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The Mirena IUD is a long-acting method of birth control that is now used by some 2 million women in the U.S. Approved in Europe in 1991, and in this country in 2000, Mirena is now indicated for contraception and as a treatment for heavy periods for women who wish to use an IUD as their primary method of birth control.
What is Mirena?
The Mirena birth control device is a small, plastic t-shaped implant that is placed directly into the uterus by a health provider, where it can remain for up to five years. While inside a woman’s body, the IUD emits levonorgestrel, a synthetic form of progestin, at a rate of approximately 20μg/day.
It’s not exactly clear how Mirena works to prevent pregnancy, but it appears that several mechanisms are responsible for its contraceptive effects. The device inhibits sperm from reaching an egg by thickening cervical mucus. The IUD also thins the uterine lining, making implantation of a fertilized egg unlikely. There is also evidence that the levonorgestrel it releases may suppress ovulation in some women.
Bayer Healthcare Pharmaceuticals, the manufacturer of the Mirena IUD, recommends that the product be used in women who have already given birth to a child. However, a growing number of medical experts have advocated that long-acting birth control methods, including IUDs, be used in teens and young women, due to their convenience and effectiveness at preventing pregnancy.
Bayer markets Mirena as the perfect method of birth control for busy women who want to “keep life simple.” But in 2009, the company was reprimanded by U.S. health regulators over a promotional campaign that marketed the IUD to “busy moms” because of statements that both downplayed its potentially serious side effects and exaggerated its benefits. Among other things, the promotion included promises to potential users that the IUD would help them “look and feel great,” and improve their sex lives.
IUD Side Effects
Mirena is associated with a number of complications, some of which have a potential to be serious. The most commonly reported side effects include:
- Breast tenderness
- Breakthrough bleeding
- Absence of periods (amenorrhea), especially after one year of use
- Mood changes
- Weight gain
- Ovarian cysts
- Abdominal or pelvic pain
While the IUD is very effective at preventing pregnancy, it is estimated less than 1% of women who use the device will become pregnant. IUD users are more likely to experience a potentially life-threatening ectopic pregnancy should they conceive. This type of pregnancy occurs outside of the uterus, usually in a fallopian tube, and can’t survive to term. Generally, emergency treatment is needed to resolve an ectopic pregnancy.
According to a report aired by 7 News in Detroit in August 2013, the U.S. Food & Drug Administration (FDA) has received more than 70,000 reports of complications in Mirena users since the birth control device was approved in 2000. These include thousands of cases of device dislocation and uterine perforations.
Bayer’s Legal Troubles
Concerns over the complications that may be associated with Mirena birth control have prompted hundreds of women to files lawsuits against Bayer Healthcare Pharmaceuticals. The majority of these claims allege that the IUD can spontaneously migrate from its proper position in the uterus long after being correctly inserted by a health care provider. According to plaintiffs in these cases, this occurrence can lead to a variety of serious side effects that can put a woman’s reproductive health – and even her life – at risk. These include:
- Uterine Perforations
- Uterine embedment
- Abscesses and infections
- Scarring and adhesions
- Intestinal perforations or obstruction
- Organ damage
- Ectopic pregnancy
According to Mirena IUD lawsuits, Bayer does not provide any warnings to patients and doctors regarding the potential for the devices to spontaneously migrate. Instead, they point out that the product’s label only states that the IUD might migrate if the uterus is perforated when it is initially inserted.
In addition to the Mirena claims involving spontaneous migration, a number of lawsuits have been filed over certain types of brain injuries. These complaints allege that exposure to levonorgestrel can result in non-stroke neurological complications, including pseudotumor cerebri (PTC, also known as idiopathic intracranial hypertension or IIH), related to increased pressure on the brain from a build-up of cerebrospinal fluid.. Consequences of these injuries include severe migraines, as well as temporary blindness, double vision and other vision loss problems, according to the claims.