- Citing the continued inconsistency in adequately informing women of the risks associated with Bayer (DE:BAYGN)'s (OTCPK:BAYRY +0.4%) permanent contraceptive device Essure, the FDA has issued an order restricting the sale and distribution of the product only to those healthcare providers and facilities that provide information to patients about the risks and benefits of the device, specifically, a patient brochure that contains a checklist to guide the discussion to ensure that all relevant topics are covered.
- The agency took action after becoming aware that some women are still not receiving information about the risks despite a boxed warning and decision checklist in the labeling.
- The new checklist is now legally required when the product is offered to the patient and must be signed by the implanting physician. The patient must be given the opportunity to sign as well.
- In the U.S., Essure sales have declined ~70% since the mandatory inclusion of the boxed warning and original patient decision checklist.
- Now read: Mereo BioPharma Proposes Terms For U.S. IPO
Original article