Most types of birth control options come with some risk, but some are worse than others. Mirena, a T-shaped intrauterine device (IUD) provides long-term contraception, but for many women, the convenience and peace-of-mind they received from “set it and forget it” birth control was not worth their pain and suffering.
There are more than two million women in the United States using Mirena, making it one of the most popular forms of birth control available. It works by thickening the mucus in the cervix and preventing sperm from fertilizing the egg. It is manufactured by Bayer Pharmaceuticals and was approved as the only hormonal lUD on the market by the United State Food and Drug Administration in 2000. Mirena is inserted for a period of five years and once it takes effect, women are told they need no other forms of birth control to prevent pregnancy. After a five year period, Mirena must be removed by a doctor.
The device was later approved in 2009 for use in treating heavy menstrual bleeding and was the first IUD that received approval for this use. According to the FDA release announcing the approval, the devices was approved for this alternative use because women who used Mirena in a clinical trial showed a “statistically significant reduction in menstrual blood loss.”
Complications from Mirena IUDs
Despite initial positive reaction to Mirena and its continued use, the FDA has received more than 70,000 adverse event reports regarding the device. There are nearly 2000 lawsuits currently in US court concerning the device, many of which claim Bayer failed to warn the medical community and users the device could become embedded in the uterus, causing tearing in the uterus, or migrate into the pelvic area.
There are also other claims. Many women using the Mirena birth control device developed infections, experienced damage to their organs, and suffered adhesions. Some also experienced hemorrhaging and required medical attention.
Mirena is considered one of the most reliable birth control methods on the market, but unfortunately, claims about the device’s effectiveness are not entirely accurate. There is evidence use of the Mirena device significantly increases the risk of ectopic pregnancy. Women have also experienced miscarriage while using the device, and some experienced infertility as a result of their Mirena use.
Mirena’s FDA Approval
Nine years after the FDA approved Mirena, the agency issued a warning letter regarding the device and claims being made at marketing events that led consumers to believe the device could enhance a user’s appearance, improve her mood, and help her be intimate with her partner.
According to the warning, Bayer had organized networking parties for internet mom’s groups and had a nurse in attendance to share information about Mirena. The scripted information provided by Bayer nurses included misleading information about the risks associated with Mirena use.
After an FDA review of the script, a warning alerting the public to the unsubstantiated claims about the device and listing the known risks associated with Mirena, including ovarian cysts, increased bleeding, amenorrhea, and pelvic inflammatory disease (PID).
Legal Action against Bayer Pharmaceuticals
Legal claims began in 2014 against Bayer in New York and New Jersey. There were approximately 1000 claims in progress against the company at the beginning of that year. Some were combined into multidistrict litigation in New York and others in the New Jersey Supreme Court. There are additional consolidated cases in New Jersey state court. Multidistrict litigation is intended to expedite the pre-trial proceedings and make the process of assigning negligence, if any is determined, as efficient as possible.
Legal claims against Bayer related to the Mirena device include:
- Misrepresentation of benefits
- Failure to warn of dangerous side effects, including device migration
- Understatement of the severity of the device’s side effects, including claiming they are uncommon
- Deceptive marketing
- Breach of implied and express warranty
- Concealment of harmful side effects of the device
- Failure to provide adequate warning or instructions for use
- Design, production and distribution of a defective product
There are numerous Mirena lawsuits pending in US court across the country. Our goal is to inform the public about the risks associated with Mirena use and help them determine whether or not they have a right to take legal action regarding the complications related to their use of the device.