Bayer to Stop Selling Essure Birth Control Device in US

• July 23, 2018
• Product Liability

Thousands of women have said the Essure birth control device caused serious health issues. On Friday, July 20, 2018 (just days before the release of The Bleeding Edge documentary), Bayer announced that it would discontinue sales of its Essure permanent birth control device in the United States after December 31. This was welcome news to the many women who have advocated against the device.

According to Bayer, this decision was not related to the current litigation or safety issues but because of a decline in sales.

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 Restrictions on Essure

In April 2018, the US FDA placed restrictions on the sale and distribution of Essure following several reported complaints. The patient safety action was a unique type of restriction requiring that any woman considering use of the permanent contraception device be fully informed of potential risks.

That meant that Bayer could sell it only to health care providers and facilities that guarantee women have been fully informed about its potential side effects.

The Essure Birth Control Device

The FDA estimates that Essure has been used by more than 750,000 women worldwide since it was first approved on November 4, 2002.

Over a 15-year period, from November 2, 2002 through 2017, the FDA received more than 26,000 reports of problems. The most frequently reported problems included pain/abdominal pain, heavier menses/menstrual irregularities, headache, fatigue and weight fluctuations. Some women have claimed Essure caused serious health issues such as the device becoming dislodged or broken, migrating to other organs in the body.

Essure has been the subject of approximately 16,000 lawsuits or claims filed by those who reported severe injuries.

What Women with Essure Should Do

This doesn’t mean that women who have the device implanted should have it removed. If you have concerns, the best advice is to speak with your gynecologist.

According to a Consumer Reports article, women who already have an Essure device implanted should take these precautions.

• Watch for symptoms such as abdominal pain, excessive bleeding and allergic reactions such as rashes, itching, hives and swelling or other symptoms that you may have developed an autoimmune condition.
• Rule out other causes should you develop any of these symptoms. Talk with your primary care provider and your gynecologist to determine if the symptoms are related to the device.
• Look for a specialist, one who has experience with Essure removals, should that be your treatment plan.
• Know your options. Talk with your doctor about what is involved in the removal of the device, the expected outcomes and the risks you will face.

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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Image from Bayer Healthcare Pharmaceuticals showing the birth control implant Essure.