Essure is under the FDA microscope from complaints from patients

Essure was approved by the FDA for sale in the U.S. in 2002. Since its approval, it has received numerous complaints and calls for it to be withdrawn from the market. Essure’s serious health risks include holes in the fallopian tubes and uterus! Severe allergic reactions have also been seen. The FDA said it will require a warning label with these serious risks to be highlighted on the box and is requesting that the public comment on what should be included. The reported complaints are anything from bleeding and chronic pain to autoimmune disorders such as lupus. Breaking or moving of the inserted device has also been reported as well as miscarriages and stillbirths. You can read the FDA’s review document on the product here.

What is Essure®?

According to Essure, it is the only permanent birth control option that doesn’t require surgery. It has gained popularity because it does not use hormones but claims to instead work with your body to create a natural barrier against pregnancy.

How Essure Works

The overall procedure to insert Essure can be done in approximately 10 minutes in a doctor’s office. The doctor places a small, permanent device into each of the fallopian tubes. These Essure inserts are suppose to keep sperm from reaching the eggs by working with the body to form a natural barrier, thus preventing the possibility of pregnancy.

Essure is under the FDA microscope from complaints from patientsFDA requires new checklist

Although the FDA didn’t take Essure off the market like many of the affected women had hoped, they are requiring that a patient decision checklist be signed by patients and doctors before they move forward with the procedure. If the patient does agree to the checklist, they will be required to test the device after three months to make sure it is functioning as it is intended to.  The FDA also claims to be taking action to increase understanding of the risks associated with the device for both patients and doctors. Bayer -the device maker- has agreed to work with the FDA towards these goals.

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