ESSURE
Report
- Report Number
- 2951250-2019-07393
- Event Type
- Injury
- Date Received
- September 20, 2019
- Report Date
- March 27, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), URINARY INCONTINENCE ("BLADDER/URINARY PROBLEMS : BLADDER PROBLEMS / INCONTINENECE"), ALOPECIA ("OTHER INJURIES/SYMPTOMS : HAIR LOSS"), MIGRAINE ("MIGRAINE/HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"), 26 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ARTHRALGIA ("HIP PAIN") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, URINARY INCONTINENCE, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND UTERINE LEIOMYOMA HAD RESOLVED, THE NEOPLASM AND ARTHRALGIA OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ARTHRALGIA, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NEOPLASM, PELVIC PAIN, URINARY INCONTINENCE, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR HAIR LOSS, TUMORS, MIGRAINE DISCREMPTENCY: INSERTION DATE- (B)(6) 2012, (B)(6) 2012. REMOVAL DATE- (B)(6) 2017, (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 863570 MANUFACTURE DATE: (B)(6) 2011 EXPIRATION DATE: (B)(6) 2014. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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. 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), URINARY INCONTINENCE ("BLADDER/URINARY PROBLEMS : BLADDER PROBLEMS / INCONTINENECE"), ALOPECIA ("OTHER INJURIES/SYMPTOMS : HAIR LOSS"), MIGRAINE ("MIGRAINE/HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2017, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ARTHRALGIA ("HIP PAIN") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, URINARY INCONTINENCE, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND UTERINE LEIOMYOMA HAD RESOLVED, THE NEOPLASM AND ARTHRALGIA OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ARTHRALGIA, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NEOPLASM, PELVIC PAIN, URINARY INCONTINENCE, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR HAIR LOSS, TUMORS, MIGRAINE DISCREMPTENCY: INSERTION DATE- (B)(6) 2012, (B)(6) 2012 REMOVAL DATE- (B)(6) 2017, (B)(6) 2017. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 01-SEP-2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-FEB-2020: PFS AND MR RECEIVED: LOT NO. WAS ADDED. EXPIRATION DATE WAS ADDED. PATIENT DEMOGRAPHIC WAS ADDED. REPORTER 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 GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), INCONTINENCE ("BLADDER/URINARY PROBLEMS : BLADDER PROBLEMS / INCONTINENECE"), ALOPECIA ("OTHER INJURIES/SYMPTOMS : HAIR LOSS"), MIGRAINE ("MIGRAINE/HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2017, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ARTHRALGIA ("HIP PAIN") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, INCONTINENCE, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND UTERINE LEIOMYOMA HAD RESOLVED, THE NEOPLASM AND ARTHRALGIA OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ARTHRALGIA, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, INCONTINENCE, MENORRHAGIA, MIGRAINE, NEOPLASM, PELVIC PAIN, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR HAIR LOSS, TUMORS, MIGRAINE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 01-SEP-2012: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2019: PFS RECEIVED: EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INCONTINENCE, FIBROIDS, HIP PAIN WERE ADDED. EVENT OUTCOME OF ALL EVENTS WERE UPDATED. LAB DATA WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 GENITAL HAEMORRHAGE ('GEN. ABNORMAL BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS: BLADDER PROBLEMS"), ALOPECIA ("OTHER INJURIES/SYMPTOMS: HAIR LOSS") AND MIGRAINE ("MIGRAINE") AND WAS FOUND TO HAVE NEOPLASM ("TUMORS"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2017, HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN HAD RESOLVED AND THE BLADDER DISORDER, ALOPECIA, NEOPLASM AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, NEOPLASM AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR HAIR LOSS, TUMORS, MIGRAINE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2012: UNSPECIFIED BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED EVENTS. EVENT INJURY DELETED AND UPDATED TO EVENTS "DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC/ABDOMINAL PAIN, GEN. ABNORMAL BLEEDING,BLADDER PROBLEMS. HAIR LOSS, TUMORS, MIGRAINE" WERE ADDED. OUTCOME OF EVENTS ":PAIN, BLEEDING" WERE UPDATED AS RECOVERED. LAB DATA WAD ADDED. INCIDENT. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 893536 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863570 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R |