Here are five things to know:
1. The nonincisional contraceptive device, approved by the FDA in 2002, is inserted into a woman’s fallopian tubes and prevents pregnancy by producing scar tissue that blocks sperm from fertilizing her eggs.
2. The company’s decision to halt sales in the U.S. comes several months after the FDA restricted the sale and distribution of Essure to ensure women are well-informed before choosing this contraceptive method.
3. In November 2016, the FDA added a box warning to the device’s label after receiving thousands of complaints from woman who experienced complications resulting in hysterectomies, hair loss, unwanted pregnancies and abnormal uterine bleeding. Sales dropped about 70 percent after the box warning.
4. Bayer’s decision “is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable,” the company said. Bayer said it stands by the device’s safety and efficacy.
5. “Women who currently have Essure in place may continue to confidently rely on the device, and Bayer will continue to support women with Essure and their healthcare providers,” the company said.
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London drugmaker boosts injectable opioid supply for US hospitals amid shortage
American Action Forum: Trade war with China could drive medical equipment costs up $400M per year
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