ESSURE
Report
- Report Number
- 2951250-2020-13406
- Event Type
- Injury
- Date Received
- August 24, 2020
- Report Date
- October 25, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') AND DEVICE DISLOCATION ('ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / NO DEVICE DETECTION IN THE RIGHT TUBE AT TRANSVAGINAL ULTRASOUND') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENARCHE IN 1996, GRAVIDA II AND PARITY 2. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN AFTER ESSURE INSERTION PROCEDURE"). IN 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE / CEPHALA / SEVERE HEADACHE"), HEAVY MENSTRUAL BLEEDING ("INCREASED MENSTRUATION FLOW WITH CLOTS"), POLYMENORRHOEA ("INCREASED FREQUENCY OF MENSTRUATION"), ABDOMINAL PAIN LOWER ("CRAMP-LIKE PAIN IN LOWER ABDOMEN"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"), DYSPAREUNIA ("SEVERE PAIN DURING SEXUAL INTERCOURSE (DYSPAREUNIA)"), VAGINAL DISCHARGE ("INCREASED VAGINAL DISCHARGE WITH ODOR") AND ANXIETY DISORDER ("ANXIETY DISORDER") WITH DIZZINESS, TREMOR AND AFFECT LABILITY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERIPHERAL SWELLING ("LIMB SWELLING / SWOLLEN LEGS"), DEPRESSION ("DEPRESSION"), ADNEXA UTERI PAIN ("BILATERAL ADNEXA PAIN / SENSATION OF UTERINE PERFORATION"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("OEDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PARAESTHESIA ("TINGLING"), BACK PAIN ("LUMBAR PAIN"), PELVIC PAIN ("PELVIC PAIN"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER THE INTERCOURSE"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), INTRA-ABDOMINAL FLUID COLLECTION ("ABDOMINAL FLUID") AND PAIN ("GENERALIZED PAIN"). THE PATIENT WAS TREATED WITH ANALGESICS, DICLOFENAC SODIUM (ANTI-INFLAMMATORY) AND ORAL CONTRACEPTIVE NOS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PROCEDURAL PAIN, HEADACHE, HEAVY MENSTRUAL BLEEDING, POLYMENORRHOEA, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, ANXIETY DISORDER, PERIPHERAL SWELLING, DEPRESSION, ADNEXA UTERI PAIN, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, PAIN IN EXTREMITY, PARAESTHESIA, BACK PAIN, PELVIC PAIN, FATIGUE, LOSS OF LIBIDO, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION AND PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ADNEXA UTERI PAIN, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MOOD SWINGS, OEDEMA, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN, UTERINE INFLAMMATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: ESSURE INSERTION WAS PERFORMED WITHOUT COMPLICATIONS. PATIENT WANTED TO HAVE ESSURE REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2019: NICKEL: 3,94 MCG/L - REFERENCE VALUE: 0,6 - 7,5 MCG/L. ULTRASOUND SCAN VAGINA - ON (B)(6) 2019: EVIDENCE OF METALLIC DEVICE IN THE LEFT FALLOPIAN TUBE, BUT NO DEVICE DETECTION IN THE RIGHT TUBE; ON (B)(6) 2019: UTERINE CERVICAL NABOTH CYST. X-RAY OF PELVIS AND HIP - ON (B)(6) 2020: ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / REAL RISK OF PERFORATING THE INTERNAL ORGANS / ESSURE FRAGMENTED IN SEVERAL PARTS. LOT NUMBER: 880437 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07 . 