implantable sterilization device; tubal implant (Essure)
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Introduction
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]
More general terms
Additional terms
References
- ↑ Jump up to: 1.0 1.1 1.2 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 - ↑ 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
- ↑ Jump up to: 3.0 3.1 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
- ↑ Jump up to: 4.0 4.1 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 - ↑ Brooks M Bayer Pulls Essure Permanent Contraceptive From US Market. Medscape - Jul 20, 2018. https://www.medscape.com/viewarticle/899624