FDA Action on the Mirena IUS

The U.S. Food and Drug Administration (FDA) has twice warned Mirena IUS manufacturer Bayer HealthCare Pharmaceuticals about the way it has portrayed its birth control product in its print and online marketing. Letters to the manufacturer in March and December 2009 called for a change to these promotional materials.

The Mirena IUS is an intrauterine device, or IUD. Bayer calls it an “intrauterine system” because of its dual approach to birth control. The Mirena IUS stops sperm from fertilizing an egg like an IUD. It also stops a fertilized egg from implanting in the uterus. The Mirena device is the same T-shape and size of a standard IUD. It is inserted by a physician for long-term birth control.

Letters of Warning to Bayer About the Mirena IUD

The FDA’s two warning letters to Bayer HealthCare Pharmaceuticals accuse the pharmaceutical giant of:

  • Overstating the effectiveness of Mirena
  • Downplaying the serious health risks of Mirena
  • Sponsoring misleading links about Mirena on Internet search engines
  • Failing to communicate proper risk information to women and their doctors.

Both warnings point out that Mirena is associated with a number of medical risks, as reflected in the Contraindications, Warnings, Precautions, and Adverse Reactions sections of its FDA-approved product labeling.

In its March 2009 warning letter, the FDA says sponsored links make representations and/or suggestions about the efficacy of Mirena but fail to communicate any risk information. “By omitting the most serious and frequently occurring risks associated with the drugs promoted in the links …, the sponsored links misleadingly suggest that … Mirena (is) safer than has been demonstrated,” the letter says.

The sponsored links for Mirena also overstate the efficacy for Mirena by failing to reveal that Mirena can be used for up to 5 years before it must be replaced, the FDA says. “By omitting this information, the link suggests that the drug can be used indefinitely, when this is not the case,” the letter says.

The December 2009 letter quotes an online ad for the Mirena IUD that the FDA says “clearly indicate(s) that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction.”

The letter continues, “FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners.”

“Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience,” the FDA’s December 2009 warning letter states.

Contact a Mirena Injury Lawyer Today

If you or a loved one has used the Mirena IUS and suffered pelvic inflammatory disease (PID), complications from the IUD moving from its insertion site or other serious adverse effects, you must protect your rights. Discuss your legal options with an experienced Mirena injury lawyer as soon as possible.

The Driscoll Firm, LLC, has a record of taking on major medical device manufacturers and standing up for the rights of injured consumers and their families. To learn how we can help you, contact us today for a free and confidential initial consultation by calling our toll-free number or completing our online contact form.

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