Mirena and the FDA

In 2001 the US Food and Drug Administration approved Bayer Pharmaceuticals new IUD named Mirena for the US drug markets. For ten years prior to its release in the USA, an estimated 2 million European women were being implanted with the Mirena IUD which was being heavily marketed by Berlex Laboratories Inc. They were told it may cause breast tenderness, migraines, and possible mood changes. Mirena was marketed as making women look and feel great with increased libido.

In 2008 the Food and Drug Administration issued a warning letter to Bayer

Pharmaceuticals not regarding the side effects of its IUD device women were experiencing, Bayer was warned over its marketing practices. They were warned over using unsubstantiated claims and overstated effectiveness. They pitched Mirena as the most effective contraceptive increases levels of intimacy and romance over all other contraceptives on the market.

Despite the warning letter the Food and Drug Administration sent to Bayer

Pharmaceuticals whereby they listed the side effects women were suffering the Food and Drug Administration continued to allow Mirena to be used and encouraged prescribing it to women who have had at least one child. The Food and Drug Administration warned Bayer again in January and February of 2009 about the implications of its wording and their promotional practices.

Many of the women who have used this device has experienced expulsion. Meaning they can no longer feel the strings or know where in their bodies its moved to. An estimated 22,000 women have experiences expulsion and an estimated 2000 women have experienced uterine perforation. Those estimates are based on the number of women who have filed Mirena lawsuits. These estimates do not include the many women who have had problems and not filed a lawsuit. Visit us to learn more about Mirena lawsuit.