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 14-JUN-2021: 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 DEVICE BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') AND DEVICE DISLOCATION ('ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES/NO DEVICE DETECTION IN THE RIGHT TUBE AT TRANSVAGINAL ULTRASOUND'). IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437), INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED: GRAVIDA II AND PARITY 2. IN 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN, AFTER ESSURE INSERTION PROCEDURE"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE/CEPHALEA"), MENORRHAGIA ("INCREASED MENSTRUATION FLOW WITH CLOTS"), POLYMENORRHOEA ("INCREASED FREQUENCY OF MENSTRUATION"), ABDOMINAL PAIN LOWER ("CRAMP-LIKE PAIN IN LOWER ABDOMEN"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"), DYSPAREUNIA ("SEVERE PAIN, DURING SEXUAL INTERCOURSE (DYSPAREUNIA)"), VAGINAL DISCHARGE ("INCREASED VAGINAL DISCHARGE WITH ODOR") AND ANXIETY DISORDER ("ANXIETY DISORDER") WITH DIZZINESS, TREMOR AND AFFECT LABILITY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERIPHERAL SWELLING ("LIMB SWELLING"), DEPRESSION ("DEPRESSION") AND ADNEXA UTERI PAIN ("BILATERAL ADNEXA PAIN"). THE PATIENT WAS TREATED WITH ANALGESICS, DICLOFENAC SODIUM (ANTI-INFLAMMATORY) AND ORAL CONTRACEPTIVE NOS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PROCEDURAL PAIN, HEADACHE, MENORRHAGIA, POLYMENORRHOEA, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, ANXIETY DISORDER, PERIPHERAL SWELLING, DEPRESSION AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ADNEXA UTERI PAIN, ANXIETY DISORDER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WAS PERFORMED, WITHOUT COMPLICATIONS. PATIENT WANTED TO HAVE ESSURE REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA: ON (B)(6) 2019, EVIDENCE OF METALLIC DEVICE IN THE LEFT FALLOPIAN TUBE, BUT NO DEVICE DETECTION IN THE RIGHT TUBE. X-RAY OF PELVIS AND HIP: ON (B)(6) 2020, ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES. REAL RISK OF PERFORATING THE INTERNAL ORGANS. ESSURE FRAGMENTED IN SEVERAL PARTS. LOT NUMBER#: 880437, MANUFACTURE DATE: 2011-07, EXPIRATION DATE: 2014-07. 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 22-FEB-2021, 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 AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("ESSURE FRAGMENTED IN SEVERAL PARTS") AND DEVICE DISLOCATION ("ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES/NO DEVICE DETECTION IN THE RIGHT TUBE AT TRANSVAGINAL ULTRASOUND") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 880437, 55043) FOR CONTRACEPTION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INSERTION DIFFICULT ("DEVICE INSERTION DIFFICULT"). THE PATIENT HAD A MEDICAL HISTORY OF MENARCHE IN 1996 AND SMOKER, DEPRESSION, OBESITY, MENSES IRREGULAR, PARITY 2 AND GRAVIDA II. CONCOMITANT PRODUCTS INCLUDED GLIFAGE XR (METFORMIN HYDROCHLORIDE), THIORIDAZINE, LITHIUM CARBONATE AND VALPROIC ACID. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, SHE EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN AFTER ESSURE INSERTION PROCEDURE"). IN 2017, SHE EXPERIENCED HEADACHE ("HEADACHE/CEPHALEA/SEVERE HEADACHE"), HEAVY MENSTRUAL BLEEDING ("INCREASED MENSTRUATION FLOW WITH CLOTS"), POLYMENORRHOEA ("INCREASED FREQUENCY OF MENSTRUATION"), ABDOMINAL PAIN LOWER ("CRAMP-LIKE PAIN IN LOWER ABDOMEN"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"), DYSPAREUNIA ("SEVERE PAIN DURING SEXUAL INTERCOURSE (DYSPAREUNIA)"), VAGINAL DISCHARGE ("INCREASED VAGINAL DISCHARGE WITH ODOR") AND ANXIETY DISORDER ("ANXIETY DISORDER"). AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), TREMOR ("TREMORS"), AFFECT LABILITY ("EMOTIONAL LABILITY"), PERIPHERAL SWELLING ("LIMB SWELLING/SWOLLEN LEGS"), DEPRESSION ("DEPRESSION"), ADNEXA UTERI PAIN ("BILATERAL ADNEXA PAIN/SENSATION