ESSURE
Report
- Report Number
- 2951250-2019-11278
- Event Type
- Injury
- Date Received
- November 7, 2019
- Report Date
- April 1, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND AXILLARY LYMPHADENECTOMY ('EXCISISONAL LYMPH NODE REMOVAL RIGHT AXILLA') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A78082) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POOR VISION, MENIERE'S DISEASE, MIGRAINE AND SEASONAL ALLERGY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, LYMPHADENOPATHY AND HEMOSTASIS. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)AFTER HAVING THE ESSURE IMPLANTED,THE CRAMPS BEGAN BEFORE I BEGAN MY PERIODS AND CONTINUED THROUGH OUT THE ENTIRE PERIOD, UNLIKE BEFORE WHEN I EXPERIENCED ONE DAY OF CRAMPING AT THE BEGINNING OF MY PERIOD"). IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"). IN (B)(6) 2018, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DYSPAREUNIA ("OTHER INJURIES OR COMPLICATIONS-PLEASE DESCRIBE: PAIN WITH INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2018, THE PATIENT EXPERIENCED VULVOVAGINAL CANDIDIASIS ("VAGINAL CUFF GRANULOMA"). ON (B)(6) 2018, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), 5 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GRANULOMA ("POSTOP REMOVAL ON (B)(6) 2018 OF VAGINAL CUFF GRANULOMA.") AND UNDERWENT AXILLARY LYMPHADENECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VULVOVAGINAL CANDIDIASIS, AXILLARY LYMPHADENECTOMY AND GRANULOMA OUTCOME WAS UNKNOWN, THE BACK PAIN, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED AND THE ENDOMETRIOSIS WAS RESOLVING. THE REPORTER CONSIDERED AXILLARY LYMPHADENECTOMY, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, GRANULOMA, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS WERE VISIBLE ON THIS SIDE. ON THE RIGHT SIDE SIMILAR PROCEDURE WAS USED AND 5 COILS WERE VISIBLE AFTER THE ESSURE WAS PLACED ESSURE CONFIRMATION DATE AND REMOVAL DATE NOTED IS SAME (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2013: ESSURE PROCEDURE HAD COMPLETELY BLOCKED HER TUBES.. PATHOLOGY TEST - ON (B)(6) 2018: SINGLE VIEW OF PELVIS: IMPRESSION: REMOVAL OF RADIOPAQUE DENSITIES IN THE PELVIS SINCE PRIOR EXAMINATION. SINGLE SPOT C- ARM VIEW IMPRESSION: CONTRACEPTIVE DEVICES IN THE PELVIS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: DYSMENORRHEA, DYSPAREUNIA, PELVIC PAIN, ENDOMETRIOSIS,. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-NOV-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 ('PELVIC PAIN') AND AXILLARY LYMPHADENECTOMY ('EXCISISONAL LYMPH NODE REMOVAL RIGHT AXILLA') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A78082) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POOR VISION, MENIERE'S DISEASE, MIGRAINE AND SEASONAL ALLERGY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, LYMPHADENOPATHY AND HEMOSTASIS. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING). ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)AFTER HAVING THE ESSURE IMPLANTED,THE CRAMPS BEGAN BEFORE I BEGAN MY PERIODS AND CONTINUED THROUGH OUT THE ENTIRE PERIOD, UNLIKE BEFORE WHEN I EXPERIENCED ONE DAY OF CRAMPING AT THE BEGINNING OF MY PERIOD"). IN (B)(6)2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6)2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"). IN (B)(6)2018, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). IN (B)(6)2018, THE PATIENT EXPERIENCED DYSPAREUNIA ("OTHER INJURIES OR COMPLICATIONS-PLEASE DESCRIBE: PAIN WITH INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6)2018, THE PATIENT EXPERIENCED VULVOVAGINAL CANDIDIASIS ("VAGINAL CUFF GRANULOMA"). ON (B)(6)2018, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), 5 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GRANULOMA ("POSTOP REMOVAL ON (B)(6)18 OF VAGINAL CUFF GRANULOMA.") