FDA limits sales of Bayer's birth control device after patient complaints: 5 things to know

The FDA on April 9 restricted the sale and distribution of Bayer's permanent birth control device Essure to ensure women are well-informed of the device's risks before choosing the contraceptive method.

Here are five things to know.

1. The device, which contains flexible metal coils, is implanted into a woman's fallopian tubes. After three months, tissue grows around the coils, blocking sperm from reaching eggs, thereby preventing pregnancy.

2. The FDA added a box warning and patient decision checklist to the device's label in November 2016 after receiving thousands of complaints from women who experienced complications such as hysterectomies, unwanted pregnancies and abnormal uterine bleeding.

3. U.S. sales of Essure dropped about 70 percent after Bayer implemented the box warning and checklist. However, the FDA determined some women are still not receiving proper information about Essure's risks before getting the device.

"We've been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option," said FDA Commissioner Scott Gottlieb, MD.

4. Under the new restrictions, Bayer may only sell and distribute Essure to healthcare providers that offer information about Essure's risks and benefits to patients. This process requires providers to review a pamphlet of the device's risks with patients, and both individuals must sign an acknowledgement form.

5. Bayer still stands by the birth control device, telling Reuters April 9: "Essure ... is a safe and effective medical device that benefits women by providing them with a valuable contraception option."


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