Five months after convening an advisory committee meeting to discuss concerns about the safety of Essure, the only non-surgical permanent contraceptive, the Food and Drug Administration on Monday announced new measures “to help women and their doctors be better informed” of potential complications linked to the device.
The FDA said it is going to require a “black box” warning–the strongest type of warning–on the device’s labeling and a “Patient Decision Checklist to help ensure women receive and understand information regarding the benefits and risks of this type of device.” In addition, the agency has ordered Bayer, the manufacturer, to conduct a new study to collect information about Essure’s risks in a “real-world” environment.
Approximately 750,000 women worldwide have opted to get Essure, according to Bayer, which received FDA approval in 2002 to market the device. In what Bayer says is usually a 10-minute office procedure, doctors insert Essure’s flexible coils through the vagina and cervix and into the fallopian tubes, which carry eggs from the ovaries to the uterus. During the next three months, tissue forms around the coils, blocking sperm from reaching the eggs. [..]
Diana Zuckerman, president of the National Center for Health Research, a nonpartisan, nonprofit think tank in Washington, D.C., isn’t as eager to pull Essure off the market, at least not yet.
“Our center hasn’t said Essure should necessarily be pulled from the market based on what we know now, but we believe that women and their doctors have been terribly misinformed about the complications, and that misinformation has greatly added to women’s suffering,” Zuckerman told me.
“I am glad to see that the FDA is requiring new data and admitting that complications are a serious problem,” she added. But Zuckerman said the agency needs to rethink this line in its announcement Monday: “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.” No one knows whether that is true, she said, given the lack of unbiased scientific data. […]