ESSURE
Report
- Report Number
- 2951250-2020-08306
- Event Type
- Injury
- Date Received
- June 3, 2020
- Date of Event
- September 1, 2012
- Report Date
- December 31, 2023
- 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 DEVICE DISLOCATION ('ESSURE DEVICES MIGRATED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PAIN") AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, PELVIC DISCOMFORT AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, MENSTRUAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUL-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE DEVICES MIGRATED / MIGRATION OF THE ESSURE DEVICES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PAIN / LOCALIZED PAIN") AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE") AND GENITAL HAEMORRHAGE ("HEAVY/ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE PELVIC DISCOMFORT AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR GENITAL HAEMORRHAGE WITH ESSURE. THE REPORTER CONSIDERED DEVICE DISLOCATION, MENSTRUAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-MAR-2021: A NEW REPORTER (LAWYER), NEW ADVERSE EVENT (HEAVY/ABNORMAL BLEEDING) AND THE NEW AS REPORTED (LOCALIZED PAIN AND MIGRATION OF THE ESSURE DEVICES) WERE PROVIDED. THE OUTCOME FOR THE ADVERSE EVENTS HEAVY/ABNORMAL BLEEDING, LOCALIZED PAIN, MIGRATION OF THE ESSURE DEVICES AND THE DATE OF THE ESSURE REMOVAL WERE UPDATED. 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 DEVICE DISLOCATION ('ESSURE DEVICES MIGRATED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PAIN") AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, PELVIC DISCOMFORT AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, MENSTRUAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUN-2020: ESSURE LOT NUMBER 925785 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE DEVICES MIGRATED / MIGRATION OF THE ESSURE DEVICES WITHIN THE PELVIS') AND PELVIC PAIN ('SEVERE PAIN / LOCALIZED PAIN/ CHRONIC PELVIC PAIN') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785,925786) INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA ON (B)(6) 2011, OVARIAN CYST ON (B)(6) 2011, ARTHRITIS, CARPAL TUNNEL SYNDROME, SCIATICA, PANIC ATTACKS, GENITAL BLEEDING, MULTIGRAVIDA AND C-SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IN 2008. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ABORTION INDUCED WITH MIRENA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE") AND GENITAL HAEMORRHAGE ("HEAVY/ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE PELVIC DISCOMFORT AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR GENITAL HAEMORRHAGE WITH ESSURE. THE REPORTER CONSIDERED DEVICE DISLOCATION, MENSTRUAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NOVASURE PROCEDURE PERFORMED IMMEDIATELY AFTER ESSURE INSERTION ON (B)(6) 2012. ESSURE WAS REMOVED DUE TO CHRONIC PELVIC PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): MAGNETIC RESONANCE IMAGING - ON (B)(6) 2014: THE RIGHT SIDED STERILIZATIONS CLIP IS JUST IDENTIFIED. THE LEFT SIDED COIL SEEMS TO HAVE ABNORMAL POSITION, BUT THIS CANNOT BE COMMENTED UPON FURTHER ON THE MRI SCAN. ULTRASOUND SCAN - ON (B)(6) 2013: LEFT OVARY: VISIBILITY: CLEARLY SEEN. LEFT OVARY CONTAINS A SIMPLE CYST: SIZE: X 47 MM X 33 MM X 45 MM. VOLUME: 36.5 ML. BOTH ESSURE ARE SITUATED NORMALLY, THE LEFT OVARY CONTAINS A CYST WITH A SOLID COMPONENT, NO DOPPLER FLOW.; ON (B)(6) 2013: BOTH OVARIES ARE NORMAL IN SIZE AND APPEARANCE. NO EVIDENCE OF AN ADNEXAL MASS/CYST. X-RAY - ON (B)(6) 2013: THERE ARE LINEAR HIGH DENSITY OBJECTS PROJECTED IN WITHIN THE PELVIS WHICH PRESUMABLY REPRESENTS THE INSERTED DEVICES; ON (B)(6) 2014: ESSURE UNCHANGED IN APPEARANCE WHEN COMPARED TO THE RADIOGRAPH OF (B)(6) 2013. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAR-2021: MEDICAL RECORDS RECEIVED. NEW REPORTERS, DRUG INDICATION, LOT NUMBER, LAB TEST WERE ADDED. THE PREVIOUS EVENT "PELVIC PAIN" WAS UPGRADED TO SERIOUS 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 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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE DEVICES MIGRATED/MIGRATION OF THE ESSURE DEVICES WITHIN THE PELVIS") AND PELVIC PAIN ("SEVERE PAIN/LOCALIZED PAIN/CHRONIC PELVIC PAIN") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925785, 925786) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR ("NOVASURE PROCEDURE DONE AT THE SAEM DAY OF ESSURE INSERTION PROCEDURE"). THE PATIENT HAD A MEDICAL HISTORY OF FIBROMYALGIA AND OVARIAN CYST IN 2011 AND C-SECTION, MULTIGRAVIDA, GENITAL BLEEDING, PANIC ATTACKS, SCIATICA, CARPAL TUNNEL SYNDROME AND ARTHRITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MIRENA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: TERMINATION OF PREGNANCY WITH MIRENA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON (B)(6) 2013, SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2014. AN UNKNOWN TIME LATER SHE EXPERIENCED MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE"), GENITAL HAEMORRHAGE ("HEAVY/ABNORMAL BLEEDING"), ABDOMINAL PAIN LOWER ("PAIN, INCLUDING CHRONIC PAIN"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION") AND MENTAL DISORDER ("PSYCHOLOGICAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY,BILATERAL SALPINGO-OOPHORECTOMY AND RETRIEVAL OF DEVICE AND LAPAROSCOPIC BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED. THE OUTCOMES FOR PELVIC DISCOMFORT AND MENSTRUAL DISORDER WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE DISLOCATION, HYPERSENSITIVITY, MENSTRUAL DISORDER, MENTAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO GENITAL HAEMORRHAGE. THE REPORTER COMMENTED: NOVASURE PROCEDURE PERFORMED IMMEDIATELY AFTER ESSURE INSERTION ON (B)(6) 2012. ESSURE WAS REMOVED DUE TO CHRONIC PELVIC PAIN. ETHNICITY: BRITISH. MENOPAUSE POST-OOPHORECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2014: THE RIGHT SIDED STERILIZATIONS CLIP IS JUST IDENTIFIED. THE LEFT SIDED COIL SEEMS TO HAVE ABNORMAL POSITION, BUT THIS CANNOT BE COMMENTED UPON FURTHER ON THE MRI SCAN. [ULTRASOUND SCAN] ON (B)(6) 2013: LEFT OVARY: VISIBILITY: CLEARLY SEEN. LEFT OVARY CONTAINS A SIMPLE CYST: SIZE: X 47 MM X 33 MM X 45 MM. VOLUME: 36.5 ML. BOTH ESSURE ARE SITUATED NORMALLY, THE LEFT OVARY CONTAINS A CYST WITH A SOLID COMPONENT, NO DOPPLER FLOW. ON (B)(6) 2013: BOTH OVARIES ARE NORMAL IN SIZE AND APPEARANCE. NO EVIDENCE OF AN ADNEXAL MASS/CYST [ULTRASOUND SCAN VAGINA] ON (B)(6) 2013: (B)(6) 2013 (PER MR). TRANSVAGINAL ULTRASOUND SCAN TO CONFIRM ESSURE POSITIONING. ESSURE PLACED (B)(6) 2012. IMPRESSION: BOTH ESSURE IN CORRECT PLACE. OVARIAN CYST SEEN ON LEFT SIDE. [X-RAY] ON (B)(6) 2013: THERE ARE LINEAR HIGH DENSITY OBJECTS PROJECTED IN WITHIN THE PELVIS WHICH PRESUMABLY REPRESENTS THE INSERTED DEVICES; ON (B)(6) 2014: ESSURE UNCHANGED IN APPEARANCE WHEN COMPARED TO THE RADIOGRAPH OF (B)(6) 2013. