The Food and Drug Administration issues a "unique type of restriction" for the sale of Bayer's permanent contraceptive product Essure to ensure that women considering their use have all available information about their risks and benefits.
The checklist was added to the Essure label in November 2016 and now includes a subtitle "to emphasize the importance of this tool," said Bayer (19659003). The patient must be given the opportunity to sign the document, and the The doctor who implants the device must sign it, the FDA said. The agency said that Bayer is committed to ensuring compliance with health care providers, and said it will take criminal and civil penalties for non-compliance.
"Patients deserve the most accurate and complete information to help them with their health care. Www.cosmetic-business.com//showarti…p?art_id=549 Bayer has trained and educated healthcare providers She said how important it is to provide each patient with adequate advice on the benefits and risks of Essure, "Bayer said in a statement. "The FDA has asked to update the label to underline this point."
The company said it will "continue to reinforce the use of health checklist and inform them about this important label update". It noted that "after a thorough review of scientific evidence, the FDA has repeatedly stated that Essure is a safe and effective medical device that offers women a valuable contraceptive option. "
The FDA has instructed Bayer to conduct a post-marketing trial in February 2016 to give a better idea of Essure's safety profile, and in November of the same year, the company had a warning message – the strongest – on the warning label Since then, Essure's revenue in the US has dropped 70 percent, and Bayer withdrew it for commercial reasons outside of the US in 2017.
Essure is the only contraceptive on the market that is not needed Surgical incision involves the placement of flexible coils into the fallopian tubes, where tissue forms over approximately three months to form a barrier that can prevent sperm from reaching the eggs and preventing conception.