Essure Update: FDA Warns Women About Risks

Earlier today, the FDA announced that it is taking steps to make it easier for women considering sterilization to get reliable information about Essure, an implanted device.  The Network recommended that the FDA take these steps, and we’re pleased that they’re taking action on this important women’s health issue.

Essure is a permanently implanted birth control device, inserted into a woman’s fallopian tubes through a procedure that does not require surgery.  Proponents hoped that it would be a safe alternative to traditional sterilization.  However, thousands of women have reported complications to the FDA, including long-lasting serious conditions such as chronic pain and autoimmune disorders.  Adequate follow up studies were never done, so women and their clinicians were left in the dark regarding long-term safety and efficacy.

When the FDA held a public meeting about Essure last fall, we urged the agency to listen to women who reported complications, to take their experience seriously, and to share this information with women considering the device.

According to today’s announcement, the FDA has told the manufacturer that it will have to:

  • Add a warning label with information about what current patients have experienced
  • Provide a patient information checklist listing risks that have been vetted by the FDA
  • Conduct a follow-up study to determine the long-term effects of the device

These are important steps forward.  Women need reliable information, and until better studies have been completed, the best way to get it will be through information provided by patients and vetted by the FDA.  The FDA is seeking feedback from patients and consumer organizations about its plans.  You can count on the Network to continue to make sure that the FDA hears from us loud and clear – women deserve reliable information about the products they use!





 

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