Essure Patient Outcomes Following Injury from Hysteroscopic Sterilization

July 25, 2016 3:44 pm Published by

 

E Scott Sills, MD, PHD
Medical Director
Reproductive Research Section
Center For Advanced Genetics
Carlsbad, California

 

Molecular and Applied
Biosciences Department
Doctoral Researcher
Faculty of Science and Technology
University of Westminster
London, UK

 

Marie M. Dalton, BSN
Graduate Assistant
Department of Political Science
Howard H. Baker, Jr. Center for Public Policy
University of Tennesee

 

 

Introduction

 

More than 3000,000 women request permanent surgical sterilization in the United States each year,¹ and until recently, laparoscopic bilateral tubal ligation was the only method available to meet this need.  However, in 2002 a technique for bilateral tubal occlusion via hysteroscopic placement of metal inserts at the utero-tubal junction presented another option.  Hysteroscopic sterilization was welcomed as an important alternative as it eliminated the need for abdominal access, ²˒³ reduced overall cost,⁴ and minimized anesthesia requirements.⁵  At present, the only HS method available is Essure ®.

 

Although FDA guidelines for Essure ® have existed since 2002, this is the first report to present patient outcomes when this product labeling is not followed.  The current research contributes to a larger understanding of Essure ® by validating the central importance of physician training in the proper use of this device, describing clinical scenarios associated with abnormal device use, and by illustrating what can go wrong when this contraceptive implant is used outside established FDA-approved guidelines.  In addition, we provide background on the FDA’s premarket approval (PMA) process for Class III medical devices and place the Essure ® device within this regulatory framework.

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