“FDA’s Actions on Essure are Steps in the Right Direction” NWHN statement in response to FDA Draft Guidance

FOR IMMEDIATE RELEASE

Contact: Cindy Pearson at cpearson@nwhn.org or 202.682.2640, ext. 0

Safe & effective contraception, including permanent contraception, is an essential component of women’s health and economic security.  Women rely on the FDA to make sure that the risks of contraceptive methods are low, and well understood.  Today, the FDA took important first steps to improve women’s knowledge about the risks of Essure, a medical device used for sterilization.

“We support the FDA’s recommendation that women and clinicians be warned about the possible serious risks of the Essure device via a “black box” on the label of the device,” said Cynthia Pearson, Executive Director of the Network.  Well done studies demonstrate that women who use Essure are several times more likely to need another surgical procedure in the first year after the device is implanted than are women who choose traditional sterilization procedures.  Even more worrisome is the experience of thousands of women who have submitted reports to the FDA about chronic and disabling complications such as severe pain and autoimmune disorders.

In addition to the “black box” warning, the FDA is also asking physicians to provide women considering Essure with a list of the risks that the FDA has found to be linked to the device.  The NWHN previously recommended that the agency require the manufacturer to include a standardized informed decision-making document in its consumer education materials.  “We know that women can make good decisions about the risks and benefits of medical treatments, including permanent contraception, if they are provided with good information”, said Pearson. “The FDA’s patient information checklist is a good way to get trustworthy information into women’s hands.”

The FDA also announced that it would require Bayer, the manufacturer of Essure, to conduct a new study of the device to get more detailed information about complications.  “More information is always good,” commented Pearson, “but women would be better served if the FDA required Bayer to fund a registry maintained by a neutral third party.  There’s a lot of suspicion of Bayer among women who’ve experienced complications with this device.”


 

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