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Essure: The harmful device that the FDA refuses to remove from the market

May 14, 2018 - Blog by

National Women’s Health Week falls on the week of Mother’s Day every year. It was created to remind women of the importance of their health and how to make healthy life choices. During this week, we want to warn women of one specific medical device that has negatively affected the health of thousands of women.

Female contraceptive options regularly come under attack for their array of side-effects that are less than desirable. Most complications suffered don’t result in life-changing altercations, but not all. Essure is one of the few contraceptive options to come under attack in recent years because of its severe and sometimes permanent side-effects.

What is Essure?

Essure consists of two nickel-titanium based alloy coils that are embedded in the fallopian tubes to permanently prevent pregnancy. During the months that follow, the insert forms a “natural” barrier and is supposed to remain securely in place.

As the only form of non-surgical form of birth control for women in the U.S, it was a very popular treatment option when it was first released. Today the story is very different. To date, over 16,000 Essure users have filed lawsuits against the manufacturer, Bayer.

Women have reported everything from persistent pain to abnormal bleeding, perforation of the uterus and unplanned pregnancies. Some complained of problems immediately, others noticed changes gradually over years. These same women had little to no warning of the possible consequences of the procedure.

The FDA’s Response:

In 2016, the FDA approved Bayer’s new packaging for Essure, which came complete with a black box warning of the severe complications. The warning reads:

“Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required.”

The warning was added 14 years after the device first found its way onto the market, and after thousands of women found themselves dealing with the aftermath of the side-effects.

Recent Updates:

Today, the U.S. is the only country in the world where Essure can still be found, however recently, the FDA has released an order to restrict sales of Essure. The new label will now require patients to complete and sign a document entitled ‘Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement’.

Bayer continues to proclaim that the benefits of Essure remain positive, however the thousands of lawsuits against the company and recent FDA updates say otherwise. We continue to hope that one-day Essure is completely off the market, but until then it is important to inform women of the risks and keep the most important thing to them top of mind – their health.

For more information on National Women’s Health Week, follow this link.

If you or some you know suffered complications from Essure, you can contact our team directly by calling 1-800-529-3476, or filling out the form here.