A panel of experts from the U.S. Food and Drug Administration’s (FDA) Medical Devices Advisory Committee discussed considerations to help ensure the continued safe and appropriate use of Essure® permanent birth control. While there was agreement among the Panel members that Essure is an important contraceptive option, the Panel provided input and guidance for the FDA and Bayer to consider. Based on information presented during this meeting, the Advisory Panel discussed a number of considerations including clinical research, patient education and counseling. The Panel also discussed training and certification of physicians; and post-procedural patient management including removal of the device.
“Patient safety is Bayer’s top priority, and we thank all presenters, panel members, and especially patients for a productive open discussion on the benefit-risk-profile of Essure”, said Dr. Michael Devoy, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer of Bayer HealthCare. “We continue to believe that the benefits of Essure continue to outweigh its risks, and we look forward to working closely with the FDA.”
The advice by the Obstetrics and Gynecology Panel is a result of the open dialogue with healthcare providers, patients, researchers, and other stakeholders at the FDA advisory panel that took place on September 24th at the FDA White Oak Campus in Silver Spring, Maryland, U.S., and will now be considered by the FDA, which makes the final decision.
As part of its longstanding commitment to women's health, Bayer believes it is important that women have access to a wide range of effective birth control options with a positive benefit-risk-profile. Permanent birth control is the second most common method of birth control used by women in the U.S. There has been more than a decade of research and development effort in addition to more than a decade of real-world experience since Essure received CE mark approval in February 2001 and US FDA approval in November 2002.
Bayer has consistently worked with the FDA and other regulatory authorities around the world and will continue to do so, particularly once new relevant data will become available.
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