ESSURE
Report
- Report Number
- 2951250-2019-03638
- Event Type
- Injury
- Date Received
- July 11, 2019
- Report Date
- January 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED DRY EYE ("VISION/EYE PROBLEMS: DRY EYES") AND GLAUCOMA ("GLAUCOMA"). IN 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN") AND EXPERIENCED PREMATURE MENOPAUSE ("HORMONAL CHANGES DESCRIBE:-EARLY MENOPAUSE"). IN 2017, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES"), PRURITUS ("RASHES OR SKIN CONDITIONS TYPE: ITCHING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: ABDOMINAL BLOATING"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND ABDOMINAL PAIN ("ABDOMINAL CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PRURITUS, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, FEMALE SEXUAL DYSFUNCTION, ALOPECIA, NAUSEA, WEIGHT INCREASED, DRY EYE, PREMATURE MENOPAUSE, VAGINAL INFECTION, ABDOMINAL PAIN AND GLAUCOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, DRY EYE, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GLAUCOMA, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PREMATURE MENOPAUSE, PRURITUS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 150 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.8 KG/SQM. HYSTEROSALPINGOGRAM: ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-DEC-2019: PFS RECEIVED :PREVIOUSLY REPORTED EVENT "HORMONAL IMBALANCE" PT UPDATED TO "PREMATURE MENOPAUSE". EVENT " GLAUCOMA "ADDED. REPORTER 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 AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES"), PRURITUS ("RASHES OR SKIN CONDITIONS TYPE: ITCHING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: ABDOMINAL BLOATING"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA "), DRY EYE ("VISION/EYE PROBLEMS: DRY EYES"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND ABDOMINAL PAIN ("ABDOMINAL CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE:-"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PRURITUS, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, FEMALE SEXUAL DYSFUNCTION, ALOPECIA, NAUSEA, WEIGHT INCREASED, DRY EYE, HORMONE LEVEL ABNORMAL, VAGINAL INFECTION AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, DRY EYE, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PRURITUS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 150 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.8 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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-CONFORMANCE'S 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 MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINES"), PRURITUS ("RASHES OR SKIN CONDITIONS TYPE: ITCHING"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: ABDOMINAL BLOATING"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA "), DRY EYE ("VISION/EYE PROBLEMS: DRY EYES"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND ABDOMINAL PAIN ("ABDOMINAL CRAMPING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE:-"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PRURITUS, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, FEMALE SEXUAL DYSFUNCTION, ALOPECIA, NAUSEA, WEIGHT INCREASED, DRY EYE, HORMONE LEVEL ABNORMAL, VAGINAL INFECTION AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, DRY EYE, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PRURITUS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.8 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUL-2019: PLAINTIFF FACT SHEET WAS RECEIVED. LOT NUMBER WERE ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MIGRAINES, HEADACHES, ITCHING, VAGINAL DISCHARGE, ABDOMINAL BLOATING, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), HAIR LOSS, NAUSEA, WEIGHT GAIN, DRY EYES, HORMONAL CHANGES, VAGINAL INFECTION, ABDOMINAL CRAMPING. REPORTER INFORMATION, MEDICAL HISTORY, LAB DATA WERE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 576720 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841534 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |