(RxWiki News) The US Food and Drug Administration (FDA) is restricting the sale and distribution of a permanent, implantable device used to prevent pregnancy.
The FDA recently announced the restriction of the sale and distribution of the Essure device. The move is part of an effort to ensure that women considering permanent contraceptive devices like Essure are given sufficient information to make an informed decision.
The Essure device, a soft, flexible insert, is inserted by a health care provider into the fallopian tubes. Over several months, tissue forms around the insert. As a result, the tissue creates a barrier that prevents sperm from reaching the eggs, which prevents pregnancy.
Essure is the only permanently implanted birth control device that does not require a surgical incision, according to the FDA. The agency said it believes some women are not being adequately informed of the risks tied to the Essure device before having it implanted.
Some women who have had the Essure device implanted have experienced adverse events like allergic reactions, perforation (puncturing) of the uterus or fallopian tubes, migration of inserts to the stomach or pelvic cavity and pain that does not go away. Some women have reported headaches, feeling tired, changes in weight, hair loss and mood changes like depression. However, the FDA said these symptoms may not necessarily be tied to Essure.
Sales of Essure have declined since the FDA ordered device maker Bayer to conduct a study and add a boxed warning and patient decision checklist to Essure's labeling. The newly required Essure labeling includes the restriction of the sale and distribution of the device to health care providers and facilities that provide information to patients about the device's risks and benefits.
This includes the patient brochure, titled “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” which the health care provider must review with the patient to ensure she understands the risks and benefits tied to Essure. Both the patient and the health care provider implanting the device must sign the brochure.
Ask your health care provider any questions you have about family planning.
Written By Anyssa Garza, PharmD, BCMAS