Our firm’s California Mirena IUD Perforation and Migration Attorneys are here to help you receive proper compensation for faulty medical device procedures. Contact our California implant injury lawyer at (949)-557-5800 for a free case evaluation.
Mirena Intrauterine Device (IUD)
Intrauterine Devices are the most commonly used reversible method of birth control worldwide. In 2002, only two percent of contraceptive use in the United States involved IUDs, largely because of the disastrous experience of many women some women in the 1970’s and 80’s who developed infections and infertility associated with the Dalkon Sheild IUD, and the unwillingness of FDA to approve new IUDs because of safety concerns However, between the years 2006‐2008, contraceptive use involving IUDs grew to five percent, and IUDs are (again) gaining popularity in the United States.
The Mirena IUD was approved in the United States in December of 2000; sales began in 2001. The Mirena device is a T-Shaped Polyethylene frame with a drug reservoir, known as the Hormone Cylinder, that contains 52 mg of Levonorgestrel, a second-generation synthetic progestin. Mirena is approved for insertion up to 5 years.
Mirena is currently approved in the United States for intrauterine contraception for up to 5 years, as well as the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception. The device is only recommended for women who have had at least one child.
Mirena IUD Side Effects and Complications
The Mirena IUD is associated with a number of risks and side effects, including device perforation (puncture of the uterine wall), migration (the shifting of the device to outside of the woman’s uterus), and embedment (the device becomes stuck in the uterine wall). The product information for the Mirena IUD also indicates that, if a woman becomes pregnant when using the device, her child may be at risk of sustaining birth defects.
In our opinion, doctors and patients in the United States have not been adequately warned about the possibility of perforation of the uterus after insertion of the device, along with migration of the IUD into other organs, many times requiring dangerous surgery and resulting on organ damage, infection, and infertility. Product labeling provided to doctors in the U.S. indicated that the perforation risk only occurs at the time of insertion, despite many reports to the manufacturer and FDA indicating that was not true. In fact, in 2010, the manufacturer of Mirena in conjunction with the Canadian FDA specifically admitted, for the first time, that “Uterine perforation may occur with MIRENA® at the time of insertion or after the insertion with limited clinical symptoms.”
While the manufacturer of the Mirena IUD understated the risks of the device in the United States, the company seems to have been more than happy to overplay the “benefits.” In 2009, the FDA chastised the company for its over-the-top Mirena IUD marketing strategy, which reportedly included advertising the device as appropriate for “busy moms,” and using a social networking web site called “Mom Central” to organize Mirena IUD parties either at people’s homes or at restaurants. According to the FDA, at the parties, a representative from Mom Central and a nurse practitioner would together explain the benefits of using a Mirena IUD, using scripted language that suggested a Mirena IUD would improve a woman’s intimacy and romance with their partners, as well as make them “look and feel great.”
Contact a California Mirena IUD Perforation and Migration Lawyer
Drug and medical device manufacturers have a legal duty to adequately warn health care professionals about the risks of products like Mirena so that patients and their doctors can make an informed choice and so that potential side effects can be monitored. When manufacturers fail to warn, or water down the effect of warnings by over emphasizing product benefits, consumers who suffer damaging side effects can sue for damages in civil court.
The Senators (Ret.) Firm, LLP is currently investigating and litigation numerous cases of injury associated with the Mirena IUD. If you have been diagnosed with perforation or migration of your Mirena IUD, you may be entitled to compensation. Contact The Senators Firm now for a free and confidential case evaluation.