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: PAIN, MENTAL DISORDER, AND ALLERGIC REACTION. 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: 30-DEC-2023: 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 DEVICE DISLOCATION ('ESSURE DEVICES MIGRATED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PAIN") AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, PELVIC DISCOMFORT AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, MENSTRUAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-FEB-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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE DEVICES MIGRATED / MIGRATION OF THE ESSURE DEVICES WITHIN THE PELVIS") AND PELVIC PAIN ("SEVERE PAIN / LOCALIZED PAIN/ CHRONIC PELVIC PAIN") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925785,925786) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR ("NOVASURE PROCEDURE DONE AT THE SAEM DAY OF ESSURE INSERTION PROCEDURE"). THE PATIENT HAD A MEDICAL HISTORY OF FIBROMYALGIA AND OVARIAN CYST IN 2011 AND C-SECTION, MULTIGRAVIDA, GENITAL BLEEDING, PANIC ATTACKS, SCIATICA, CARPAL TUNNEL SYNDROME AND ARTHRITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MIRENA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: TERMINATION OF PREGNANCY WITH MIRENA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON (B)(6) 2013 SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2014. AN UNKNOWN TIME LATER SHE EXPERIENCED MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE"), GENITAL HAEMORRHAGE ("HEAVY/ABNORMAL BLEEDING"), ABDOMINAL PAIN LOWER ("PAIN, INCLUDING CHRONIC PAIN"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION") AND MENTAL DISORDER ("PSYCHOLOGICAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY,BILATERAL SALPINGO-OOPHORECTOMY AND RETRIEVAL OF DEVICE AND LAPAROSCOPIC BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED. THE OUTCOMES FOR PELVIC DISCOMFORT AND MENSTRUAL DISORDER WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE DISLOCATION, HYPERSENSITIVITY, MENSTRUAL DISORDER, MENTAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO GENITAL HAEMORRHAGE. THE REPORTER COMMENTED: NOVASURE PROCEDURE PERFORMED IMMEDIATELY AFTER ESSURE INSERTION ON (B)(6) 2012. ESSURE WAS REMOVED DUE TO CHRONIC PELVIC PAIN ETHNICITY: BRITISH. MENOPAUSE POST-OOPHORECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2014: THE RIGHT SIDED STERILIZATIONS CLIP IS JUST IDENTIFIED. THE LEFT SIDED COIL SEEMS TO HAVE ABNORMAL POSITION, BUT THIS CANNOT BE COMMENTED UPON FURTHER ON THE MRI SCAN. [ULTRASOUND SCAN] ON (B)(6) 2013: LEFT OVARY: VISIBILITY: CLEARLY SEEN. LEFT OVARY CONTAINS A SIMPLE CYST: SIZE: X 47 MM X 33 MM X 45 MM. VOLUME: 36.5 ML. BOTH ESSURE ARE SITUATED NORMALLY, THE LEFT OVARY CONTAINS A CYST WITH A SOLID COMPONENT, NO DOPPLER FLOW.; ON (B)(6) 2013: BOTH OVARIES ARE NORMAL IN SIZE AND APPEARANCE. NO EVIDENCE OF AN ADNEXAL MASS/CYST. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2013: (B)(6) 2013 (PER MR). TRANSVAGINAL ULTRASOUND SCAN TO CONFIRM ESSURE POSITIONING ESSURE PLACED (B)(6) 2012 IMPRESSION: BOTH ESSURE IN CORRECT PLACE. OVARIAN CYST SEEN ON LEFT SIDE. [X-RAY] ON (B)(6) 2013: THERE ARE LINEAR HIGH DENSITY OBJECTS PROJECTED IN WITHIN THE PELVIS WHICH PRESUMABLY REPRESENTS THE INSERTED DEVICES; ON (B)(6) 2014: ESSURE UNCHANGED IN APPEARANCE WHEN COMPARED TO THE RADIOGRAPH OF (B)(6) 2013. LOT NUMBER: 925785 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11. LOT NUMBER: 925786 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:PAIN,MENTAL DISORDER,ALLERGIC REACTION. 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: 01-DEC-2023: NEW EVENT ADDED:PAIN,MENTAL DISORDER,ALLERGIC REACTION.REPORTERS,MEDICAL HISTORY,LAB DATA,PATIENT INFORMATION,LOT NO.,REMOVAL DATE,NON DRUG TREATMENT 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE DEVICES MIGRATED / MIGRATION OF THE ESSURE DEVICES WITHIN THE PELVIS') AND PELVIC PAIN ('SEVERE PAIN / LOCALIZED PAIN/ CHRONIC PELVIC PAIN') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785,925786) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVASURE PROCEDURE DONE AT THE SAEM DAY OF ESSURE INSERTION PROCEDURE". THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA ON (B)(6) 2011, OVARIAN CYST ON (B)(6) 2011, ARTHRITIS, CARPAL TUNNEL SYNDROME, SCIATICA, PANIC ATTACKS, GENITAL BLEEDING, MULTIGRAVIDA AND C-SECTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IN 2008. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ABORTION INDUCED WITH MIRENA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE") AND GENITAL HAEMORRHAGE ("HEAVY/ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE PELVIC DISCOMFORT AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR GENITAL HAEMORRHAGE WITH ESSURE. THE REPORTER CONSIDERED DEVICE DISLOCATION, MENSTRUAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NOVASURE PROCEDURE PERFORMED IMMEDIATELY AFTER ESSURE INSERTION ON (B)(6) 2012. ESSURE WAS REMOVED DUE TO CHRONIC PELVIC PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): MAGNETIC RESONANCE IMAGING - ON (B)(6) 2014: THE RIGHT SIDED STERILIZATIONS CLIP IS JUST IDENTIFIED. THE LEFT SIDED COIL SEEMS TO HAVE ABNORMAL POSITION, BUT THIS CANNOT BE COMMENTED UPON FURTHER ON THE MRI SCAN.. ULTRASOUND SCAN - ON (B)(6) 2013: LEFT OVARY: VISIBILITY: CLEARLY SEEN. LEFT OVARY CONTAINS A SIMPLE CYST: SIZE: X 47 MM X 33 MM X 45 MM. VOLUME: 36.5 ML. BOTH ESSURE ARE SITUATED NORMALLY, THE LEFT OVARY CONTAINS A CYST WITH A SOLID COMPONENT, NO DOPPLER FLOW. ON (B)(6) 2013: BOTH OVARIES ARE NORMAL IN SIZE AND APPEARANCE. NO EVIDENCE OF AN ADNEXAL MASS/CYST. X-RAY - ON (B)(6) 2013: THERE ARE LINEAR HIGH DENSITY OBJECTS PROJECTED IN WITHIN THE PELVIS WHICH PRESUMABLY. REPRESENTS THE INSERTED DEVICES; ON (B)(6) 2014: ESSURE UNCHANGED IN APPEARANCE WHEN COMPARED TO THE RADIOGRAPH OF (B)(6) 2013. LOT NUMBER: 925785 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11, LOT NUMBER: 925786 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11. 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 7-APR-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 DEVICE DISLOCATION ('ESSURE DEVICES MIGRATED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PAIN") AND PELVIC DISCOMFORT ("SEVERE DISCOMFORT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("SIGNIFICANT CHANGES TO HER MENSTRUAL CYCLE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, PELVIC DISCOMFORT AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, MENSTRUAL DISORDER, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 577281 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 925785,925786 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention| O |