An intrauterine device called Mirena which is marketed by pharmaceutical giant Bayer Inc. has been found to cause some rather serious complications, among them uterine perforation. Last year, the U.S. Food & Drug Administration (FDA) sent Bayer a warning letter over what it felt was an overstatement of the efficacy of the Mirena. The FDA also communicated to Bayer that the company had left out information about some of the risks linked to the device while minimizing others.
The Mirena (levonorgestrel-releasing intrauterine system) is a T-shaped frame (Tbody) made of polyethylene. The frame is outfitted with a steroid-containing reservoir (hormone elastomer core) on which the vertical stem rests. It is this steroid reservoir that holds the slow-release hormone treatment progestogen levonorgestrel. The hormones are secreted into the uterus. The Mirena must be inserted by a health care professional who has been trained in the process of insertion.
The Mirena can be left in the uterus for up to 5 years. After this, the system is either replaced or removed and discontinued in favor of another type of contraception or to take a break to have a baby. Women who have had one or more children are the best candidates for the device.
But women should also be aware of the risks inherent in the use of Mirena, which has been linked to ovarian cysts, a higher profile for pelvic inflammatory disease (PID), amenorrhea, or irregular bleeding. Also, in the rare case in which a woman conceives while using the Mirena, a resultant loss of pregnancy and a possible permanent loss of fertility may result.
A year after the FDA sent Bayer a warning, Health Canada communicated to health care providers in that country that the risk of uterine perforation in Mirena users is rare but quite serious, occurring at a rate of 1 in 1,000 women and during 1/10,000 Mirena insertions. Though the rate of this complication remains stable since 2001 in Canada, increased use of the device has increased the number of uterine perforations.
In some cases, says Health Canada, some cases of perforation went unnoticed after insertion was completed. The risk for perforation increases with use just after birth, while nursing, and in women who have an atypical uterine shape, such as in the case of a fixed, retroverted uterus.
The FDA turned its focus on Bayer after it aired a promotional program for the Mirena device. Bayer created a direct marketing program that featured a series of parties hosted by Mom Central (a social networking site) members in their homes including representatives from the social networking site along with a nurse practitioner who used a script to speak about the Mirena.
Among the issues that sparked the warning letter from the FDA includes the numerous inferences in the script that claimed the Mirena can help users with their love lives.