ESSURE
Report
- Report Number
- 2951250-2019-09177
- Event Type
- Injury
- Date Received
- October 1, 2019
- Date of Event
- February 1, 2008
- Report Date
- January 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
- WV, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 624477) 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 ANY CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2007, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS-D"). IN (B)(6) 2007, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH MACULAR ("RASHES OR SKIN CONDITIONS TYPE: RED BLOTCHES ON CHEST UPPER TORSO"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), FEELING ABNORMAL ("BRAIN FOG") AND TOOTH DISORDER ("DENTAL PROBLEM") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAI"). IN 2008, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN /KNEES PAIN/ ELBOW PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES / BLADDER LEAKAGE"), DISTURBANCE IN ATTENTION ("INABILITY TO CONCENTRATE") AND MUSCULOSKELETAL PAIN ("SHOULDERS PAIN") AND UNDERWENT ENDOMETRIAL ABLATION ("ABLATION"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, RASH MACULAR, MIGRAINE, FEELING ABNORMAL, ARTHRALGIA AND MUSCULOSKELETAL PAIN WAS RESOLVING AND THE URINARY INCONTINENCE, DYSPAREUNIA, FATIGUE, ALOPECIA, DISTURBANCE IN ATTENTION, TOOTH DISORDER AND ENDOMETRIAL ABLATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, FATIGUE, FEELING ABNORMAL, IRRITABLE BOWEL SYNDROME, MIGRAINE, MUSCULOSKELETAL PAIN, RASH MACULAR, TOOTH DISORDER, URINARY INCONTINENCE AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2007 (AS WRITTEN- DISCREPANCY NOTED) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-SEP-2019: PFS RECEIVED. REPORTER'S INFORMATION WAS ADDED. PATIENT'S DEMOGRAPHICS WAS ADDED. ADDED EVENT ABLATION, BLADDER OR URINARY PROBLEMS OR CHANGES / BLADDER LEAKAGE , DYSMENORRHEA(CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IBS-D, HAIR LOSS, MIGRAINES / HEADACHES, RASHES OR SKIN CONDITIONS TYPE: RED BLOTCHES ON CHEST UPPER TORSO, SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), WEIGHT GAIN, BRAIN FOG, INABILITY TO CONCENTRATE, PAIN: JOINT PAIN ELBOWS, SHOULDERS, KNEES, DENTAL PROBLEMS, PLAINTIFF DID NOT UNDERGO ANY CONFIRMATION TEST. UPDATED EVENT ONSET DATE. LOT NUMBER ADDED. 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 DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 624477) 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 ANY CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2007, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS-D"). ON (B)(6) 2007, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION ("ABLATION"), 2 YEARS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2007, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), RASH MACULAR ("RASHES OR SKIN CONDITIONS TYPE: RED BLOTCHES ON CHEST UPPER TORSO"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), FEELING ABNORMAL ("BRAIN FOG") AND TOOTH DISORDER ("DENTAL PROBLEM") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAI"). IN 2008, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN /KNEES PAIN/ ELBOW PAIN"). IN 2017, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES / BLADDER LEAKAGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISTURBANCE IN ATTENTION ("INABILITY TO CONCENTRATE") AND MUSCULOSKELETAL PAIN ("SHOULDERS PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, RASH MACULAR, MIGRAINE, FEELING ABNORMAL, ARTHRALGIA AND MUSCULOSKELETAL PAIN WAS RESOLVING AND THE ENDOMETRIAL ABLATION, PELVIC PAIN, URINARY INCONTINENCE, DYSPAREUNIA, FATIGUE, IRRITABLE BOWEL SYNDROME, ALOPECIA, DISTURBANCE IN ATTENTION AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, FATIGUE, FEELING ABNORMAL, IRRITABLE BOWEL SYNDROME, MIGRAINE, MUSCULOSKELETAL PAIN, PELVIC PAIN, RASH MACULAR, TOOTH DISORDER, URINARY INCONTINENCE AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2007 (AS WRITTEN- DISCREPANCY NOTED) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. LOT NUMBER: 624477, MANUFACTURING DATE: 2007/05, EXPIRATION DATE: 2009/04. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JAN-2020: PFS RECEIVED. NEW EVENT 'PELVIC PAIN' WAS ADDED. 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 DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND ENDOMETRIAL ABLATION ('ABLATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 624477) 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 ANY CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2007, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS-D"). IN (B)(6) 2007, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). IN (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH MACULAR ("RASHES OR SKIN CONDITIONS TYPE: RED BLOTCHES ON CHEST UPPER TORSO"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), FEELING ABNORMAL ("BRAIN FOG") AND TOOTH DISORDER ("DENTAL PROBLEM") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAI"). IN 2008, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN /KNEES PAIN/ ELBOW PAIN"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES / BLADDER LEAKAGE"), DISTURBANCE IN ATTENTION ("INABILITY TO CONCENTRATE") AND MUSCULOSKELETAL PAIN ("SHOULDERS PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, RASH MACULAR, MIGRAINE, FEELING ABNORMAL, ARTHRALGIA AND MUSCULOSKELETAL PAIN WAS RESOLVING AND THE ENDOMETRIAL ABLATION, URINARY INCONTINENCE, DYSPAREUNIA, FATIGUE, ALOPECIA, DISTURBANCE IN ATTENTION AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL ABLATION, FATIGUE, FEELING ABNORMAL, IRRITABLE BOWEL SYNDROME, MIGRAINE, MUSCULOSKELETAL PAIN, RASH MACULAR, TOOTH DISORDER, URINARY INCONTINENCE AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2007 (AS WRITTEN- DISCREPANCY NOTED) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.5 KG/SQM. LOT NUMBER: 624477 MANUFACTURING DATE: 2007/05 EXPIRATION DATE: 2009/04 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-OCT-2019: QUALITY-SAFETY EVALUATION OF PTC. 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 MEDICAL DEVICE REMOVAL ('I AM OFFICIALLY ESSURE FREE AS OF TODAY') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE (ESS205). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2019: SOCIAL MEDIA RECEIVED. THIS CASE BECAME INCIDENT. EVENT: INJURY TO HERSELF WERE UPDATED TO MEDICAL DEVICE REMOVAL. 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. A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA WAS CONDUCTED; 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 |
|---|---|---|---|---|---|---|---|
| 936317 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 624477 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R |