ESSURE
Report
- Report Number
- 2951250-2017-03944
- Event Type
- Injury
- Date Received
- September 25, 2017
- Date of Event
- April 29, 2011
- Report Date
- May 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE DISEASE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATEINT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENSES IRREGULAR AND INTRAMURAL LEIOMYOMA OF UTERUS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH,"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY DUE TO COMPLICATIONS OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE AUTOIMMUNE DISORDER, DYSPAREUNIA, ALOPECIA, MENSTRUAL DISORDER, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, DEPRESSION, DYSPAREUNIA, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: (B)(6) 2016 - PATHOLOGIC DIAGNOSIS. CERVIX, UTERUS, AND BILATERAL TUBES (179.5 G); ROBOTICALLY. ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL. SALPINGECTOMY: MILD CHRONIC CERVICITIS. BENIGN INACTIVE ENDOMETRIUM. LEIOMYOMA. BENIGN FALLOPIAN TUBES. SPECIMEN(S) RECEIVED. CERVIX, UTERUS, BILATERAL TUBES. CLINICAL HISTORY: PRE-OPERATIVE DIAGNOSIS POST- OPERATIVE DIAGNOSIS: FIBROID UTERUS. SURGICAL PROCEDURE. ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT) INCIDENT AT THE TIME: OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENSES IRREGULAR, INTRAMURAL LEIOMYOMA OF UTERUS, INFLAMMATORY ARTHRITIS, NUMBNESS, TINGLING, SWELLING NOS, TENDERNESS, OSTEOARTHRITIS AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D3) SINCE 2010, CYCLOBENZAPRINE SINCE 2010, ELETRIPTAN SINCE 2011, ESOMEPRAZOLE MAGNESIUM (NEXIUM) SINCE 2010, EUGYNON (AVIANE) FROM (B)(6) 2011 TO (B)(6) 2011, METOPROLOL SINCE 2010, MULTIVITAMIN SINCE 2010, NORTRIPTYLINE SINCE 2014 AND TOPIRAMATE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URTICARIA ("HIVES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OSTEOARTHRITIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: ARTHRITIS/OSTEOARTHRITIS") WITH ARTHRALGIA AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH,"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), CHEST PAIN ("STERNAL PAIN") AND MYALGIA ("MUSCLE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY DUE TO COMPLICATIONS OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN LOWER WAS RESOLVING AND THE OSTEOARTHRITIS, DYSPAREUNIA, ALOPECIA, MENSTRUAL DISORDER, MIGRAINE, HYPERSENSITIVITY, DEPRESSION, ANXIETY, HEADACHE, URTICARIA, DYSMENORRHOEA, CHEST PAIN AND MYALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, CHEST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MYALGIA, OSTEOARTHRITIS, PELVIC PAIN, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.3 KG/SQM. (B)(6) 2016 - PATHOLOGIC DIAGNOSIS: CERVIX, UTERUS, AND BILATERAL TUBES (179.5 G); ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: MILD CHRONIC CERVICITIS. BENIGN INACTIVE ENDOMETRIUM. LEIOMYOMA. BENIGN FALLOPIAN TUBES. SPECIMEN(S) RECEIVED CERVIX, UTERUS, BILATERAL TUBES CLINICAL HISTORY: PRE-OPERATIVE DIAGNOSIS POST- OPERATIVE DIAGNOSIS: FIBROID UTERUS SURGICAL PROCEDURE ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2018: PFS RECEIVED: EVENT AUTOIMMUNE DISORDER UPDATED TO ARTHRITIS/OSTEOARTHRITIS, HEADACHES, HIVES, DYSMENORRHEA, WEIGHT LOSS, LOWER ABDOMINAL PAIN, STERNAL PAIN, JOINT PAIN, MUSCLE PAIN ADDED. EVENT ABNORMAL BLEEDING, CRAMPING OUTCOME ADDED AS RECOVERING AND CONCOMITANT MEDICATION, CONCURRENT CONDITION ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE DISEASE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "PATEINT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENSES IRREGULAR AND INTRAMURAL LEIOMYOMA OF UTERUS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH,"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY DUE TO COMPLICATIONS OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE AUTOIMMUNE DISORDER, DYSPAREUNIA, ALOPECIA, MENSTRUAL DISORDER, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, DEPRESSION, DYSPAREUNIA, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: (B)(6) 2016 - PATHOLOGIC DIAGNOSIS. CERVIX, UTERUS, AND BILATERAL TUBES (179.5 G); ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: MILD CHRONIC CERVICITIS. BENIGN INACTIVE ENDOMETRIUM. LEIOMYOMA. BENIGN FALLOPIAN TUBES. SPECIMEN(S) RECEIVED CERVIX, UTERUS, BILATERAL TUBES CLINICAL HISTORY: PRE-OPERATIVE DIAGNOSIS POST- OPERATIVE DIAGNOSIS: FIBROID UTERUS. SURGICAL PROCEDURE: ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUL-2018: NEW PFS + MR RECEIVED- NEW EVENTS ADDED: ABNORMAL BLEEDING (VAGINAL,MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH,PATIENT DID NOT UNDERWENT ESUURE CONFIRMATION TEST WERE ADDED. LOT NUMBER AND NEW REPORTER WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENSES IRREGULAR, INTRAMURAL LEIOMYOMA OF UTERUS, INFLAMMATORY ARTHRITIS, NUMBNESS, TINGLING, SWELLING NOS, TENDERNESS, OSTEOARTHRITIS AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D3) SINCE 2010, CYCLOBENZAPRINE SINCE 2010, ELETRIPTAN SINCE 2011, ESOMEPRAZOLE SINCE 2010, ETHINYLESTRADIOL;LEVONORGESTREL (AVIANE) FROM APRIL 2011 TO MAY 2011, METOPROLOL SINCE 2010, NORTRIPTYLINE SINCE 2014, TOPIRAMATE AND VITAMINS NOS (MULTIVITAMIN) SINCE 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URTICARIA ("HIVES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OSTEOARTHRITIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: ARTHRITIS/OSTEOARTHRITIS") WITH ARTHRALGIA AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH,"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), CHEST PAIN ("STERNAL PAIN") AND MYALGIA ("MUSCLE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY DUE TO COMPLICATIONS OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN LOWER WAS RESOLVING, THE OSTEOARTHRITIS, DYSPAREUNIA, ALOPECIA, MENSTRUAL DISORDER, MIGRAINE, DEPRESSION, ANXIETY, HEADACHE, URTICARIA, DYSMENORRHOEA, CHEST PAIN AND MYALGIA OUTCOME WAS UNKNOWN AND THE HYPERSENSITIVITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, CHEST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MYALGIA, OSTEOARTHRITIS, PELVIC PAIN, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING AND ALLERGIC REACTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.3 KG/SQM. PATHOLOGY TEST - ON (B)(6) 2016: CERVIX, UTERUS, AND BILATERAL TUBES (179.5 G); ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL. SALPINGECTOMY: MILD CHRONIC CERVICITIS. BENIGN INACTIVE ENDOMETRIUM. LEIOMYOMA. BENIGN FALLOPIAN TUBES. SPECIMEN(S) RECEIVED CERVIX, UTERUS, BILATERAL TUBES CLINICAL HISTORY: PRE-OPERATIVE DIAGNOSIS POST- OPERATIVE DIAGNOSIS: FIBROID UTERUS SURGICAL PROCEDURE ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED: EVENT OUTCOME WAS ADDED FOR ALLERGIC REACTION. 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 ('SEVERE PELVIC PAIN') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENSES IRREGULAR, INTRAMURAL LEIOMYOMA OF UTERUS, INFLAMMATORY ARTHRITIS, NUMBNESS, TINGLING, SWELLING NOS, TENDERNESS, OSTEOARTHRITIS AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CHOLECALCIFEROL (VITAMIN D3) SINCE 2010, CYCLOBENZAPRINE SINCE 2010, ELETRIPTAN SINCE 2011, ESOMEPRAZOLE SINCE 2010, ETHINYLESTRADIOL;LEVONORGESTREL (AVIANE) (B)(6) 2011, METOPROLOL SINCE 2010, NORTRIPTYLINE SINCE 2014, TOPIRAMATE AND VITAMINS NOS (MULTIVITAMIN) SINCE 2010. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA"). ON (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URTICARIA ("HIVES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED OSTEOARTHRITIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: ARTHRITIS/OSTEOARTHRITIS") WITH ARTHRALGIA AND HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MIGRAINE ("MIGRAINES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH,"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), CHEST PAIN ("STERNAL PAIN") AND MYALGIA ("MUSCLE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY DUE TO COMPLICATIONS OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN LOWER WAS RESOLVING, THE OSTEOARTHRITIS, DYSPAREUNIA, ALOPECIA, MENSTRUAL DISORDER, MIGRAINE, DEPRESSION, ANXIETY, HEADACHE, URTICARIA, DYSMENORRHOEA, CHEST PAIN AND MYALGIA OUTCOME WAS UNKNOWN AND THE HYPERSENSITIVITY HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, CHEST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MYALGIA, OSTEOARTHRITIS, PELVIC PAIN, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING AND ALLERGIC REACTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.3 KG/SQM. PATHOLOGY TEST - ON (B)(6) 2016: CERVIX, UTERUS, AND BILATERAL TUBES (179.5 G); ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: MILD CHRONIC CERVICITIS. BENIGN INACTIVE ENDOMETRIUM. LEIOMYOMA. BENIGN FALLOPIAN TUBES. SPECIMEN(S) RECEIVED CERVIX, UTERUS, BILATERAL TUBES CLINICAL HISTORY: PRE-OPERATIVE DIAGNOSIS POST- OPERATIVE DIAGNOSIS: FIBROID UTERUS SURGICAL PROCEDURE ROBOTICALLY ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY. LOT NUMBER: 822372 MANUFACTURING DATE: 2011-01, EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAY-2020: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 ("SEVERE PELVIC PAIN") AND AUTOIMMUNE DISORDER ("AUTO-IMMUNE DISEASE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY DUE TO COMPLICATIONS OF ESSURE DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, DYSPAREUNIA, ALOPECIA, MENSTRUAL DISORDER AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE DISORDER, DYSPAREUNIA, MENSTRUAL DISORDER, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669294 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | AVIANE| AVIANE| AVIANE| CYCLOBENZAPRINE| CYCLOBENZAPRINE| CYCLOBENZAPRINE| ELETRIPTAN| ELETRIPTAN| ELETRIPTAN| ESOMEPRAZOLE| ESOMEPRAZOLE| METOPROLOL| METOPROLOL| METOPROLOL| MULTIVITAMIN| MULTIVITAMIN [VITAMINS NOS]| MULTIVITAMIN [VITAMINS NOS]| NEXIUM| NORTRIPTYLINE| NORTRIPTYLINE| NORTRIPTYLINE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| VITAMIN D3| VITAMIN D3| VITAMIN D3 |