ESSURE
Report
- Report Number
- 2951250-2019-03870
- Event Type
- Injury
- Date Received
- July 15, 2019
- Date of Event
- November 1, 2011
- Report Date
- May 26, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CARPAL TUNNEL SYNDROME, FATIGUE, POLYDIPSIA, NAUSEA, ABDOMINAL BLOATING, DIARRHEA, RIGHT UPPER QUADRANT PAIN, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN PAIN, SORE THROAT, HYPERMENORRHEA, CHRONIC CERVICITIS AND ENERGY DECREASED. CONCURRENT CONDITIONS INCLUDED CHRONIC GASTRITIS, OVARIAN CYST, POLYCYSTIC OVARIES, ABDOMINAL CRAMPS, GERD, PAIN IN HIP, CHRONIC CHOLECYSTITIS, POLYCYSTIC OVARIES, LYMPHADENOPATHY, LIPOMA, FLANK PAIN, IRREGULAR MENSTRUAL CYCLE AND OVARIAN MASS. FAMILY HISTORY INCLUDED DIABETES. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM MARCH 2012 TO JUNE 2015 FOR HEAVY PERIODS AS WELL AS MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM JULY 2015 TO DECEMBER 2015, ORAL CONTRACEPTIVE NOS SINCE JANUARY 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE NOVEMBER 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN NOVEMBER 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/HYPERMENORRHEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH METFORMIN, NORETHISTERONE (MICRONOR), NSAIDS AND SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA AND ABDOMINAL PAIN WAS RESOLVING AND THE DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE REMOVAL DETAILS: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO WITH 5 VISIBLE RINGS ON THE RIGHT ,5 VISIBLE RINGS ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND ABDOMEN - ON (B)(6) 2012: RETROVERTED UTERUS, UNREMARKABLE. MILDLY COMPLEX 2.6 CM OVARIAN CYST AND UNILOCULAR BENIGN APPEARING 1.5 CM LEFT OVARIAN CYST. CONSIDER FOLLOW UP SONOGRAPHY IN 4-6 WEEKS DUE TO MILD COMPLEXITY OF RIGHT OVARIAN CYST.. LOT NUMBER: 882191 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-NOV-2019: PFS RECEIVED. UPDATED OUTCOME OF EVENT PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA, ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA FORM UNKNOWN TO RECOVERING / RESOLVING. CONCOMITANT DRUGS, TREATMENTS DRUGS,PATIENT AKA NAME WAS ADDED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CARPAL TUNNEL SYNDROME, FATIGUE, POLYDIPSIA, NAUSEA, ABDOMINAL BLOATING, DIARRHEA, RIGHT UPPER QUADRANT PAIN, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN PAIN, SORE THROAT, HYPERMENORRHEA, CHRONIC CERVICITIS AND ENERGY DECREASED. CONCURRENT CONDITIONS INCLUDED CHRONIC GASTRITIS, OVARIAN CYST, POLYCYSTIC OVARIES, ABDOMINAL CRAMPS, GERD, PAIN IN HIP, CHRONIC CHOLECYSTITIS, POLYCYSTIC OVARIES, LYMPHADENOPATHY, LIPOMA, FLANK PAIN, IRREGULAR MENSTRUAL CYCLE AND OVARIAN MASS. FAMILY HISTORY INCLUDED DIABETES. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2012 TO (B)(6) 2015 FOR HEAVY PERIODS AS WELL AS MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2015 TO(B)(6)2015, ORAL CONTRACEPTIVE NOS SINCE (B)(6) 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6)2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/HYPERMENORRHEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), METRORRHAGIA ("METRORRHAGIA") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION"). THE PATIENT WAS TREATED WITH METFORMIN, NORETHISTERONE (MICRONOR), NSAIDS AND SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN, GENITAL HAEMORRHAGE AND METRORRHAGIA HAD RESOLVED, THE VAGINAL HAEMORRHAGE AND DYSMENORRHOEA WAS RESOLVING AND THE DEPRESSION, ANXIETY AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, METRORRHAGIA, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE REMOVAL DETAILS: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO WITH 5 VISIBLE RINGS ON THE RIGHT ,5 VISIBLE RINGS ON THE LEFT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM. ON(B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND ABDOMEN. ON (B)(6)2012: RETROVERTED UTERUS, UNREMARKABLE. MILDLY COMPLEX 2.6 CM OVARIAN CYST AND UNILOCULAR BENIGN APPEARING 1.5 CM LEFT OVARIAN CYST. CONSIDER FOLLOW UP SONOGRAPHY IN 4-6 WEEKS DUE TO MILD COMPLEXITY OF RIGHT OVARIAN CYST.. LOT NUMBER: 882191 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: PFS RECEIVED. NEW EVENTS: GEN. ABNORMAL BLEEDING, METRORRHAGIA, POST PROCEDURAL COMPLICATION WERE ADDED. OUTCOME FOR PAIN, BLEEDING UPDATED. 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 PELVIC PAIN ('PAIN/PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CARPAL TUNNEL SYNDROME, FATIGUE, POLYDIPSIA, NAUSEA, ABDOMINAL BLOATING, DIARRHEA, RIGHT UPPER QUADRANT PAIN, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN PAIN, SORE THROAT, HYPERMENORRHEA, CHRONIC CERVICITIS, ENERGY DECREASED, RASH, HEADACHE UNILATERAL, PHOTOPHOBIA, APPENDECTOMY, DRUG HYPERSENSITIVITY, DRUG HYPERSENSITIVITY, LIPOMA EXCISION AND ENDOMETRIOSIS. CONCURRENT CONDITIONS INCLUDED CHRONIC GASTRITIS, OVARIAN CYST, POLYCYSTIC OVARIES, ABDOMINAL CRAMPS, GERD, PAIN IN HIP, CHRONIC CHOLECYSTITIS, POLYCYSTIC OVARIES, LYMPHADENOPATHY, LIPOMA, FLANK PAIN, IRREGULAR MENSTRUAL CYCLE AND OVARIAN MASS. FAMILY HISTORY INCLUDED DIABETES. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2012 TO (B)(6) 2015 FOR HEAVY PERIODS AS WELL AS MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2015 TO (B)(6) 2015, ORAL CONTRACEPTIVE NOS SINCE (B)(6) 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)/HYPERMENORRHEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). THE PATIENT WAS TREATED WITH METFORMIN, NORETHISTERONE (MICRONOR), NSAIDS AND SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEAVY MENSTRUAL BLEEDING, ABDOMINAL PAIN, GENITAL HAEMORRHAGE AND INTERMENSTRUAL BLEEDING HAD RESOLVED, THE VAGINAL HAEMORRHAGE AND DYSMENORRHOEA WAS RESOLVING AND THE DEPRESSION, ANXIETY, POST PROCEDURAL COMPLICATION AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, ENDOMETRIOSIS, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE REMOVAL DETAILS: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO WITH 5 VISIBLE RINGS ON THE RIGHT ,5 VISIBLE RINGS ON THE LEFT. TREATMENT RECEIVED FOR PELVIC PAIN, MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL). PRODUCT REMOVAL DATE UPDATED FROM (B)(6) 2015 TO (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND ABDOMEN - ON (B)(6) 2012: RETROVERTED UTERUS, UNREMARKABLE. MILDLY COMPLEX 2.6 CM OVARIAN CYST AND UNILOCULAR BENIGN APPEARING 1.5 CM LEFT OVARIAN CYST. CONSIDER FOLLOW UP SONOGRAPHY IN 4-6 WEEKS DUE TO MILD COMPLEXITY OF RIGHT OVARIAN CYST.. LOT NUMBER: 882191, MANUFACTURE DATE: 2011-07, EXPIRATION DATE: 2014-07. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-MAY-2021: 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 PELVIC PAIN ('PAIN/PELVIC AREA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CARPAL TUNNEL SYNDROME, FATIGUE, POLYDIPSIA, NAUSEA, ABDOMINAL BLOATING, DIARRHEA, RIGHT UPPER QUADRANT PAIN, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN PAIN, SORE THROAT, HYPERMENORRHEA, CHRONIC CERVICITIS, ENERGY DECREASED, RASH, HEADACHE UNILATERAL, PHOTOPHOBIA, APPENDECTOMY, DRUG HYPERSENSITIVITY, DRUG HYPERSENSITIVITY, LIPOMA EXCISION AND ENDOMETRIOSIS. CONCURRENT CONDITIONS INCLUDED CHRONIC GASTRITIS, OVARIAN CYST, POLYCYSTIC OVARIES, ABDOMINAL CRAMPS, GERD, PAIN IN HIP, CHRONIC CHOLECYSTITIS, POLYCYSTIC OVARIES, LYMPHADENOPATHY, LIPOMA, FLANK PAIN, IRREGULAR MENSTRUAL CYCLE AND OVARIAN MASS. FAMILY HISTORY INCLUDED DIABETES. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORGESTIMATE (SPRINTEC) FROM (B)(6) 2012 TO (B)(6) 2015 FOR HEAVY PERIODS AS WELL AS MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2015 TO (B)(6) 2015, ORAL CONTRACEPTIVE NOS SINCE (B)(6) 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)/HYPERMENORRHEA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). THE PATIENT WAS TREATED WITH METFORMIN, NORETHISTERONE (MICRONOR), NSAIDS AND SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEAVY MENSTRUAL BLEEDING, ABDOMINAL PAIN, GENITAL HAEMORRHAGE AND INTERMENSTRUAL BLEEDING HAD RESOLVED, THE VAGINAL HAEMORRHAGE AND DYSMENORRHOEA WAS RESOLVING AND THE DEPRESSION, ANXIETY, POST PROCEDURAL COMPLICATION AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, ENDOMETRIOSIS, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE REMOVAL DETAILS: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. WITH 5 VISIBLE RINGS ON THE RIGHT ,5 VISIBLE RINGS ON THE LEFT. TREATMENT RECEIVED FOR PELVIC PAIN, MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL). PRODUCT REMOVAL DATE UPDATED FROM (B)(6) 2015 TO (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND ABDOMEN - ON (B)(6) 2012: RETROVERTED UTERUS, UNREMARKABLE. MILDLY COMPLEX 2.6 CM OVARIAN CYST AND UNILOCULAR BENIGN APPEARING 1.5 CM LEFT OVARIAN CYST. CONSIDER FOLLOW UP SONOGRAPHY IN 4-6 WEEKS DUE TO MILD COMPLEXITY OF RIGHT OVARIAN CYST.. LOT NUMBER: 882191 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA. 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAY-2021: MR RECEIVED. REPORTER INFORMATION, PATIENT MIDDLE NAME, MEDICAL HISTORY, RCC ADDED. PRODUCT REMOVAL DATE UPDATED. EVENTS ENDOMETRIOSIS ADDED. 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 PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CARPAL TUNNEL SYNDROME, FATIGUE, POLYDIPSIA, NAUSEA, ABDOMINAL BLOATING, DIARRHEA, RIGHT UPPER QUADRANT PAIN, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN PAIN, SORE THROAT, HYPERMENORRHEA, CHRONIC CERVICITIS AND ENERGY DECREASED. CONCURRENT CONDITIONS INCLUDED CHRONIC GASTRITIS, OVARIAN CYST, POLYCYSTIC OVARIES, ABDOMINAL CRAMPS, GERD, PAIN IN HIP, CHRONIC CHOLECYSTITIS, POLYCYSTIC OVARIES, LYMPHADENOPATHY, LIPOMA, FLANK PAIN, IRREGULAR MENSTRUAL CYCLE AND OVARIAN MASS. FAMILY HISTORY INCLUDED DIABETES. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2015 TO (B)(6) 2015, ORAL CONTRACEPTIVE NOS SINCE (B)(6) 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE REMOVAL DETAILS: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. WITH 5 VISIBLE RINGS ON THE RIGHT ,5 VISIBLE RINGS ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND ABDOMEN - ON (B)(6) 2012: RETROVERTED UTERUS, UNREMARKABLE. MILDLY COMPLEX 2.6 CM OVARIAN CYST AND UNILOCULAR BENIGN APPEARING 1.5 CM LEFT OVARIAN CYST. CONSIDER FOLLOW UP SONOGRAPHY IN 4-6 WEEKS DUE TO MILD COMPLEXITY OF RIGHT OVARIAN CYST. LOT NUMBER: 882191 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CARPAL TUNNEL SYNDROME, FATIGUE, POLYDIPSIA, NAUSEA, ABDOMINAL BLOATING, DIARRHEA, RIGHT UPPER QUADRANT PAIN, MENOMETRORRHAGIA, DYSFUNCTIONAL UTERINE BLEEDING, OVARIAN PAIN, SORE THROAT, HYPERMENORRHEA, CHRONIC CERVICITIS AND ENERGY DECREASED. CONCURRENT CONDITIONS INCLUDED CHRONIC GASTRITIS, OVARIAN CYST, POLYCYSTIC OVARIES, ABDOMINAL CRAMPS, GERD, PAIN IN HIP, CHRONIC CHOLECYSTITIS, POLYCYSTIC OVARIES, LYMPHADENOPATHY, LIPOMA, FLANK PAIN, IRREGULAR MENSTRUAL CYCLE AND OVARIAN MASS. FAMILY HISTORY INCLUDED DIABETES. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2015 TO (B)(6) 2015, ORAL CONTRACEPTIVE NOS SINCE (B)(6) 2011 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE REMOVAL DETAILS: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. WITH 5 VISIBLE RINGS ON THE RIGHT ,5 VISIBLE RINGS ON THE LEFT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND ABDOMEN - ON (B)(6) 2012: RETROVERTED UTERUS, UNREMARKABLE. MILDLY COMPLEX 2.6 CM OVARIAN CYST AND UNILOCULAR BENIGN APPEARING 1.5 CM LEFT OVARIAN CYST. CONSIDER FOLLOW UP SONOGRAPHY IN 4-6 WEEKS DUE TO MILD COMPLEXITY OF RIGHT OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-JUL-2019: REPORTER AND PATIENT DEMOGRAPHICS, MEDICAL HISTORY, FAMILY HISTORY WERE ADDED. LOT NUMBER ADDED. ADDED EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH, DYSMENORRHEA (CRAMPING), PAIN, ABDOMINAL PAIN. MEDICAL DEVICE COMPLICATION EVENT WAS DELETED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584350 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882191 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| SPRINTEC| SPRINTEC| SPRINTEC| SPRINTEC| ACETAMINOPHEN| DEPO-PROVERA| ORAL CONTRACEPTIVE NOS |