Description of Event or Problem · 0
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: SAX MR; WARWAR RE; DYSART SE; KARNITIS VJ, INTERSTITIAL ECTOPIC PREGNANCY IN A (B)(6) YEAR-OLD WOMAN AFTER REMOVAL OF ESSURE MICROINSERTS AND REVERSAL OF HYSTEROSCOPIC STERILIZATION, THE AMERICAN JOURNAL OF CASE REPORTS, 2022, 23:XXX. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTI GRAVIDA AND PARITY 3. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (UNDERGONE ESSURE STERILIZATION REVERSAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT HAD UNDERGONE STERILIZATION REVERSAL, WITH REMOVAL OF BILATERAL ESSURE DEVICES, 2 YEARS PRIOR TO THIS PRESENTATION. ABSTRACT: QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. INTERSTITIAL ECTOPIC PREGNANCY, A PREGNANCY OCCURRING IN THE PART OF THE FALLOPIAN TUBE THAT IS WITHIN THE BODY OF THE UTERUS, POSES A SIGNIFICANT RISK TO PATIENTS, WITH A MORTALITY RATE OF UP TO 2.5%, WHICH IS 7 TIMES HIGHER THAN FOR TUBAL ECTOPIC PREGNANCIES. HYSTEROSCOPIC STERILIZATION REVERSAL CARRIES A POTENTIAL RISK OF INTERSTITIAL ECTOPIC PREGNANCY; THEREFORE, IT IS IMPORTANT TO COUNSEL PATIENTS APPROPRIATE AND REVIEW THE ALTERNATIVE OPTION FOR IN VITRO FERTILIZATION. IN VITRO FERTILIZATION HAS BEEN SHOWN TO HAVE A SUPERIOR PREGNANCY AND LIVE BIRTH RATE IN COMPARISON TO STERILIZATION REVERSAL. WOMEN WHO HAVE UNDERGONE STERILIZATION VIA HYSTEROSCOPIC PLACEMENT OF THE ESSURE DEVICE MAY COMPLETE IN VITRO FERTILIZATION WITH STERILIZATION DEVICES LEFT IN SITU WITHOUT SIGNIFICANTLY REDUCING THE PREGNANCY RATE. CASE REPORT: A (B)(6) WOMAN, (B)(6) , PRESENTED TO THE EMERGENCY DEPARTMENT AFTER INCIDENTAL DETECTION OF LEFT INTERSTITIAL ECTOPIC PREGNANCY MEASURING 9 WEEKS OF GESTATION. SHE HAD PREVIOUSLY UNDERGONE A RIGHT SALPINGECTOMY FOR ECTOPIC PREGNANCY SOON AFTER REVERSAL OF ESSURE STERILIZATION VIA BILATERAL TUBOUTERINE REIMPLANTATION; THIS IS A PROCEDURE THAT IS INFREQUENTLY PERFORMED DUE TO LIMITED EVIDENCE TO SUGGEST THAT THIS IS A SAFE AND EFFICACIOUS METHOD TO ACHIEVE FUTURE PREGNANCIES. THIS PATIENT UNDERWENT AN UNCOMPLICATED LEFT CORNUOSTOMY AND SALPINGECTOMY, RENDERING THE NEED FOR IN VITRO FERTILIZATION TO CONCEIVE IN THE FUTURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2022: QUALITY SAFETY EVALUATION OF PTC BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.