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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Why is the FDA Silent on IUD Migration and Surgical Removal?

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In 2000, the FDA approved the use of Mirena, an IUD to treat heavy menstrual bleeding in IUD Users. Millions of women use IUDs, including Mirena, manufactured by Bayer Pharmaceuticals. Since this approval in 2000, and additional approvals in 2009, over 45,000 cases of adverse events related to the IUD have been reported. Cases filed against Bayer specifically allege that the benefits of such IUDs were misrepresented, that there was no warning of the potentially serious side effects, and that it was initially a defective design that was then concealed by the company for marketing purposes. The allegations that Bayer had designed, produced, and knowingly sold a defective product leaves many users wondering why the FDA has not provided any more news or research into the potentially dangerous IUD.

Mirena has caused to women a great deal of side effects, many which were not advertised or properly disclosed by Bayer prior to IUD use. Better warnings should have been provided. But no surprise, when such warnings might cause doctors to think twice before prescribing this birth control had they known of all of the dangers. Such side effects from Mirena include abscess, birth defects, migration of the IUD and embedding elsewhere in the body, infertility, peritonitis, intestinal perforation or obstruction, and perforation of the uterus. The most serious adverse reactions since approval have included ectopic pregnancy (in which the egg grows outside of the uterus),and intrauterine pregnancy (a pregnancy with the IUD still in place). The Department of Health and Human Services, in a 2009 facsimile release, reported that Bayer “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act.” – Carrie Newcomer, Regulatory Review Officer (Department of Health and Human Services)

As patients and users of Mirena become increasingly aware of the symptoms and dangerous side effects of the IUD, more and more attention should be brought to the FDA to raise awareness as to the potential negative effects it may have on the user. Keeping the appropriate agencies informed as to your symptoms and experiences can prevent any further damage to you, or future users.