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Manufacturer announcement to halt Essure sales in the U.S- 

Statement from FDA Commissioner

FDA notified by Bayer that Essure permanent birth control device will no longer be sold or distributed after December 31, 2018

Steps taken by FDA based on increased reporting to MAUDE database

  • September 2015: Input from expert panel on abdominal pain, abnormal uterine bleeding, device migration
  • February 2016: Ordered Bayer to conduct a postmarket study on safety profile
  • October 2016: FDA final Guidance on device and updated labeling with boxed warning and Patient Decision Checklist
  • February 2018: FDA meeting with women implanted with Essure and patient advocates
  • March 2018:FDA report on rise in safety reporitng with >90%  on device removal
  • April 2018: FDA restriction on sale and distribution

FDA will remain vigilant in protecting patients with implanted device

  • Restriction on sale and distribution will remain in place
  • Postmarket study, will continue to enroll new participants
  • Each study participant will be followed for a total of three years
  • Bayer will continue to submit reports on study’s progress and results

READ

WATCH: The Bleeding Edge


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Biomarkers and Surrogate Markers

Biomarker is objective measure of normal biological processes, pathologic processes, responses to exposure or therapeutic intervention

  • May be used for identifying patients for clinical trial enrollment, monitoring safety and effectiveness

Surrogate endpoints (SEs) are  small subclass of biomarkers

  • Clearly predicts beneficial effect through appropriate studies
  • More efficient drug development programs

FDA steps to enhance SE use in drug development

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Examples of Pre-Market Submissions that Include Mobile Medical Apps (MMAs)  Cleared or Approved by FDA

Mobile apps are software programs run on smartphones and other mobile communication devices

  • Are medical devices if meet definition of medical device or accessory to regulated medical device or transform mobile platform into regulated medical device
  • Consumers can use both mobile medical apps and mobile apps to manage health and wellness

FDA providing listing of MMAs cleared or approved since 1997

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Image credits: Bayer, FDA

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