Mirena is made from a polyethylene T-shaped frame that houses a hormone reservoir delivering a slow and small release of levonorgesterel. Bayer’s IUD is intended to be used internally for up to 5 years, after which time the device must be removed. According to Bayer’s Mirena website, the contraceptive device is “recommended for women who have had a child.”
To date, the Mirena IUD is the only IUD contraceptive that has been approved by the U.S. Food and Drug Administration (FDA). Mirena received FDA approval in December 2000. However, despite its FDA approval, Bayer has been warned by the FDA of employing misleading marketing strategies in order to sell the contraceptive device to women.
In a letter sent by the FDA’s Division of Drug Marketing, Advertising, and Communications to Bayer in December 2009, the FDA stated that the Mirena presentation script exaggerated the effectiveness of the IUD. In addition, Bayer’s Mirena marketing strategies violated the Federal Food, Drug, and Cosmetic Act.
The Mirena presentation is a live marketing program held in consumers’ homes or in a private gathering space, and they are presented by a Mom Central representative and a nurse practitioner.
According to a FDA letter to Bayer, the Mirena parties were scripted in a manner that promoted Mirena as a contraceptive device that improved intimacy between partners and thus led to “emotional satisfaction.” In addition, the Mirena presentation script claimed that the IUD improves overall health and self-esteem. However, the FDA found this claim to be highly unsupported due to the documented Mirena side effects of ovarian cysts, headaches, nausea, weight gain, acne, shifts in mood, and other side effects that could seriously impact romantic connection, health, confidence, and emotional contentment.
In addition to targeting Bayer’s deceptive Mirena marketing campaign, the FDA has been the recipient of more than 45,000 adverse event reports.
Mirena lawsuits have been filed across the country, with a large number being filed in New Jersey. Individuals who have filed Mirena lawsuits have alleged that the Mirena device dislodged and traveled to another part of the body.
There are cases where the Mirena device has traveled into the fallopian tubes, the abdomen, and other vulnerable locations causing damage to internal organs. Oftentimes, these individuals had to receive surgery to remove the Mirena device.
If you or someone you love has used the Mirena IUD, and following device insertion, has experienced any of the serious side effects and health complications described here, you and your loved one may be eligible to receive compensation for such undue pain and suffering.
For a free legal evaluation about your Mirena case and for more information about filing a Mirena lawsuit, contact an experienced defective medical device lawyer at Carey Danis & Lowe by calling 800.721.2519
Mirena (Levonorgestrel Intrauterine Device IUD)
FDA Approval: December 6, 2000 as an IUD classified as a long-acting reversible contraceptive method
Generic Availability: N/A