The Courtroom Controversy Behind Popular Contraceptive Mirena

The Courtroom Controversy Behind Popular Contraceptive Mirena
By Victoria Bekiempis - Newsweek Magazine
April 24, 2014

“She is one of more than 1,200 women nationwide claiming side effects, including perforation, migration, pelvic inflammatory disease, ectopic pregnancy and, in the most extreme cases like K.'s, painful surgeries and even hysterectomy. Many have filed lawsuits against Bayer, which makes Mirena, and the cases are moving toward class-action status.

And yet K.'s story is exceedingly unusual from a medical standpoint. Approximately 2 million women across the country, and millions more worldwide, use Mirena, and the overwhelming majority have done so for years without incident. The risk of adverse effects like K.'s is approximately one in a thousand, which clinicians, the Food and Drug Administration (FDA) and, of course, Bayer, have agreed is an acceptable rate and comparable to other forms of birth control.

Many plaintiffs' lawyers aren't arguing that Mirena is flawed per se; instead, they're saying Bayer should have done more to warn patients about worst-case-scenario side effects, rather than just mentioning it in the full prescribing information. Bayer rejects that.”

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