ESSURE
Report
- Report Number
- 2951250-2019-11493
- Event Type
- Injury
- Date Received
- November 14, 2019
- Date of Event
- January 1, 2013
- Report Date
- January 30, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('HEAVY AND PAINFUL BLEEDING') AND DYSMENORRHOEA ('HEAVY AND PAINFUL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785 / 925782) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ABLATION IN 2014 / HYSTERECTOMY IN (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA AND MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON (B)(6) 2012 AND (B)(6) 2012. THE EVENTS STARTED APPROXIMATELY 12 MONTHS AFTER INSERTION. AN ABLATION PROCEDURE WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. LOT NUMBER:925782. MANUFACTURE DATE: 2011-11. EXPIRATION DATE: 2014-11. LOT NUMBER:925785. MANUFACTURE DATE: 2011-11. EXPIRATION DATE: 2014-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: 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.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY REFERENCE NUMBER: (B)(4) ON 12-NOV-2019. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-DEC-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") AND DYSMENORRHOEA ("HEAVY AND PAINFUL BLEEDING") IN A 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925785 / 925782) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 3, MULTI GRAVIDA, SKIN WARM, ILLNESS, ABDOMINAL PAIN AGGRAVATED, STRESS INCONTINENCE (A PRESENTING CONDITION OF STRESS INCONTINENCE. THE FLUID DIARY SHOWED AN INPUT OF 2.4 LITERS AT FREQUENCY OF FOUR TO SEVEN TIMES WITH FOUR TO EIGHT EPISODES OF INCONTINENCE CHARTED DAILY. THERE IS NO NOCTURIA HOWEVER THE PATIENT DOES REPORT LEAKING WHILST ASLEEP IF SHE HAS BEEN COUGHING A LOT AT NIGHT. THE MAXIMUM FUNCTIONAL CAPACITY WAS 670 ML. PATIENT CURRENTLY DRINKS THREE TO FOUR TEAS EACH DAY. IN CONCLUSION THIS LADY HAS A STABLE BLADDER WITH URODYNAMICALLY PROVEN STRESS INCONTINENCE), HEADACHE, ADENOMYOSIS, BULKY UTERUS, VAGINAL BLEEDING, PARITY 3, VAGINAL CANDIDIASIS AND LOW BACK PAIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013 SHE EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) AND UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). AT AN UNKNOWN TIME, SHE EXPERIENCED PELVIC PAIN ("LOCALISED PAIN"), MENTAL DISORDER ("PSYCHOLOGICAL/PSYCHIATRIC PROBLEMS"), HAEMORRHAGIC DISORDER ("ABNORMAL BLEEDING") AND DYSPAREUNIA ("DYSPAREUNIA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND ). AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL AND MENTAL DISORDER HAD NOT RESOLVED. THE OUTCOMES FOR MEDICAL DEVICE REMOVAL, DYSMENORRHOEA AND HAEMORRHAGIC DISORDER WERE UNKNOWN. ESSURE WAS REMOVED ON (B)(6) 2019. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, HAEMORRHAGIC DISORDER, HORMONE LEVEL ABNORMAL, MEDICAL DEVICE REMOVAL, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON (B)(6) 2012. THE EVENTS STARTED APPROXIMATELY 12 MONTHS AFTER INSERTION. AN ABLATION PROCEDURE WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. NO DEVICE MIGRATION. THERE WERE CONTINUING SYMPTOMS (UNSPECIFIED WHICH) AFTER THE HYSTERECTOMY WITH ESSURE REMOVAL. DISCREPANCY NOTED AS ESSURE REMOVAL DATE (B)(6) 2018. ON HYSTEROSCOPY THE RIGHT TUBE WAS SEEN AND MICROINSERTS WAS PLACED UNDER DIRECT VISUALIZATION. THE MICROINSERTS WAS INSERTED DEEP AND TREAD COIL COULD NOT NO SEEN. OTHER SIDE LOOKED AND BLOCKED AND TUBE OPENING COULD NOT SEE. SHE FOUND PROCEDURE VERY PAINFUL. ENDOSCOPIC BILATERAL CLIPPING OF FALLOPIAN TUBES ¿ HYSTEROSCOPIC ESSURE STERILIZATION GA (LEFT SIDE). INDICATION PERMANENT STERILIZATION. BOTH OSTIA SEEN. EASY INSERTION (3-4 COILS SEEN). TO USE ALTERNATIVE CONTRACEPTION UNTIL 3- MONTH, CHECK-UP. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ULTRASOUND SCAN VAGINA] ON (B)(6) 2017: THE UTERUS IS ANTEVERTED AND MEASURES 92 X 45 X 57MM. IT IS NORMAL IN SHAPE AND ECHOGENICITY. THE ENDOMETRIUM IS INDISTINCT IN KEEPING WITH AN ABLATION. WHERE VISIBLE THE ENDOMETRIUM IS NOT THICKENED WITH AN ET OF 2 MM. THE LEFT OVARY WAS ONLY POORLY VISUALIZED DUE TO HEAVILY LOADED BOWEL AND MEASURES 22 X 14 X 16MM AND APPEARS NORMAL. THE RIGHT OVARY MEASURES 40 X 28 28MM AND APPEARS NORMAL. THERE WERE NO MASSES OR FREE FLUID IN THE PELVIS. UNABLE TO ASSESS POSITION OF ESSURE CLIPS AS NO ACCESS TO 3D PROBE AT BHC IMPRESSION: NO OBVIOUS CAUSE FOR PAIN SEEN. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: GENITAL HAEMORRHAGE, DYSPAREUNIA, MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 01-DEC-2023: MEDICAL RECORD RECEIVED. REPORTERS INFORMATION ADDED. PATIENT MEDICAL HISTORY AND LAB DATA ADDED. NON DRUG TREATMENT UPDATED. EVENTS GENITAL HAEMORRHAGE, DYSPAREUNIA, MEDICAL DEVICE REMOVAL ADDED. THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY REFERENCE NUMBER: (B)(4) ON 12-NOV-2019. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-DEC-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") AND DYSMENORRHOEA ("HEAVY AND PAINFUL BLEEDING") IN A 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925785 / 925782) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 3, MULTI GRAVIDA, SKIN WARM, ILLNESS, ABDOMINAL PAIN AGGRAVATED, STRESS INCONTINENCE (A PRESENTING CONDITION OF STRESS INCONTINENCE. THE FLUID DIARY SHOWED AN INPUT OF 2.4 LITERS AT FREQUENCY OF FOUR TO SEVEN TIMES WITH FOUR TO EIGHT EPISODES OF INCONTINENCE CHARTED DAILY. THERE IS NO NOCTURIA HOWEVER THE PATIENT DOES REPORT LEAKING WHILST ASLEEP IF SHE HAS BEEN COUGHING A LOT AT NIGHT. THE MAXIMUM FUNCTIONAL CAPACITY WAS 670 ML. PATIENT CURRENTLY DRINKS THREE TO FOUR TEAS EACH DAY. IN CONCLUSION THIS LADY HAS A STABLE BLADDER WITH URODYNAMICALLY PROVEN STRESS INCONTINENCE), HEADACHE, ADENOMYOSIS, BULKY UTERUS, VAGINAL BLEEDING, PARITY 3, VAGINAL CANDIDIASIS AND LOW BACK PAIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013 SHE EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) AND UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN ("LOCALISED PAIN"), MENTAL DISORDER ("PSYCHOLOGICAL/PSYCHIATRIC PROBLEMS"), HAEMORRHAGIC DISORDER ("ABNORMAL BLEEDING") AND DYSPAREUNIA ("DYSPAREUNIA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND ). AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL AND MENTAL DISORDER HAD NOT RESOLVED. THE OUTCOMES FOR MEDICAL DEVICE REMOVAL, DYSMENORRHOEA AND HAEMORRHAGIC DISORDER WERE UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, HAEMORRHAGIC DISORDER, HORMONE LEVEL ABNORMAL, MEDICAL DEVICE REMOVAL, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON (B)(6) 2012. THE EVENTS STARTED APPROXIMATELY 12 MONTHS AFTER INSERTION. AN ABLATION PROCEDURE WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. NO DEVICE MIGRATION. THERE WERE CONTINUING SYMPTOMS (UNSPECIFIED WHICH) AFTER THE HYSTERECTOMY WITH ESSURE REMOVAL. DISCREPANCY NOTED AS ESSURE REMOVAL DATE (B)(6) 2018. ON HYSTEROSCOPY THE RIGHT TUBE WAS SEEN AND MICROINSERTS WAS PLACED UNDER DIRECT VISUALIZATION. THE MICROINSERTS WAS INSERTED DEEP AND TREAD COIL COULD NOT NO SEEN. OTHER SIDE LOOKED AND BLOCKED AND TUBE OPENING COULD NOT SEE. SHE FOUND PROCEDURE VERY PAINFUL. ENDOSCOPIC BILATERAL CLIPPING OF FALLOPIAN TUBES ¿ HYSTEROSCOPIC ESSURE STERILIZATION GA (LEFT SIDE). INDICATION PERMANENT STERILIZATION. BOTH OSTIA SEEN. EASY INSERTION (3-4 COILS SEEN). TO USE ALTERNATIVE CONTRACEPTION UNTIL 3- MONTH, CHECK-UP. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ULTRASOUND SCAN VAGINA] ON (B)(6) 2017: THE UTERUS IS ANTEVERTED AND MEASURES 92 X 45 X 57MM. IT IS NORMAL IN SHAPE AND ECHOGENICITY. THE ENDOMETRIUM IS INDISTINCT IN KEEPING WITH AN ABLATION. WHERE VISIBLE THE ENDOMETRIUM IS NOT THICKENED WITH AN ET OF 2 MM. THE LEFT OVARY WAS ONLY POORLY VISUALIZED DUE TO HEAVILY LOADED BOWEL AND MEASURES 22 X 14 X 16MM AND APPEARS NORMAL. THE RIGHT OVARY MEASURES 40 X 28 28MM AND APPEARS NORMAL. THERE WERE NO MASSES OR FREE FLUID IN THE PELVIS. UNABLE TO ASSESS POSITION OF ESSURE CLIPS AS NO ACCESS TO 3D PROBE AT BHC IMPRESSION: NO OBVIOUS CAUSE FOR PAIN SEEN. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: GENITAL HAEMORRHAGE, DYSPAREUNIA, MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 01-DEC-2023: MEDICAL RECORD RECEIVED. REPORTERS INFORMATION ADDED. PATIENT MEDICAL HISTORY AND LAB DATA ADDED. NON DRUG TREATMENT UPDATED. EVENTS GENITAL HAEMORRHAGE, DYSPAREUNIA, MEDICAL DEVICE REMOVAL ADDED. 01-DEC-2023: PRIMARY REPORTER ADDRESS UPDATED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('HEAVY AND PAINFUL BLEEDING, ABNORMAL') AND DYSMENORRHOEA ('HEAVY AND PAINFUL BLEEDING') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785 / 925782) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("LOCALISED PAIN") AND MENTAL DISORDER ("PSYCHOLOGICAL/PSYCHIATRIC PROBLEMS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION IN 2014 / HYSTERECTOMY IN (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, HORMONE LEVEL ABNORMAL AND MENTAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON (B)(6) 2012 AND (B)(6) 2012. THE EVENTS STARTED APPROXIMATELY 12 MONTHS AFTER INSERTION. AN ABLATION PROCEDURE WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. NO DEVICE MIGRATION. THERE WERE CONTINUING SYMPTOMS (UNSPECIFIED WHICH) AFTER THE HYSTERECTOMY WITH ESSURE REMOVAL. LOT NUMBER:925782 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11. LOT NUMBER:925785 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-MAR-2021: LAWYER REPORTED NEW EVENTS: HORMONAL PROBLEMS, LOCALISED PAIN, PSYCHOLOGICAL/PSYCHIATRIC PROBLEMS. NO DEVICE MIGRATION. THERE WERE CONTINUING SYMPTOMS (UNSPECIFIED WHICH) AFTER THE HYSTERECTOMY WITH ESSURE REMOVAL. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('HEAVY AND PAINFUL BLEEDING') AND DYSMENORRHOEA ('HEAVY AND PAINFUL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785 / 925782) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ABLATION IN 2014 / HYSTERECTOMY IN (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA AND MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON (B)(6) 2012. THE EVENTS STARTED APPROXIMATELY 12 MONTHS AFTER INSERTION. AN ABLATION PROCEDURE WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: ESSURE LOT NUMBER 925785 / 925782 WAS INSERTED ON (B)(6) 2012. 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.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY (REFERENCE NUMBER: (B)(4)) ON 12-NOV-2019. THE MOST RECENT INFORMATION WAS RECEIVED ON 30-JAN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") AND DYSMENORRHOEA ("HEAVY AND PAINFUL BLEEDING") IN A 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925782, 925785) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 3, MULTI GRAVIDA, SKIN WARM, ILLNESS, ABDOMINAL PAIN AGGRAVATED, STRESS INCONTINENCE (A PRESENTING CONDITION OF STRESS INCONTINENCE. THE FLUID DIARY SHOWED AN INPUT OF 2.4 LITERS AT FREQUENCY OF FOUR TO SEVEN TIMES WITH FOUR TO EIGHT EPISODES OF INCONTINENCE CHARTED DAILY. THERE IS NO NOCTURIA HOWEVER THE PATIENT DOES REPORT LEAKING WHILST ASLEEP IF SHE HAS BEEN COUGHING A LOT AT NIGHT. THE MAXIMUM FUNCTIONAL CAPACITY WAS 670 ML. PATIENT CURRENTLY DRINKS THREE TO FOUR TEAS EACH DAY. IN CONCLUSION THIS LADY HAS A STABLE BLADDER WITH URODYNAMICALLY PROVEN STRESS INCONTINENCE), HEADACHE, ADENOMYOSIS, BULKY UTERUS, VAGINAL BLEEDING, PARITY 3, VAGINAL CANDIDIASIS AND LOW BACK PAIN. ON 13-JUL-2012, THE PATIENT HAD ESSURE INSERTED. IN 2013 SHE EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) AND UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED ON 18-SEP-2019. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN ("LOCALISED PAIN"), MENTAL DISORDER ("PSYCHOLOGICAL/PSYCHIATRIC PROBLEMS"), HAEMORRHAGIC DISORDER ("ABNORMAL BLEEDING") AND DYSPAREUNIA ("DYSPAREUNIA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND ). AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL AND MENTAL DISORDER HAD NOT RESOLVED. THE OUTCOMES FOR MEDICAL DEVICE REMOVAL, DYSMENORRHOEA AND HAEMORRHAGIC DISORDER WERE UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, HAEMORRHAGIC DISORDER, HORMONE LEVEL ABNORMAL, MEDICAL DEVICE REMOVAL, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON 13-JUL-2012 AND 02-AUG-2012. THE EVENTS STARTED APPROXIMATELY 12 MONTHS AFTER INSERTION. AN ABLATION PROCEDURE WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. NO DEVICE MIGRATION. THERE WERE CONTINUING SYMPTOMS (UNSPECIFIED WHICH) AFTER THE HYSTERECTOMY WITH ESSURE REMOVAL. DISCREPANCY NOTED AS ESSURE REMOVAL DATE 05-SEP-2018. ON HYSTEROSCOPY THE RIGHT TUBE WAS SEEN AND MICROINSERTS WAS PLACED UNDER DIRECT VISUALIZATION. THE MICROINSERTS WAS INSERTED DEEP AND TREAD COIL COULD NOT NO SEEN. OTHER SIDE LOOKED AND BLOCKED AND TUBE OPENING COULD NOT SEE. SHE FOUND PROCEDURE VERY PAINFUL. ENDOSCOPIC BILATERAL CLIPPING OF FALLOPIAN TUBES ¿ HYSTEROSCOPIC ESSURE STERILIZATION GA (LEFT SIDE). INDICATION PERMANENT STERILIZATION. BOTH OSTIA SEEN. EASY INSERTION (3-4 COILS SEEN). TO USE ALTERNATIVE CONTRACEPTION UNTIL 3- MONTH, CHECK-UP. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ULTRASOUND SCAN VAGINA] ON 28-NOV-2017: THE UTERUS IS ANTEVERTED AND MEASURES 92 X 45 X 57MM. IT IS NORMAL IN SHAPE AND ECHOGENICITY. THE ENDOMETRIUM IS INDISTINCT IN KEEPING WITH AN ABLATION. WHERE VISIBLE THE ENDOMETRIUM IS NOT THICKENED WITH AN ET OF 2 MM. THE LEFT OVARY WAS ONLY POORLY VISUALIZED DUE TO HEAVILY LOADED BOWEL AND MEASURES 22 X 14 X 16MM AND APPEARS NORMAL. THE RIGHT OVARY MEASURES 40 X 28 28MM AND APPEARS NORMAL. THERE WERE NO MASSES OR FREE FLUID IN THE PELVIS. UNABLE TO ASSESS POSITION OF ESSURE CLIPS AS NO ACCESS TO 3D PROBE AT BHC IMPRESSION: NO OBVIOUS CAUSE FOR PAIN SEEN. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: GENITAL HAEMORRHAGE, DYSPAREUNIA, MEDICAL DEVICE REMOVAL LOT NUMBER: 925782 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11 LOT NUMBER: 925785 MANUFACTURE DATE: 2010-11 EXPIRATION DATE: 2013-11. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINTNO 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: 30-JAN-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 REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('HEAVY AND PAINFUL BLEEDING') AND DYSMENORRHOEA ('HEAVY AND PAINFUL BLEEDING'). IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785 / 925782) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ABLATION IN 2014, HYSTERECTOMY ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA AND MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON (B)(6) 2012. THE EVENTS STARTED APPROXIMATELY (B)(6) MONTHS AFTER INSERTION. AN ABLATION PROCEDURE WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. LOT NUMBER#: 925782, MANUFACTURE DATE: 2011-11, EXPIRATION DATE: 2014-11; LOT NUMBER#: 925785, MANUFACTURE DATE: 2011-11, EXPIRATION DATE: 2014-11. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021, NEW REPORTER ADDED. SIGNIFICANT, DUE TO IMDRF-FDA SYNCHRONIZATION. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('HEAVY AND PAINFUL BLEEDING') AND DYSMENORRHOEA ('HEAVY AND PAINFUL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ABLATION IN 2014 / HYSTERECTOMY IN (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA AND MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON (B)(6) 2012 AND (B)(6) 2012. THE EVENTS STARTED APPROXIMATELY 12 MONTHS AFTER INSERTION. AN ABLATION PROCEDURE WAS PERFORMED IN AN ATTEMPT TO STOP THE BLEEDING. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 1118720 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 925782, 925785 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Required Intervention| O |