ESSURE
Report
- Report Number
- 2951250-2019-07889
- Event Type
- Injury
- Date Received
- September 23, 2019
- Report Date
- August 27, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLOOD DISORDER ("BLOOD/HEART DISORDER"), BLOOD LOSS ANAEMIA ("BLOOD LOSS ANEMIA (7.6)"), DYSPAREUNIA ("DYSPAREUNIA,CHRONIC"), CARDIAC DISORDER ("HEART DISORDER"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS,"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), PROLONGED PERIODS ("LONG PERIODS"), ARTHRALGIA ("HIP PAIN"), MUSCLE SPASMS ("MUSCLE CRAMPS"), AMNESIA ("MEMORY LOSS"), VISUAL IMPAIRMENT ("VISION PROBLEMS") AND DEVICE EXPULSION ("FOREIGN BODY LN THE UTERUS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH BLOOD, WHOLE (BLOOD), LEVONORGESTREL (MIRENA) AND SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, BLOOD DISORDER, DYSPAREUNIA AND CARDIAC DISORDER HAD RESOLVED AND THE BLOOD LOSS ANAEMIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, MIGRAINE, HEADACHE, WEIGHT INCREASED, WEIGHT DECREASED, PROLONGED PERIODS, ARTHRALGIA, MUSCLE SPASMS, AMNESIA, VISUAL IMPAIRMENT AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AMNESIA, ARTHRALGIA, BLADDER DISORDER, BLOOD DISORDER, BLOOD LOSS ANAEMIA, CARDIAC DISORDER, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, MIGRAINE, MUSCLE SPASMS, URINARY TRACT DISORDER, VISUAL IMPAIRMENT, WEIGHT DECREASED, WEIGHT INCREASED AND PROLONGED PERIODS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT-7, RIGHT-7. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HAEMOGLOBIN (G/DL) - ON AN UNKNOWN DATE: 7.6 G/DL. PREGNANCY TEST URINE - ON AN UNKNOWN DATE: PREGNANCY TEST URINE NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-AUG-2020: MR RECEIVED-LOT NUMBER ADDED AND FOREIGN BODY IN THE UTERUS EVENT WAS ADDED. LAB DATA ADDED, REPORTER 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 MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLOOD DISORDER ("BLOOD/HEART DISORDER"), BLOOD LOSS ANAEMIA ("BLOOD LOSS ANEMIA (7.6)"), DYSPAREUNIA ("DYSPAREUNIA,CHRONIC"), CARDIAC DISORDER ("HEART DISORDER"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS,"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), PROLONGED PERIODS ("LONG PERIODS"), ARTHRALGIA ("HIP PAIN"), MUSCLE SPASMS ("MUSCLE CRAMPS"), AMNESIA ("MEMORY LOSS"), VISUAL IMPAIRMENT ("VISION PROBLEMS") AND DEVICE EXPULSION ("FOREIGN BODY LN THE UTERUS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH BLOOD, WHOLE (BLOOD), LEVONORGESTREL (MIRENA) AND SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, BLOOD DISORDER, DYSPAREUNIA AND CARDIAC DISORDER HAD RESOLVED AND THE BLOOD LOSS ANAEMIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, MIGRAINE, HEADACHE, WEIGHT INCREASED, WEIGHT DECREASED, PROLONGED PERIODS, ARTHRALGIA, MUSCLE SPASMS, AMNESIA, VISUAL IMPAIRMENT AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AMNESIA, ARTHRALGIA, BLADDER DISORDER, BLOOD DISORDER, BLOOD LOSS ANAEMIA, CARDIAC DISORDER, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, MIGRAINE, MUSCLE SPASMS, URINARY TRACT DISORDER, VISUAL IMPAIRMENT, WEIGHT DECREASED, WEIGHT INCREASED AND PROLONGED PERIODS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT-7, RIGHT-7. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HAEMOGLOBIN (G/DL) - ON AN UNKNOWN DATE: 7.6 G/DL. PREGNANCY TEST URINE - ON AN UNKNOWN DATE: PREGNANCY TEST URINE NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-AUG-2020: 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 MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLOOD DISORDER ("BLOOD/HEART DISORDER"), BLOOD LOSS ANAEMIA ("BLOOD LOSS ANEMIA (7.6)"), DYSPAREUNIA ("DYSPAREUNIA,CHRONIC"), CARDIAC DISORDER ("HEART DISORDER"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS,"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH BLOOD, WHOLE (BLOOD), LEVONORGESTREL (MIRENA) AND SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, BLOOD