Critic questions FDA’s handling of Essure product complaints

FDA continues to update how it is informing the public about the controversial Essure permanent birth control device from Bayer. But at least one prominent critic sees holes in FDA’s efforts.

“Many women are still being implanted with the device without adequate warnings of the risks associated with the device,” attorney Holly Ennis wrote in an April 20 blog post.

Essure is a small metal coil that is implanted in the fallopian tubes via catheter. In 2015, FDA reported that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after using the device. There were also complaints of the device breaking, and more than 1,000 unplanned pregnancies. In addition to 5 fetal deaths, there were 4 reports of adult deaths caused by infection and uterine perforation, FDA said. However, FDA has stated that it believes the benefits of the device outweigh its risks, and that updated labeling helps to ensure that women are appropriately informed of the risks.

Get the whole story at our sister site, Medical Design & Outsourcing. 

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