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Multiple Mirena FDA Warnings Reveal Misbranding for Mirena IUD

Mirena FDA Warnings Expose Failure to Warn Consumers of Mirena IUD Side Effects

Mirena FDA Warning

Mirena FDA warnings have been issued on multiple occasions to Bayer HealthCare Pharmaceuticals, the corporation that manufactures Mirena IUDs. Bayer has received stern Mirena FDA warnings accusing Bayer of developing and implementing advertising campaigns that make false or unproven claims regarding the uses and efficacy of the Mirena IUD. Furthermore, Bayer has been accused of failing to adequately warn consumers of the varied Mirena side effects that accompany use of the medical device. On more than one occasion, Mirena FDA warnings have been issued demanding that the company discontinue the use of advertising materials that make false claims about the Mirena IUD.

On March 26, 2009, one Mirena FDA warning letter was issued regarding Bayer advertising materials published on the company’s Mirena IUD website. The FDA warning letter stated that specific pages on the company’s websites failed to contain any warning information regarding the serious health risks associated with using the Mirena IUD.

Mirena IUD FDA WarningThe particular website in question in the Mirena FDA warning was entitled “Effective Birth Control that Helps Keep Life Simple”. Overall, the content of the website suggested that the Mirena IUD could simplify a busy mother’s life, said the Mirena FDA warning. The Mirena FDA warning letter pointed out a number of inconsistencies in the materials presented in the website. More importantly perhaps, the Mirena FDA warning indicated that the website content made no mention of the significant side effects associated with the Mirena IUD. The website suggested that the Mirena IUD could be used indefinitely by all women, when in fact the Mirena FDA warning points out that the device is indicated only for women who have given birth to at least one child and for a period of no more than five years.

These omissions and falsehoods, the Mirena FDA warning states, amount to medical device misbranding and violate the federal Food, Drug and Cosmetic Act.

Mirena Misbranding Amounts to Violation of Federal Law, Say Mirena FDA Warnings

Later that same year, on December 30, 2009, Bayer received yet another Mirena FDA warning. The subject of this Mirena FDA warning was the advertising script used in Mirena IUD promotional parties. These events were designed to be hosted in a home or other intimate setting by healthcare professionals and pharmaceutical representatives in order to recruit women to use the Mirena IUD. This Mirena IUD warning is a meticulous examination of the script that was utilized for these promotional events, and made a number of serious accusations. The Mirena FDA warning stated that the promotional script

  • overstated the efficacy of Mirena
  • presented unsubstantiated claims
  • minimized the risks of using the Mirena IUD
  • included false and misleading statements

Mirena FDA WarningThe Mirena FDA warning states that the script implied using Mirena would bring couples an increase in connection, romance and intimacy. The Mirena FDA warning noted that these claims are unproven and that, in fact, at least 5% of patients involved in clinical trials reported a decreased libido when using the Mirena IUD. The Mirena FDA warning also accused Bayer of false advertising by promising using the Mirena IUD would make you “look and feel great”. The wide range of Mirena side effects, including severe pain, infection, decreased libido, headaches and migraines, and depression, the Mirena FDA warning said, would contribute to neither looking nor feeling “great”. On the basis of these accusations, the Mirena FDA warning demanded that Bayer “immediately cease the dissemination of violative promotional materials for Mirena”. In both of the Mirena FDA warnings, the agency reported violations of the federal Food, Drug and Cosmetic Act.

For patients who have a Mirena IUD, there is no need for alarm unless you are experiencing health problems.  If you are having health problems such as pelvic pain, abnormal vaginal bleeding, supposed infection, or other problems, you may learn about your legal rights by filling out our form and speaking with an experienced Mirena IUD lawyer.


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