ESSURE
Report
- Report Number
- 2951250-2023-03565
- Event Type
- Injury
- Date Received
- December 14, 2023
- Date of Event
- April 24, 2015
- Report Date
- January 5, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("THE LEFT ESSURE MICRO INSERT OVERLIES LEFT ILIUM WITH DISPLACEMENT OF THE PROXIMAL PLATINUM BAND.") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF OVERWEIGHT, JOINT STIFFNESS (HOSPITALISED), GENERAL BODY PAIN (HOSPITALISED), FATIGUE (HOSPITALISED), PAST TOBACCO SMOKING, SURGERY (LEFT BREAST BIOPSY DURING BREAST SURGERY VARICOSE VEIN LIGATION.), ALLERGY (ALLERGIC RHINITIS DUE TO ANIMALS, DUST MITE, MOLD AND POLLEN), DRUG ALLERGY (DIFLUCAN), PARITY 2, GRAVIDA II, ANAPHYLAXIS, ANXIETY AND FACTOR V LEIDEN CARRIER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MIRENA. THE PATIENT HAD A FAMILY HISTORY OF BREAST CANCER. ON (B)(6) 2015,, SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY. AND PARTIAL OMENTECTOMY WITH REMOVAL OF AN IDENTIFIABLE PORTION). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 27.459 KG/SQM. [BLOOD PRESSURE MEASUREMENT] ON (B)(6) 2015: BLOOD PRESSURE IS 111/73. [HEART RATE] ON (B)(6) 2015: 67. [HYSTEROSALPINGOGRAM] IN 2011: SHE HAD ESSURE PLACED IN AN OFFICE SETTING, PERFORMED IN 2011 AND HER HYSTEROSALPINGOGRAM CONFIRMATION SHOWED NO TUBAL DYE LEAKAGE, BUT THERE WAS NON VISUALIZATION ACCORDING TO PATIENT OF HER RIGHT-SIDED COIL. I; ON (B)(6) 2012: IMPRESSION: HYSTEROSALPINGOGRAM TO EVALUATE ESSURE DEVICE PLACEMENT. THE RIGHT ESSURE DEVICE DOES APPEAR IN PLACE WITH A NONPATENT FALLOPIAN TUBE. THE LEFT ESSURE DEVICE APPEARS DISPLACED INTO THE LEFT HEMIPELVIS, HOWEVER, THERE ONLY LIMITED VISUALIZATION OF THE PROXIMAL LEFT FALLOPIAN POWER, THERE IS NO DEFINITE FREE SPILLAGE OF CONTRAST SEEN ON THE LEFT. INDICATION: ESSURE PLACEMENT RIGHT FALLOPIAN TUBE TO THE LEVEL OF ESSURE DEVICE. THERE IS NO FREE SPILLAGE OF CONTRAST ON THE RIGHT. ON THE LEFT, THE FALLOPIAN TUBE IS NOT CONFIDENTLY VISUALIZED. THERE DOES APPEAR TO BE SOME MINIMAL OPACIFICATION IN THE PROXIMAL ASPECT OF THE TUBE. THERE IS NO FREE SPILLAGE IDENTIFIED. CONTRAST WAS INSTILLED UNTIL THE PATIENT COMPLAINED OF SIGNIFICANT CRAMPING. NO DEFINITE FREE INTRAPERITONEAL SPILLAGE OF CONTRAST WAS VISUALIZED. [PATHOLOGY TEST] ON (B)(6) 2015: SURGICAL PATHOLOGY REPORT SPECIMEN A. RIGHT FALLOPIAN TUBE B. LEFT FALLOPIAN TUBE CLINICAL INFORMATION POSSIBLE MIGRATED LEFT ESSURE IMPLANT GROSS DESCRIPTION: ALSO RECEIVED SEPARATELY WITHIN THE BASE OF THE CONTAINER ARE TWO SEPARATE PORTIONS OF WIRE. ONE OF THESE IS A COILED PORTION OF WIRE WHICH HAS THE APPEARANCE OF 4 SPRING WHICH IS 2 CM. IN LENGTH X 0.2 CM. IN DIAMETER. THE OTHER IS A PORTION OF WIRE WHICH HAS A HOOK NEAR ONE END. THIS PORTION OF WIRE IS UP TO 6 CM. IN LENGTH BY LESS THAN 0.1 CM. IN DIAMETER. WITHIN THIS ADIPOSE TISSUE IS 4 SINGLE COILED METALLIC STRUCTURE WHICH IS 3.5 CM. IN LENGTH BY UP TO 0.2 CM. IN DIAMETER. FINAL DIAGNOSIS A. RIGHT SALPINGECTOMY: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. FOCAL CAUTERY DISTORTION. BENIGN PARATUBAL CYST. METALLIC STRUCTURE CONSISTENT WITH ESSURE IMPLANT. B. LEFT SALPINGECTOMY: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. FOCAL CAUTERY DISTORTION. PORTION OF BENIGN PERITONEAL