FDA restricts Essure birth control device sales

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The Food and Drug Administration is threatening Bayer with civil and criminal penalties if it doesn't better inform women about risks from one of the company's contraceptive devices.

"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information", said FDA Commissioner Scott Gottlieb, in a statement.

USA sales of Essure have dropped approximately 70 percent since the agency ordered the company to conduct a post-market study, the FDA said in the statement.

In a financial statement on January 30, Bayer said it had been served USA lawsuits from approximately 16,100 users of Essure.

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The FDA is mandating a unique type of restriction on the device to restrict the sale and distribution, imposing additional requirements needed to provide a reasonable assurance of its safety and effectiveness. In a procedure that takes about 10 minutes, doctors insert two sets of tiny coils through the vagina and cervix and into a woman's fallopian tubes, which carry eggs from the ovaries to the uterus. "Every single woman receiving this device should fully understand the associated risk". Essure was first approved in 2002. Although Essure sales have decreased by ~70%, the FDA believes that some women are still not being informed about the established risks of Essure prior to implantation.

Additionally, women have reported headache, fatigue, weight changes, hair loss and mood changes like depression, however, it's unknown whether these are related to Essure. The FDA-approved Decision Checklist based on the Final Guidance should be used to facilitate these discussions and ensure patients understand the benefits and risks. Sale and distribution of Essure is limited to healthcare providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation.

Bayer is required to implement the restrictions immediately and must ensure the process going forward results in health care provider compliance with the sales restriction. The company added that FDA evidence reviews have determined Essure to be "a safe and effective medical device that benefits women by providing them with a valuable contraception option".

The move by the FDA signals the agency's increasing oversight of health products already on the market.

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Thousands of women have reported serious problems with what was once a popular choice for birth control. The agency is now monitoring the company's progress.

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.

Patients deserve the most accurate and comprehensive information to help them make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure. Although the company is making "adequate progress", the FDA said today that it will require additional study sites to enroll more patients in the study.

For more on female sterilization, visit the U.S. Department of Health and Human Services.

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