The Food and Drug Administration (FDA) has issued an order to restrict the sale and distribution of Bayer‘s Essure, a permanent contraception device, to ensure that all women considering its use are adequately informed about the risks associated with the device before making a decision.
Essure, approved by the FDA in 2002, is a permanently implanted contraceptive device for women that does not require a surgical incision. The flexible coils are inserted through the vagina and cervix and into the fallopian tubes. Over ~3 months, as tissue forms around the inserts, a barrier is formed that prevents sperm from reaching the egg.
The FDA announced their decision after learning that some women were still not being adequately informed of the risks associated with Essure before implantation despite efforts to educate doctors and patients about these risks. Adverse events such as perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions have been reported in some women after Essure implantation.
The new Essure labeling restricts the sale and distribution of Essure to only healthcare providers and facilities that provide information to patients about the risks and benefits of the device. The updated patient brochure, which includes the new “Acceptance of Risk and Informed Decision Acknowledgement,” must be reviewed with the patient to ensure that she understands the information regarding Essure. Moreover, both the patient and physician must sign the acknowledgement.
In February 2016, the FDA required Bayer to conduct a post-marketing study which resulted in the addition of a Boxed Warning and patient decision checklist to the labeling 7 months later. Although Essure sales have decreased by ~70%, the FDA believes that some women are still not being informed about the established risks of Essure prior to implantation. FDA Commissioner Scott Gottlieb, MD, said, “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.”
In a press statement, Bayer reiterated that the benefit/risk profile of Essure has not changed and remains positive. “As the FDA has repeatedly determined – after a rigorous review of the scientific evidence – Essure, the only non-incisional option available for those who seek permanent birth control, is a safe and effective medical device that benefits women by providing them with a valuable contraception option.”
For more information call Bayer at (800) 288-8371 or visit FDA.gov.