Skilled Mirena Injury Attorneys
Mirena: Long-Term Contraception
Mirena (levonorgestrel-releasing intrauterine system), manufactured by Bayer pharmaceuticals, is a form of long term contraception implanted into the uterus. Approved for use in the United States in 2001, the T-shaped implant holds a steroid reserve that is released slowly over time to prevent conception. Mirena is intended for use by women who have had at least one child. The implant is designed to last up to five years; if pregnancy prevention is still required after that, the device must be replaced. Unfortunately for many women who intended to use Mirena for worry-free contraception, the device has been shown to cause serious and severe side-effects.
Side-effects of Mirena use include:
- Increased risk of Pelvic Inflammatory Disease (PID)
- Ovarian cysts
- Irregular bleeding
- Amenorrhea (loss of menstrual period)
Mirena Injures Tens of Thousands, Still on Market
Ask yourself this question: would you use a contraceptive that has injured or killed almost 50,000 women since 1997? Of course you wouldn't, unless, that is, you weren't aware of the hidden dangers of that form of birth control. For many unsuspecting women who chose to use Mirena, that has, unfortunately, been the case.
Mirena, an IUD made by Bayer pharmaceuticals, has been advertised as a worry-free form of contraception that can boost your love life and simplify your family planning for up to five years. While Bayer has been playing up all the benefits their IUD can offer, they have failed to properly warn women about the potentially deadly side effects associated with Mirena. Between 1997 and 2010, there have been 47,506 adverse events associated with Mirena use.
Negative experiences ranged from painful to life threatening; the top complaints were:
- Device Expulsion
- Device Dislocation
- Vaginal Hemorrhage
- Medical Device Complication
- Abdominal Pain
- Amenorrhea (Loss of Menstrual Cycle)
- Pregnancy with Contraceptive Device
- Procedural Pain
- Abdominal Pain
- Genital Hemorrhage
While some complications were repaired with minimal invasion, many side effects resulted in serious complications. Many sent women implanted with Mirena devices to the hospital and 440 side-effects left women permanently disabled. More frightening, 355 women were placed in life-threatening conditions because of their Mirena implants, and 53 were killed by a medication designed to "help couples keep life simple."
Bayer Pulls a Fast One with Mirena Parties
In order to promote their product, Bayer has marketed Mirena as a means for "busy moms" to simplify their lifestyle and not worry about contraception. One of its best marketing tools was hosting "Mirena Parties" in conjunction with the social networking site Mom Central. Members of the Mom Central community hosted parties, welcoming a representative from Mom Central and a nurse practitioner. At the parties, Bayer had their representatives deliver a direct marketing script to the attendees. The FDA has taken issue with these scripts, because they contain misleading promises, making claims that the Mirena device will make them "look and feel great," and provide a "simple way to reconnect with (themselves) and (their) partners," and offer a way to make couples "more likely to be intimate."
Due to these unsubstantiated promises, the FDA issued Bayer a warning letter as far back as December 2009 saying that the claims made in the marketing script "clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena." The letter also noted that the FDA was "not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great." The agency also noted that the pharma company's script failed to warn women about the serious risks of using Mirena, including migration of the device; vaginal bleeding and infections; and perforation of the uterus and other organs.
According to the FDA, not only did Bayer not mention the risks, they actually downplayed those dangers by utilizing the statement "look and feel great" in relation to the device. Finally, the FDA censured Bayer for including a statement that Mirena "has no daily, weekly, or monthly routines to comply with," which the agency said was false.
Harmed by Mirena? Our Medical Injury Lawyers Can Help!
In addition to these side effects, women implanted with Mirena are at an increased risk of ectopic and intrauterine pregnancies, both of which can cause pregnancy loss, infertility, and even death to the mother. Women using Mirena also run the risk of having the device embed itself in the uterus, perforate the uterus, or be unexpectedly expelled from the uterus. The potential side effects of Mirena are devastating enough, but worse still is the fact that Bayer underplayed the serious side effects of their IUD. Countless women who were promised more romance in their relationship and a simpler life have found themselves suffering instead. If you or a loved one is among the many women harmed by their Mirena IUD, the medical injury attorneys at Arnold & Itkin are ready to help.