FAT: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. ENTRAPPED METALLIC STRUCTURE CONSISTENT WITH ESSURE IMPLANT. [URINARY SYSTEM X-RAY] ON (B)(6) 2015: TYPE/EXAM: RADIOLOGY-DIAGNOSTIC/ KUB OR FLAT PLATE ABDOMINAL CLINICAL HISTORY: TO DETERMINE ESSURE LOCATION FINDINGS: SUPINE AP VIEW OF THE ABDOMEN AND PELVIS WAS OBTAINED ON THREE IMAGES. THERE IS AN ESSURE MICRO-INSERT OVERLYING THE LEFT ILIUM. THE APPEARS TO BE MEDIAL DISPLACEMENT OF THE PROXIMAL PLATINUM BAND WITHIN THE LEFT HEMI PELVIS. THERE IS ALSO AN ESSURE MICRO INSERT ADJACENT TO THE RIGHT ISCHIAL SPINE. THERE IS NO ABNORMAL GASEOUS INTESTINAL DISTENSION. SOFT TISSUE PLANES ARE PRESERVED. THERE IS NO EVIDENCE OF ORGANOMEGALY. NO EVIDENCE OF ABNORMAL CALCIFICATION ALONG EXPECTED COURSE OF THE BILIARY OR URINARY TRACTS. THERE IS A MILD TO MODERATE AMOUNT OF STOOL WITHIN THE COLON. IMPRESSION: 1. THE LEFT ESSURE MICRO INSERT OVERLIES LEFT ILIUM WITH DISPLACEMENT OF THE PROXIMAL PLATINUM BAND. 2. THE RIGHT ESSURE MICRO INSERT IS IN THE REGION OF THE EXPECTED POSITION OF THE RIGHT FALLOPIAN TUBE. AND TYPE/EXAM: RADIOLOGY-DIAGNOSTIC/ KUB OR FLAT PLATE ABDOMINAL CLINICAL HISTORY: LAPAROSCOPIC SALPINGECTOMY POST OP ALREADY DONE. FINDINGS: GAS IS SEEN THROUGHOUT THE COLON TO THE RECTUM. THERE IS NO INTESTINAL DILATATION OR EXTRALUMINAL AIR. LARGE AMOUNT OF STOOL WITHIN THE COLON. NO ABNORMAL ABDOMINAL CALCIFICATION. PREVIOUSLY SEEN ESSURE COILS HAVE BEEN REMOVED. IMPRESSION: 1. NON OBSTRUCTING BOWEL GAS PATTERN. LARGE AMOUNT OF STOOL WITHIN THE COLON. 2. PREVIOUSLY SEEN ESSURE COILS HAVE BEEN REMOVED. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 05-JAN-2024: 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.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("THE LEFT ESSURE MICRO INSERT OVERLIES LEFT ILIUM WITH DISPLACEMENT OF THE PROXIMAL PLATINUM BAND.") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF OVERWEIGHT, JOINT STIFFNESS (HOSPITALISED), GENERAL BODY PAIN (HOSPITALISED), FATIGUE (HOSPITALISED), PAST TOBACCO SMOKING, SURGERY (LEFT BREAST BIOPSY DURING BREAST SURGERY VARICOSE VEIN LIGATION.), ALLERGY (ALLERGIC RHINITIS DUE TO ANIMALS, DUST MITE, MOLD AND POLLEN), DRUG ALLERGY (DIFLUCAN), PARITY 2, GRAVIDA II, ANAPHYLAXIS, ANXIETY AND FACTOR V LEIDEN CARRIER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MIRENA. THE PATIENT HAD A FAMILY HISTORY OF BREAST CANCER. ON (B)(6) 2015,, SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY. AND PARTIAL OMENTECTOMY WITH REMOVAL OF AN IDENTIFIABLE PORTION). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 27.459 KG/SQM. [BLOOD PRESSURE MEASUREMENT] ON (B)(6) 2015: BLOOD PRESSURE IS 111/73 [HEART RATE] ON (B)(6) 2015: 67 [HYSTEROSALPINGOGRAM] IN 2011: SHE HAD ESSURE PLACED IN AN OFFICE SETTING, PERFORMED IN 2011 AND HER HYSTEROSALPINGOGRAM CONFIRMATION SHOWED NO TUBAL DYE LEAKAGE, BUT THERE WAS NON VISUALIZATION ACCORDING TO PATIENT OF HER RIGHT-SIDED COIL. I; ON (B)(6) 2012: IMPRESSION: HYSTEROSALPINGOGRAM TO EVALUATE ESSURE DEVICE PLACEMENT. THE RIGHT ESSURE DEVICE DOES APPEAR IN PLACE WITH A NONPATENT FALLOPIAN TUBE. THE LEFT ESSURE DEVICE APPEARS DISPLACED INTO THE LEFT HEMIPELVIS, HOWEVER, THERE ONLY LIMITED VISUALIZATION OF THE PROXIMAL LEFT FALLOPIAN