Tell women the truth about Mirena IUD birth control

The Issue

The Mirena IUD is marketed as an effective hassle free method of birth control, with absolutely ZERO side effects. The device works much like a normal IUD, but with the addition of Levonorgestrel, a synthetic progestogen. Supposedly, the hormone works only within the uterus, and it's therefore impossible for it to cause systemic damage to the rest of the body.

However the trial for this drug was conducted on a small, homogenous group of Caucasian women in Finland. Now, hundreds of thousands of women worldwide are using the device, many of whom are complaining of heart palpitations and numbness of extremities, nutritional deficiency, unusual weight gain (i.e. beer belly, swollen breasts), fatigue, migraines, etc. But their doctors refuse to believe their symptoms are related to Mirena, simply because Bayer's brochure said so.

The only possible complications listed are mechanical malfunctions of the IUD itself, uterine perforation, expulsion and such, but no mention of the effects of the hormone Levonorgestrel.

We ask that the FDA and Bayer admit that such systemic side effects to the hormone in Mirena do indeed exist, and to instruct physicians to properly inform women of these risks before recommending this device.

This petition had 409 supporters

The Issue

The Mirena IUD is marketed as an effective hassle free method of birth control, with absolutely ZERO side effects. The device works much like a normal IUD, but with the addition of Levonorgestrel, a synthetic progestogen. Supposedly, the hormone works only within the uterus, and it's therefore impossible for it to cause systemic damage to the rest of the body.

However the trial for this drug was conducted on a small, homogenous group of Caucasian women in Finland. Now, hundreds of thousands of women worldwide are using the device, many of whom are complaining of heart palpitations and numbness of extremities, nutritional deficiency, unusual weight gain (i.e. beer belly, swollen breasts), fatigue, migraines, etc. But their doctors refuse to believe their symptoms are related to Mirena, simply because Bayer's brochure said so.

The only possible complications listed are mechanical malfunctions of the IUD itself, uterine perforation, expulsion and such, but no mention of the effects of the hormone Levonorgestrel.

We ask that the FDA and Bayer admit that such systemic side effects to the hormone in Mirena do indeed exist, and to instruct physicians to properly inform women of these risks before recommending this device.

The Decision Makers

Oliver Renner
Oliver Renner
Head of Global Corporate Communications & Public Affairs Bayer HealthCare AG
Erica Jefferson
Erica Jefferson
FDA, Drug Approval Process
Morgan Liscinsky
Morgan Liscinsky
FDA, Center for Drug Evaluation and Research
Stephanie Yao
Stephanie Yao
FDA, Center for Drug Evaluation and Research
Sandy Walsh
Sandy Walsh
FDA, Adverse Event Reporting System (AERS)

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Petition created on March 5, 2012