ESSURE
Report
- Report Number
- 2951250-2017-10624
- Event Type
- Injury
- Date Received
- December 12, 2017
- Date of Event
- May 1, 2012
- Report Date
- February 20, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940871 INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HEMORRHAGE ("HEAVY VAGINAL BLEEDING / ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE/ DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("PAINFUL INTERCOURSE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), INFECTION ("MULTIPLE INFECTION"), MIGRAINE ("MIGRAINE") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (B)(6) 2013 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY WITH LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN, DYSPAREUNIA, INFECTION, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HEMORRHAGE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUL-2018: QUALITY DEPARTMENT MENTIONED THAT THE REPORTED LOT NUMBER 940871 WAS INVALID. FDA CODES WERE ADDED. NO FOLLOW-UP PTC INVESTIGATION WILL BE PROVIDED. INCIDENT: NO VALID 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940871) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING / ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE/ DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("PAINFUL INTERCOURSE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), INFECTION ("MULTIPLE INFECTION"), MIGRAINE ("MIGRAINE") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2013 HYSTERECTOMY WITH BILATERAL SALPHINGECTOMY WITH LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN, DYSPAREUNIA, INFECTION, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2018: PFS RECEIVED: THE EVENT MENORRHAGIA ADDED. REPORTER AND LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940871 NOT VALID, 940971) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING / ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE/ DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("PAINFUL INTERCOURSE, DYSPAREUNIA PAINFUL SEXUAL INTERCOURSE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME ("POTS"). IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE/ MIGRAINES/ HEADACHES"), NAUSEA ("NAUSEA"), DIARRHOEA ("DIARRHEA"), IRRITABLE BOWEL SYNDROME ("IBS"), MENTAL IMPAIRMENT ("MENTAL FOG") AND DIZZINESS ("DIZZINESS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), RASH ("SKIN RASHES"), URTICARIA ("HIVES"), INFECTION ("MULTIPLE INFECTION"), ALOPECIA ("HAIR LOSS"), CHRONIC FATIGUE SYNDROME ("CFS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), ARTHRALGIA ("JOINT PAIN"), ABDOMINAL PAIN UPPER ("UPPER ABDOMEN PAIN/ STOMACH PAIN"), RENAL PAIN ("KIDNEY PAIN"), LYMPHADENOPATHY ("SWOLLEN LYMPH NODES"), OVARIAN CYST RUPTURED ("RUPTURING OVARIAN CYSTS"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY DISORDERS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND BLOOD PRESSURE ABNORMAL ("BLOOD PRESSURE ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN, DYSPAREUNIA, RASH, URTICARIA, INFECTION, MIGRAINE, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, WEIGHT INCREASED, NAUSEA, DIARRHOEA, ALOPECIA, CHRONIC FATIGUE SYNDROME, IRRITABLE BOWEL SYNDROME, MENTAL IMPAIRMENT, DIZZINESS, WEIGHT FLUCTUATION, ARTHRALGIA, ABDOMINAL PAIN UPPER, RENAL PAIN, LYMPHADENOPATHY, BLOOD PRESSURE ABNORMAL, OVARIAN CYST RUPTURED, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ALOPECIA, ARTHRALGIA, BLADDER DISORDER, BLOOD PRESSURE ABNORMAL, CHRONIC FATIGUE SYNDROME, DIARRHOEA, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, INFECTION, IRRITABLE BOWEL SYNDROME, LYMPHADENOPATHY, MENORRHAGIA, MENTAL IMPAIRMENT, MIGRAINE, NAUSEA, OVARIAN CYST RUPTURED, PELVIC PAIN, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, RASH, RENAL PAIN, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATES: (B)(6) 2012. DISCREPANCY NOTED IN REMOVAL DATES: (B)(6) 2013 & (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JAN-2020: PLAINTIFF FACT SHEET RECEIVED: LOT NO ADDED. NEW EVENTS - POTS, WEIGHT GAIN, NAUSEA, DIARRHEA, HAIR LOSS, CFS, SKIN RASHES, IBS, MENTAL FOG, DIZZINESS, WEIGHT FLUCTUATION, JOINT PAIN, UPPER ABDOMEN PAIN, KIDNEY PAIN, BLOOD PRESSURE ISSUES, RUPTURING OVARIAN CYSTS, DID NOT UNDERGO ESSURE CONFIRMATION TEST, BLADDER PROBLEMS, URINARY DISORDERS WERE ADDED. REPORTER¿S INFORMATION, PATIENT DEMOGRAPHY, MEDICAL HISTORY, CONCOMITANT CONDITION, CONCOMITANT 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/ PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940871 NOT VALID, 940971) 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 "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING / ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE/ DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("PAINFUL INTERCOURSE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME ("POTS"). IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE/ MIGRAINES/ HEADACHES"), NAUSEA ("NAUSEA"), DIARRHOEA ("DIARRHEA"), IRRITABLE BOWEL SYNDROME ("IBS"), MENTAL IMPAIRMENT ("MENTAL FOG") AND DIZZINESS ("DIZZINESS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), RASH ("SKIN RASHES"), URTICARIA ("HIVES"), INFECTION ("MULTIPLE INFECTION"), ALOPECIA ("HAIR LOSS"), CHRONIC FATIGUE SYNDROME ("CFS"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATION"), ARTHRALGIA ("JOINT PAIN"), ABDOMINAL PAIN UPPER ("UPPER ABDOMEN PAIN/ STOMACH PAIN"), RENAL PAIN ("KIDNEY PAIN"), LYMPHADENOPATHY ("SWOLLEN LYMPH NODES"), OVARIAN CYST RUPTURED ("RUPTURING OVARIAN CYSTS"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY DISORDERS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND BLOOD PRESSURE ABNORMAL ("BLOOD PRESSURE ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND LEFT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN, DYSPAREUNIA, RASH, URTICARIA, INFECTION, MIGRAINE, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, WEIGHT INCREASED, NAUSEA, DIARRHOEA, ALOPECIA, CHRONIC FATIGUE SYNDROME, IRRITABLE BOWEL SYNDROME, MENTAL IMPAIRMENT, DIZZINESS, WEIGHT FLUCTUATION, ARTHRALGIA, ABDOMINAL PAIN UPPER, RENAL PAIN, LYMPHADENOPATHY, BLOOD PRESSURE ABNORMAL, OVARIAN CYST RUPTURED, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ALOPECIA, ARTHRALGIA, BLADDER DISORDER, BLOOD PRESSURE ABNORMAL, CHRONIC FATIGUE SYNDROME, DIARRHOEA, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, INFECTION, IRRITABLE BOWEL SYNDROME, LYMPHADENOPATHY, MENORRHAGIA, MENTAL IMPAIRMENT, MIGRAINE, NAUSEA, OVARIAN CYST RUPTURED, PELVIC PAIN, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, RASH, RENAL PAIN, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATES: (B)(6)2012 DISCREPANCY NOTED IN REMOVAL DATES: (B)(6)2013, (B)(6)2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25 KG/SQM. LOT NUMBER 940871 IS INVALID. LOT NUMBER: 940971 MANUFACTURE DATE: 2012-01 EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-FEB-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLE"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING") AND INFECTION ("MULTIPLE INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED SURGICALLY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, MIGRAINE, HEADACHE AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, INFECTION, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE 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 |
|---|---|---|---|---|---|---|---|
| 888337 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 940871 NOT VALID, 940971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R |