Essureal Journey: Concepts, Concerns and Considerations for Hysteroscopic Sterilization

E. Scott Sills (Editor)
Applied Biotechnology Research Group, University of Westminster, London, UK

Series: Medical Procedures, Testing and Technology
BISAC: MED082000

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Special issue: Resilience in breaking the cycle of children’s environmental health disparities
Edited by I Leslie Rubin, Robert J Geller, Abby Mutic, Benjamin A Gitterman, Nathan Mutic, Wayne Garfinkel, Claire D Coles, Kurt Martinuzzi, and Joav Merrick

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Hysteroscopic sterilization (HS) is the most important, and perhaps most revolutionary, advancement in female sterilization over the past 100 years. Soon after receiving FDA approval in 2002, the Essure® system became the “preferred, non-incisional alternative” to standard tubal ligation. Even as this innovative birth control technique continues to be offered to hundreds of thousands of women worldwide, the method is not without controversy. At present, no single work of reference summarizes the full HS picture, from its clinical trials to approval, its entry into the global medical market, and its post-marketing activity.

This book fills an immediate niche as an essential reference for anyone interested in HS and its place in modern contraceptive practices. It is particularly well-suited for primary care physicians, reproductive surgeons, GPs, family nurse practitioners, gynecologists, women’s healthcare providers, counselors, attorneys, reproductive ethicists, public health policy advocates, as well as patients and their partners.

Dedication

Foreword


Erin Brockovich

Preface

Acknowledgements

About the Editor

Chapter 1. Essure Problems: A Personal Journey
Angie M. Firmalino (Essure Problems Community and Support Group/ASHES Inc.; Tannersville, USA)

Chapter 2. Hysteroscopic Sterilization with an Essure: Public Safety and Premarket Approval
Kerry E. Drury, Erinma P. Ukoha, Shuai Xu and Jessica R. Walter (Feinberg School of Medicine, Northwestern University, Chicago, USA, and others)

Chapter 3. Patient Selection and Operative Techniques for Essure Removal: The University of California, Davis Experience
Melissa J. Chen and Melody Y. Hou (Department of Obstetrics and Gynecology, University of California—Davis, Sacramento, USA)

Chapter 4. An Evidence-Based Analysis of the Essure Contraceptive System: Effectiveness Data from the Ontario, Canada Experience
Kristen I. McMartin and Kellee Kaulback (Evidence Development and Standards Division, Health Quality Ontario, Toronto, Canada)

Chapter 5. Adverse Events for Post-Market Essure Surveillance Using Device Events: Telling the Story with Data
Madris Tomes (Founder and Chief Executive Officer; Device Events, York, USA)

Chapter 6. Manufacturing Fault and Product Liability in the Age of Essure
Holly Kelly Ennis, Ennis and Ennis (P.A., Fort Lauderdale, USA)

Chapter 7. Considerations and Techniques for the Surgical Removal of an Essure: Device Migration and Fragmentation
Shadi Rezai, Richard Giovane and Cassandra E. Henderson (Department of Obstetrics and Gynecology, Lincoln Medical and Mental Health Center, Bronx, USA)

Chapter 8. Surgical Essure Removal: A Case Series Reviewing Outcomes Following Hysterectomy with Bilateral Salpingectomy vs. Modified Coring Salpingectomy Alone
Shawn Tassone (Department of Women's Health, Dell Medical School, University of Texas, Austin, USA)

Chapter 9. Patient Selection and Operative Techniques for Tubal Reanastomosis after an Essure Procedure: The Texas Experience
Robert N. Smith, Jr. (Texas Health Huguley Hospital Fort Worth South, Fort Worth, USA)

Chapter 10. The Essure System: Concerns Regarding Polyethylene Terephthalate in Women's Health
Julio Cesar Novoa (Department of Obstetrics and Gynecology, Novoa Medical Services, P.A, El Paso, USA)

Chapter 11. A Systematic Approach to Discover the Long-Term Local Tissue Effects of Intratubal Contraceptive Implants
E. Scott Sills and Xiang Li (Reproductive Research Section, Center for Advanced Genetics, Carlsbad, USA)

Chapter 12. Hysteroscopic Sterilization with an Essure: Post-Approval Studies and a Future Outlook
Erinma P. Ukoha, Kerry E. Drury, Shuai Xu and Jessica R. Walter (Feinberg School of Medicine, Northwestern University, Chicago, USA, and others)

Index

"When the Essure permanent birth control system hit the market in 2002, the medical community viewed it as an innovation in permanent female sterilization. Because of its first-in-class design, the U.S. Food and Drug Administration classified it as a high-risk device. This protects the manufacturer from liability. Now, more than a decade after its release, thousands of women who suffered adverse events after implantation demand a ban on the device and the ability to sue for damages." READ MORE... - Michelle Y. Llamas, senior content writer at Drugwatch

Audience: Clinical, academic, legal/judicial, as well as medical consumers. Specifically, primary care physicians, reproductive surgeons, GPs, family nurse practitioners, gynecologists, women’s healthcare providers, counsellors, attorneys, reproductive ethicists, public health policy advocates, as well as patients and their partners.

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