Mirena IUDs (Intrauterine devices) are birth control devices implanted through the uterus to prevent pregnancy. Intrauterine devices such as Mirena are intended to prevent pregnancy for up to five years by acting as a hormonal contraceptive. The IUD is inserted into the uterus to disrupt the pathway between the egg and the sperm. Mirena also releases levonorgestrel, which inhibits a woman from releasing eggs by thickening the wall of mucous lining the uterus and decreasing sperm motility and survival rates, thus decreasing the likelihood of pregnancy. When functioning properly, Mirena has been found to be effective in preventing pregnancy 99% of the time.
Mirena is produced by Bayer pharmaceuticals and has been used in Europe since 1991. Mirena was later approved for marketing in the United States in 2000. In recent years, Mirena has been heavily marketing to younger women, even women in their early twenties and teens, and touted as a worry free, effective alternative to other birth control methods. Notably, Bayer also marketed Mirena as a means to improve relationships and sex lives and stated in several promotional materials that Mirena would “look and feel great”.
Contrary to what one may believe from its heavy marketing, Mirena has been linked to very serious complications. One of the most serious complications is “spontaneous” perforation, during which the Mirena IUD may perforate the uterine wall and migrate years after insertion. While Bayer indicated there was a risk for perforation, labeling only focused on the possibility of perforation during insertion and did not reflect the possibility of perforation after surgery.
In December 2009, the FDA sent a warning letter the Bayer, the manufacturer of Mirena, stating that the promotional materials overstated Mirena’s efficacy, included unsubstantiated claims, and discounted scientific literature which pointed to the possibility of spontaneous perforation and IUD migration. The FDA noted claims made in presentations to doctors were often misleading and sometimes outright false. The FDA noted that atleast 5% of all recipeitns reported decreased libido, which is the exact opposite of Bayer’s claims that Mirena would increase one’s libido and sex life.
Since marketing began, the FDA has reported over 45,000 adverse reports. Complications include:
- “Spontaneous” Uterine Perforation
- Migration or Movement
- Ectopic Pregnancy (pregnancy that occurs outside of the uterus)
- Urinary Tract Infections
- Surgical Removal of UID
- Pelvic Inflammatory Disease
- Irregular Bleeding
- Ovarian Cysts
- Back pain
- Weight Gain
- Breast Pain
Your Potential Claim:
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