsuits also claim Bayer’s lavish marketing plan for Mirena, entitled “Simple Style,” failed to adequately warn women about the possibility of spontaneous device migration or expulsion. The tactical marketing plan received much attention from the FDA in 2009 after it was found that many of the statements in the program were found to be more flashy than truthful. The FDA issued an official warning to Bayer, saying the manufacturer tended to downplay the possible side effects of the IUD in the marketing program.

Skyla seems to be more of the same for Bayer. Side effects for the new IUD include: bleeding pattern alterations, vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, ovarian cyst and headache. In addition, there is a warning on the website, a site designed by Bayer for marketing Skyla, that the new IUD may attach to or go through the uterus and cause other problems. It also states pregnancy while using Skyla is uncommon but can be life-threatening and may result in loss of pregnancy or fertility. Ovarian cysts could occur but usually disappear, it says.

If you or someone you know has suffered problems while using Mirena, there is help available. The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.