ESSURE
Report
- Report Number
- 2951250-2019-03980
- Event Type
- Injury
- Date Received
- July 18, 2019
- Report Date
- January 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: COIL EMBEDDED IN OTHER TISSUE') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISORDER') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922806- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SKIN DISORDER, NAUSEA, GRAVIDA (4) AND PARITY 3. CONCURRENT CONDITIONS INCLUDED RESTLESS LEG SYNDROME, FLANK PAIN, VOMITING AND SHOULDER PAIN. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL) AND PROMETHAZINE. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ARTHRALGIA ("JOINT ACHES /PAIN"), AMENORRHOEA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: AMENORRHEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL DISTENSION ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BLOATING"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), INFECTION ("INFECTION (OTHER)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MIGRAINE ("MIGRAINES/HEADACHE") AND FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, VULVOVAGINAL PAIN, ARTHRALGIA, AMENORRHOEA, ABDOMINAL DISTENSION, MOOD SWINGS, INFECTION, DEPRESSION, ANXIETY, MIGRAINE AND FEELING ABNORMAL OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, AMENORRHOEA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, DEPRESSION, DYSMENORRHOEA, EMBEDDED DEVICE, FEELING ABNORMAL, INFECTION, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE DISCREPANCY NOTED- (B)(6)2012. 2010. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6)2019: UTERUS AND CERVIX, WITH BILATERAL TUBES: PROLIFERATIVE ENDOMETRIUM. INTRAMURAL LEIOMYOMA. CERVIX WITH NABOTHIAN CYSTS. PORTION OF BILATERAL UNREMARKABLE FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JAN-2020: UPDATE OF INFORMATION (BATCH IS INVALID) PRODUCT TECHNICAL PROBLEM. 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 EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: COIL EMBEDDED IN OTHER TISSUE') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISORDER') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922806) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SKIN DISORDER, NAUSEA, GRAVIDA (4) AND PARITY 3. CONCURRENT CONDITIONS INCLUDED RESTLESS LEG SYNDROME, FLANK PAIN, VOMITING AND SHOULDER PAIN. CONCOMITANT PRODUCTS INCLUDED KETOROLAC TROMETHAMINE (TORADOL) AND PROMETHAZINE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ARTHRALGIA ("JOINT ACHES /PAIN"), AMENORRHOEA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: AMENORRHEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL DISTENSION ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BLOATING"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), INFECTION ("INFECTION (OTHER)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MIGRAINE ("MIGRAINES/HEADACHE") AND FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, VULVOVAGINAL PAIN, ARTHRALGIA, AMENORRHOEA, ABDOMINAL DISTENSION, MOOD SWINGS, INFECTION, DEPRESSION, ANXIETY, MIGRAINE AND FEELING ABNORMAL OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA AND WEIGHT INCREASED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, AMENORRHOEA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, DEPRESSION, DYSMENORRHOEA, EMBEDDED DEVICE, FEELING ABNORMAL, INFECTION, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE DISCREPANCY NOTED- (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2019: UTERUS AND CERVIX, WITH BILATERAL TUBES: PROLIFERATIVE ENDOMETRIUM. INTRAMURAL LEIOMYOMA. CERVIX WITH NABOTHIAN CYSTS. PORTION OF BILATERAL UNREMARKABLE FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-DEC-2019: PFS AND MR RECEIVED. REPORTER INFORMATION UPDATED. LOT NUMBER ADDED. OUTCOME FOR PREVIOUSLY REPORTED EVENTS: WEIGHT GAIN, PELVIC PAIN, DYSMENORRHEA (CRAMPING) WAS UPDATED TO RECOVERED / RESOLVED. MEDICAL HISTORY, CONCOMITANT DRUGS AND LAB DATA 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 EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: COIL EMBEDDED IN OTHER TISSUE') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISORDER') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ARTHRALGIA ("JOINT ACHES /PAIN"), AMENORRHOEA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: AMENORRHEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL DISTENSION ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BLOATING"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), INFECTION ("INFECTION (OTHER)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MIGRAINE ("MIGRAINES/HEADACHE") AND FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, PELVIC PAIN, VULVOVAGINAL PAIN, ARTHRALGIA, AMENORRHOEA, DYSMENORRHOEA, ABDOMINAL DISTENSION, MOOD SWINGS, INFECTION, DEPRESSION, ANXIETY, MIGRAINE, FEELING ABNORMAL AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, AMENORRHOEA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, DEPRESSION, DYSMENORRHOEA, EMBEDDED DEVICE, FEELING ABNORMAL, INFECTION, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUL-2019: NEW PFS RECEIVED: PREVIOUSLY REPORTED EVENT ¿INJURY¿ UPDATED TO ¿PELVIC PAIN¿, NEW EVENTS ADDED: VAGINAL PAIN, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: COIL EMBEDDED IN OTHER TISSUE, MOOD SWINGS, INFECTION (OTHER), DEPRESSION, ANXIETY, AUTOIMMUNE DISORDER, MIGRAINES / HEADACHES, AMENORRHEA, BLOATING, BRAIN FOG, DYSMENORRHEA (CRAMPING), WEIGHT GAIN, JOINT ACHES/PAIN¿, REPORTER AND 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595699 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922806- NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | PROMETHAZINE| PROMETHAZINE| TORADOL| TORADOL |