ESSURE
Report
- Report Number
- 2951250-2020-15856
- Event Type
- Injury
- Date Received
- December 16, 2020
- Report Date
- December 8, 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 PELVIC PAIN ('PAIN') AND MENORRHAGIA ('HEAVY MENSTRUAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 (VAGINAL), ABDOMINAL PAIN, MENORRHAGIA AND ENDOMETRIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA AND IMPLANT. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENORRHAGIA WITH MIRENA AND IMPLANT. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION (B)(6) 2016 AND ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON (B)(6) 2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6) 2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: NOT REPORTED. HYSTEROSCOPY - ON (B)(6) 2017: STENOSED CERVICAL CANAL. ULTRASOUND SCAN - ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785 MANUFACTURING 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 23-FEB-2021: NEW REPORTER ADDED. SIGNIFICANT DUE TO IMDRF-FDA SYNCHRONIZATION. 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') AND MENORRHAGIA ('HEAVY MENSTRUAL BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY, ABDOMINAL PAIN, BLEEDING MENSTRUAL HEAVY AND ENDOMETRIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED GENITAL HAEMORRHAGE WITH MIRENA. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION (B)(6) 2016 AND ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON (B)(6) 2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6) 2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: NOT REPORTED. HYSTEROSCOPY - ON (B)(6) 2017: STENOSED CERVICAL CANAL. ULTRASOUND SCAN - ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785 MANUFACTURING DATE: 2011-11 EXPIRATION DATE:2014-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: AFTER INTERNAL REVIEW, THE EVENTS HEAVY MENSTRUAL BLEEDING (SERIOUS INCIDENT) AND ADENOMYOSIS WERE ADDED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 PELVIC PAIN ("PAIN") AND HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING / HEAVY/ABNORMAL BLEEDING") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925785) FOR STERILIZATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF INFERTILITY IN 2005 AND MENOPAUSAL SYMPTOMS, PALPITATIONS, ANXIETY, PAINFUL INTERCOURSE, BLEEDING RECTAL, PAINFUL PERIODS, POLYCYSTIC OVARIES, LAPAROSCOPY (TREATMENT TO ENDOMETRIOSIS), ENDOMETRIOSIS, MENORRHAGIA, ABDOMINAL PAIN AND PARITY 2 (VAGINAL). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CLOMID FOR INFERTILITY AND MIRENA, CONTRACEPTIVES AND FOLIC ACID. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: MENORRHAGIA: BLED CONSTANTLY WITH MIRENA AND MENORRHAGIA WITH CONTRACEPTIVES. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 607 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN ("MECHANICAL BACK PAIN"). ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY AND NOVASURE ABLATION (B)(6) 2016). AT THE TIME OF THE REPORT, THE HEAVY MENSTRUAL BLEEDING HAD RESOLVED. THE OUTCOMES FOR PELVIC PAIN, ADENOMYOSIS AND BACK PAIN WERE UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, BACK PAIN, HEAVY MENSTRUAL BLEEDING AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON (B)(6) 2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6) 2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DISCREPANCY NOTED IN ESSURE INSERTION DATE: (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2013: NOT REPORTED. [HYSTEROSCOPY] ON (B)(6) 2017: STENOSED CERVICAL CANAL. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2014: THIS HAS NOT SHOWN ANY EVIDENCE OF ANY SIGNIFICANT DEGENERATION IN HER LUMBAR SPINE AND THERE IS CERTAINLY NO NEUROLOGICAL COMPRESSION. DIAGNOSES: MECHANICAL BACK PAIN. [ULTRASOUND SCAN] ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785. MANUFACTURING DATE: 2011-11. EXPIRATION DATE:2014-11. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 11-OCT-2022: MEDICAL RECORDS RECEIVED: OTHER HEALTH PROFESSIONAL'S REPORTER,LAB DATA, EVENT BACK PAIN, IMDRF CODES UPDATED. 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') AND HEAVY MENSTRUAL BLEEDING ('HEAVY MENSTRUAL BLEEDING / HEAVY/ABNORMAL BLEEDING') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INFERTILITY IN 2005, PARITY 2 (VAGINAL), ABDOMINAL PAIN, MENORRHAGIA, ENDOMETRIOSIS, LAPAROSCOPY (TREATMENT TO ENDOMETRIOSIS), POLYCYSTIC OVARIES, PAINFUL PERIODS, BLEEDING RECTAL, PAINFUL INTERCOURSE, ANXIETY, PALPITATIONS AND MENOPAUSAL SYMPTOMS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR INFERTILITY: CLOMID; FOR AN UNREPORTED INDICATION: FOLIC ACID, IMPLANT AND MIRENA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENORRHAGIA WITH MIRENA AND IMPLANT. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED BACK PAIN ("MECHANICAL BACK PAIN"), 1 YEAR 7 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION (B)(6) 2016 AND ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ADENOMYOSIS AND BACK PAIN OUTCOME WAS UNKNOWN AND THE HEAVY MENSTRUAL BLEEDING HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, BACK PAIN, HEAVY MENSTRUAL BLEEDING AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON (B)(6)2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6) 2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DISCREPANCY NOTED IN ESSURE INSERTION DATE: (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: NOT REPORTED. HYSTEROSCOPY - ON (B)(6) 2017: STENOSED CERVICAL CANAL. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2014: THIS HAS NOT SHOWN ANY EVIDENCE OF ANY SIGNIFICANT DEGENERATION IN HER LUMBAR SPINE AND THERE IS CERTAINLY NO NEUROLOGICAL COMPRESSION. DIAGNOSES: MECHANICAL BACK PAIN. ULTRASOUND SCAN - ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785, MANUFACTURING 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 17-OCT-2022: QUALITY SAFETY EVALUATION OF PTC. 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') AND MENORRHAGIA ('HEAVY MENSTRUAL BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 (VAGINAL), ABDOMINAL PAIN, MENORRHAGIA AND ENDOMETRIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA AND IMPLANT. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENORRHAGIA WITH MIRENA AND IMPLANT. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION (B)(6) 2016 AND ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON (B)(6) 2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6) 2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: NOT REPORTED. HYSTEROSCOPY - ON (B)(6) 2017: STENOSED CERVICAL CANAL. ULTRASOUND SCAN - ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785, MANUFACTURING 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 22-DEC-2020: UPDATED QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ("PAIN") AND HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING / HEAVY/ABNORMAL BLEEDING") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925785) FOR STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF INFERTILITY IN 2005 AND POST COITAL BLEEDING, LOWER ABDOMINAL PAIN, VAGINAL DISCHARGE, OVARIAN CYST, MENOPAUSAL SYMPTOMS, PALPITATIONS, ANXIETY, PAINFUL INTERCOURSE, BLEEDING RECTAL, PAINFUL PERIODS, POLYCYSTIC OVARIES, LAPAROSCOPY (TREATMENT TO ENDOMETRIOSIS), ENDOMETRIOSIS, MENORRHAGIA, ABDOMINAL PAIN AND PARITY 2 (VAGINAL). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CLOMID FOR INFERTILITY AND MIRENA, CONTRACEPTIVES AND FOLIC ACID. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: MENORRHAGIA: BLED CONSTANTLY WITH MIRENA AND MENORRHAGIA WITH CONTRACEPTIVES. AS CONCURRENT CONDITION THE REPORT MENTIONED STOMACH CRAMPS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 607 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN ("MECHANICAL BACK PAIN"). ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), ADENOMYOSIS ("ADENOMYOSIS"), GENITAL HAEMORRHAGE (". ABNORMAL BLEEDING"), DYSPAREUNIA ("DYSPAREUNIA") AND MENTAL DISORDER (". PSYCHOLOGICAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY AND NOVASURE ABLATION (B)(6) (2016). AT THE TIME OF THE REPORT, THE HEAVY MENSTRUAL BLEEDING HAD RESOLVED. THE OUTCOMES FOR PELVIC PAIN, ADENOMYOSIS, BACK PAIN, GENITAL HAEMORRHAGE AND DYSPAREUNIA WERE UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON (B)(6)2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6)2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DISCREPANCY NOTED IN ESSURE INSERTION DATE: (B)(6) 2014 ESSURE CONFIRMATION TEST DONE ON (B)(6)2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6)2013: NOT REPORTED. [HYSTEROSCOPY] ON (B)(6) 2017: STENOSED CERVICAL CANAL. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2014: THIS HAS NOT SHOWN ANY EVIDENCE OF ANY SIGNIFICANT DEGENERATION IN HER LUMBAR SPINE AND THERE IS CERTAINLY NO NEUROLOGICAL COMPRESSION. DIAGNOSES: MECHANICAL BACK PAIN. [ULTRASOUND SCAN] ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785 MANUFACTURING DATE: 2011-11 EXPIRATION DATE:2014-11. 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: MEDICAL RECORD RECEIVED. EVENTS DYSPAREUNIA , PSYCHOLOGICAL ISSUES & GENITAL BLEEDING WERE ADDED. MEDICAL HISTORY & REPORTER INFORMATION UPDATED. 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') AND MENORRHAGIA ('HEAVY MENSTRUAL BLEEDING / HEAVY/ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 (VAGINAL), ABDOMINAL PAIN, MENORRHAGIA AND ENDOMETRIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA AND IMPLANT. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENORRHAGIA WITH MIRENA AND IMPLANT. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION (B)(6) 2016 AND ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON 23-JAN-2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON (B)(6) 2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6) 2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: NOT REPORTED. HYSTEROSCOPY - ON (B)(6) 2017: STENOSED CERVICAL CANAL. ULTRASOUND SCAN - ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785 MANUFACTURING 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: ESSURE INSERTION DATE UPDATED; EVENT "PELVIC PAIN FEMALE" OUTCOME UPDATED; EVENTS DESCRIPTIONS UPDATED 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') AND MENORRHAGIA ('HEAVY MENSTRUAL BLEEDING / HEAVY/ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INFERTILITY IN 2005, PARITY 2 (VAGINAL), ABDOMINAL PAIN, MENORRHAGIA, ENDOMETRIOSIS, LAPAROSCOPY (TREATMENT TO ENDOMETRIOSIS), POLYCYSTIC OVARIES AND PAINFUL PERIODS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR INFERTILITY: CLOMID; FOR AN UNREPORTED INDICATION: FOLIC ACID, IMPLANT AND MIRENA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED MENORRHAGIA WITH MIRENA AND IMPLANT. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION (B)(6) 2016 AND ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON (B)(6) 2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6) 2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: NOT REPORTED. HYSTEROSCOPY - ON (B)(6) 2017: STENOSED CERVICAL CANAL. ULTRASOUND SCAN - ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785 MANUFACTURING 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 26-MAR-2021: THE FOLLOW INFORMATION WERE UPDATED: NEW HCP'S REPORTERS, HISTORICAL DRUG AND MEDICAL HISTORY. 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') AND MENORRHAGIA ('HEAVY MENSTRUAL BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785) INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY, ABDOMINAL PAIN, BLEEDING MENSTRUAL HEAVY AND ENDOMETRIOSIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED GENITAL HAEMORRHAGE WITH MIRENA. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION (B)(6) 2016 AND ON (B)(6) 2019 LAPAROSCOPIC TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ADENOMYOSIS OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ADENOMYOSIS, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2013 ESSURE IMPLANTS WERE PLACED. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE DEVICE WAS DEPLOYED INTO BOTH TUBES. 2 AND 4 COILS WERE VISIBLE ON THE RIGHT AND LEFT SIDE RESPECTIVELY FOLLOWING THE PROCEDURE. ON 02-SEP-2016 SHE UNDERWENT A NOVASURE (16E12RC) ENDOMETRIAL ABLATION WITH LAPAROSCOPY DUE TO HEAVY MENSTRUAL BLEEDING. NO BLEEDING SINCE ABLATION. ON (B)(6) 2019 ESSURE IMPLANTS WERE REMOVED. SHE WAS DIAGNOSED WITH ADENOMYOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2013: NOT REPORTED. HYSTEROSCOPY ON (B)(6) 2017: STENOSED CERVICAL CANAL. ULTRASOUND SCAN ON (B)(6) 2013: SIGNIFICANT ASYMMETRY OF ESSURE IMPLANTS. LOT NUMBER: 925785 MANUFACTURING 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 9-DEC-2020: CASE UPGRADED TO SERIOUS INCIDENT. NEW REPORTER, PATIENT'S RELEVANT HISTORY, ESSURE REMOVAL DATE, LAB TESTS DRUG INDICATION WERE ADDED; PATIENT'S INITIALS, ESSURE INSERTION DATE WERE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1487659 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 925785 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention| O |