Mirena is an intrauterine device (IUD) for birth control. IUDs are small T-shaped devices that are implanted into the patient’s uterus. Once implanted, the Mirena device can last for up to five years. Mirena is manufactured by pharmaceutical giant Bayer HealthCare Pharmaceuticals. Since its approval in 2000, Mirena has been used by more than 15 million worldwide. Roughly two million of these users reside in the United States.
To date, neither the FDA nor Bayer has issued a Mirena recall. However, controversy surrounds the device and its safety concerns. Mirena users have reported a number of side effects, some of which are life-threatening. The FDA has received an estimated 45,000 adverse event reports from Mirena users. Side effects that may lead to a Mirena recall include organ perforation, device migration, and pelvic inflammatory disease.
Mirena Side Effects
Mirena side effects range from minor to life-threatening. A number of Mirena patients experience side effects such as nausea, nervousness, headaches, and mood changes. Many Mirena users experience changes in their menstrual cycle. Roughly 20 percent of Mirena users stop having their menstrual periods after a year of Mirena treatment. These side effects are more common and are less likely to contribute to the request for a Mirena recall.
Mirena Organ Perforation and Migration
Migration and organ perforation are two serious concerns of the Mirena device. Many have urged for a Mirena recall based on the severity of these incidences. Several Mirena users have reported the device perforating the uterus. Uterine perforation can lead to life-threatening bleeding, severe pain, and long-term organ damage.
If the Mirena device perforates the uterus, it may migrate to other areas in the abdominal cavity. Patients have undergone surgery to remove the Mirena device from the bladder, pelvis, fallopian tubes, and other areas. In some cases, X-rays, ultrasounds, and several surgeries were required before the Mirena device was successfully located and removed.
Pelvic Inflammatory Disease
The risk of pelvic inflammatory disease (PID) has also prompted the demand for a Mirena recall. PID is a bacterial infection that affects the uterus as well as other reproductive organs. PID can cause serious complications such as constant pain, infertility, and ectopic pregnancy. In a normal pregnancy, the fertilized egg attaches itself to the uterine wall. Ectopic pregnancy occurs when the fertilized egg attaches itself outside of the uterus.
In 2009, the U.S. Food and Drug Administration (FDA) issued a warning to Bayer regarding Mirena. This warning increased the public demand for a Mirena recall. In the warning, the FDA discussed the health risks associated with using the Mirena device. The warning also addressed advertising and marketing misconduct from Bayer. In marketing campaigns, Bayer overstated the efficacy of Mirena. Bayer also made unsubstantiated claims and misleading statements to consumers. The FDA ordered that Bayer immediately cease distribution of these marketing materials.
Overstatement of Efficacy and Unsubstantiated Claims
In a Mirena advertising program, a nurse practitioner discusses the benefits of Mirena. These benefits include improvement in romance, intimacy, and reconnecting with the patient’s sexual partner. The FDA noted that no evidence of these claims was observed. The FDA holds strict requirements that claims regarding quality of life outcomes must be accompanied by substantial evidence to support these claims. Many consumers felt betrayed by these claims, adding to the desire for a Mirena recall.
In the Mirena advertising program, the script states that “no daily, weekly, or monthly routines” are required, as opposed to other birth control methods. The FDA found that this claim is misleading. Bayer recommends that Mirena patients receive a gynecological examination four to 12 weeks after the device is inserted. Examinations are recommended once a year after the initial examination. Additionally, it is recommended that Mirena users check on the placement of the device’s threads after each menstrual cycle. This equates to a monthly routine.