ESSURE
Report
- Report Number
- 2951250-2021-03343
- Event Type
- Injury
- Date Received
- October 11, 2021
- Report Date
- October 14, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628311) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT DONE" AND DEVICE DIFFICULT TO USE "THERE WAS DIFFICULTY INSERTING BOTH ESSURE COILS DUE TO NOT BEING ABLE TO SEE BOTH OSTIA CLEARLY". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CERVICITIS. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("CHRONIC, DYSMENNORHEA (CRAMPING),"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN 2011, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2015, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITION: MEMORY LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), BACK PAIN ("BACK PAIN"), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEED"), INTERMENSTRUAL BLEEDING ("METORHAGIA (BLEEDING B/WC PERIODS)"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), HEADACHE ("HEADACHES"), ANXIETY ("ANXIETY"), BLADDER DISORDER ("BLADDER PROBLEMS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), WEIGHT FLUCTUATION ("WEIGHT GAIN / WEIGHT LOSS"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND DEPRESSION ("DEPRESSION") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, VAGINAL HAEMORRHAGE, IRON DEFICIENCY ANAEMIA, VAGINAL DISCHARGE, HEADACHE, ANXIETY, BLADDER DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, HORMONE LEVEL ABNORMAL, NAUSEA, WEIGHT FLUCTUATION, URINARY TRACT DISORDER, DEPRESSION, MIGRAINE AND AMNESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, INTERMENSTRUAL BLEEDING, IRON DEFICIENCY ANAEMIA, MIGRAINE, NAUSEA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR CHRONIC, DYSMENNORHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, PSYCH INJURY RELATED TO ESSURE, THERE WAS DIFFICULTY INSERTING BOTH ESSURE COILS DUE TO NOT BEING ABLE TO SEE BOTH OSTIA CLEARLY; HOWEVER A COIL WAS IMPLANTED IN MY LEFT TUBE. AFTERWARDS, DOCTOR CONTINUED WITH TUBAL LIGATION FOR THE RIGHT TUBE. (B)(6) 2009). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2021: CERVIX ¿ ACUTE AND CHRONIC CERVICITIS. ENDOMETRIUM - SECRETORY PHASE. MYOMETRIUM - NO SIGNIFICANT PATHOLOGIC ABNORMALITY. UTERINE SEROSA - NO SIGNIFICANT PATHOLOGIC ABNORMALITY. FALLOPIAN TUBES - NO SIGNIFICANT PATHOLOGIC ABNORMALITY; COMPLETE TUBAL CROSS-SECTIONS IDENTIFIED. LOT NUMBER: 628311, MANUFACTURING DATE: 2008/10 ,EXPIRATION DATE: 2011/10. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-OCT-2021: 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 ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628311) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT DONE" AND DEVICE DIFFICULT TO USE "THERE WAS DIFFICULTY INSERTING BOTH ESSURE COILS DUE TO NOT BEING ABLE TO SEE BOTH OSTIA CLEARLY". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CERVICITIS. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("CHRONIC, DYSMENORRHEA (CRAMPING),"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MIGRAINE ("MIGRAINES / HEADACHES"). IN 2011, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2015, THE PATIENT EXPERIENCED AMNESIA ("NEUROLOGICAL CONDITION: MEMORY LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), BACK PAIN ("BACK PAIN"), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEED"), INTERMENSTRUAL BLEEDING ("MASTORRHAGIA (BLEEDING B/WC PERIODS)"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), HEADACHE ("HEADACHES"), ANXIETY ("ANXIETY"), BLADDER DISORDER ("BLADDER PROBLEMS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), TOOTH DISORDER ("DENTAL PROBLEMS"), NAUSEA ("NAUSEA"), WEIGHT FLUCTUATION ("WEIGHT GAIN / WEIGHT LOSS"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND DEPRESSION ("DEPRESSION") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, VAGINAL HAEMORRHAGE, IRON DEFICIENCY ANAEMIA, VAGINAL DISCHARGE, HEADACHE, ANXIETY, BLADDER DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, TOOTH DISORDER, HORMONE LEVEL ABNORMAL, NAUSEA, WEIGHT FLUCTUATION, URINARY TRACT DISORDER, DEPRESSION, MIGRAINE AND AMNESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, INTERMENSTRUAL BLEEDING, IRON DEFICIENCY ANAEMIA, MIGRAINE, NAUSEA, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR CHRONIC, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, PSYCH INJURY RELATED TO ESSURE, THERE WAS DIFFICULTY INSERTING BOTH ESSURE COILS DUE TO NOT BEING ABLE TO SEE BOTH OSTIA CLEARLY; HOWEVER A COIL WAS IMPLANTED IN MY LEFT TUBE. AFTERWARDS, DOCTOR CONTINUED WITH TUBAL LIGATION FOR THE RIGHT TUBE, (B)(6) 2009). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2021: CERVIX ¿ ACUTE AND CHRONIC CERVICITIS, ENDOMETRIUM - SECRETORY PHASE, MYOMETRIUM - NO SIGNIFICANT PATHOLOGIC ABNORMALITY, UTERINE SEROSA - NO SIGNIFICANT PATHOLOGIC ABNORMALITY, FALLOPIAN TUBES - NO SIGNIFICANT PATHOLOGIC ABNORMALITY; COMPLETE TUBAL CROSS-SECTIONS IDENTIFIED. LOT NUMBER: 628311, MANUFACTURING DATE: 2008/10, EXPIRATION DATE: 2011/10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 01-OCT-2021: MR RECEIVED. CASE BECAME SERIOUS INCIDENT AS ESSURE WAS REMOVED. ESSURE REMOVAL DETAILS, REPORTER AND MEDICAL HISTORY 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1508692 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 628311 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |