ESSURE
Report
- Report Number
- 2951250-2020-08866
- Event Type
- Malfunction
- Date Received
- June 17, 2020
- Report Date
- July 1, 2020
- 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'), DEVICE DISLOCATION ('ESSURE IRREGULARLY POSITIONED / DEVICE IN IRREGULAR POSITION / DISLOCATION OF ESSURE / ESSURE MOVING INSIDE HER BODY') AND UTERINE INFLAMMATION ('UTERINE INFLAMMATION') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925777) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 3. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIENOGEST. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN LOWER ABDOMEN AFTER INSERTION"). IN 2017, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE CRAMPS IN LOWER ABDOMEN, LIKE TWINGES / SEVERE CRAMPS"), MENORRHAGIA ("CONSIDERABLE INCREASE IN MENTRUAL FLOW / MENSTRUATION LASTING 15 DAYS WITH SOME CLOTS"), POLYMENORRHOEA ("CHANGE IN HER MENSTRUAL CYCLE / MENSTRUAL PERIOD 3 TIMES A MONTH"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW") AND HEADACHE ("SEVERE HEADACHES"). IN 2018, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS / SUSPICION OF ADENOMYOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("MANY PHYSICAL PAINS / GENERALIZED PAIN"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("EDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PERIPHERAL SWELLING ("SWELLING IN HER LEGS"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LOW BACK PAIN / LUMBAR PAIN"), PELVIC PAIN ("PAIN IN PELVIC AREA / SEVERE PAIN IN HER PELVIC AREA, PRECISELY ON THE RIGHT SIDE"), UTERINE PAIN ("SENSATION OF PERFORATION IN THE UTERUS / TWINGES"), FATIGUE ("FATIGUE / EXTREME FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), DYSPAREUNIA ("PAIN DURING AND AFTER SEXUAL INTERCOURSE"), COITAL BLEEDING ("BLEEDING DURING AND AFTER SEXUAL INTERCOURSE"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("CONSTANT MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN THE ABDOMEN"), OFFENSIVE VAGINAL DISCHARGE ("ODOR FROM VAGINAL DISCHARGE"), ANXIETY DISORDER ("ANXIETY DISORDERS AND ANGUISH"), DEPRESSION ("DEPRESSION") WITH CRYING, RECTAL HAEMORRHAGE ("RECTAL BLEEDING"), AMNESIA ("MEMORY LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VULVOVAGINAL PRURITUS ("PRURITUS") AND DIARRHOEA ("SPORADIC AND INTERMITTENT DIARRHEA ASSOCIATED WITH MENSTRUAL CYCLE"). THE PATIENT WAS TREATED WITH ANALGESICS, ANTIDEPRESSANTS AND ANXIOLYTICS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, UTERINE INFLAMMATION, PAIN, ABDOMINAL PAIN LOWER, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, MENORRHAGIA, POLYMENORRHOEA, DYSMENORRHOEA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, PELVIC PAIN, UTERINE PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, OFFENSIVE VAGINAL DISCHARGE, ANXIETY DISORDER, DEPRESSION, RECTAL HAEMORRHAGE, AMNESIA, VAGINAL DISCHARGE, VULVOVAGINAL PRURITUS AND DIARRHOEA OUTCOME WAS UNKNOWN AND THE PROCEDURAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, AMNESIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MENORRHAGIA, MOOD SWINGS, OEDEMA, OFFENSIVE VAGINAL DISCHARGE, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN, RECTAL HAEMORRHAGE, TREMOR, UTERINE INFLAMMATION, UTERINE PAIN, VULVOVAGINAL PRURITUS AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: SOME EVENTS STARTED 3 MONTHS AFTER ESSURE INSERTION, BUT IN (B)(6) 2018, SHE OBSERVED THAT HER SYMPTOMS WORSENED. SHE WENT TO A GYNECOLOGIST AND WHEN PERFORMED THE REQUESTED EXAMS, SHE WAS DIAGNOSED WITH ADENOMYOSIS. THE REPORTER INFORMED THAT THE ESSURE WAS CLOSE TO PERFORATE PATIENT'S INTERNAL ORGANS, MORE PRECISELY THE REPRODUCTIVE ORGAN. AT THE TIME OF THIS REPORT, PAIN AND PROBLEMS RELATED TO THE DEVICE ARE INTENSIFIED, AND A MEDICAL APPOINTMENT WAS SCHEDULED FOR (B)(6) 2020. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): GYNAECOLOGICAL EXAMINATION - IN 2018: ADENOMYOSIS. ULTRASOUND SCAN VAGINA - ON (B)(6) 2018: UTERINE ENLARGEMENT WITH MYOMETRIAL HETEROGENEITY, SUGGESTING ADENOMYOSIS. X-RAY - IN 2019: ESSURE IS IRREGULARLY POSITIONED ON HER FALLOPIAN TUBES. LOT NUMBER: 925777 MANUFACTURING DATE: 2011-11 EXPIRATION DATE: 2014-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS'), DEVICE DISLOCATION ('ESSURE IRREGULARLY POSITIONED / DEVICE IN IRREGULAR POSITION / DISLOCATION OF ESSURE / ESSURE MOVING INSIDE HER BODY') AND UTERINE INFLAMMATION ('UTERINE INFLAMMATION') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925777) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 3. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIENOGEST. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN LOWER ABDOMEN AFTER INSERTION"). IN 2017, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE CRAMPS IN LOWER ABDOMEN, LIKE TWINGES / SEVERE CRAMPS"), MENORRHAGIA ("CONSIDERABLE INCREASE IN MENTRUAL FLOW / MENSTRUATION LASTING 15 DAYS WITH SOME CLOTS"), POLYMENORRHOEA ("CHANGE IN HER MENSTRUAL CYCLE / MENSTRUAL PERIOD 3 TIMES A MONTH"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW") AND HEADACHE ("SEVERE HEADACHES"). IN 2018, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS / SUSPICION OF ADENOMYOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE INFLAMMATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("MANY PHYSICAL PAINS / GENERALIZED PAIN"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("EDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PERIPHERAL SWELLING ("SWELLING IN HER LEGS"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LOW BACK PAIN / LUMBAR PAIN"), PELVIC PAIN ("PAIN IN PELVIC AREA / SEVERE PAIN IN HER PELVIC AREA, PRECISELY ON THE RIGHT SIDE"), UTERINE PAIN ("SENSATION OF PERFORATION IN THE UTERUS / TWINGES"), FATIGUE ("FATIGUE / EXTREME FATIGUE"), LOSS OF LIBIDO ("LACK OF LIBIDO"), DYSPAREUNIA ("PAIN DURING AND AFTER SEXUAL INTERCOURSE"), COITAL BLEEDING ("BLEEDING DURING AND AFTER SEXUAL INTERCOURSE"), ARTHRALGIA ("JOINT PAIN"), MOOD SWINGS ("CONSTANT MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN THE ABDOMEN"), OFFENSIVE VAGINAL DISCHARGE ("ODOR FROM VAGINAL DISCHARGE"), ANXIETY DISORDER ("ANXIETY DISORDERS AND ANGUISH"), DEPRESSION ("DEPRESSION") WITH CRYING, RECTAL HAEMORRHAGE ("RECTAL BLEEDING"), AMNESIA ("MEMORY LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VULVOVAGINAL PRURITUS ("PRURITUS") AND DIARRHOEA ("SPORADIC AND INTERMITTENT DIARRHEA ASSOCIATED WITH MENSTRUAL CYCLE"). THE PATIENT WAS TREATED WITH ANALGESICS, ANTIDEPRESSANTS AND ANXIOLYTICS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, UTERINE INFLAMMATION, PAIN, ABDOMINAL PAIN LOWER, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, MENORRHAGIA, POLYMENORRHOEA, DYSMENORRHOEA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, PELVIC PAIN, UTERINE PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, OFFENSIVE VAGINAL DISCHARGE, ANXIETY DISORDER, DEPRESSION, RECTAL HAEMORRHAGE, AMNESIA, VAGINAL DISCHARGE, VULVOVAGINAL PRURITUS AND DIARRHOEA OUTCOME WAS UNKNOWN AND THE PROCEDURAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, AMNESIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MENORRHAGIA, MOOD SWINGS, OEDEMA, OFFENSIVE VAGINAL DISCHARGE, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN, RECTAL HAEMORRHAGE, TREMOR, UTERINE INFLAMMATION, UTERINE PAIN, VULVOVAGINAL PRURITUS AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SOME EVENTS STARTED 3 MONTHS AFTER ESSURE INSERTION, BUT IN (B)(6) 2018, SHE OBSERVED THAT HER SYMPTOMS WORSENED. SHE WENT TO A GYNECOLOGIST AND WHEN PERFORMED THE REQUESTED EXAMS, SHE WAS DIAGNOSED WITH ADENOMYOSIS. THE REPORTER INFORMED THAT THE ESSURE WAS CLOSE TO PERFORATE PATIENT'S INTERNAL ORGANS, MORE PRECISELY THE REPRODUCTIVE ORGAN. AT THE TIME OF THIS REPORT, PAIN AND PROBLEMS RELATED TO THE DEVICE ARE INTENSIFIED, AND A MEDICAL APPOINTMENT WAS SCHEDULED FOR (B)(6) 2020. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): GYNAECOLOGICAL EXAMINATION - IN 2018: ADENOMYOSIS. ULTRASOUND SCAN VAGINA - ON (B)(6) 2018: UTERINE ENLARGEMENT WITH MYOMETRIAL HETEROGENEITY, SUGGESTING ADENOMYOSIS. X-RAY - IN 2019: ESSURE IS IRREGULARLY POSITIONED ON HER FALLOPIAN TUBES. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: CASE CORRECTION. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 DEVICE BREAKAGE ('ESSURE FRAGMENTED IN SEVERAL PARTS') IN A (B)(6) OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925777) INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 3. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIENOGEST. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN IN LOWER ABDOMEN AFTER INSERTION"). IN 2017, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE CRAMPS IN LOWER ABDOMEN, LIKE TWINGES/SEVERE CRAMPS"), MENORRHAGIA ("CONSIDERABLE INCREASE IN MENTRUAL FLOW / MENSTRUATION LASTING 15 DAYS WITH SOME CLOTS"), POLYMENORRHOEA ("CHANGE IN HER MENSTRUAL CYCLE / MENSTRUAL PERIOD 3 TIMES A MONTH"), DYSMENORRHOEA ("SEVERE PAIN DURING MENSTRUAL FLOW") AND HEADACHE ("SEVERE HEADACHES"). IN 2018, THE PATIENT EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS/ SUSPICION OF ADENOMYOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION ("ESSURE IRREGULARLY POSITIONED / DEVICE IN IRREGULAR POSITION / DISLOCATION OF ESSURE/ESSURE MOVING INSIDE HER BODY"), PAIN ("MANY PHYSICAL PAINS / GENERALIZED PAIN"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("EDEMA"), PAIN IN EXTREMITY ("LEG PAIN"), PERIPHERAL SWELLING ("SWELLING IN HER LEGS"), PARAESTHESIA ("TINGLING"), TREMOR ("TREMORS"), BACK PAIN ("LOW BACK PAIN / LUMBAR PAIN"), PELVIC PAIN ("PAIN IN PELVIC AREA / SEVERE PAIN IN HER PELVIC AREA, PRECISELY ON THE RIGHT SIDE"), UTERINE PAIN ("SENSATION OF PERFORATION IN THE UTERUS / TWINGES"), FATIGUE ("FATIGUE / EXTREME 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"), INTRA-ABDOMINAL FLUID COLLECTION ("FLUID IN THE ABDOMEN"), OFFENSIVE VAGINAL DISCHARGE ("ODOR FROM VAGINAL DISCHARGE"), ANXIETY DISORDER ("ANXIETY DISORDERS AND ANGUISH"), DEPRESSION ("DEPRESSION") WITH CRYING, RECTAL HAEMORRHAGE ("RECTAL BLEEDING"), AMNESIA ("MEMORY LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VULVOVAGINAL PRURITUS ("PRURITUS") AND DIARRHOEA ("SPORADIC AND INTERMITTENT DIARRHEA ASSOCIATED WITH MENSTRUAL CYCLE"). THE PATIENT WAS TREATED WITH ANALGESICS, ANTIDEPRESSANTS AND ANXIOLYTICS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PAIN, ABDOMINAL PAIN LOWER, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, MENORRHAGIA, POLYMENORRHOEA, DYSMENORRHOEA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, PARAESTHESIA, TREMOR, BACK PAIN, PELVIC PAIN, UTERINE PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD SWINGS, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, OFFENSIVE VAGINAL DISCHARGE, ANXIETY DISORDER, DEPRESSION, RECTAL HAEMORRHAGE, AMNESIA, VAGINAL DISCHARGE, VULVOVAGINAL PRURITUS AND DIARRHOEA OUTCOME WAS UNKNOWN AND THE PROCEDURAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ALOPECIA, AMNESIA, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MENORRHAGIA, MOOD SWINGS, OEDEMA, OFFENSIVE VAGINAL DISCHARGE, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PERIPHERAL SWELLING, POLYMENORRHOEA, PROCEDURAL PAIN, RECTAL HAEMORRHAGE, TREMOR, UTERINE INFLAMMATION, UTERINE PAIN, VULVOVAGINAL PRURITUS AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SOME EVENTS STARTED 3 MONTHS AFTER ESSURE INSERTION, BUT IN (B)(6) 2018, SHE OBSERVED THAT HER SYMPTOMS WORSENED. SHE WENT TO A GYNECOLOGIST AND WHEN PERFORMED THE REQUESTED EXAMS, SHE WAS DIAGNOSED WITH ADENOMYOSIS. THE REPORTER INFORMED THAT THE ESSURE WAS CLOSE TO PERFORATE PATIENT'S INTERNAL ORGANS, MORE PRECISELY THE REPRODUCTIVE ORGAN. AT THE TIME OF THIS REPORT, PAIN AND PROBLEMS RELATED TO THE DEVICE ARE INTENSIFIED, AND A MEDICAL APPOINTMENT WAS SCHEDULED FOR (B)(6) 2020. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): GYNAECOLOGICAL EXAMINATION - IN 2018: ADENOMYOSIS. ULTRASOUND SCAN VAGINA - ON (B)(6) 2018: UTERINE ENLARGEMENT WITH MYOMETRIAL HETEROGENEITY, SUGGESTING ADENOMYOSIS. X-RAY - IN 2019: ESSURE IS IRREGULARLY POSITIONED ON HER FALLOPIAN TUBES. 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 |
|---|---|---|---|---|---|---|---|
| 628149 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 925777 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other |