A permanent, implantable birth control is under investigation after the U.S. Food and Drug Administration orders a restriction on its sales and distribution Monday, April 9.
The FDA issued an order to restrict sale and distribution of the Essure device, to ensure that women considering the permanent contraception device are provided with adequate risk information to make informed decisions.
The FDA says the order was made after the administration discovered some women were not being adequately informed of Essure's risk before getting the device implanted.
Essure is the only permanently implanted birth control device on the market that does not require surgery. Some patients with implanted Essure have experienced holes in the uterus or fallopian tubes, devices moving into their abdominal or pelvic cavities, persistent pain and suspected allergic or hypersensitive reactions. Some women have reported headaches, fatigue, weight changes, hair loss, and mood changes (such as depression).
Previously, the FDA ordered Essure's device manufacturer, Bayer, to conduct a post-market study and add a boxed warning and patient decision checklist to the labeling. Since then, Essure sales have gone down approximately 70-percent in the U.S. The FDA says that some women are still not receiving information about the known risks of Essure before implantation.
The new Essure labeling, which will now be legally required when this product is offered to a patient, will only be sold to health care providers and facilities that provide information to patients about the risks and benefits of this device. The patient brochure must be reviewed with the prospective patient with their health care provider to ensure the patient understands the risks, benefits and other information about Essure implantation.
The patient must be given the opportunity to sign the acknowledgment, and it must be signed by the physician implanting the device.
The FDA is expecting Bayer to implement these new regulations immediately, stating they will review and monitor Bayer's plans to comply with the restrictions. The FDA says failure to comply will lead to applicable criminal and civil penalties.
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April Stevens is a multi-platform producer at WZZM 13. Have a news tip? Email news@wzzm13.com, visit our Facebook page or Twitter.
