Though Essure was removed from the U.S. market in December 2018 due to poor sales and serious controversies, the U.S. Food and Drug Administration said it will track and monitor the safety and efficacy of the device. If you were implanted with the Essure permanent birth control device, there’s important information you should know.
First: If you were implanted with Essure and you are suffering severe adverse events or if you were forced to undergo fallopian tube and/or uterine removal due to complications with the device, you have rights including the right to hold Essure maker Bayer responsible for your injuries. We can help. Contact us today to learn if you are entitled to seek justice and compensation for your injuries.
Second: While the device is no longer being sold in the U.S. tens of thousands of women were implanted with it. The FDA said it would continue to monitor the safety and efficacy of the device by reviewing clinical trial information, post-approval study data, medical literature, and adverse events and medical device reports that are filed with the agency.
Third: The FDA requires that women who received the device undergo routine blood tests on follow-up visits so that the levels of inflammation and immune reactions that have been associated with the device can be studied.
Finally: The FDA will maintain oversight of the device and has extended and revised requirements for the postmarketing surveillance study it ordered Bayer to perform in 2016. While the study was initially to continue for three years, the federal watchdog agency has extended the study to five years in an effort to provide the FDA with longer-term data regarding adverse risks and problems that can cause women to undergo device removal. The FDA said it will continue to monitor the use of the device and will make updates and study results available to the public on the Essure Postmarket Surveillance Study Webpage
Prior to these initiatives, the FDA required labeling updates to include a Boxed Warning with significant adverse events associated with the device through clinical trials and user experience. A patient checklist was also required to highlight key benefits and risks associated with the device and the procedure, to include probability rates.
In 2018, the FDA restricted sales of Essure to only those medical facilities that agreed to provide patients with a 28-page Acceptance of Risk and Informed Decision Acknowledgement that patients had to sign before receiving the device.
Essure was approved in 2002 by the FDA through a controversial program that allows new devices to be sold on the U.S. market faster than devices going through the traditional approval process. By 2015, thousands of adverse events had been reported including:
Many of the women who received the Essure device and developed severe complications and experienced adverse events are filing lawsuits against Bayer alleging the company failed to warn them of the risks associated with the device and denied them the opportunity to make informed healthcare decisions. If you or a woman you love suffered injuries after receiving the Essure permanent birth control device, contact us today to learn more about how we can help, and whether you are eligible to seek significant compensation for your injuries.