Overview: Bayer is being sued once again over its Mirena IUD birth control. According to the Pennsylvania Record, an Arizona woman has filed a lawsuit against the company alleging that she suffered a number of injuries when Mirena perforated through her uterus and become embedded in her body. The suit was filed on March 25th in the U.S. District Court in Philadelphia.
- An Arizona woman is suing Bayer alleging that the Mirena IUD perforated her uterus and became embedded in her body; the suit alleges that she suffered renal failure and a slow heartbeat while hospitalized
- The Plaintiff says she suffers from neck pain, limited mobility, abdominal pain, heavy menstrual bleeding and severe cramping since she had the IUD removed
- Bayer allegedly failed to warn about the risks of the contraceptive device
Product: Mirena® intrauterine device (IUD)
Manufacturer: Bayer, Inc.
Side Effects & Complications
- Intrauterine pregnancy
- Streptococcal sepsis
- Pelvic inflammatory disease
- Perforation of cervix or uterine wall
Mirena IUD Became Embedded, Caused Injuries
The lawsuit names Bayer Corp., Bayer Healthcare LLC, Bayer Pharmaceuticals Corp., Bayer Healthcare Pharmaceuticals Inc., Berlex Laboratories Inc., Berlex Inc., Bayer AG and Bayer OY as Defendants. The Plaintiff, Cynthia Solano, alleges in her civil action that the Mirena IUD perforated her uterus and became embedded in her body. She received the birth control device in January 2011. Her lawsuit states that she suffered from cramping, pain and spotting after receiving the device, even though she was assured that the IUD was properly in place during multiple doctor visits. Following a visit to her doctor last December, however, Solano vomited and went to the hospital for treatment. There, a CT scan was performed, showing that Mirena was the cause of her health issues. She alleges that during her hospitalization, she suffered from renal failure and a slow heartbeat. The Plaintiff also claims that she has suffered persistent neck pain, limited mobility, abdominal pain, heavy menstrual bleeding and severe cramping after her surgery. She is suing Bayer for failure to warn and alleges that the company improperly designed and marketed the allegedly defective product.
The U.S. Food and Drug Administration (FDA) approved the Mirena IUD in 2000. A hormonal IUD, it releases levonorgestrel when placed inside the uterus, where it can remain for up to five years to prevent pregnancy. Mirena is a small, plastic T-shaped device attached to two strings; it must be implanted and removed by a healthcare professionals and is recommended for women who have already had a child. In recent years, women have reported serious injuries with the device. In this lawsuit and others, women allege that the IUD migrates from its intended location and breaks through the wall of the uterus, in which case it is no longer effective at preventing pregnancy.
Bayer has had a history of misrepresenting Mirena IUD in the past. In 2009, the FDA contacted the company over unsubstantiated claims made in their “Simply Style” program, which featured live presentations catered to busy moms. The script of the program claimed that Mirena would help women “look and feel great” as well as increase libido. The FDA stated that there is no evidence for these claims and furthermore, that Bayer had not warned about side effects such as weight gain, acne and breast pain.