Background on Mirena FDA Approval for Birth Control in 2009

    Mirena FDA Approval

    The U.S. Food and Drug Administration approved Bayer’s Mirena intrauterine device (IUD) in 2000. Since then, many women got the Mirena for long-term contraception. However, many women reported IUD complications in the decade after Bayer gained Mirena FDA approval. In fact, the FDA received more than 70,000 Mirena adverse event reports involving IUD perforation, migration and embedment.

    Mirena FDA Approval Given, Despite Migration Injury Risks

    Mirena releases a progestin hormone called levonorgestrel. Bayer claims the IUD releases most hormones into a woman’s uterus, not her bloodstream. While Mirena claims 99% effectiveness for birth control, women should know about other complication risks. Device manufacturer Bayer says Mirena can migrate away from your original insertion site. If this happens, Mirena may embed itself within the uterine wall. Once it’s stuck there, the IUD can cause serious health problems.

    When this happens, women may experience pain and cramping, along with excess bleeding or dizziness. Your doctor must identify complications (such as embedment and perforation) early to avoid long-term damage.

    The FDA also warns about embedment and perforation risks. Other possible Mirena side effects include ovarian cysts, intrauterine pregnancy and even breast cancer.

    Bayer Gains Additional Mirena FDA Approval in 2009 for Heavy Bleeding

    In 2009, Bayer gained a new Mirena FDA approval to treat heavy menstrual bleeding in women with IUDs. Yet according to the agency’s updated Mirena FDA approval, those women also risked IUD complications.

    “The most common adverse events reported by patients in the primary clinical trial using Mirena to treat heavy menstrual bleeding included uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness,” the FDA said in 2009.

    These IUD complications also affect women using Mirena for birth control purposes, such as ovarian cysts and abnormal bleeding.

    If you or someone you love has Mirena complications, get your free claim evaluation online in less than two minutes. It’s the fastest way to see if your injuries may qualify for a cash settlement from the manufacturer. Once you’ve submitted your information, an experienced lawyer will call to discuss your case and financial compensation options.

    Related: Depression: The Secret Mirena Side Effect

    Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.

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