A panel of experts from the US 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, US, 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 US. 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.
Essure is the first permanent birth control method that can be performed in the comfort of a physician's office. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around and through the inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor is able to perform an Essure Confirmation Test to confirm that the inserts are properly placed.
The Essure procedure is over 99 per cent effective at permanently preventing pregnancy based on reported efficacy in published clinical studies. Essure belongs to Bayer since June 2013 and is being commercialized in many countries worldwide.
The Bayer Group is a global enterprise with core competencies in the fields of health care and agriculture. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.