ESSURE
Report
- Report Number
- 2951250-2017-04358
- Event Type
- Injury
- Date Received
- October 6, 2017
- Date of Event
- July 11, 2012
- Report Date
- May 22, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 12530959, 940970, A02662, A02662) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED OMEPRAZOLE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 28 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA AND ABDOMINAL PAIN LOWER WAS RESOLVING AND THE MENSTRUAL DISORDER, WEIGHT INCREASED, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, VAGINAL DISCHARGE, FATIGUE AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION WAS RECEIVED IN INSERTION DATE-(B)(6) 2013 AND (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 70.748 KGS. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUL-2018: PFS AND MEDICAL RECORD RECEIVED: LOT NUMBER, REPORTER INFORMATION, PATIENT DETAILS, LAB DATA, PRODUCT INFORMATION, CONCOMITANT DRUG AND EVENTS: ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, MENTAL ANGUISH, MIGRAINES, HEADACHES, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, HAIR LOSS, PAIN PELVIC AREA, CRAMPING 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 12530959, 940970, A02662-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED OMEPRAZOLE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 29 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA AND ABDOMINAL PAIN LOWER WAS RESOLVING AND THE MENSTRUAL DISORDER, WEIGHT INCREASED, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, VAGINAL DISCHARGE, FATIGUE AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION WAS RECEIVED IN INSERTION DATE (B)(6) 2013 AND (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 70.748 KGS. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. LOT NUMBERS AND EXP/MFG DATES: BATCH NUMBER: 12530959 MAN DATE: 2012/05 EXP DATE: 2015/03. BATCH NUMBER: 940970 MAN DATE: 2012/01 EXP DATE: 2015/01. BATCH NUMBER: A02662 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINTS. 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 / PELVIC AREA') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 12530959, 940970) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND OMEPRAZOLE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN LOWER ("CRAMPING") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED, THE MENSTRUAL DISORDER, WEIGHT INCREASED, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, VAGINAL DISCHARGE, FATIGUE AND ALOPECIA OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANT INFORMATION WAS RECEIVED IN INSERTION DATE- (B)(6) 2013 AND (B)(6) 2012 LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS-ESSURE REMOVAL RECEIVED TREATMENT FOR PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBERS AND EXP/MFG DATES BATCH NUMBER: 12530959, MAN DATE: 2012/05, EXP DATE: 2015/03. BATCH NUMBER: 940970, MAN DATE: 2012/01, EXP DATE: 2015/01. BATCH NUMBER: A02662 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: EVENT GENITAL BLEEDING WAS ADDED. OUTCOME OF THE EVENT PAIN UPDATED TO RECOVERED. 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") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUAL DISORDER AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER, PELVIC PAIN AND WEIGHT INCREASED 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 |
|---|---|---|---|---|---|---|---|
| 704422 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 12530959, 940970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | IBUPROFEN| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE |