ESSURE
Report
- Report Number
- 2951250-2019-02411
- Event Type
- Injury
- Date Received
- June 3, 2019
- Report Date
- December 21, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ACUTE ABDOMINAL PAIN'), UTERINE INJURY ('UTERINE LACERATIONS'), GENITAL INJURY ('FALLOPIAN TUBES LACERATIONS'), GENITAL HAEMORRHAGE ('HAEMORRHAGES') AND SYNCOPE ('FAINTING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SYNCOPE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GROIN PAIN ("INGUINAL PAIN"), BACK PAIN ("LUMBAR PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENORRHAGIA ("IRREGULARITY OF PERIOD (ABUNDANT OR NON-EXISTENT OR OF ABNORMAL DURATION)"), OLIGOMENORRHOEA ("IRREGULARITY OF PERIOD (ABUNDANT OR NON-EXISTENT OR OF ABNORMAL DURATION)"), VAGINAL DISCHARGE ("VAGINAL LEAKAGES"), DIZZINESS ("DIZZINESS"), ARTHRALGIA ("JOINT PAIN (KNEES, HANDS, FEET AND ARMS)"), NAUSEA ("NAUSEA"), VOMITING ("VOMITING"), ALOPECIA ("LOSS OF HAIR"), TOOTH LOSS ("DENTAL PROBLEMS (TOOTH LOSS)"), FOOD INTOLERANCE ("FOOD INTOLERANCES"), FATIGUE ("FATIGUE FEELING"), INSOMNIA ("INSOMNIA"), AFFECTIVE DISORDER ("MOOD DISORDERS"), LIBIDO DECREASED ("DECREASE OF LIBIDO"), TACHYCARDIA ("TACHYCARDIA"), DEPRESSION ("DEPRESSION"), CYSTITIS ("CYSTITIS"), DERMATITIS ("DERMATITIS"), VISUAL IMPAIRMENT ("DECREASES OF SIGHT"), EAR DISORDER ("EAR DISORDERS"), WEIGHT FLUCTUATION ("ABNORMAL WEIGHT CHANGES (BOTH INCREASING AND DECREASING)"), MIGRAINE ("SEVERE MIGRAINES"), AMNESIA ("AMNESIAS"), PARAESTHESIA ("TINGLING OF LIMBS"), PERIPHERAL SWELLING ("SWELLING OF THE HANDS AND ANKLES"), JOINT SWELLING ("SWELLING OF THE HANDS AND ANKLES") AND HYPERHIDROSIS ("ABNORMAL SWEATING") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, UTERINE INJURY, GENITAL INJURY, GENITAL HAEMORRHAGE, SYNCOPE, GROIN PAIN, BACK PAIN, HYPERSENSITIVITY, MENORRHAGIA, OLIGOMENORRHOEA, VAGINAL DISCHARGE, DIZZINESS, UTERINE LEIOMYOMA, ARTHRALGIA, NAUSEA, VOMITING, ALOPECIA, TOOTH LOSS, FOOD INTOLERANCE, FATIGUE, INSOMNIA, AFFECTIVE DISORDER, LIBIDO DECREASED, TACHYCARDIA, DEPRESSION, CYSTITIS, DERMATITIS, VISUAL IMPAIRMENT, EAR DISORDER, WEIGHT FLUCTUATION, MIGRAINE, AMNESIA, PARAESTHESIA, PERIPHERAL SWELLING, JOINT SWELLING AND HYPERHIDROSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AFFECTIVE DISORDER, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, CYSTITIS, DEPRESSION, DERMATITIS, DIZZINESS, EAR DISORDER, FATIGUE, FOOD INTOLERANCE, GENITAL HAEMORRHAGE, GENITAL INJURY, GROIN PAIN, HYPERHIDROSIS, HYPERSENSITIVITY, INSOMNIA, JOINT SWELLING, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, NAUSEA, OLIGOMENORRHOEA, PARAESTHESIA, PERIPHERAL SWELLING, SYNCOPE, TACHYCARDIA, TOOTH LOSS, UTERINE INJURY, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, VOMITING AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-DEC-2020: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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 