Drug giant Bayer Pharmaceuticals announced last month that, following FDA approval of their new Intra-Uterine Device contraceptive Skyla, they will release the product in the United States beginning in early February.
It remains to be seen, however, whether Skyla will be a safer alternative to the company’s Mirena IUD, which has prompted thousands of injury complaints to the FDA and growing litigation from those affected.
Skyla, which is the first IUD released in 12 years, is designed to provide up to 99% pregnancy prevention for up to 3 years once implanted. By contrast, the Mirena is designed to last for up to 5 years.
Mirena has been on the market since 2000. Since then, the FDA has received over 45,000 reports of complications among patients. In more than 5,000 cases, women experienced device dislocation and nearly 1,500 experienced migration of the IUD, which can perforate or damage the uterine wall and other organs. Over 6% of patients required hospitalization or surgery.
The FDA has warned Bayer in the past about misleading marketing of Mirena. The agency complained that the company failed to disclose safety risks while claiming the devices could help busy moms with intimacy and make them “look and feel great.”
So far, there has been no Mirena recall. However, lawyers are helping those affected file claims against Bayer for failing to properly warn of the dangers.
Due to the rising number of Mirena lawsuits, victims recently asked a federal judicial panel to consolidate the cases to a special Multi-District Litigation court in Ohio. The petition estimates that, with more than 2 million Mirena users, hundreds of perforation cases may be filed.
Based on early reports, the new Skyla IUD from Bayer uses a similar design to Mirena, which could lead to the same dislocation, migration and perforation injuries. Experts are waiting for the release of the new device to see if Bayer has added additional warnings for patients.
If you or a loved one suffered dislocation, perforation, embedment or migration of a Mirena device which required surgery, it is important to speak with a lawyer to learn your legal options. Due to the specialized nature of federal MDL drug injury cases, the Drug Risk ResourceCenter only recommends lawyers who are already handling Mirena lawsuits.
For more information on the research, side effects and litigation news related to Mirena, or to speak with a lawyer, contact us today.