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Abstract:
Objective: We present clinical data on two patients who underwent hysteroscopic sterilization (HS) 11 years apart using the Essure® (Bayer Inc., Whippany, NJ) device.
Materials and Methods: Symptoms and resolution are described for symptomatic Essure® patients.
Results: Case 1 (G3P1) underwent HS in 2004 at age 21. Performed in a physician’s office without anesthesia, HS involved placement of >2 Essure® devices which was followed by severe, unrelenting pelvic pain. Confirmatory hysterosalpingogram (HSG) three months after HS revealed five devices. Surgical costs for laparoscopic assisted vaginal hysterectomy (LAVH) were fully reimbursed by the device manufacturer seven months later. Case 2 (G8P4) underwent HS in 2015 at age 32. One year earlier, the patient’s right fallopian tube was removed due to ectopic pregnancy. Essure® devices were placed bilaterally in a physician’s office without anesthesia; HS was accompanied by sharp pelvic pain. The patient obtained HSG three weeks after HS due to constant discomfort. Bilateral tubal occlusion was verified, but abnormal device loop configuration suggesting myometrial penetration was noted on the right. At laparoscopy, the left Essure® device was excised intact but the right coil could not be located. Thus far, there has been no offer in Case 2 from the device manufacturer to offset medical expenses.
Conclusions: While HS has been FDA approved for use in the United States since 2002, this is the first description of clinical sequela when FDA labeling for the Essure® procedure is ignored. These cases illustrate the importance of proper physician training in HS and underscore the need for improved tracking of Essure® associated symptoms.
Authors:
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 Tennessee, Knoxville, Tennessee
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