OF UTERINE PERFORATION"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("OEDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PARAESTHESIA ("TINGLING"), BACK PAIN ("LUMBAR PAIN"), PELVIC PAIN ("PELVIC PAIN"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER THE INTERCOURSE"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), INTRA-ABDOMINAL FLUID COLLECTION ("ABDOMINAL FLUID"), PAIN ("GENERALIZED PAIN"), PERINEAL PAIN ("PERINEAL PAIN") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY (DICLOFENAC SODIUM), ANALGESICS, ORAL CONTRACEPTIVE NOS AND CLINDAMYCIN AS WELL AS SURGERY (HYSTERECTOMY & BILATERAL SALPINGECTOMY AND HYSTEROCTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR DEVICE BREAKAGE, DEVICE DISLOCATION, PROCEDURAL PAIN, HEADACHE, HEAVY MENSTRUAL BLEEDING, POLYMENORRHOEA, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, ANXIETY DISORDER, PERIPHERAL SWELLING, DEPRESSION, ADNEXA UTERI PAIN, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, PAIN IN EXTREMITY, PARAESTHESIA, BACK PAIN, PELVIC PAIN, FATIGUE, LOSS OF LIBIDO, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, PAIN, PERINEAL PAIN AND URINARY TRACT INFECTION WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ADNEXA UTERI PAIN, AFFECT LABILITY, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MOOD SWINGS, OEDEMA, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERINEAL PAIN, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN, TREMOR, URINARY TRACT INFECTION, UTERINE INFLAMMATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE INSERTION WAS PERFORMED WITHOUT COMPLICATIONS. PATIENT WANTED TO HAVE ESSURE REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALLERGY TEST] ON (B)(6) 2019: NICKEL: 3,94 MCG/L - REFERENCE VALUE: 0,6 - 7,5 MCG/L. [CULTURE URINE] ON (B)(6) 2023: POSITIVE STREPTOCOCCUS AGALACTIA ¿ RESISTANT TO QUINOLONES AND OTHER ANTIBIOTICS (ATB). TV US ((B)(6) 2023): UTERUS 68 CM³, ENDOMETRIUM 3.1 MM, OVARIES NOT VISUALISED. [CYTOLOGY] ON (B)(6) 2022: SPATULA (E) SAMPLE, MODERATE INFLAMMATION, BACILLI AND COCCI. ¿SURGICAL RISK IN THE PATIENT¿S ELECTRONIC MEDICAL RECORD (PEMR [HUMAN CHORIONIC GONADOTROPIN] ON (B)(6) 2014: NEGATIVE. [PATHOLOGY TEST] (DATE UNKNOWN): TUBAL LIGATION WITH ESSURE INTRATUBARY MICRODEVICE. . PATIENT IN LITHOTOMY POSITION; VAGINAL SPECULUM PASSAGE; DIAGNOSTIC HYSTEROSCOPY: UTERINE CAVITY WITHOUT CHANGES, TUBAL OSTIA VISUALISED; INSERTION OF INTRATUBARY MICRODEVICE BILATERALLY; WITHDRAWAL OF INSTRUMENTS; UNINTERRUPTED PROCEDURE. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2019: EVIDENCE OF METALLIC DEVICE IN THE LEFT FALLOPIAN TUBE, BUT NO DEVICE DETECTION IN THE RIGHT TUBE AND UTERINE CERVICAL NABOTH CYST, DESCRIBES ONLY ESSURE ON THE LEFT. [X-RAY OF PELVIS AND HIP] ON (B)(6) 2020: ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES/REAL RISK OF PERFORATING THE INTERNAL ORGANS/ESSURE FRAGMENTED IN SEVERAL PARTS; ON (B)(6) 2022: PRESENCE OF DEVICES BILATERALLY. LOT NUMBER: 880437. MANUFACTURE DATE: 2011-07. EXPIRATION DATE: 2014-07. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 28-SEP-2023: EVEN PERINEAL PAIN, DEVICE INSERTION DIFFICULTY, UTI WAS ADDED. MEDICAL HISTORY AND TREATMENT DRUGS ARE ADDED. LOT NUMBER ADDED .LAB DATA ADDED. PATIENT, REPORTER & PRODUCT INFORMATION UPDATED. ESSURE REMOVAL SURGERY DETAILS UPDATED. ON 03-OCT-2023: FOLLOW UP 6 AND 7 PROCESSED TOGETHER. 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 AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("ESSURE FRAGMENTED IN SEVERAL PARTS") AND DEVICE DISLOCATION ("ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / NO DEVICE DETECTION IN THE RIGHT TUBE AT TRANSVAGINAL ULTRASOUND") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 880437) FOR CONTRACEPTION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INSERTION DIFFICULT ("DEVICE INSERTION DIFFICULT"). THE PATIENT HAD A MEDICAL HISTORY OF MENARCHE IN 1996 AND SMOKER, DEPRESSION, OBESITY, MENSES IRREGULAR, PARITY 2 AND GRAVIDA II. CONCOMITANT PRODUCTS INCLUDED GLIFAGE XR (METFORMIN HYDROCHLORIDE), THIORIDAZINE, LITHIUM CARBONATE AND VALPROIC ACID. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, SHE EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN AFTER ESSURE INSERTION PROCEDURE"). IN 2017, SHE EXPERIENCED HEADACHE ("HEADACHE/CEPHALEA/SEVERE HEADACHE"), HEAVY MENSTRUAL BLEEDING ("INCREASED MENSTRUATION FLOW WITH CLOTS"), POLYMENORRHOEA ("INCREASED FREQUENCY OF MENSTRUATION"), ABDOMINAL PAIN LOWER ("CRAMP-LIKE PAIN IN LOWER ABDOMEN"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"), DYSPAREUNIA ("SEVERE PAIN DURING SEXUAL INTERCOURSE (DYSPAREUNIA)"), VAGINAL DISCHARGE ("INCREASED VAGINAL DISCHARGE WITH ODOR") AND ANXIETY DISORDER ("ANXIETY DISORDER"). AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DIZZINESS ("DIZZINESS"), TREMOR ("TREMORS"), AFFECT LABILITY ("EMOTIONAL LABILITY"), PERIPHERAL SWELLING ("LIMB SWELLING/SWOLLEN LEGS"), DEPRESSION ("DEPRESSION"), ADNEXA UTERI PAIN ("BILATERAL ADNEXA PAIN/SENSATION OF UTERINE PERFORATION"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("OEDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PARAESTHESIA ("TINGLING"), BACK PAIN ("LUMBAR PAIN"), PELVIC PAIN ("PELVIC PAIN"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER THE INTERCOURSE"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), INTRA-ABDOMINAL FLUID COLLECTION ("ABDOMINAL FLUID"), PAIN ("GENERALIZED PAIN"), PERINEAL PAIN ("PERINEAL PAIN") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY (DICLOFENAC SODIUM), ANALGESICS, ORAL CONTRACEPTIVE NOS AND CLINDAMYCIN AS WELL AS SURGERY (HYSTERECTOMY & BILATERAL SALPINGECTOMY AND HYSTEROCTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR DEVICE BREAKAGE, DEVICE DISLOCATION, PROCEDURAL PAIN, HEADACHE, HEAVY MENSTRUAL BLEEDING, POLYMENORRHOEA, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, ANXIETY DISORDER, PERIPHERAL SWELLING, DEPRESSION, ADNEXA UTERI PAIN, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, PAIN IN EXTREMITY, PARAESTHESIA, BACK PAIN, PELVIC PAIN, FATIGUE, LOSS OF LIBIDO, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, PAIN, PERINEAL PAIN AND URINARY TRACT INFECTION WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ADNEXA UTERI PAIN, AFFECT LABILITY, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MOOD SWINGS, OEDEMA, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERINEAL PAIN, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN, TREMOR, URINARY TRACT INFECTION, UTERINE INFLAMMATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE INSERTION WAS PERFORMED WITHOUT COMPLICATIONS. PATIENT WANTED TO HAVE ESSURE REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALLERGY TEST] ON (B)(6) 2019: NICKEL: 3,94 MCG/L - REFERENCE VALUE: 0,6 - 7,5 MCG/L. [CULTURE URINE] ON (B)(6) 2023: POSITIVE STREPTOCOCCUS AGALACTIA ¿ RESISTANT TO QUINOLONES AND OTHER ANTIBIOTICS (ATB). TV US ((B)(6) 2023): UTERUS 68 CM³, ENDOMETRIUM 3.1 MM, OVARIES NOT VISUALISED. [CYTOLOGY] ON (B)(6) 2022: SPATULA (E) SAMPLE, MODERATE INFLAMMATION, BACILLI AND COCCI. ¿SURGICAL RISK IN THE PATIENT¿S ELECTRONIC MEDICAL RECORD (PEMR [HUMAN CHORIONIC GONADOTROPIN] ON (B)(6) 2014: NEGATIVE. [PATHOLOGY TEST] (DATE UNKNOWN): TUBAL LIGATION WITH ESSURE INTRATUBARY MICRODEVICE. PATIENT IN LITHOTOMY POSITION; VAGINAL SPECULUM PASSAGE; DIAGNOSTIC HYSTEROSCOPY: UTERINE CAVITY WITHOUT CHANGES, TUBAL OSTIA VISUALISED; INSERTION OF INTRATUBARY MICRODEVICE BILATERALLY; WITHDRAWAL OF INSTRUMENTS; UNINTERRUPTED PROCEDURE. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2019: EVIDENCE OF METALLIC DEVICE IN THE LEFT FALLOPIAN TUBE, BUT NO DEVICE DETECTION IN THE RIGHT TUBE AND UTERINE CERVICAL NABOTH CYST, DESCRIBES ONLY ESSURE ON THE LEFT. [X-RAY OF PELVIS AND HIP] ON (B)(6) 2020: ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES/REAL RISK OF PERFORATING THE INTERNAL ORGANS/ESSURE FRAGMENTED IN SEVERAL PARTS; ON (B)(6) 2022: PRESENCE OF DEVICES BILATERALLY. LOT NUMBER: 880437. MANUFACTURE DATE: 2011-07. EXPIRATION DATE: 2014-07. LOT NUMBER: 55043 REPORT CIOMS IS INVALID. 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: 23-OCT-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 BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') AND DEVICE DISLOCATION ('ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / NO DEVICE DETECTION IN THE RIGHT TUBE AT TRANSVAGINAL ULTRASOUND') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2. IN 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN AFTER ESSURE INSERTION PROCEDURE"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE / CEPHALEA"), MENORRHAGIA ("INCREASED MENSTRUATION FLOW WITH CLOTS"), POLYMENORRHOEA ("INCREASED FREQUENCY OF MENSTRUATION"), ABDOMINAL PAIN LOWER ("CRAMP-LIKE PAIN IN LOWER ABDOMEN"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"), DYSPAREUNIA ("SEVERE PAIN DURING SEXUAL INTERCOURSE (DYSPAREUNIA)"), VAGINAL DISCHARGE ("INCREASED VAGINAL DISCHARGE WITH ODOR") AND ANXIETY DISORDER ("ANXIETY DISORDER") WITH DIZZINESS, TREMOR AND AFFECT LABILITY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERIPHERAL SWELLING ("LIMB SWELLING"), DEPRESSION ("DEPRESSION") AND ADNEXA UTERI PAIN ("BILATERAL ADNEXA PAIN"). THE PATIENT WAS TREATED WITH ANALGESICS, DICLOFENAC SODIUM (ANTI-INFLAMMATORY) AND ORAL CONTRACEPTIVE NOS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PROCEDURAL PAIN, HEADACHE, MENORRHAGIA, POLYMENORRHOEA, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, ANXIETY DISORDER, PERIPHERAL SWELLING, DEPRESSION AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ADNEXA UTERI PAIN, ANXIETY DISORDER, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WAS PERFORMED WITHOUT COMPLICATIONS. PATIENT WANTED TO HAVE ESSURE REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2019: EVIDENCE OF METALLIC DEVICE IN THE LEFT FALLOPIAN TUBE, BUT NO DEVICE DETECTION IN THE RIGHT TUBE. X-RAY OF PELVIS AND HIP - ON (B)(6) 2020: ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / REAL RISK OF PERFORATING THE INTERNAL ORGANS / ESSURE FRAGMENTED IN SEVERAL PARTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: INFORMATION UPDATED: ESSURE INSERTION DATE, INSERTION DETAILS, TREATMENT DRUG, EVENTS ADDED (LIMB SWELLING, DEPRESSION, BILATERAL ADNEXA PAIN). 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 BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') AND DEVICE DISLOCATION ('ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / NO DEVICE DETECTION IN THE RIGHT TUBE AT TRANSVAGINAL ULTRASOUND') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2. IN 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN AFTER ESSURE INSERTION PROCEDURE"). IN 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE"), MENORRHAGIA ("INCREASED MENSTRUATION FLOW WITH CLOTS"), POLYMENORRHOEA ("INCREASED FREQUENCY OF MENSTRUATION"), ABDOMINAL PAIN LOWER ("CRAMP-LIKE PAIN IN LOWER ABDOMEN"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"), DYSPAREUNIA ("SEVERE PAIN DURING SEXUAL INTERCOURSE (DYSPAREUNIA)"), VAGINAL DISCHARGE ("INCREASED VAGINAL DISCHARGE WITH ODOR") AND ANXIETY DISORDER ("ANXIETY DISORDER") WITH DIZZINESS, TREMOR AND AFFECT LABILITY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH ANALGESICS AND DICLOFENAC SODIUM (ANTI-INFLAMMATORY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PROCEDURAL PAIN, HEADACHE, MENORRHAGIA, POLYMENORRHOEA, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND ANXIETY DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY DISORDER, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA, POLYMENORRHOEA, PROCEDURAL PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2019: EVIDENCE OF METALLIC DEVICE IN THE LEFT FALLOPIAN TUBE, BUT NO DEVICE DETECTION IN THE RIGHT TUBE. X-RAY OF PELVIS AND HIP - ON (B)(6) 2020: ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / REAL RISK OF PERFORATING THE INTERNAL ORGANS / ESSURE FRAGMENTED IN SEVERAL PARTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-SEP-2020: QUALITY-SAFETY EVALUATION OF PTC. 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 BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') AND DEVICE DISLOCATION ('ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / NO DEVICE DETECTION IN THE RIGHT TUBE AT TRANSVAGINAL ULTRASOUND') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENARCHE IN 1996, GRAVIDA II AND PARITY 2. IN 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN AFTER ESSURE INSERTION PROCEDURE"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE / CEPHALEA / SEVERE HEADACHE"), HEAVY MENSTRUAL BLEEDING ("INCREASED MENSTRUATION FLOW WITH CLOTS"), POLYMENORRHOEA ("INCREASED FREQUENCY OF MENSTRUATION"), ABDOMINAL PAIN LOWER ("CRAMP-LIKE PAIN IN LOWER ABDOMEN"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"), DYSPAREUNIA ("SEVERE PAIN DURING SEXUAL INTERCOURSE (DYSPAREUNIA)"), VAGINAL DISCHARGE ("INCREASED VAGINAL DISCHARGE WITH ODOR") AND ANXIETY DISORDER ("ANXIETY DISORDER") WITH DIZZINESS, TREMOR AND AFFECT LABILITY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERIPHERAL SWELLING ("LIMB SWELLING / SWOLLEN LEGS"), DEPRESSION ("DEPRESSION"), ADNEXA UTERI PAIN ("BILATERAL ADNEXA PAIN / SENSATION OF UTERINE PERFORATION"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("OEDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PARAESTHESIA ("TINGLING"), BACK PAIN ("LUMBAR PAIN"), PELVIC PAIN ("PELVIC PAIN"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), COITAL BLEEDING ("BLEEDING DURING AND AFTER THE INTERCOURSE"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), INTRA-ABDOMINAL FLUID COLLECTION ("ABDOMINAL FLUID") AND PAIN ("GENERALIZED PAIN"). THE PATIENT WAS TREATED WITH ANALGESICS, DICLOFENAC SODIUM (ANTI-INFLAMMATORY) AND ORAL CONTRACEPTIVE NOS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PROCEDURAL PAIN, HEADACHE, HEAVY MENSTRUAL BLEEDING, POLYMENORRHOEA, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, ANXIETY DISORDER, PERIPHERAL SWELLING, DEPRESSION, ADNEXA UTERI PAIN, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, PAIN IN EXTREMITY, PARAESTHESIA, BACK PAIN, PELVIC PAIN, FATIGUE, LOSS OF LIBIDO, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION AND PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ADNEXA UTERI PAIN, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MOOD SWINGS, OEDEMA, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN, UTERINE INFLAMMATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION WAS PERFORMED WITHOUT COMPLICATIONS. PATIENT WANTED TO HAVE ESSURE REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2019: NICKEL: 3,94 MCG/L - REFERENCE VALUE: 0,6 - 7,5 MCG/L. ULTRASOUND SCAN VAGINA - ON (B)(6) 2019: EVIDENCE OF METALLIC DEVICE IN THE LEFT FALLOPIAN TUBE, BUT NO DEVICE DETECTION IN THE RIGHT TUBE; ON (B)(6) 2019: UTERINE CERVICAL NABOTH CYST. X-RAY OF PELVIS AND HIP - ON (B)(6) 2020: ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / REAL RISK OF PERFORATING THE INTERNAL ORGANS / ESSURE FRAGMENTED IN SEVERAL PARTS. LOT NUMBER: 880437 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. 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 31-MAY-2021: MEDICAL HISTORY AND LAB DATAS HAVE BEEN ADDED. NEW ADVERSE EVENTS: MASTALGIA, DISTENSION, OEDEMA, LEG PAIN, TINGLING, LUMBAR PAIN, PELVIC PAIN, FATIGUE, LACK OF LIBIDO, BLEEDING DURING AND AFTER THE INTERCOURSE, UTERINE INFLAMMATION, JOINT PAIN, MOOD SWINGS, HAIR LOSS, SUSPICION OF ADENOMYOSIS, ABDOMINAL FLUID AND GENERALIZED PAIN. 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 BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 2. IN 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN AFTER ESSURE INSERTION PROCEDURE"). IN 2017, THE PATIENT EXPERIENCED HEADACHE ("HEADACHE"), MENORRHAGIA ("INCREASED MENSTRUATION FLOW WITH CLOTS"), POLYMENORRHOEA ("INCREASED FREQUENCY OF MENSTRUATION"), ABDOMINAL PAIN LOWER ("CRAMP-LIKE PAIN IN LOWER ABDOMEN"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"), DYSPAREUNIA ("SEVERE PAIN DURING SEXUAL INTERCOURSE (DYSPAREUNIA)"), VAGINAL DISCHARGE ("INCREASED VAGINAL DISCHARGE WITH ODOR") AND ANXIETY DISORDER ("ANXIETY DISORDER") WITH DIZZINESS, TREMOR AND AFFECT LABILITY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DISLOCATION ("ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / NO DEVICE DETECTION IN THE RIGHT TUBE AT TRANSVAGINAL ULTRASOUND"). THE PATIENT WAS TREATED WITH ANALGESICS AND ANTIINFLAMMATORY AGENTS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PROCEDURAL PAIN, HEADACHE, MENORRHAGIA, POLYMENORRHOEA, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND ANXIETY DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANXIETY DISORDER, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA, POLYMENORRHOEA, PROCEDURAL PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA ON (B)(6) 2019: EVIDENCE OF METALLIC DEVICE IN THE LEFT FALLOPIAN TUBE, BUT NO DEVICE DETECTION IN THE RIGHT TUBE. X-RAY OF PELVIS AND HIP ON (B)(6) 2020: ESSURE IN WRONG POSITION IN THE FALLOPIAN TUBES / REAL RISK OF PERFORATING THE INTERNAL ORGANS / ESSURE FRAGMENTED IN SEVERAL PARTS. 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 |
|---|---|---|---|---|---|---|---|
| 906860 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880437 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Other| R | GLIFAGE XR| GLIFAGE XR| LITHIUM CARBONATE| LITHIUM CARBONATE| THIORIDAZINE| THIORIDAZINE| VALPROIC ACID| VALPROIC ACID |