ESSURE
Report
- Report Number
- 2951250-2019-04033
- Event Type
- Injury
- Date Received
- July 19, 2019
- Date of Event
- February 1, 2012
- Report Date
- March 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ENDOMETRIAL ABLATION PERFORMED ON THE SAME DAY WITH ESSURE MICRO-INSERT IMPLANTATION". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: THYROID VIATMIN D. CONCOMITANT PRODUCTS INCLUDED VITAMIN D NOS (VITAMIN D) SINCE 2000 FOR THYROID DISORDER AS WELL AS CONTRACEPTIVES FROM FEBRUARY 2018 TO MARCH 2018, HORMONES SINCE 2017, HYDROXYQUINOLINE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE APRIL 2018 AND THYROID SINCE 2000. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), TENDERNESS ("HORMONAL CHANGES DESCRIBE: TENDERNESS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE"), UTERINE PAIN ("UTERUS PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), AUTOIMMUNE ANAEMIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: ANEMIC") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON (B)(6) 2018, THE PATIENT EXPERIENCED OVARIAN CYST ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: OVARIAN CYSTS"), 6 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND ANAEMIA ("ANEMIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), WITH BLATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, UTERINE PAIN AND URINARY TRACT INFECTION HAD RESOLVED, THE TENDERNESS, FEMALE SEXUAL DYSFUNCTION, URINARY TRACT DISORDER, MIGRAINE, FATIGUE, DYSMENORRHOEA AND OVARIAN CYST OUTCOME WAS UNKNOWN AND THE BLADDER DISORDER, DYSPAREUNIA, AUTOIMMUNE ANAEMIA AND ANAEMIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANAEMIA, AUTOIMMUNE ANAEMIA, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, OVARIAN CYST, TENDERNESS, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAR-2020: PFS RECEIVED : EVENTS ADDED- ANEMIA. EVENTS OUTCOME UPDATED, EVENTS ONSET DATE ADDED. 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 ABDOMINAL PAIN ('ABDOMINAL PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ENDOMETRIAL ABLATION PERFORMED ON THE SAME DAY WITH ESSURE MICRO-INSERT IMPLANTATION". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: THYROID VITAMIN D. CONCOMITANT PRODUCTS INCLUDED VITAMIN D NOS (VITAMIN D) SINCE (B)(6) FOR THYROID DISORDER AS WELL AS THYROID SINCE (B)(6). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE"), UTERINE PAIN ("UTERUS PAIN") AND DYSPAREUNIA ("PAINFUL INTERCOURSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, HORMONE LEVEL ABNORMAL, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, FATIGUE, UTERINE PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BLADDER DISORDER, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, URINARY TRACT DISORDER, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-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 ABDOMINAL PAIN ('ABDOMINAL PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ENDOMETRIAL ABLATION PERFORMED ON THE SAME DAY WITH ESSURE MICRO-INSERT IMPLANTATION". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: THYROID VIATMIN D. CONCOMITANT PRODUCTS INCLUDED VITAMIN D NOS (VITAMIN D) SINCE 2000 FOR THYROID DISORDER AS WELL AS CONTRACEPTIVES FROM (B)(6) 2018 TO (B)(6) 2018, HORMONES SINCE 2017, HYDROXYQUINOLINE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE (B)(6) 2018 AND THYROID SINCE 2000. ON (B)(6) 2011 , THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), TENDERNESS ("HORMONAL CHANGES DESCRIBE: TENDERNESS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE"), UTERINE PAIN ("UTERUS PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), ANAEMIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: ANEMIC") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND OVARIAN CYST ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: OVARIAN CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), WITH BLATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, UTERINE PAIN AND URINARY TRACT INFECTION HAD RESOLVED, THE TENDERNESS, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, FATIGUE, DYSMENORRHOEA AND OVARIAN CYST OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA AND ANAEMIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANAEMIA, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, OVARIAN CYST, TENDERNESS, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-NOV-2019: PFS RECEIVED. NEW EVENTS: INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI, AUTOIMMUNE DISORDER TYPE OF DISORDER: ANEMIC, DYSMENORRHEA (CRAMPING),OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: OVARIAN CYSTS WERE ADDED. HORMONAL CHANGES UPDATED TO HORMONAL CHANGES DESCRIBE: TENDERNESS, EVENT ONSET DATES UPDATED. OUTCOME FOR EVENTS AND CONCOMITANT DRUGS WERE 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 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 ABDOMINAL PAIN ('ABDOMINAL PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ENDOMETRIAL ABLATION PERFORMED ON THE SAME DAY WITH ESSURE MICRO-INSERT IMPLANTATION". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: THYROID VITAMIN D. CONCOMITANT PRODUCTS INCLUDED VITAMIN D NOS (VITAMIN D) SINCE 2000 FOR THYROID DISORDER AS WELL AS THYROID SINCE 2000. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE"), UTERINE PAIN ("UTERUS PAIN") AND DYSPAREUNIA ("PAINFUL INTERCOURSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, HORMONE LEVEL ABNORMAL, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, FATIGUE, UTERINE PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BLADDER DISORDER, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, URINARY TRACT DISORDER, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUL-2019: PFS RECEIVED. THIS CASE BECAME INCIDENT. PREVIOUSLY REPORTED EVENT INJURY WAS REPLACED WITH NEW EVENTS- ABDOMINAL PAIN, HORMONAL CHANGES, ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES / HEADACHES, FATIGUE, UTERUS PAIN, PAINFUL INTERCOURSE AND ENDOMETRIAL ABLATION PERFORMED ON THE SAME DAY WITH ESSURE MICRO-INSERT IMPLANTATION. LOT NUMBER WAS ADDED. LAB DATA WAS ADDED. REPORTER'S INFORMATION AND CONCOMITANT DRUG WERE 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 |
|---|---|---|---|---|---|---|---|
| 602634 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863570 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R | CONTRACEPTIVES| CONTRACEPTIVES| DEPO PROVERA| DEPO PROVERA| HORMONES| HORMONES| HYDROXYQUINOLINE| HYDROXYQUINOLINE| THYROID| THYROID| THYROID| THYROID| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| THYROID| VITAMIN D [VITAMIN D NOS] |