At the request of the Food and Drug Administration, Leverkusen, Germany-based Bayer will now add a box warning and patient decision checklist to the label of its permanent birth control device Essure.
The device, which contains flexible metal coils, is implanted into a woman's fallopian tubes. After three months, tissue grows around the coils, blocking sperm from reaching eggs, thereby preventing pregnancy.
The warning reminds women to use an alternate form of birth control for the first three months after being implanted with the device and also lists various risks associated with Essure.
The FDA hopes the updated label will ensure women understand the benefits and risks associated with the permanent control device.
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