ESSURE
Report
- Report Number
- 2951250-2021-01008
- Event Type
- Malfunction
- Date Received
- March 25, 2021
- Report Date
- March 30, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925777) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN"), LASTING 2 DAYS. IN 2017, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL DISTENSION / ABDOMINAL SWELLING"), HEADACHE ("INTENSE HEADACHE"), PERIPHERAL SWELLING ("SWELLING IN HER LEGS / SWELLING OF THE LOWER LIMBS"), POLYMENORRHAGIA ("INCREASED FLOW AND FREQUENCY OF MENSTRUATION (HYPERPOLYMENORRHEA) INCLUDING CLOTS") AND DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE CRAMPS UNDER THE BELLY, PRICK-LIKE"), BREAST PAIN ("MASTALGIA"), LOCALISED OEDEMA ("ABDOMINAL EDEMA"), MENORRHAGIA ("CONSIDERABLE AND INTENSE INCREASE IN MENSTRUAL FLOW, REACHING UP TO 15 (FIFTEEN) DAYS IN THE MENSTRUAL PERIOD, INCLUDING THE PRESENCE OF CLOTS"), PAIN IN EXTREMITY ("PAIN IN HER LEGS"), PARAESTHESIA ("TINGLING TOO MUCH"), TREMOR ("TREMORS"), BACK PAIN ("LOWER BACK PAIN"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), DYSPAREUNIA ("PAIN DURING AND AFTER EXUAL INTERCOURSE"), COITAL BLEEDING ("BLEEDING DURING AND AFTER SEXUAL INTERCOURSE"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("CONSTANT MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPECTED ADENOMYOSIS"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN THE ABDOMEN"), PAIN ("GENERALIZED PAIN"), VAGINAL DISCHARGE ("STRONG ODOR FROM THE VAGINAL FLUID / INCREASED FREQUENCY OF VAGINAL DISCHARGE"), ANXIETY DISORDER ("ANXIETY DISORDER / ANGUISH"), NERVOUSNESS ("NERVOUSNESS"), STRESS ("STRESS") AND PRURITUS GENITAL ("PRURITUS GENITAL"). THE PATIENT WAS TREATED WITH ANALGESICS AND DICLOFENAC DIETHYLAMINE (ANTI INFLAMMATORY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BREAST PAIN, ABDOMINAL DISTENSION, LOCALISED OEDEMA, MENORRHAGIA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, PAIN, VAGINAL DISCHARGE, ANXIETY DISORDER, NERVOUSNESS, STRESS, POLYMENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN, THE PROCEDURAL PAIN HAD RESOLVED AND THE PRURITUS GENITAL HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ADENOMYOSIS, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOCALISED OEDEMA, LOSS OF LIBIDO, MENORRHAGIA, MOOD SWINGS, NERVOUSNESS, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PERIPHERAL SWELLING, POLYMENORRHAGIA, PROCEDURAL PAIN, PRURITUS GENITAL, STRESS, TREMOR, UTERINE INFLAMMATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2020 GYNECOLOGIST REPORTS SHE NEEDS AN EMERGENCY SURGERY, THE ESSURE DEVICE HAVE BEEN CAUSING INTENSE PHYSICAL AND PSYCHOLOGICAL SUFFERING, CAUSING A REAL AND IMMINENT RISK OF REACHING A VITAL ORGAN. ADVERSE EVENT ANXIETY DISORDER / ANGUISH HAVE BEEN TREATED WITH HERBAL MEDICINES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2018: CT SCAN LOWER AND UPPER ABDOMEN, METALLIC DEVICE ADJACENT TO THE UTERUS, SMALL AMOUNTS OF FREE LIQUID IN THE PELVIS, USUAL FOR THE AGE GROUP. X-RAY - ON (B)(6) 2018: PELVIS X-RAY SHOWS LINEAR METALLIC MATERIAL IN PELVIS IN TOPOGRAPHY OF UTERUS.. LOT NUMBER: 925777, MANUFACTURING DATE: 2011/11, EXPIRATION DATE: 2014/11. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925777) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN THE LOWER ABDOMEN"), LASTING 2 DAYS. IN 2017, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("ABDOMINAL DISTENSION / ABDOMINAL SWELLING"), HEADACHE ("INTENSE HEADACHE"), PERIPHERAL SWELLING ("SWELLING IN HER LEGS / SWELLING OF THE LOWER LIMBS"), POLYMENORRHOEA ("INCREASED FLOW AND FREQUENCY OF MENSTRUATION (HYPERPOLYMENORRHEA) INCLUDING CLOTS") AND DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW (DYSMENORRHEA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE CRAMPS UNDER THE BELLY, PRICK-LIKE"), BREAST PAIN ("MASTALGIA"), LOCALISED OEDEMA ("ABDOMINAL EDEMA"), MENORRHAGIA ("CONSIDERABLE AND INTENSE INCREASE IN MENSTRUAL FLOW, REACHING UP TO 15 (FIFTEEN) DAYS IN THE MENSTRUAL PERIOD, INCLUDING THE PRESENCE OF CLOTS"), PAIN IN EXTREMITY ("PAIN IN HER LEGS"), PARAESTHESIA ("TINGLING TOO MUCH"), TREMOR ("TREMORS"), BACK PAIN ("LOWER BACK PAIN"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), DYSPAREUNIA ("PAIN DURING AND AFTER SEXUAL INTERCOURSE"), COITAL BLEEDING ("BLEEDING DURING AND AFTER SEXUAL INTERCOURSE"), UTERINE INFLAMMATION ("UTERINE INFLAMMATION"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("CONSTANT MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPECTED ADENOMYOSIS"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN THE ABDOMEN"), PAIN ("GENERALIZED PAIN"), VAGINAL DISCHARGE ("STRONG ODOR FROM THE VAGINAL FLUID / INCREASED FREQUENCY OF VAGINAL DISCHARGE"), ANXIETY DISORDER ("ANXIETY DISORDER / ANGUISH"), NERVOUSNESS ("NERVOUSNESS"), STRESS ("STRESS") AND PRURITUS GENITAL ("PRURITUS GENITAL"). THE PATIENT WAS TREATED WITH ANALGESICS AND DICLOFENAC DIETHYLAMINE (ANTI INFLAMMATORY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BREAST PAIN, ABDOMINAL DISTENSION, LOCALISED OEDEMA, MENORRHAGIA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, PAIN, VAGINAL DISCHARGE, ANXIETY DISORDER, NERVOUSNESS, STRESS, POLYMENORRHOEA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN, THE PROCEDURAL PAIN HAD RESOLVED AND THE PRURITUS GENITAL HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ADENOMYOSIS, ALOPECIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOCALISED OEDEMA, LOSS OF LIBIDO, MENORRHAGIA, MOOD SWINGS, NERVOUSNESS, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN, PRURITUS GENITAL, STRESS, TREMOR, UTERINE INFLAMMATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2020 GYNECOLOGIST REPORTS SHE NEEDS AN EMERGENCY SURGERY, THE ESSURE DEVICE HAVE BEEN CAUSING INTENSE PHYSICAL AND PSYCHOLOGICAL SUFFERING, CAUSING A REAL AND IMMINENT RISK OF REACHING A VITAL ORGAN. ADVERSE EVENT ANXIETY DISORDER / ANGUISH HAVE BEEN TREATED WITH HERBAL MEDICINES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2018: CT SCAN LOWER AND UPPER ABDOMEN, METALLIC DEVICE ADJACENT TO THE UTERUS, SMALL AMOUNTS OF FREE LIQUID IN THE PELVIS, USUAL FOR THE AGE GROUP. X-RAY- ON (B)(6) 2018: PELVIS X-RAY SHOWS LINEAR METALLIC MATERIAL IN PELVIS IN TOPOGRAPHY OF UTERUS. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464438 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 925777 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other |