DISORDER, DYSPAREUNIA AND CARDIAC DISORDER HAD RESOLVED AND THE BLOOD LOSS ANAEMIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, MIGRAINE, HEADACHE, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BLADDER DISORDER, BLOOD DISORDER, BLOOD LOSS ANAEMIA, CARDIAC DISORDER, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, MIGRAINE, URINARY TRACT DISORDER, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HAEMOGLOBIN (G/DL) - ON AN UNKNOWN DATE: 7.6 G/DL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: WITH FOLLOW UP RECEIVED ON 23-MAR-2020 THIS RECORD WAS DETECTED TO BE A DUPLICATE TO RECORD # US-BAYER-2019-225903 (MEDWATCH 3500A MFR NUMBER 2951250-2019-12226) WHICH WILL BE DELETED FROM BAYER SAFETY DATABASE AFTER ALL INFORMATION WAS TRANSFERRED TO THIS RECORD # US-BAYER-2018-231262 WHICH WILL BE RETAINED. NEW: PATIENT POSTED THAT TWO YEARS EARLIER (DATE NOT PROVIDED) SHE HAD 7.6 (HEMOGLOBIN) AND HAD EMERGENCY BLOOD TRANSFUSIONS AND DOCTOR INSERTED MIRENA TO STOP HER PERIOD. SHE NEEDED BOTH OUT OF HER. 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 MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLOOD DISORDER ("BLOOD/HEART DISORDER"), BLOOD LOSS ANAEMIA ("BLOOD LOSS ANEMIA (7.6)"), DYSPAREUNIA ("DYSPAREUNIA,CHRONIC"), CARDIAC DISORDER ("HEART DISORDER"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS,"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), PROLONGED PERIODS ("LONG PERIODS"), ARTHRALGIA ("HIP PAIN"), MUSCLE SPASMS ("MUSCLE CRAMPS"), AMNESIA ("MEMORY LOSS") AND VISUAL IMPAIRMENT ("VISION PROBLEMS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH BLOOD, WHOLE (BLOOD), LEVONORGESTREL (MIRENA) AND SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, BLOOD DISORDER, DYSPAREUNIA AND CARDIAC DISORDER HAD RESOLVED AND THE BLOOD LOSS ANAEMIA, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, MIGRAINE, HEADACHE, WEIGHT INCREASED, WEIGHT DECREASED, PROLONGED PERIODS, ARTHRALGIA, MUSCLE SPASMS, AMNESIA AND VISUAL IMPAIRMENT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AMNESIA, ARTHRALGIA, BLADDER DISORDER, BLOOD DISORDER, BLOOD LOSS ANAEMIA, CARDIAC DISORDER, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, MIGRAINE, MUSCLE SPASMS, URINARY TRACT DISORDER, VISUAL IMPAIRMENT, WEIGHT DECREASED, WEIGHT INCREASED AND PROLONGED PERIODS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HAEMOGLOBIN (G/DL) - ON AN UNKNOWN DATE: 7.6 G/DL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: INFORMATION RECEIVED VIA SOCIAL MEDIA: ADDED THE NEW' EVENTS LONG PERIODS, HIP PAIN, MUSCLE CRAMPS, MEMORY LOSS, VISION PROBLEMS''. REPORTER INFORMATION ADDED. 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 MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA,CHRONIC"), BLOOD DISORDER ("BLOOD/HEART DISORDER"), CARDIAC DISORDER ("HEART DISORDER"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS,"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN,") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, DYSPAREUNIA, BLOOD DISORDER AND CARDIAC DISORDER HAD RESOLVED AND THE BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, MIGRAINE, HEADACHE, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BLADDER DISORDER, BLOOD DISORDER, CARDIAC DISORDER, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, MIGRAINE, URINARY TRACT DISORDER, WEIGHT DECREASED 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 9-SEP-2019: PFS RECEIVED: PREVIOUSLY REPORTED EVENT INJURY WAS DELETED AND WAS UPDATED TO NEW EVENTS. FOLLOWING EVENTS WERE ADDED : DYSPAREUNIA, MENORRHAGIA, BLOOD/HEART DISORDER, BLADDER PROBS., URINARY PROBS, FATIGUE, GI CONDITIONS, HAIR LOSS, MIGRAINES, HEADACHES, WEIGHT GAIN, WEIGHT LOSS, 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 |
|---|---|---|---|---|---|---|---|
| 900979 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893029 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |