ESSURE
Report
- Report Number
- 2951250-2020-00426
- Event Type
- Injury
- Date Received
- January 15, 2020
- Date of Event
- December 1, 2011
- Report Date
- March 3, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2133036- NOT VALID, 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2, CESAREAN SECTION, HYPERTENSION, ANXIETY AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION, TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NIGHT SWEATS ("NIGHT SWEATS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, ENDOMETRIOSIS, HOT FLUSH, NIGHT SWEATS, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, HOT FLUSH, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE COIL WAS PROTRUDING INTO THE RIGHT FALLOPIAN TUBE THREE COILS WERE PROTRUDING INTO THE LEFT FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT OF THE TEST: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-FEB-2020: 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2133036- NOT VALID, 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 AND CESAREAN SECTION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION, TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NIGHT SWEATS ("NIGHT SWEATS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, ENDOMETRIOSIS, HOT FLUSH, NIGHT SWEATS, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, HOT FLUSH, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE COIL WAS PROTRUDING INTO THE RIGHT FALLOPIAN TUBE THREE COILS WERE PROTRUDING INTO THE LEFT FALLOPIAN TUBE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT OF THE TEST: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2020: MEDICAL RECORDS RECEIVED. LOT NUMBER ADDED. REPORTER INFORMATION UPDATED. HISTORICAL & CONCOMITANT CONDITIONS , DRUGS 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 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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2133036- NOT VALID, 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2, CESAREAN SECTION, HYPERTENSION, ANXIETY AND ANEMIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION, TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NIGHT SWEATS ("NIGHT SWEATS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, ENDOMETRIOSIS, HOT FLUSH, NIGHT SWEATS, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, HOT FLUSH, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE COIL WAS PROTRUDING INTO THE RIGHT FALLOPIAN TUBE THREE COILS WERE PROTRUDING INTO THE LEFT FALLOPIAN TUBE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT OF THE TEST: TOTAL BILATERAL OCCLUSION. LOT NUMBER REPORTED ( 2133036) IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). ON (B)(6) 2020: MEDICAL RECORDS RECEIVED : MEDICAL HISTORY 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 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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2133036- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION, TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NIGHT SWEATS ("NIGHT SWEATS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, ENDOMETRIOSIS, HOT FLUSH, NIGHT SWEATS, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, HOT FLUSH, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT OF THE TEST: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JAN-2020: ¿UPDATE OF INFORMATION (BATCH IS NOT VALID).¿ BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2133036) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION, TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS"), HOT FLUSH ("HORMONAL CHANGES DESCRIBE: HOT FLASHES"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NIGHT SWEATS ("NIGHT SWEATS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, MIGRAINE, DYSPAREUNIA, ENDOMETRIOSIS, HOT FLUSH, NIGHT SWEATS, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, HOT FLUSH, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT OF THE TEST: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-DEC-2019: FU 2 & FU 3 WERE PROCESSED TOGETHER. PLAINTIFF FACT SHEET RECEIVED: LOT NO. WAS ADDED. NEW EVENTS - HORMONAL CHANGES DESCRIBE: HOT FLASHES, NIGHT SWEATS, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), MIGRAINES / HEADACHES, REPRODUCTIVE SYSTEM DISORDER OR CONDITION, TYPE OF DISORDER OR CONDITION: ENDOMETRIOSIS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, VAGINAL PAIN, ABDOMINAL PAIN, FATIGUE, HAIR LOSS WERE ADDED. REPORTER'S INFORMATION, PATIENT DEMOGRAPHY WERE ADDED. SEVERITY OF EVENT VAGINAL PAIN, PELVIC PAIN, ABDOMINAL PAIN WERE UPDATED AS SEVERE. ON 27-DEC-2019: FU 2 & FU 3 WERE PROCESSED TOGETHER. PLAINTIFF FACT SHEET RECEIVED: CONCOMITANT DRUG WAS ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 56287 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 2133036- NOT VALID, 882184 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA |