The Food and Drug Administration recommended a boxed warning for Bayer’s permanent birth control product, Essure, and other similar devices stating that some women may not be understanding the risks and benefits of such implants.
These devices are known as hysteroscopically-placed tubal implants and are designed to be a less-invasive alternative to permanent sterilization.
This warning from the FDA has come about in light of the frequent and severe problems reported relating to Essure.
There have been several lawsuits against Bayer related to Essure, “including an Idaho federal lawsuit brought by a woman who says she became pregnant with twins while implanted with the device, 11 California state lawsuits brought by women who say they were injured by the device and a consolidated Pennsylvania federal lawsuit brought by five women who say Bayer marketed the devices in a way that downplayed their risks.”
These concerns will be addressed by the FDA’s requirement to include a boxed warning and a patient decision checklist as part of premarket approval applications.
The boxed warning will include possible associated common problems of the given device, as well as a statement stating that those risks should be communicated to the patient during the decision making process.
The FDA also explained how the checklist, which is intended to be reviewed and signed by both the patient and their doctor, will highlight key risk and benefit information as well as other important information and potential alternatives of the device.
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