The FDA has not issued a recall of the Mirena IUD, but the agency had some difficulty with the device’s manufacturer regarding Mirena. In a letter dated December 30, 2009, the FDA told Bayer that the marketing for the device was highly flawed for a number of reasons:
- The FDA believed the manufacturer’s advertising script violated the Federal Food, Drug, and Cosmetic Act
- The agency warned Bayer that that the advertisements included “false or misleading presentations” and misbranded the drug.
- The FDA determined that Bayer was making many false claims in its marketing, including that use of the Mirena device will result in “increased levels of intimacy, romance and by implication emotional satisfaction,” although Bayer provides no tangible evidence to support this claim.
- The FDA said that Bayer falsely insinuated that women who use Mirena will “look and feel great.” This is direct contradiction to the device’s potential side effects, since women using the product may experience weight gain, breast pain, back pain, and acne.
- The manufacturer’s advertising neglected to provide important instructions regarding proper use of the device.
- Bayer was warned that the device’s advertising fails to mention the risks of complications.
Our Kentucky Mirena IUD attorneys have worked to provide compensation and comfort to those who have been injured due to corporate negligence. If you have suffered an injury due to a Mirena device, call Gray and White today at (800) 634-8767, or fill out the contact form on this page to get started on your FREE consultation.