ABDOMINAL PAIN ('ACUTE ABDOMINAL PAIN'), UTERINE INJURY ('UTERINE LACERATIONS'), GENITAL INJURY ('FALLOPIAN TUBES LACERATIONS'), GENITAL HAEMORRHAGE ('HAEMORRHAGES') AND SYNCOPE ('FAINTING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SYNCOPE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GROIN PAIN ("INGUINAL PAIN"), BACK PAIN ("LUMBAR PAIN"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), MENOMETRORRHAGIA ("IRREGULARITY OF PERIOD (ABUNDANT OR NON-EXISTENT OR OF ABNORMAL DURATION)"), AMENORRHOEA ("IRREGULARITY OF PERIOD (ABUNDANT OR NON-EXISTENT OR OF ABNORMAL DURATION)"), VAGINAL DISCHARGE ("VAGINAL LEAKAGES"), DIZZINESS ("DIZZINESS"), ARTHRALGIA ("JOINT PAIN (KNEES, HANDS, FEET AND ARMS)"), NAUSEA ("NAUSEA"), VOMITING ("VOMITING"), ALOPECIA ("LOSS OF HAIR"), TOOTH LOSS ("DENTAL PROBLEMS (TOOTH LOSS)"), FOOD INTOLERANCE ("FOOD INTOLERANCES"), FATIGUE ("FATIGUE FEELING"), INSOMNIA ("INSOMNIA"), AFFECTIVE DISORDER ("MOOD DISORDERS"), LIBIDO DECREASED ("DECREASE OF LIBIDO"), TACHYCARDIA ("TACHYCARDIA"), DEPRESSION ("DEPRESSION"), CYSTITIS ("CYSTITIS"), DERMATITIS ("DERMATITIS"), VISUAL IMPAIRMENT ("DECREASES OF SIGHT"), EAR DISORDER ("EAR DISORDERS"), WEIGHT FLUCTUATION ("ABNORMAL WEIGHT CHANGES (BOTH INCREASING AND DECREASING)"), MIGRAINE ("SEVERE MIGRAINES"), AMNESIA ("AMNESIAS"), PARAESTHESIA ("TINGLING OF LIMBS"), PERIPHERAL SWELLING ("SWELLING OF THE HANDS AND ANKLES"), JOINT SWELLING ("SWELLING OF THE HANDS AND ANKLES") AND HYPERHIDROSIS ("ABNORMAL SWEATING") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, UTERINE INJURY, GENITAL INJURY, GENITAL HAEMORRHAGE, SYNCOPE, GROIN PAIN, BACK PAIN, HYPERSENSITIVITY, MENOMETRORRHAGIA, AMENORRHOEA, VAGINAL DISCHARGE, DIZZINESS, UTERINE LEIOMYOMA, ARTHRALGIA, NAUSEA, VOMITING, ALOPECIA, TOOTH LOSS, FOOD INTOLERANCE, FATIGUE, INSOMNIA, AFFECTIVE DISORDER, LIBIDO DECREASED, TACHYCARDIA, DEPRESSION, CYSTITIS, DERMATITIS, VISUAL IMPAIRMENT, EAR DISORDER, WEIGHT FLUCTUATION, MIGRAINE, AMNESIA, PARAESTHESIA, PERIPHERAL SWELLING, JOINT SWELLING AND HYPERHIDROSIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AFFECTIVE DISORDER, ALOPECIA, AMENORRHOEA, AMNESIA, ARTHRALGIA, BACK PAIN, CYSTITIS, DEPRESSION, DERMATITIS, DIZZINESS, EAR DISORDER, FATIGUE, FOOD INTOLERANCE, GENITAL HAEMORRHAGE, GENITAL INJURY, GROIN PAIN, HYPERHIDROSIS, HYPERSENSITIVITY, INSOMNIA, JOINT SWELLING, LIBIDO DECREASED, MENOMETRORRHAGIA, MIGRAINE, NAUSEA, PARAESTHESIA, PERIPHERAL SWELLING, SYNCOPE, TACHYCARDIA, TOOTH LOSS, UTERINE INJURY, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, VOMITING AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. 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 COMPLAINTS RECORDS AND OTHER NON-CONFORMANCE'S 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 |
|---|---|---|---|---|---|---|---|
| 456586 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |