ESSURE
Report
- Report Number
- 2951250-2022-01039
- Event Type
- Injury
- Date Received
- August 30, 2022
- Report Date
- February 13, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CHRONIC PAIN IN THE PELVIC REGION") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 863580) FOR FEMALE STERILIZATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF UMBILICAL HERNIA REPAIR, HEMORRHOID OPERATION, CAESAREAN SECTION (2) AND MULTIGRAVIDA (2). DENIES DRUG ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CEFTRIAXONE FOR PYELONEPHRITIS AND ORAL CONTRACEPTIVE NOS AND CONTRACEPTIVES. CONCURRENT CONDITIONS WERE LISTED AS TYPE I DIABETES MELLITUS AND HYPERTENSION. CONCOMITANT PRODUCTS INCLUDED CLOR METFORMINA (METFORMIN HYDROCHLORIDE) FOR TYPE 2 DIABETES MELLITUS, HCTZ (HYDROCHLOROTHIAZIDE) FOR HYPERTENSION AND ENALAPRIL FOR HYPERTENSION. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE DAY OF ESSURE INSERTION, SHE EXPERIENCED A FIRST EPISODE OF PROCEDURAL PAIN ("ACUTE AND INTENSE PAIN"). ON (B)(6) 2017 SHE EXPERIENCED ABDOMINAL PAIN LOWER ("HYPOGASTRIC PAIN") AND PYREXIA ("FEVER"). ON (B)(6) 2017 SHE EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2022 SHE EXPERIENCED DEVICE EXPULSION ("SUSPICION OF ESSURE DISLOCATION/ LEFT ESSURE DEVICE CLOSE TO THE DORSAL ASPECT OF THE UTERUS, INDICATING POSSIBLE MALPOSITION/CORNUAL PORTION OF THE UTERUS"). ON (B)(6) 2022 SHE EXPERIENCED ENDOMETRIOSIS ("DEEP ENDOMETRIOSIS"). AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING ("SHE STARTED TO HAVE MORE THAN 20 DAYS OF HEAVY VAGINAL BLEEDING / MENSTRUAL FLOW INCREASE"), DYSPAREUNIA ("DYSPAREUNIA /PAIN DURING AND AFTER INTERCOURSE"), DYSMENORRHOEA ("HEAVY CRAMPS"), INFLAMMATION ("ABDOMINAL INFLAMMATION THAT SOMETIMES PREVENTED THE PATIENT FROM WALKING"), HEADACHE ("SEVERE HEADACHE"), PAIN IN EXTREMITY ("LEG PAIN"), FATIGUE ("FATIGUE"), PRURITUS ALLERGIC ("ITCHY ALLERGIES ALL OVER THE BODY"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER INTERCOURSE"), URINARY TRACT INFECTION ("FREQUENT URINARY INFECTIONS"), PERIPHERAL SWELLING ("LEG SWELLING"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LUMBAR PAIN"), UTERINE PAIN ("SENSATION OF UTERINE PERFORATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("CONSTANT MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), VAGINAL ODOUR ("STRONG ODOR FROM VAGINAL FLUID") AND A SECOND EPISODE OF PROCEDURAL PAIN ("POST PROCEDURAL PAIN (AFTER ESSURE REMOVAL)"). THE PATIENT WAS TREATED WITH SURGERY (HISTERECTOMY AND TOTAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE EXPULSION, ENDOMETRIOSIS, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, INFLAMMATION, HEADACHE, PAIN IN EXTREMITY, FATIGUE, PRURITUS ALLERGIC, LOSS OF LIBIDO, COITAL BLEEDING, URINARY TRACT INFECTION, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, UTERINE PAIN, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, VAGINAL ODOUR, DYSURIA, ABDOMINAL PAIN LOWER AND PYREXIA WERE RESOLVING AND THE DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, BACK PAIN, COITAL BLEEDING, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INFLAMMATION, LOSS OF LIBIDO, MOOD SWINGS, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, THE FIRST EPISODE OF PROCEDURAL PAIN, THE SECOND EPISODE OF PROCEDURAL PAIN, PRURITUS ALLERGIC, TREMOR, URINARY TRACT INFECTION, UTERINE PAIN AND VAGINAL ODOUR TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ENDOMETRIOSIS OR PYREXIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALANINE AMINOTRANSFERASE ( 17- 31 U/L)] ON (B)(6) 2021: 8 U/L [ASPARTATE AMINOTRANSFERASE ( 15- 32 U/L)] ON (B)(6) 2021: 13 U/L [BIOPSY FALLOPIAN TUBE] (DATE UNKNOWN): CHRONIC INFLAMMATORY PROCESS [BIOPSY UTERUS] (DATE UNKNOWN): CHRONIC INFLAMMATORY PROCESS [BLOOD GLUCOSE ( 74- 99 MG/DL)] ON (B)(6) 2022: 101 MG/DL [HAEMOGLOBIN (< 5.7 %)] ON (B)(6) 2022: 5.9 [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2022: THICKENING OF THE UTEROSACRAL LIGAMENTS AND UTERINE TORUS WITH IMPINGEMENT ON THE ANTERIOR WALL OF THE RECTUM, WITHOUT SIGNS OF INVASION, AS WELL AS SLIGHT PINCHING BETWEEN THE SEROSA OF THE POSTERIOR FUNDIC REGION OF THE UTERUS AND THE SIGMOID (FINDINGS MAY BE RELATED TO ENDOMETRIOSIS); LEFT ESSURE DEVICE CLOSE TO THE DORSAL ASPECT OF THE UTERUS, INDICATING POSSIBLE MALPOSITION. [PATHOLOGY TEST] ON (B)(6) 2022: TWO INTACT ESSURE DEVICES IN TUBES AND CORNUAL PORTION OF THE UTERUS [SMEAR CERVIX] ON (B)(6) 2022: NEGATIVE FOR INTRAEPITHELIAL LESION AND FOR MALIGNANCY. [ULTRASOUND ABDOMEN] ON (B)(6) 2021: LYMPH NODES IN THE INGUINAL REGIONS PROBABLY REACTIONAL. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2019: ESSURE VISUALIZED IN UTERINE HORNS WELL PLACED.; IN (B)(6) 2021: ESSURE WELL POSITIONED; ON (B)(6) 2021: UTERUS AND OVARIES WITHOUT ALTERATIONS. HYPERECHOIC TUBULAR IMAGE IN THE CORNUAL REGION, PROXIMAL TUBE, BILATERAL, SUGGESTIVE OF ESSURE. [URINE ANALYSIS] ON (B)(6) 2022: NO BACTERIAL GROWTH [X-RAY OF PELVIS AND HIP] ON (B)(6) 2021: IMAGE OF TWO INTRATUBAL MICRODEVICES FOR CONTRACEPTION PROJECTED INTO THE PELVIC CAVITY. LOT NUMBER: 863580, MANUFACTURE DATE: 2011-05 AND EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 02-SEP-2022: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CHRONIC PAIN IN THE PELVIC REGION") AND UTERINE PERFORATION ("SENSATION OF PERFORATION IN THE UTERUS") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO: 863580) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF DIABETES MELLITUS, UMBILICAL HERNIA REPAIR, HEMORRHOID OPERATION, CAESAREAN SECTION (2) AND GRAVIDA II (2). DENIES DRUG ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CEFTRIAXONE FOR PYELONEPHRITIS AND ORAL CONTRACEPTIVE NOS, CONTRACEPTIVES AND METFORMIN. CONCURRENT CONDITIONS WERE LISTED AS TYPE I DIABETES MELLITUS AND HYPERTENSION. CONCOMITANT PRODUCTS INCLUDED CLOR METFORMINA (METFORMIN HYDROCHLORIDE) FOR TYPE 2 DIABETES MELLITUS, HCTZ (HYDROCHLOROTHIAZIDE) FOR HYPERTENSION AND ENALAPRIL FOR HYPERTENSION. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE DAY OF ESSURE INSERTION, SHE EXPERIENCED A FIRST EPISODE OF PROCEDURAL PAIN ("ACUTE AND INTENSE PAIN"). ON (B)(6) 2017 SHE EXPERIENCED ABDOMINAL PAIN LOWER ("HYPOGASTRIC PAIN") AND PYREXIA ("FEVER"). ON (B)(6) 2017, SHE EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2022, SHE EXPERIENCED DEVICE EXPULSION ("SUSPICION OF ESSURE DISLOCATION/ LEFT ESSURE DEVICE CLOSE TO THE DORSAL ASPECT OF THE UTERUS, INDICATING POSSIBLE MALPOSITION/CORNUAL PORTION OF THE UTERUS"). ON (B)(6) 2022, SHE EXPERIENCED ENDOMETRIOSIS ("DEEP ENDOMETRIOSIS"). AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING ("SHE STARTED TO HAVE MORE THAN 20 DAYS OF HEAVY VAGINAL BLEEDING / MENSTRUAL FLOW INCREASE"), DYSPAREUNIA ("DYSPAREUNIA /PAIN DURING AND AFTER INTERCOURSE"), DYSMENORRHOEA ("HEAVY CRAMPS"), INFLAMMATION ("ABDOMINAL INFLAMMATION THAT SOMETIMES PREVENTED THE PATIENT FROM WALKING"), HEADACHE ("SEVERE HEADACHE"), PAIN IN EXTREMITY ("LEG PAIN"), FATIGUE ("FATIGUE"), PRURITUS ALLERGIC ("ITCHY ALLERGIES ALL OVER THE BODY"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER INTERCOURSE"), URINARY TRACT INFECTION ("FREQUENT URINARY INFECTIONS"), PERIPHERAL SWELLING ("LEG SWELLING"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LUMBAR PAIN"), UTERINE PAIN ("SENSATION OF UTERINE PERFORATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("CONSTANT MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), VAGINAL ODOUR ("STRONG ODOR FROM VAGINAL FLUID"), A SECOND EPISODE OF PROCEDURAL PAIN ("POST PROCEDURAL PAIN (AFTER ESSURE REMOVAL)"), ABDOMINAL PAIN ("AFTER IMPLANTATION, THE PLAINTIFF BEGAN TO SUFFER STRONG AND CHRONIC PAIN IN THE BELLY"), UMBILICAL HERNIA ("UMBILICAL HERNIA"), NEPHROLITHIASIS ("NEPHROLITHIASIS"), SALPINGITIS ("CHRONIC SALPINGITIS") AND CHILLS ("CHILLS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND TOTAL SALPINGECTOMY AND HYSTEROTOMY & BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE PERFORATION, DEVICE EXPULSION, ENDOMETRIOSIS, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, INFLAMMATION, HEADACHE, PAIN IN EXTREMITY, FATIGUE, PRURITUS ALLERGIC, LOSS OF LIBIDO, COITAL BLEEDING, URINARY TRACT INFECTION, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, UTERINE PAIN, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, VAGINAL ODOUR, DYSURIA, ABDOMINAL PAIN LOWER, PYREXIA, UMBILICAL HERNIA, NEPHROLITHIASIS, SALPINGITIS AND CHILLS WERE RESOLVING AND THE DYSPAREUNIA HAD RESOLVED. THE OUTCOME OF ABDOMINAL PAIN WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, BACK PAIN, CHILLS, COITAL BLEEDING, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INFLAMMATION, LOSS OF LIBIDO, MOOD SWINGS, NEPHROLITHIASIS, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, THE FIRST EPISODE OF PROCEDURAL PAIN, THE SECOND EPISODE OF PROCEDURAL PAIN, PRURITUS ALLERGIC, SALPINGITIS, TREMOR, UMBILICAL HERNIA, URINARY TRACT INFECTION, UTERINE PAIN, UTERINE PERFORATION AND VAGINAL ODOUR TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ENDOMETRIOSIS OR PYREXIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALANINE AMINOTRANSFERASE ( 17- 31 U/L)] ON (B)(6) 2021: 8 U/L [ASPARTATE AMINOTRANSFERASE ( 15- 32 U/L)] ON (B)(6) 2021: 13 U/L [BIOPSY FALLOPIAN TUBE] (DATE UNKNOWN): CHRONIC INFLAMMATORY PROCESS [BIOPSY UTERUS] (DATE UNKNOWN): THE INFLAMMATORY PROCESS TRIGGERED BY THE ESSURE DEVICE IN HER BODY WAS CHRONIC, WORSENING OVER TIME AND TRIGGERING DIFFERENT IMMUNOLOGICAL RESPONSES IN HER BODY, WHICH, IN TURN, ARE MANIFESTED IN THE VARIOUS PAINFUL ADVERSE REACTIONS THAT SHE HAS EXPERIENCED IN RECENT YEARS. [BLOOD GLUCOSE ( 74- 99 MG/DL)] ON (B)(6) 2022: 101 MG/DL [COMPUTERISED TOMOGRAM] ON (B)(6) 2017: LIVER IN SHAPE, CONTOURS PRESERVED, SHOWING DIFFUSE ATTENUATION INDICATING STEATOSIS. ABSENCE OF FREE FLUID OR ABDOMINAL COLLECTIONS. IN THE RIGHT ADNEXAL REGION, AN EXPANSIVE FORMATION WITH A HYPOATTENUATING CORTICAL APPEARANCE AND THICK WALLS, MEASURING 38 X 38 MM, IS OBSERVED, WITH PROBABLE OVARIAN ORIGIN. [HAEMOGLOBIN (< 5.7 %)] ON (B)(6) 2022: 5.9. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2022: THICKENING OF THE UTEROSACRAL LIGAMENTS AND UTERINE TORUS WITH IMPINGEMENT ON THE ANTERIOR WALL OF THE RECTUM, WITHOUT SIGNS OF INVASION, AS WELL AS SLIGHT PINCHING BETWEEN THE SEROSA OF THE POSTERIOR FUNDIC REGION OF THE UTERUS AND THE SIGMOID (FINDINGS MAY BE RELATED TO ENDOMETRIOSIS); LEFT ESSURE DEVICE CLOSE TO THE DORSAL ASPECT OF THE UTERUS, INDICATING POSSIBLE MALPOSITION. [PATHOLOGY TEST] ON (B)(6) 2022: TWO INTACT ESSURE DEVICES IN TUBES AND CORNUAL PORTION OF THE UTERUS. [SMEAR CERVIX] ON (B)(6) 2022: NEGATIVE FOR INTRAEPITHELIAL LESION AND FOR MALIGNANCY. [ULTRASOUND ABDOMEN] ON (B)(6) 2021: LYMPH NODES IN THE INGUINAL REGIONS PROBABLY REACTIONAL. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2019: ESSURE VISUALIZED IN UTERINE HORNS WELL PLACED; ON (B)(6) 2021: ESSURE WELL POSITIONED; ON (B)(6) 2021: UTERUS AND OVARIES WITHOUT ALTERATIONS. HYPERECHOIC TUBULAR IMAGE IN THE CORNUAL REGION, PROXIMAL TUBE, BILATERAL, SUGGESTIVE OF ESSURE. AND UTERUS AND OVARIES UNCHANGED. WE OBSERVED A HYPERECHOIC TUBULAR IMAGE IN THE CORNUAL REGION, PROXIMAL TUBE, BILATERAL, SUGGESTIVE OF ESSURE. [URINE ANALYSIS] ON (B)(6) 2022: NO BACTERIAL GROWTH [X-RAY OF PELVIS AND HIP] ON (B)(6) 2021: IMAGE OF TWO INTRATUBAL MICRODEVICES FOR CONTRACEPTION PROJECTED INTO THE PELVIC CAVITY. LOT NUMBER: 863580, MANUFACTURE DATE: 2011-05, EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 21-NOV-2023: NEW EVENTS ABDOMINAL PAIN, UTERINE PERFORATION, UMBILICAL HERNIA, NEPHROLITHIASIS, CHILLS, SALPINGITIS ADDED. LAB DATA, MEDICAL HISTORY, ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("SENSATION OF PERFORATION IN THE UTERUS") AND PELVIC PAIN ("SEVERE AND CHRONIC PAIN IN THE PELVIC REGION") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 863580) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF DIABETES MELLITUS, UMBILICAL HERNIA REPAIR, HEMORRHOID OPERATION, CAESAREAN SECTION (2) AND GRAVIDA II (2). DENIES DRUG ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CEFTRIAXONE FOR PYELONEPHRITIS AND ORAL CONTRACEPTIVE NOS, CONTRACEPTIVES AND METFORMIN. CONCURRENT CONDITIONS WERE LISTED AS TYPE I DIABETES MELLITUS AND HYPERTENSION. CONCOMITANT PRODUCTS INCLUDED CLOR METFORMINA (METFORMIN HYDROCHLORIDE) FOR TYPE 2 DIABETES MELLITUS, HCTZ (HYDROCHLOROTHIAZIDE) FOR HYPERTENSION AND ENALAPRIL FOR HYPERTENSION. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE DAY OF ESSURE INSERTION, SHE EXPERIENCED A FIRST EPISODE OF PROCEDURAL PAIN ("ACUTE AND INTENSE PAIN"). ON (B)(6) 2017 SHE EXPERIENCED ABDOMINAL PAIN LOWER ("HYPOGASTRIC PAIN") AND PYREXIA ("FEVER"). ON (B)(6) 2017 SHE EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2022 SHE EXPERIENCED DEVICE EXPULSION ("SUSPICION OF ESSURE DISLOCATION/ LEFT ESSURE DEVICE CLOSE TO THE DORSAL ASPECT OF THE UTERUS, INDICATING POSSIBLE MALPOSITION/CORNUAL PORTION OF THE UTERUS"). ON (B)(6) 2022 SHE EXPERIENCED ENDOMETRIOSIS ("DEEP ENDOMETRIOSIS"). ON UNKNOWN DATE SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING ("SHE STARTED TO HAVE MORE THAN 20 DAYS OF HEAVY VAGINAL BLEEDING / MENSTRUAL FLOW INCREASE"), DYSPAREUNIA ("DYSPAREUNIA /PAIN DURING AND AFTER INTERCOURSE"), DYSMENORRHOEA ("HEAVY CRAMPS"), INFLAMMATION ("ABDOMINAL INFLAMMATION THAT SOMETIMES PREVENTED THE PATIENT FROM WALKING"), HEADACHE ("SEVERE HEADACHE"), PAIN IN EXTREMITY ("LEG PAIN"), FATIGUE ("FATIGUE"), PRURITUS ALLERGIC ("ITCHY ALLERGIES ALL OVER THE BODY"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER INTERCOURSE"), URINARY TRACT INFECTION ("FREQUENT URINARY INFECTIONS"), PERIPHERAL SWELLING ("LEG SWELLING"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LUMBAR PAIN"), UTERINE PAIN ("SENSATION OF UTERINE PERFORATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("CONSTANT MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), VAGINAL ODOUR ("STRONG ODOR FROM VAGINAL FLUID"), A SECOND EPISODE OF PROCEDURAL PAIN ("POST PROCEDURAL PAIN (AFTER ESSURE REMOVAL)"), ABDOMINAL PAIN ("AFTER IMPLANTATION, THE PLAINTIFF BEGAN TO SUFFER STRONG AND CHRONIC PAIN IN THE BELLY"), UMBILICAL HERNIA ("UMBILICAL HERNIA"), NEPHROLITHIASIS ("NEPHROLITHIASIS"), SALPINGITIS ("CHRONIC SALPINGITIS") AND CHILLS ("CHILLS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY & BILATERAL SALPINGECTOMY AND HISTERECTOMY AND TOTAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PELVIC PAIN, DEVICE EXPULSION, ENDOMETRIOSIS, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, INFLAMMATION, HEADACHE, PAIN IN EXTREMITY, FATIGUE, PRURITUS ALLERGIC, LOSS OF LIBIDO, COITAL BLEEDING, URINARY TRACT INFECTION, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, UTERINE PAIN, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, VAGINAL ODOUR, DYSURIA, ABDOMINAL PAIN LOWER, PYREXIA, UMBILICAL HERNIA, NEPHROLITHIASIS, SALPINGITIS AND CHILLS WERE RESOLVING AND THE DYSPAREUNIA HAD RESOLVED. THE OUTCOME OF ABDOMINAL PAIN WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, BACK PAIN, CHILLS, COITAL BLEEDING, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INFLAMMATION, LOSS OF LIBIDO, MOOD SWINGS, NEPHROLITHIASIS, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, THE FIRST EPISODE OF PROCEDURAL PAIN, THE SECOND EPISODE OF PROCEDURAL PAIN, PRURITUS ALLERGIC, SALPINGITIS, TREMOR, UMBILICAL HERNIA, URINARY TRACT INFECTION, UTERINE PAIN, UTERINE PERFORATION AND VAGINAL ODOUR TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ENDOMETRIOSIS OR PYREXIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALANINE AMINOTRANSFERASE ( 17- 31 U/L)] ON (B)(6) 2021: 8 U/L [ASPARTATE AMINOTRANSFERASE ( 15- 32 U/L)] ON (B)(6) 2021: 13 U/L [BIOPSY FALLOPIAN TUBE] (DATE UNKNOWN): CHRONIC INFLAMMATORY PROCESS [BIOPSY UTERUS] (DATE UNKNOWN): THE INFLAMMATORY PROCESS TRIGGERED BY THE ESSURE DEVICE IN HER BODY WAS CHRONIC, WORSENING OVER TIME AND TRIGGERING DIFFERENT IMMUNOLOGICAL RESPONSES IN HER BODY, WHICH, IN TURN, ARE MANIFESTED IN THE VARIOUS PAINFUL ADVERSE REACTIONS THAT SHE HAS EXPERIENCED IN RECENT YEARS. [BLOOD GLUCOSE ( 74- 99 MG/DL)] ON (B)(6) 2022: 101 MG/DL [COMPUTERISED TOMOGRAM] ON (B)(6) 2017: LIVER IN SHAPE, CONTOURS PRESERVED, SHOWING DIFFUSE ATTENUATION INDICATING STEATOSIS. ABSENCE OF FREE FLUID OR ABDOMINAL COLLECTIONS. IN THE RIGHT ADNEXAL REGION, AN EXPANSIVE FORMATION WITH A HYPOATTENUATING CORTICAL APPEARANCE AND THICK WALLS, MEASURING 38 X 38 MM, IS OBSERVED, WITH PROBABLE OVARIAN ORIGIN. [HAEMOGLOBIN (< 5.7 %)] ON (B)(6) 2022: 5.9 [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2022: THICKENING OF THE UTEROSACRAL LIGAMENTS AND UTERINE TORUS WITH IMPINGEMENT ON THE ANTERIOR WALL OF THE RECTUM, WITHOUT SIGNS OF INVASION, AS WELL AS SLIGHT PINCHING BETWEEN THE SEROSA OF THE POSTERIOR FUNDIC REGION OF THE UTERUS AND THE SIGMOID (FINDINGS MAY BE RELATED TO ENDOMETRIOSIS); LEFT ESSURE DEVICE CLOSE TO THE DORSAL ASPECT OF THE UTERUS, INDICATING POSSIBLE MALPOSITION. [PATHOLOGY TEST] ON (B)(6) 2022: TWO INTACT ESSURE DEVICES IN TUBES AND CORNUAL PORTION OF THE UTERUS [SMEAR CERVIX] ON (B)(6) 2022: NEGATIVE FOR INTRAEPITHELIAL LESION AND FOR MALIGNANCY. [ULTRASOUND ABDOMEN] ON (B)(6) 2021: LYMPH NODES IN THE INGUINAL REGIONS PROBABLY REACTIONAL. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2019: ESSURE VISUALIZED IN UTERINE HORNS WELL PLACED.; IN (B)(6) 2021: ESSURE WELL POSITIONED; ON (B)(6) 2021: UTERUS AND OVARIES WITHOUT ALTERATIONS. HYPERECHOIC TUBULAR IMAGE IN THE CORNUAL REGION, PROXIMAL TUBE, BILATERAL, SUGGESTIVE OF ESSURE. AND UTERUS AND OVARIES UNCHANGED. WE OBSERVED A HYPERECHOIC TUBULAR IMAGE IN THE CORNUAL REGION, PROXIMAL TUBE, BILATERAL, SUGGESTIVE OF ESSURE. [URINE ANALYSIS] ON (B)(6) 2022: NO BACTERIAL GROWTH [X-RAY OF PELVIS AND HIP] ON (B)(6) 2021: IMAGE OF TWO INTRATUBAL MICRODEVICES FOR CONTRACEPTION PROJECTED INTO THE PELVIC CAVITY. LOT NUMBER: 863580, MANUFACTURE DATE: 2011-05, AND EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 09-FEB-2024: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND CHRONIC PAIN IN THE PELVIC REGION") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 863580) FOR FEMALE STERILIZATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF HERNIA REPAIR, HEMORRHOID OPERATION, CAESAREAN SECTION (2) AND PREGNANCY (2). DENIES DRUG ALLERGY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CEFTRIAXONE FOR PYELONEPHRITIS AND ORAL CONTRACEPTIVE NOS AND CONTRACEPTIVES. CONCURRENT CONDITIONS WERE LISTED AS TYPE I DIABETES MELLITUS AND HYPERTENSION. CONCOMITANT PRODUCTS INCLUDED CLOR METFORMIN (METFORMIN HYDROCHLORIDE) FOR TYPE 2 DIABETES MELLITUS, HCTZ (HYDROCHLOROTHIAZIDE) FOR HYPERTENSION AND ENALAPRIL FOR HYPERTENSION. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE DAY OF ESSURE INSERTION, SHE EXPERIENCED A FIRST EPISODE OF PROCEDURAL PAIN ("ACUTE AND INTENSE PAIN"). ON (B)(6) 2017 SHE EXPERIENCED ABDOMINAL PAIN LOWER ("HYPOGASTRIC PAIN") AND PYREXIA ("FEVER"). ON (B)(6) 2017 SHE EXPERIENCED DYSURIA ("DYSURIA"). ON (B)(6) 2022 SHE EXPERIENCED DEVICE EXPULSION ("SUSPICION OF ESSURE DISLOCATION/ LEFT ESSURE DEVICE CLOSE TO THE DORSAL ASPECT OF THE UTERUS, INDICATING POSSIBLE MALPOSITION/CORNUAL PORTION OF THE UTERUS"). ON (B)(6) 2022 SHE EXPERIENCED ENDOMETRIOSIS ("DEEP ENDOMETRIOSIS"). AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING ("SHE STARTED TO HAVE MORE THAN 20 DAYS OF HEAVY VAGINAL BLEEDING /MENSTRUAL FLOW INCREASE"), DYSPAREUNIA ("DYSPAREUNIA /PAIN DURING AND AFTER INTERCOURSE"), DYSMENORRHOEA ("HEAVY CRAMPS"), INFLAMMATION ("ABDOMINAL INFLAMMATION THAT SOMETIMES PREVENTED THE PATIENT FROM WALKING"), HEADACHE ("SEVERE HEADACHE"), PAIN IN EXTREMITY ("LEG PAIN"), FATIGUE ("FATIGUE"), PRURITUS ("ITCHY ALLERGIES ALL OVER THE BODY"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER INTERCOURSE"), URINARY TRACT INFECTION ("FREQUENT URINARY INFECTIONS"), PERIPHERAL SWELLING ("LEG SWELLING"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LUMBAR PAIN"), UTERINE PAIN ("SENSATION OF UTERINE PERFORATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("CONSTANT MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), VAGINAL ODOUR ("STRONG ODOR FROM VAGINAL FLUID") AND A SECOND EPISODE OF PROCEDURAL PAIN ("POST PROCEDURAL PAIN (AFTER ESSURE REMOVAL)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND TOTAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE EXPULSION, ENDOMETRIOSIS, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, INFLAMMATION, HEADACHE, PAIN IN EXTREMITY, FATIGUE, PRURITUS, LOSS OF LIBIDO, COITAL BLEEDING, URINARY TRACT INFECTION, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, UTERINE PAIN, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, VAGINAL ODOUR, DYSURIA, ABDOMINAL PAIN LOWER AND PYREXIA WERE RESOLVING AND THE DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, ARTHRALGIA, BACK PAIN, COITAL BLEEDING, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INFLAMMATION, LOSS OF LIBIDO, MOOD SWINGS, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, THE FIRST EPISODE OF PROCEDURAL PAIN, THE SECOND EPISODE OF PROCEDURAL PAIN, PRURITUS, TREMOR, URINARY TRACT INFECTION, UTERINE PAIN AND VAGINAL ODOUR TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ENDOMETRIOSIS OR PYREXIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALANINE AMINOTRANSFERASE (17- 31 U/L)] ON (B)(6) 2021: 8 U/L. [ASPARTATE AMINOTRANSFERASE (15- 32 U/L)] ON (B)(6) 2021: 13 U/L. [BIOPSY FALLOPIAN TUBE] (DATE UNKNOWN): CHRONIC INFLAMMATORY PROCESS. [BIOPSY UTERUS] (DATE UNKNOWN): CHRONIC INFLAMMATORY PROCESS. [BLOOD GLUCOSE (74- 99 MG/DL)] ON (B)(6) 2022: 101 MG/DL. [HAEMOGLOBIN (< 5.7 %)] ON (B)(6) 2022: 5.9. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2022: THICKENING OF THE UTEROSACRAL LIGAMENTS AND UTERINE TORUS WITH IMPINGEMENT ON THE ANTERIOR WALL OF THE RECTUM, WITHOUT SIGNS OF INVASION, AS WELL AS SLIGHT PINCHING BETWEEN THE SEROSA OF THE POSTERIOR FUNDIC REGION OF THE UTERUS AND THE SIGMOID (FINDINGS MAY BE RELATED TO ENDOMETRIOSIS); LEFT ESSURE DEVICE CLOSE TO THE DORSAL ASPECT OF THE UTERUS, INDICATING POSSIBLE MALPOSITION. [PATHOLOGY TEST] ON (B)(6) 2022: TWO INTACT ESSURE DEVICES IN TUBES AND CORNUAL PORTION OF THE UTERUS. [SMEAR CERVIX] ON (B)(6) 2022: NEGATIVE FOR INTRAEPITHELIAL LESION AND FOR MALIGNANCY. [ULTRASOUND ABDOMEN] ON (B)(6) 2021: LYMPH NODES IN THE INGUINAL REGIONS PROBABLY REACTIONAL. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2019: ESSURE VISUALIZED IN UTERINE HORNS WELL PLACED; IN (B)(6) 2021: ESSURE WELL POSITIONED; ON (B)(6) 2021: UTERUS AND OVARIES WITHOUT ALTERATIONS. HYPERECHOIC TUBULAR IMAGE IN THE CORNUAL REGION, PROXIMAL TUBE, BILATERAL, SUGGESTIVE OF ESSURE. [URINE ANALYSIS] ON (B)(6) 2022: NO BACTERIAL GROWTH. [X-RAY OF PELVIS AND HIP] ON (B)(6) 2021: IMAGE OF TWO INTRATUBAL MICRODEVICES FOR CONTRACEPTION PROJECTED INTO THE PELVIC CAVITY. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2089383 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863580 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | Required Intervention | CLOR METFORMINA| CLOR METFORMINA| CLOR METFORMINA| CLOR METFORMINA| ENALAPRIL| ENALAPRIL| ENALAPRIL| ENALAPRIL| HCTZ| HCTZ| HCTZ| HCTZ |