Mirena IUD Potential Complications in Spotlight
When the FDA approved Bayer Healthcare Pharmaceuticals’ Mirena IUD in 2000, the hormonal intrauterine devise was considered a safe and effective reversible birth control solution that would remain effective for five years. Today 2 million women in the United States rely the device as do more than 15 million internationally.
Mirena is a flexible, T-shaped plastic device that medical practitioners may insert through the opening of the cervix into the uterus. It prevents pregnancy by releasing levonorgestrel, a hormone, into the uterus, which thickens the cervical mucous thus preventing sperm from entering. In addition, it also thins out the uterine lining making it impossible for a fertilized egg to adhere to the wall. Levonorgestrel is the same hormone used in Norplant and at a higher dosage in Plan B, the “morning-after pill.” Norplant has been taken off the market in North America.
Despite its effectiveness as a method of birth control, the Mirena IUD is not without problems. Complications from Mirena have included:
- Perforation of the uterine wall
- Intestinal obstruction
- Ovarian cysts
- Perforation of the intestine
- Erosion of the IUD into the uterus
- Ectopic pregnancy
- Migration of the IUD
- Pelvic inflammatory disease
- Severe cramping
Perhaps the most serious of these potential complications is the possibility of perforation of the uterus, which in many cases has required the uterus to be repaired surgically or removed. If perforation occurs, there is an opportunity for the device to migrate into the abdominal cavity where it can potentially cause life-threatening injury including organ damage, sepsis, or intestinal obstruction.
Currently, Bayer Corporation is the defendant in a number of lawsuits relating to the Mirena IUD and the company has received two warning letters from the FDA indicating the company failed to adequately inform the public of potential risks.
One of these lawsuits, filed on behalf of an Indiana woman on July 26, 2012, claims that Bayer Corporation and Berlex Laboratories, Inc. did not warn women and their physicians about the possibility of spontaneous migration of the device, stating only that migration may take place if the uterus is perforated during insertion of the IUD. The 24-year-old plaintiff, who had the Mirena IUD inserted in March 2009, underwent a hysteroscopy to remove the device in September 2010. Unfortunately, her physician could not find the IUD anywhere near the uterus even with the aid of an intraoperative ultrasound. A subsequent CT scan revealed that the IUD had migrated and was firmly imbedded in the patient’s abdominal wall.
In addition to lack of proper warning of the possibility of migration, Bayer Corporation is accused of making exaggerated marketing claims about the device’s performance and of understating its potential complications.
If you or someone in your family has suffered complications arising from the use of a Mirena IUD, we encourage you to contact the attorneys atBachus & Schanker, LLC immediately. You can reach us by phone at 866-468-5508 or email us now through this link to arrange a no cost, no obligation consultation.