(RxWiki News) The US Food and Drug Administration (FDA) has approved labeling changes for Essure, a permanent birth control device.
The label changes include a boxed warning and a patient decision checklist. These changes were made to help women understand the risks and benefits of birth control options like Essure.
The patient decision checklist was included to encourage women to read about the device and discuss any questions they may with their health care providers, according to the FDA.
Bayer's Essure is a permanent, implanted birth control device. When implanting the device, the health care provider inserts the device's flexible coils into the fallopian tubes, which are the tubes that carry eggs to the uterus from the ovaries. After about three months, the body forms tissues around the inserts and, in turn, blocks sperm from reaching the eggs.
Essure does not immediately prevent pregnancy. Another form of contraception is needed for the first three months, the FDA noted.
Implanting Essure does not require an incision or anesthesia.
The new boxed warning notes a risk of the device poking through the fallopian tubes or uterus, causing persistent pain, moving or prompting allergic reactions.
Other complications that have been reported with Essure include changes in menstrual cycles and symptoms similar to those in autoimmune diseases like joint pain and fatigue. Some women who have had complications have had the device surgically removed.
Ask your doctor about the risks and benefits of any form of contraception.