An online petition has been created to highlight the widespread problems surrounding the intrauterine device (IUD) Mirena and has already signed by almost 1,500 women. Many who have signed the petition, as well as others on sites around the internet, have communicated the serious complications that Mirena has had on them. These range from embedment in the uterus to uterine perforation to Pelvic Inflammatory Disease (PID).
We, the undersigned, respectfully request the U.S. Food and Drug administration do the following in regard to the Mirena IUD birth control.
Mirena is a small, T-shaped plastic device inserted into the uterus to prevent pregnancy. The Mirena IUD releases a small amount of Levonorgestrel, which is a synthetic progestin hormone. The petition alleges that while the device’s patient information only includes warnings for Pelvic Inflammatory Disease, infection, embedment, perforation, discomfort during placement, expulsion, missed menstrual periods, changes in bleeding, and ovarian cysts, there are many more in the physician information that are not frequently communicated with potential patients. These include:
“abdominal/pelvic pain, vaginal discharge, nausea, headache, nervousness, vulvovaginitis, dysmerorrhea (cramps), back pain, weight increase, breast pain/tenderness, acne, decreased libido, depressed mood, cervicitis (vaginal infection), hypertension, migraine, vomiting, anemia, dyspareunia (painful intercourse), alopecia (hair loss), eczema, pruritus (itchiness), rash, urticaria (hives), abdominal distension, altered mood, hirsutism (abnormal hair growth), edema (swelling).”
The aforementioned petition begins as such: “We, the undersigned, respectfully request the U.S. Food and Drug administration do the following in regard to the Mirena IUD birth control:
- Require the manufacturer of the Mirena UID, (Bayer Healthcare Pharmaceuticals), to revise the patient information for this device to include all potential Mirena side effects currently listed only in the physician information portion of the label.
- Require all medical practitioners inserting the Mirena to provide the patient with this information BEFORE the Mirena is inserted.
- Require all medical practitioners to forward this updated information, along with an explanation of the changes, to all Patients for which they have prescribed/inserted the Mirena.
- Recommend investigation into the additional temporary and long term side effects being reported (as outlined here) that are not currently mentioned in either the doctor or patient information for the Mirena device."
The FDA sent a letter to Bayer in 2010 which said their direct advertising program “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”