Mirena, is a T-shaped intrauterine device (IUD) prescribed to prevent pregnancy and to treat heavy periods. The progestin-containing plastic IUD is inserted into the uterus where it releases hormones. Approved in 2000, Bayer Pharmaceuticals claims Mirena is 99 percent effective. It can be left in up to five years.

The IUD has been the subject of enough controversy and injury that the U.S. Food and Drug Administration (FDA) has increased its warnings and precautions.

Mirena (Levonorgestrel-Releasing Intrauterine System) had the safety labeling changes approved by the FDA last month. The warning says that Mirena was not the subject of any clinical trial on breast-feeding women and there is an indication from a large post-market study that Mirena can increase the risk of perforation of the uterus in a woman who is breast-feeding.

That is just the latest in a series of warnings issued by the agency.

Five years ago the FDA approved additional safety label changes warning users that if a pregnancy should occur with the Mirena in place it should be removed. However, that obviously puts the fetus in danger and could jeopardize a woman’s future fertility.

Courtesy of Andy Dann

Sketch of a Dalkon Shield IUD – this IUD was the subject of numerous lawsuits in the late 20th century.

Some data had suggested that a female fetus could risk “masculinization” of the external genitalia. That’s because of the exposure to progestins in the womb from Mirena at levels higher than oral birth control.

The Mirena IUD also has a potential to embed in the uterus making it a less effective form of contraception. For women who are lactating, who are post-partum or who have a uterus that leans toward the rectum (retroverted), there is an additional risk of perforation of the uterus.

For those women who have given birth, insertion of the Mirena should not occur until a minimum of six weeks postpartum. Waiting up to 12 weeks is suggested by the FDA.

For women with a risk of cancer, who suffer migraines or severe headaches or who have high blood pressure, Mirena was already contraindicated.

Mirena was aggressively marketed by Bayer through consumer-driven Mirena parties online. In 2009 the FDA sent Bayer a letter to stop those parties because dangerous side effects were being omitted while the company was making “unsubstianted claims” about safety.

The FDA has received more than 4,000 reports of the IUD dislocating and more than 1-thousand reports of uterine perforation. The adverse event reporting system has over 50,000 reports of injury associated with the use of Mirena.

Product liability lawsuits filed by our firm claim Mirena is a dangerous medical device and that women were not warned of the risks. Also alleged is a break of express and implied warranties, as well as fraudulent misrepresentation and concealment.

Many women have been left infertile, in pain and in need of additional surgeries.