Black Box Warning Added to Essure

One of the key responsibilities of the Food and Drug Administration (FDA) is to protect the public health by ensuring the safety and efficacy of pharmaceuticals and medical devices.  While it is the responsibility of a manufacturer to perform safety testing, the FDA approves a drug or device based on the safety studies conducted and reported by the manufacturer. In instances where a safety issue does not become apparent until after a drug or device…

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Getting Essure Removed: What You Need to Know

Since the permanent birth control device Essure went on the market in 2002, 26,000 complaints and 16,000 lawsuits have been filed against Bayer, the manufacturer of the device. As a result of the chronic and debilitating side effects (nickel poisoning, abnormal/heavy menstrual bleeding, autoimmune disorders, severe abdominal/pelvic pain, etc.) caused by Essure, many women have had to have the device removed. However, prior to implantation, women were not only ill-informed about the side effects of…

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