POWER, THERE IS NO DEFINITE FREE SPILLAGE OF CONTRAST SEEN ON THE LEFT. INDICATION: ESSURE PLACEMENT RIGHT FALLOPIAN TUBE TO THE LEVEL OF ESSURE DEVICE. THERE IS NO FREE SPILLAGE OF CONTRAST ON THE RIGHT. ON THE LEFT, THE FALLOPIAN TUBE IS NOT CONFIDENTLY VISUALIZED. THERE DOES APPEAR TO BE SOME MINIMAL OPACIFICATION IN THE PROXIMAL ASPECT OF THE TUBE. THERE IS NO FREE SPILLAGE IDENTIFIED. CONTRAST WAS INSTILLED UNTIL THE PATIENT COMPLAINED OF SIGNIFICANT CRAMPING. NO DEFINITE FREE INTRAPERITONEAL SPILLAGE OF CONTRAST WAS VISUALIZED. [PATHOLOGY TEST] ON (B)(6) 2015: SURGICAL PATHOLOGY REPORT SPECIMEN A. RIGHT FALLOPIAN TUBE B. LEFT FALLOPIAN TUBE CLINICAL INFORMATION POSSIBLE MIGRATED LEFT ESSURE IMPLANT GROSS DESCRIPTION: ALSO RECEIVED SEPARATELY WITHIN THE BASE OF THE CONTAINER ARE TWO SEPARATE PORTIONS OF WIRE. ONE OF THESE IS A COILED PORTION OF WIRE WHICH HAS THE APPEARANCE OF 4 SPRING WHICH IS 2 CM. IN LENGTH X 0.2 CM. IN DIAMETER. THE OTHER IS A PORTION OF WIRE WHICH HAS A HOOK NEAR ONE END. THIS PORTION OF WIRE IS UP TO 6 CM. IN LENGTH BY LESS THAN 0.1 CM. IN DIAMETER. WITHIN THIS ADIPOSE TISSUE IS 4 SINGLE COILED METALLIC STRUCTURE WHICH IS 3.5 CM. IN LENGTH BY UP TO 0.2 CM. IN DIAMETER. FINAL DIAGNOSIS A. RIGHT SALPINGECTOMY: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. FOCAL CAUTERY DISTORTION. BENIGN PARATUBAL CYST. METALLIC STRUCTURE CONSISTENT WITH ESSURE IMPLANT. B. LEFT SALPINGECTOMY: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. FOCAL CAUTERY DISTORTION. PORTION OF BENIGN PERITONEAL FAT: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. ENTRAPPED METALLIC STRUCTURE CONSISTENT WITH ESSURE IMPLANT. [URINARY SYSTEM X-RAY] ON (B)(6) 2015: TYPE/EXAM: RADIOLOGY-DIAGNOSTIC/ KUB OR FLAT PLATE ABDOMINAL CLINICAL HISTORY: TO DETERMINE ESSURE LOCATION FINDINGS: SUPINE AP VIEW OF THE ABDOMEN AND PELVIS WAS OBTAINED ON THREE IMAGES. THERE IS AN ESSURE MICRO-INSERT OVERLYING THE LEFT ILIUM. THE APPEARS TO BE MEDIAL DISPLACEMENT OF THE PROXIMAL PLATINUM BAND WITHIN THE LEFT HEMI PELVIS. THERE IS ALSO AN ESSURE MICRO INSERT ADJACENT TO THE RIGHT ISCHIAL SPINE. THERE IS NO ABNORMAL GASEOUS INTESTINAL DISTENSION. SOFT TISSUE PLANES ARE PRESERVED. THERE IS NO EVIDENCE OF ORGANOMEGALY. NO EVIDENCE OF ABNORMAL CALCIFICATION ALONG EXPECTED COURSE OF THE BILIARY OR URINARY TRACTS. THERE IS A MILD TO MODERATE AMOUNT OF STOOL WITHIN THE COLON. IMPRESSION: 1. THE LEFT ESSURE MICRO INSERT OVERLIES LEFT ILIUM WITH DISPLACEMENT OF THE PROXIMAL PLATINUM BAND. 2. THE RIGHT ESSURE MICRO INSERT IS IN THE REGION OF THE EXPECTED POSITION OF THE RIGHT FALLOPIAN TUBE. AND TYPE/EXAM: RADIOLOGY-DIAGNOSTIC/ KUB OR FLAT PLATE ABDOMINAL CLINICAL HISTORY: LAPAROSCOPIC SALPINGECTOMY POST OP ALREADY DONE. FINDINGS: GAS IS SEEN THROUGHOUT THE COLON TO THE RECTUM. THERE IS NO INTESTINAL DILATATION OR EXTRALUMINAL AIR. LARGE AMOUNT OF STOOL WITHIN THE COLON. NO ABNORMAL ABDOMINAL CALCIFICATION. PREVIOUSLY SEEN ESSURE COILS HAVE BEEN REMOVED. IMPRESSION: 1. NON OBSTRUCTING BOWEL GAS PATTERN. LARGE AMOUNT OF STOOL WITHIN THE COLON. 2. PREVIOUSLY SEEN ESSURE COILS HAVE BEEN REMOVED. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1770175 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Other| R |