FDA Outlines Actions for Continued Safe, Effective and Appropriate Use of Essure® for Permanent Birth Control

The U.S. Food and Drug Administration (FDA) issued a communication outlining actions on Essure® permanent birth control today, following a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015. The FDA outlined actions including the collection of additional data and proposed updates to the Essure labeling. Essure is an important permanent birth control option with a positive benefit-risk profile. Bayer will continue to work with FDA to implement measures to support the continued safe, effective and appropriate use of Essure.

Patient safety and appropriate use of Essure are our greatest priorities. A woman’s decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure.

No form of birth control is without risk and appropriate for every woman. It is imperative that women consult with their healthcare providers before making any contraceptive choice, to fully understand both the risks and determine the best option to meet their needs. It is also important for women to continue that dialogue anytime they have any concerns or questions about a product or procedure.

As part of our long-standing commitment to Women´s Health, we believe it is important that women have access to a wide range of birth control options. Permanent birth control is the second most common form of contraception used by women in the United States[1] and the most common birth control method globally[2].

[1] Guttmacher Institute (2015), Fact Sheet: Contraceptive Use in the United States. Available at: http://www.guttmacher.org/pubs/fb_contr_use.html. Last accessed 18 February 2016.

[2] United Nations (2013),World Contraceptive Patterns. Available at: http://www.un.org/de/development/desa/population/publications/pdf/family/worldContraceptivePatternsWallChart2013.pdf. Last accessed 18 February 2016.