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND UNDERWENT AXILLARY LYMPHADENECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND REMOVAL). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VULVOVAGINAL CANDIDIASIS, AXILLARY LYMPHADENECTOMY, GRANULOMA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE BACK PAIN, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED AND THE ENDOMETRIOSIS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, AXILLARY LYMPHADENECTOMY, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, GRANULOMA, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS WERE VISIBLE ON THIS SIDE. ON THE RIGHT SIDE SIMILAR PROCEDURE WAS USED AND 5 COILS WERE VISIBLE AFTER THE ESSURE WAS PLACED ESSURE CONFIRMATION DATE AND REMOVAL DATE NOTED IS SAME (B)(6)2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6)2013: ESSURE PROCEDURE HAD COMPLETELY BLOCKED HER TUBES.. PATHOLOGY TEST - ON (B)(6)2018: SINGLE VIEW OF PELVIS: IMPRESSION: REMOVAL OF RADIOPAQUE DENSITIES IN THE PELVIS SINCE PRIOR EXAMINATION. SINGLE SPOT C- ARM VIEW IMPRESSION: CONTRACEPTIVE DEVICES IN THE PELVIS.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: DYSMENORRHEA, DYSPAREUNIA, PELVIC PAIN, ENDOMETRIOSIS,. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-NOV-2019: PFS RECEIVED: EVENT WAS ADDED- ABDOMINAL PAIN. 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 ('PELVIC PAIN') AND AXILLARY LYMPHADENECTOMY ('EXCISISONAL LYMPH NODE REMOVAL RIGHT AXILLA') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A78082) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POOR VISION, MENIERE'S DISEASE, MIGRAINE AND SEASONAL ALLERGY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, LYMPHADENOPATHY AND HEMOSTASIS. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)AFTER HAVING THE ESSURE IMPLANTED,THE CRAMPS BEGAN BEFORE I BEGAN MY PERIODS AND CONTINUED THROUGH OUT THE ENTIRE PERIOD, UNLIKE BEFORE WHEN I EXPERIENCED ONE DAY OF CRAMPING AT THE BEGINING OF MY PERIOD"). IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"). IN (B)(6) 2018, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DYSPAREUNIA ("OTHER INJURIES OR COMPLICATIONS-PLEASE DESCRIBE: PAIN WITH INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2018, THE PATIENT EXPERIENCED VULVOVAGINAL CANDIDIASIS ("VAGINAL CUFF GRANULOMA"). ON (B)(6) 2018, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), 5 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GRANULOMA ("POSTOP REMOVAL ON (B)(6) 18 OF VAGINAL CUFF GRANULOMA."), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FLATULENCE ("POST-OP GAS PAIN WERE BAD FOR 8 TO 10 HOURS"), DYSCHEZIA ("PAINFUL POO") AND FAECES HARD ("TAKING STOOL SOFTENER,EITHER PILL FORM OR NATURAL") AND UNDERWENT AXILLARY LYMPHADENECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VULVOVAGINAL CANDIDIASIS, AXILLARY LYMPHADENECTOMY, GRANULOMA, ABDOMINAL PAIN, FLATULENCE, DYSCHEZIA AND FAECES HARD OUTCOME WAS UNKNOWN, THE BACK PAIN, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED AND THE ENDOMETRIOSIS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, AXILLARY LYMPHADENECTOMY, BACK PAIN, DYSCHEZIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FAECES HARD, FLATULENCE, GRANULOMA, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS WERE VISIBLE ON THIS SIDE. ON THE RIGHT SIDE SIMILAR PROCEDURE WAS USED AND 5 COILS WERE VISIBLE AFTER THE ESSURE WAS PLACED ESSURE CONFIRMATION DATE AND REMOVAL DATE NOTED IS SAME (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2013: ESSURE PROCEDURE HAD COMPLETELY BLOCKED HER TUBES.; IN (B)(6) 2018: TOTAL BILATERAL OCCLUSION; IN (B)(6) 2018: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2018: SINGLE VIEW OF PELVIS: IMPRESSION: REMOVAL OF RADIOPAQUE DENSITIES IN THE PELVIS SINCE PRIOR EXAMINATION.SINGLE SPOT C- ARM VIEW IMPRESSION: CONTRACEPTIVE DEVICES IN THE PELVIS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: DYSMENORRHEA, DYSPAREUNIA, PELVIC PAIN, ENDOMETRIOSIS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: FLATULENCE, GASTROINTESTINAL DISORDER AND FAECES HARD QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-MAR-2020: SOCIAL MEDIA RECEIVED- NEW EVENT POST-OP GAS PAIN WERE BAD FOR 8 TO 10 HOURS, BOWEL PREP WAS NOT ORDERED, TAKING STOOL SOFTENER EITHER PILL FORM OR NATURAL WERE ADDED. REPORTER INFORMATION WAS ADDED. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND LYMPHADENECTOMY ('EXCISIONAL LYMPH NODE REMOVAL RIGHT AXILLA') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A78082) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POOR VISION, MENIERE'S DISEASE, MIGRAINE AND SEASONAL ALLERGY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, LYMPHADENOPATHY AND HEMOSTASIS. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL; ETONOGESTREL (NUVARING). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) AFTER HAVING THE ESSURE IMPLANTED,THE CRAMPS BEGAN BEFORE I BEGAN MY PERIODS AND CONTINUED THROUGH OUT THE ENTIRE PERIOD, UNLIKE BEFORE WHEN I EXPERIENCED ONE DAY OF CRAMPING AT THE BEGINNING OF MY PERIOD"). IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"). IN (B)(6) 2018, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DYSPAREUNIA ("OTHER INJURIES OR COMPLICATIONS-PLEASE DESCRIBE: PAIN WITH INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2018, THE PATIENT EXPERIENCED VULVOVAGINAL CANDIDIASIS ("VAGINAL CUFF GRANULOMA"). ON (B)(6) 2018, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), 5 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GRANULOMA ("POSTOP REMOVAL ON (B)(6) 2018 OF VAGINAL CUFF GRANULOMA.") AND UNDERWENT LYMPHADENECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VULVOVAGINAL CANDIDIASIS, LYMPHADENECTOMY AND GRANULOMA OUTCOME WAS UNKNOWN, THE BACK PAIN, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED AND THE ENDOMETRIOSIS WAS RESOLVING. THE REPORTER CONSIDERED BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, GRANULOMA, LYMPHADENECTOMY, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS WERE VISIBLE ON THIS SIDE. ON THE RIGHT SIDE SIMILAR PROCEDURE WAS USED AND 5 COILS WERE VISIBLE AFTER THE ESSURE WAS PLACED ESSURE CONFIRMATION DATE AND REMOVAL DATE NOTED IS SAME (B)(6) 2018. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2013: ESSURE PROCEDURE HAD COMPLETELY BLOCKED HER TUBES.. PATHOLOGY TEST - ON (B)(6) 2018: SINGLE VIEW OF PELVIS: IMPRESSION: REMOVAL OF RADIOPAQUE DENSITIES IN THE PELVIS SINCE PRIOR EXAMINATION. SINGLE SPOT C- ARM VIEW. IMPRESSION: CONTRACEPTIVE DEVICES IN THE PELVIS.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: DYSMENORRHEA, DYSPAREUNIA, PELVIC PAIN, ENDOMETRIOSIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-OCT-2019: PFS AND MR RECEIVED. LOT NUMBER ADDED. NEW EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ENDOMETRIOSIS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, LOWER BACK PAIN, POST OP REMOVAL OF VAGINAL CUFF GRANULOMA,EXCISIONAL LYMPH NODE REMOVAL RIGHT AXILLA WERE ADDED. EVENT OUTCOME OF DYSMENORRHEA(CRAMPING), PAIN(LOWER BACK), ENDOMETRIOSIS, ABNORMAL BLEEDING(VAGINAL), DYSPAREUNIA, VAGINAL DISCHARGE WERE UPDATED. DATE OF REMOVAL ADDED. MEDICAL HISTORY, CONCOMITANT CONDITIONS AND DRUGS WERE ADDED. LAB DATA 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1087304 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A78082 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | NUVARING| NUVARING| NUVARING| NUVARING |