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FDA Restrictions Placed on Essure

Essure FDA Restrictions

Permanent birth control is one of the most widely used methods of contraception today. It can be highly effective, doesn’t require a surgical procedure and women no longer have to remember to take a daily pill. So why has the FDA restricted the sale and distribution of the Essure device and required boxed warnings?


What is Essure?

Essure is a permanently implanted birth control device for women, an alternative to having your “tubes tied.” A physician inserts flexible coils through the vagina and cervix and into the fallopian tubes. Over a period of about three months, tissue forms around the inserts. This build-up of tissue creates a barrier that keeps sperm from reaching the eggs.


FDA Places Restrictions on Essure

April 9, 2018. The FDA announced that it has restricted the sale and distribution of the Essure device to ensure that any woman considering use of the permanent contraception device is fully informed of potential risks as they consider permanent birth control options.

This unique restriction ensures that it will be available only to providers who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement.” This step will help ensure that women are adequately informed of Essure’s risks before implantation.

The FDA also approved Bayer’s new labeling that includes:

  • The following statement: The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.
  • Bayer’s Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement, which is part of the patient information booklet, and has key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.

Why the restrictions on this device? The FDA has been monitoring a growing number of adverse event reports associated with the use of Essure, which include:

  • Persistent pain
  • Perforation of the uterus and/or fallopian tubes
  • Intra-abdominal or pelvic device migration
  • Abnormal or irregular bleeding
  • Allergy or hypersensitivity reactions

Some women have had to have surgical procedures to remove the device.


Essure Complications

Angie Firmalino, founder of the Facebook group called Essure Problems, was implanted with the device. She said the procedure was “extremely painful” and the discomfort she had months after the implantation was nearly debilitating. An ultrasound showed that the implant, which was originally inserted in the fallopian tubes, had dislodged and migrated to her uterus. The device was removed; however, it left behind metal fragments that ravaged her reproductive system.

The FDA has reported that over 15 years (from its approval in November, 2002 to December 2017), it has received 26,773 reports of problems, including pain, heavier periods and irregular bleeding, headaches and fatigue along with reports that the device had become dislodged or broken. In addition, it has also received reports of eight adult deaths related to Essure.

More than 750,000 Essure devices have been sold worldwide since it was introduced in 2002 and close to 1,000 women have filed lawsuits against Bayer over Essure.

The Battle Over Essure


Need Legal Advice?

Complications from the Essure device are migration and perforation of the fallopian tubes, which can puncture the uterus and other organs. If you have suffered serious complications due to an Essure device, contact one of our attorneys for a free, no-obligation review of your situation.

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