This past April, the FDA issued an order to restrict the sale and distribution of the Essure implantable permanent birth control device to ensure that women and doctors understand the risks of the implant.
According to the FDA, women implanted with Essure have experienced severe adverse events like perforation of fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain, and suspected allergy or hypersensitive reactions. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss, and mood changes.
This isn’t the first time the implant has been met with FDA scrutiny. Back in 2016, the FDA released an initial news release informing women about the risks of using Essure. At that time, the FDA also required the manufacturer of Essure, Bayer, to conduct a mandatory clinical study and required changes to product labeling, including a boxed warning.
Why is the FDA restricting sales of Essure?
The FDA is restricting sales after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous efforts to educate patients and doctors about the risks associated with this device.
What will requirements for Essure now look like?
The potential patient and their doctor will be required to review the patient brochure titled “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” to ensure they understand the risks, benefits, and other information about the Essure implant.
How does Essure work?
Essure works by your doctor permanently placing a small Essure insert into each of your fallopian tubes through a minimally invasive procedure. These inserts work with your body to form a natural barrier that keeps sperm from reaching the eggs, preventing pregnancy.
It usually takes about 3 months for the barrier to form once Essure has been inserted; therefore, you must use an alternative form of birth control during this time.
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