FDA Warns Women of Potential Risks of Essure
The U.S. Food and Drug Administration (FDA) recently announced that it would take actions to provide women with information about the risks of using Essure, a form of permanent birth control. This form of birth control involves inserting flexible coils through the cervix and vagina into the fallopian tubes. After about three months, scar tissue forms around the coils and makes a barrier in order to prevent conception.
The FDA recognized that there are potential complications related to these types of implantable forms of sterilization and that it should take actions in order to address these risks. These actions include requiring a clinical study to assess the risks and requiring warnings on the product labels. The FDA stated that the actions recognize that “more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring that food and drugs are safe for people to use. The FDA’s position is that while Essure is safe for most women, some women may be at risk for complications. Those complications may include pain, tears, bleeding, and allergic reactions.