ESSURE
Report
- Report Number
- 2951250-2019-01198
- Event Type
- Injury
- Date Received
- March 22, 2019
- Date of Event
- January 1, 2019
- Report Date
- December 3, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('MIGRATION OF ESSURE DEVICE LOCATION/LEFT COIL SHIFTED AND WAS POKING INTO HER SIDE'), PELVIC PAIN ('PELVIC PAIN/ PAIN / LEFT SIDE PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2019, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAINS/ LEFT SIDE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BACK PAIN ("LOWER BACK PAIN"), BACTERIAL INFECTION ("BACTERIAL INFECTIONS"), MIGRAINE ("MIGRAINES"), FEELING ABNORMAL ("BRAIN FOG"), ARTHRALGIA ("JOINT PAIN"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), MUSCULOSKELETAL PAIN ("PAIN IN BUTTOCKS") AND COMPLICATION OF DEVICE REMOVAL ("COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE:PHYSICIAN STATED THAT IT TOOK A VERY LONG TIME TO FIND AND REMOVE THE LEFT COIL."). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, BACK PAIN, BACTERIAL INFECTION, MIGRAINE, FEELING ABNORMAL, ARTHRALGIA, HEADACHE, DYSMENORRHOEA, VULVOVAGINAL PAIN AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND MUSCULOSKELETAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ARTHRALGIA, BACK PAIN, BACTERIAL INFECTION, COMPLICATION OF DEVICE REMOVAL, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, MUSCULOSKELETAL PAIN, PELVIC PAIN AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE. PREVIOUSLY REPORTED AS: (B)(6) 2011 IN CURRENT FOLLOW UP REPORTED AS: (B)(6) 2011 DISCREPANCY NOTED IN ESSURE REMOVAL DATE-(B)(6) 2019 AND (B)(6) 2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-NOV-2019: PLAINTIFF FACT SHEET WAS RECEIVED. REPORTER INFORMATION, LOT NUMBER, EVENT ONSET DATE 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('MIGRATION OF ESSURE DEVICE LOCATION/LEFT COIL SHIFTED AND WAS POKING INTO HER SIDE'), PELVIC PAIN ('PELVIC PAIN/ PAIN / LEFT SIDE PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN 2019, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAINS/ LEFT SIDE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BACK PAIN ("LOWER BACK PAIN"), BACTERIAL INFECTION ("BACTERIAL INFECTIONS"), MIGRAINE ("MIGRAINES"), FEELING ABNORMAL ("BRAIN FOG"), ARTHRALGIA ("JOINT PAIN"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), MUSCULOSKELETAL PAIN ("PAIN IN BUTTOCKS") AND COMPLICATION OF DEVICE REMOVAL ("COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE:PHYSICIAN STATED THAT IT TOOK A VERY LONG TIME TO FIND AND REMOVE THE LEFT COIL."). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, BACK PAIN, BACTERIAL INFECTION, MIGRAINE, FEELING ABNORMAL, ARTHRALGIA, HEADACHE, DYSMENORRHOEA, VULVOVAGINAL PAIN AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND MUSCULOSKELETAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ARTHRALGIA, BACK PAIN, BACTERIAL INFECTION, COMPLICATION OF DEVICE REMOVAL, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, MUSCULOSKELETAL PAIN, PELVIC PAIN AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE. PREVIOUSLY REPORTED AS: (B)(6)2011. IN CURRENT FOLLOW UP REPORTED AS: (B)(6)2011. DISCREPANCY NOTED IN ESSURE REMOVAL DATE-(B)(6)2019 AND (B)(6)2019 . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE; ON (B)(6)2014: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 802745 MANUFACTURE DATE: 2010-11 EXPIRATION DATE: 2013-11 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-DEC-2019: QUALITY SAFETY EVALUATION OF PTC. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("MIGRATION OF ESSURE DEVICE LOCATION/LEFT COIL SHIFTED AND WAS POKING INTO HER SIDE"), PELVIC PAIN ("PELVIC PAIN/ PAIN/LEFT SIDE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAINS/ LEFT SIDE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING"), BACK PAIN ("LOWER BACK PAIN"), BACTERIAL INFECTION ("BACTERIAL INFECTIONS"), MIGRAINE ("MIGRAINES"), FEELING ABNORMAL ("BRAIN FOG"), ARTHRALGIA ("JOINT PAIN"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), MUSCULOSKELETAL PAIN ("PAIN IN BUTTOCKS") AND COMPLICATION OF DEVICE REMOVAL ("COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE:PHYSICIAN STATED THAT IT TOOK A VERY LONG TIME TO FIND AND REMOVE THE LEFT COIL."). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, BACK PAIN, BACTERIAL INFECTION, MIGRAINE, FEELING ABNORMAL, ARTHRALGIA, HEADACHE, DYSMENORRHOEA, VULVOVAGINAL PAIN AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND MUSCULOSKELETAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ARTHRALGIA, BACK PAIN, BACTERIAL INFECTION, COMPLICATION OF DEVICE REMOVAL, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, MUSCULOSKELETAL PAIN, PELVIC PAIN AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE. PREVIOUSLY REPORTED AS: (B)(6) 2011. IN CURRENT FOLLOW UP REPORTED AS: (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAR-2019: PFS RECEIVED. LAB DATA ADDED. CONCOMITANT MEDICATION ADDED. EVENTS :MIGRATION OF ESSURE DEVICE LOCATION/LEFT COIL SHIFTED AND WAS POKING INTO HER SIDE, DYSMENORRHEA (CRAMPING) AND COMPLICATIONS FROM ESSURE REMOVAL PROCEDURE: PHYSICIAN STATED THAT IT TOOK A VERY LONG TIME TO FIND AND REMOVE THE LEFT COIL WERE ADDED. EVENTS : ABDOMINAL PAIN, CRAMPING, PELVIC PAIN, PAIN WITH INTERCOURSE OUTCOMES UPDATED. 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 |
|---|---|---|---|---|---|---|---|
| 238759 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802745 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R | IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN |