Essure Under a Sales and Distribution Restriction

Essure Under a Sales and Distribution Restriction

Essure is a transcervical contraceptive tubal occlusion device which prevents pregnancy and ends fertility in women of child-bearing age. The procedure includes the  insertion of a small device into each fallopian tube, which forms a barrier preventing sperm from meeting and fertilizing the egg. This device is not effective until up to three months after the procedure, at which time the procedure is permanent.

FDA Restriction

As of April 9, 2018, the U.S. Food and Drug Administration issued an order to restrict the sales and distribution of the Essure device. This restriction comes after patients have come forward that they were not adequately informed about Essure and its risks. This comes just two years after the FDA required the manufacturer to include a boxed warning and a patient decision checklist was added to the labeling. The FDA has issued the current restriction due to new information that women are still inadequately warned of Essure's risks before getting the device implanted.

New Guidelines

If you are considering Essure as a permanent form of birth control, and have no medical necessity to go through with implantation, there are new guidelines your doctor must follow. Effective immediately, Essure will only be available when the following criteria is met:

  • The patient brochure will be presented to the patient.
  • The physician will review, specifically, the "Patient-Doctor Discussion Checklist" with patient.
  • Both the patient and the doctor implanting the device must sign the acknowledgement.

These guidelines are effective immediately, and the FDA will continue to monitor this device as information becomes available. Since it's approval in 2002, Essure remains the only permanently implanted birth control device for women that doesn't require a surgical incision.

About Essure

When you agree to an Essure procedure your health care provider will insert flexible coils into the fallopian tubes by way of the vagina and cervix. About three months after the procedure, tissue forms around the coils, creating a barrier that prevents sperm from reaching the eggs, preventing pregnancy. This procedure cannot be reversed and the device cannot be removed without a surgical procedure. Patients who have this procedure must be tested following the procedure to be sure it was effective and will need to use another form of birth control in the meantime.

Some women implanted with the Essure system of permanent birth control have reported adverse effects including: perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal cavity or pelvic cavity, persistent pain, and allergic or hypersensitivity reactions.  In order to relieve serious and adverse reactions, the device requires surgical removal.

Essure may not be right for you. Discuss all options for birth control with your trusted medical care provider. If you are offered Essure Permanent Birth Control and have not been presented with the patient brochure and asked to sign the acknowledgement, ask your doctor about it today. Essure is a valid and safe option for patients who understand the risks and benefits. Find out if you're right for Essure today.

Essure Under a Sales and Distribution Restriction

Meet the Author:

Rachel Ashworth


Rachel Ashworth is originally from the Midwest, her expertise is writing research-based articles about health and wellness. Specific interests include mental health and addiction. Rachel has written on a wide range of topics including parenting, fitness, health, fire safety, home maintenance, medical insurance, and dental care. She spends her time writing, volunteering with her church and community, and teaching her children.


Rachel Ashworth is originally from the Midwest, her expertise is writing research-based articles about health and wellness. Specific interests include mental health and addiction. Rachel has written on a wide range of topics including parenting, fitness, health, fire safety, home maintenance, medical insurance, and dental care. She spends her time writing, volunteering with her church and community, and teaching her children.