The US Food and Drug Administration (FDA) has taken steps to restrict the sale and distribution of the Essure device, citing the lack of awareness of the risks and benefits among many women opting for this form of contraception as one of its main concerns.
“Based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb, MD.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks,” he added.
The Essure device from pharmaceutical giant Bayer is the only permanently implanted birth control device available for women in the United States. Flexible coils are inserted through the vagina and cervix and into the fallopian tubes where, over the next three months, tissue forms around the coils, creating a natural barrier to prevent conception.
Ensure was first approved in 2002, but in February 2016, the FDA took steps to improve education and information about the device to ensure women and their doctors are better informed of the benefits, risks and potential complications.
In 2016, the FDA asserted that the device was suitable for the majority of women seeking permanent birth control, but noted some may be at risk of serious complications, such as persistent pain, perforation of the uterus or fallopian tubes, abnormal bleeding, and allergy or hypersensitivity reactions.
Under the new labeling restrictions, the product can only be offered to a patient by healthcare providers and facilities that provide patients information about the risks and benefits of the device. The patient brochure Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement must be reviewed with the prospective patient to ensure they understand the potential benefits and risks. Bayer is required to implement the restrictions immediately and their plan to ensure compliance with the sales restriction will be monitored and reviewed by the FDA.
Several different birth control options are available to patients in the United States. Most are hormonal birth control in the form of pills or implants, which work by preventing the release of eggs. These include monophasic contraceptives, biphasic contraceptives, triphasic contraceptives, extended cycle contraceptives, and progestogen-only contraceptives. For advice on which form of birth control is suitable for your individual needs, speak to your healthcare provider.
In October 2017, generic drugs manufacturer Teva Pharmaceuticals announced the introduction of a cheaper generic version of the progestogen only contraceptive Depo-Provera (medroxyprogesterone) into the US market. Depo-Provera is a form of hormonal birth control administered by injection, which works by preventing ovulation.
