Mirena is an intrauterine device linked to adverse side effects. Its primary role is as a contraceptive and works by thickening the mucus in the cervical wall, helping to prevent sperm from reaching an egg.
Bayer Inc., the device’s manufacturer, has been accused of failing to warn the public about the product’s risks and side effects.
Mirena is a small plastic, T-shaped intrauterine device (IUD) inserted into the uterus by a physician, and works by slowly releasing the progestin levonorgestrel into the body. The hormone thickens the cervical mucus to prevent sperm from reaching or fertilizing an egg. The device is safe to use for five years after the initial insertion date. The Food and Drug Administration approved Mirena for market use in 2000, and remains the only FDA-approved hormonal IUD.
FDA Red Flags Mirena IUD’s Marketing Tactics
Bayer created a marketing strategy for the contraceptive device called “Mirena Parties,” hosted by members of a social networking site called Mom Central and typically held at a consumer’s home or another private setting. At the parties, a nurse practitioner and a Mom Central member would follow a script, using phrases such as “look and feel great”, “simple ways to reconnect with ourselves and our partners,” and “more likely to be more intimate.”
In December 2009, the FDA sent a warning letter to Bayer, stating that the script’s claims clearly indicated that the using Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction, and “misleadingly overstate the proven efficacy of Mirena.”
In addition, the FDA claimed the script left out information about potential side effects and other risks.
Uterus Perforation from Mirena IUDs
One of Mirena’s more serious side effects is uterus perforation, which can occur when the device is first inserted. Uterine perforation can also occur when the contraceptive has moved from its proper location. After the IUD punctures the uterus, it can migrate or become lost in the abdominal cavity, possibly puncturing the bladder, intestines or bowels. According to research, certain demographics are more susceptible to uterine perforation including breastfeeding mothers, and women who have had C-sections, abortions, and/or cervical surgeries.
Any of the following symptoms could indicate your uterus may have been perforated by the Mirena IUD:
- Heavy vaginal bleeding
- Abdominal pain
- Inability to locate the Mirena IUD string
- Rapid heartbeat
You should seek medical attention if you have any of the symptoms listed above.
Severe Side Effects of Mirena IUD
- Extopic pregnancy
- Group A streptococcal sepsis
- Embedment of the device in the uterine wall
- Breast cancer
- Cervix cancer
- Rectal cancer
- Gastric cancer
- Thyroid cancer
- Ovarian cancer
- Uterine cancer