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implantable sterilization device; tubal implant (Essure)

FDA-approved in 2002. Bayer pulls Essure from U.S. market July 2018. Procedure: - small coil hysteroscopically implanted in a woman's fallopian tubes to make her permanently sterile Complications: - > 4000 reports of serious complications [1] - pelvic pain - dysmenorrhea - injury to the fallopian tube with migration to adjacent organs - 5 fetal deaths in women who became pregnant while using Essure - 4 deaths in women after infection & uterine perforation [1] * includes boxed warning & a patient decision checklist [3] * FDA-approved informational brochure to all patients, including a consent form [4]

Related

contraceptive implant

General

implant reproductive sterilization gynecologic surgery

References

  1. Orciari Herman A, Fairchild DG, Hefner JE Implantable Sterilization Device Under Scrutiny Over Safety Concerns. Physician's First Watch, May 5, 2015 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - Orciari Herman A, Sofair A, Chavey WE Implantable Sterilization Device to Face FDA Panel Over Safety Concerns Physician's First Watch, June 26, 2015 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
  2. FDA News Release. February 29, 2016 FDA takes additional action to better understand safety of Essure, inform patients of potential risks. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm488313.htm
  3. FDA Safety Watch. Nov 15, 2016 Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm529241.htm
  4. Gever J FDA Puts Restrictions on Essure. But controversial device still allowed to remain on market. MedPage Today. April 09, 2018 https://www.medpagetoday.com/obgyn/generalobgyn/72223 - FDA Safety Alert. April 9, 2018 Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm604126.htm
  5. Brooks M Bayer Pulls Essure Permanent Contraceptive From US Market. Medscape - Jul 20, 2018. https://www.medscape.com/viewarticle/899624