Today, April 9th, the United States Food and Drug Administration has issued an order to restrict the sale and distribution of the Essure contraceptive device. According to the FDA’s website, the institution released this order “to ensure all women considering the use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions.” The FDA followed up this statement by stating they were made aware that women were not being sufficiently informed of the risks of using Essure before undergoing the device implantation procedure, thus prompting this restriction.
Schneider Hammers has been covering the issues associated with Essure and released an article regarding the ban of the medical device in every country outside the United States. In the months following our October 2017 report, the FDA implemented a post-market study regarding the device and added a boxed warning to Essure’s label. However, even though there was a 70 percent decline in Essure sales within the United States, the FDA ultimately concluded that women still were not receiving sufficient information about the risks of implanting such a device before the procedure.
Essure will now be distributed with new, legally required labeling that communicates the restriction of the sale and distribution of the device to only health care providers that inform patients about the benefits and potential risks of the device. Furthermore, a “Patient-Doctor Discussion Checklist” will be reviewed during all consultations between a patient and healthcare providers to ensure the clarification of all benefits, risks and other information regarding the implantation of Essure. Lastly, as stated by the FDA, “The patient must be given the opportunity to sign the acknowledgment, and it must be signed by the physician implanting the device. Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction.”
If you or a loved on has suffered a personal injury as a result of a defective medical device like Essure, contact one of our attorney’s at Schneider Hammers today. We’re dedicated to holding medical manufacturers accountable for their actions.