ESSURE
Report
- Report Number
- 2951250-2024-00566
- Event Type
- Injury
- Date Received
- September 24, 2024
- Report Date
- September 25, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BAYER CASE NUMBER:(B)(4). SINCE THE DEVICES ARE ANCHORED AND EMBEDDED IN THE TISSUES [EMBEDDED DEVICE] TWO INTRATUBAL METALLIC FRAGMENTS COMPATIBLE WITH ESSURES [DEVICE BREAKAGE] SINCE IMPLANTATION, THE PATIENT NOTICED CHANGES IN MENSTRUATION, BECOMING MORE PAINFUL AND WITH ABUNDANT CLOTS [PERIOD PAINS] SINCE IMPLANTATION, THE PATIENT NOTICED CHANGES IN MENSTRUATION, BECOMING MORE PAINFUL AND WITH ABUNDANT CLOTS [MENSTRUAL CLOTS] ALLERGIC REACTION [ALLERGIC REACTION] PELVIC PAIN [PELVIC PAIN FEMALE] ABDOMINAL CRAMP [ABDOMINAL CRAMP] EXCESSIVE BLEEDING [GENITAL BLEEDING] INTENSE HEADACHES [FREQUENT HEADACHES] EXTREME FATIGUE [FATIGUE EXTREME] HAIR LOSS [HAIR LOSS] ANXIETY [ANXIETY] DEPRESSION [DEPRESSION] WHICH INEVITABLY LEADS TO IMMENSE EMOTIONAL SUFFERING [EMOTIONAL SUFFERING] CASE NARRATIVE: THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("SINCE THE DEVICES ARE ANCHORED AND EMBEDDED IN THE TISSUES"), DEVICE BREAKAGE ("TWO INTRATUBAL METALLIC FRAGMENTS COMPATIBLE WITH ESSURES"), DYSMENORRHOEA ("SINCE IMPLANTATION, THE PATIENT NOTICED CHANGES IN MENSTRUATION, BECOMING MORE PAINFUL AND WITH ABUNDANT CLOTS") AND MENSTRUAL CLOTS ("SINCE IMPLANTATION, THE PATIENT NOTICED CHANGES IN MENSTRUATION, BECOMING MORE PAINFUL AND WITH ABUNDANT CLOTS") IN A 35 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 852527 NOT VALID) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF MENSTRUAL DISORDER, BACTERIAL VAGINOSIS, HYPOTENSION, DISCOMFORT, CESAREAN SECTION, PARITY 1, ABORTION, MULTIGRAVIDA, HYPOGASTRIC PAIN, POST COITAL BLEEDING AND METRORRHAGIA. THE PATIENT, WITH NO RELEVANT PERSONAL MEDICAL HISTORY AT THE TIME OF THE EVENTS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CERAZET. CONCURRENT CONDITIONS WERE LISTED AS FIBROIDS, GENITAL BLEEDING, ABDOMINAL PAIN, OVERACTIVE BLADDER, ABNORMAL UTERINE BLEEDING, URINARY INCONTINENCE, URINARY URGENCY, VERTIGO, NAUSEA, DIZZINESS, HYPERMENORRHEA, ENDOCERVICAL POLYP, INTERMENSTRUAL BLEEDING, BREAST PAIN, VAGINAL ODOR, VAGINAL DISCHARGE AND DYSPAREUNIA. CONCOMITANT PRODUCTS INCLUDED AMCHAFIBRIN (TRANEXAMIC ACID) AND MIRENA (LEVONORGESTREL). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2024. ON UNKNOWN DATE SHE EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERION HOSPITALISATION), MENSTRUAL CLOTS (SERIOUSNESS CRITERION HOSPITALISATION), HYPERSENSITIVITY ("ALLERGIC REACTION"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL CRAMP"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), HEADACHE (" INTENSE HEADACHES"), FATIGUE ("EXTREME FATIGUE"), ALOPECIA (" HAIR LOSS"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION") AND EMOTIONAL DISTRESS ("WHICH INEVITABLY LEADS TO IMMENSE EMOTIONAL SUFFERING"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013 LAPAROSCOPIC BILATERAL SALPINGECTOMY AND SURGICAL HYSTEROSCOPY AND HYSTEROCTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR EMBEDDED DEVICE, DYSMENORRHOEA, MENSTRUAL CLOTS, HYPERSENSITIVITY, PELVIC PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, FATIGUE, ALOPECIA, ANXIETY, DEPRESSION AND EMOTIONAL DISTRESS WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, EMBEDDED DEVICE, EMOTIONAL DISTRESS, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENSTRUAL CLOTS AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE PATIENT'S TEMPORARY DISABILITY REPORTS ARE PROVIDED. THE PATIENT HAS SUFFERED DISPROPORTIONATE HARM BECAUSE OF THE ESSURE IMPLANTATION. ACCORDING TO THE LAWYER, THERE WAS A LACK OF INFORMATION AND INFORMED CONSENT THROUGHOUT THE ENTIRE CARE PROCESS IN THE LEGALLY AND CONSTITUTIONALLY ACCEPTED TERMS. THE PATIENT HAS NOT RECEIVED THE INFORMATION THAT SHOULD HAVE BEEN PROVIDED TO HER IN UNDERSTANDABLE TERMS ABOUT THE MEDICAL, SURGICAL AND OTHER MEDICAL PROCEDURES THAT REQUIRED IT. THERE HAS BEEN HARM, AND THE PATIENT WAS NOT INFORMED OF ANY RISKS IN ANY WAY THAT WOULD AFFECT HER HEALTH. SHE WAS VERBALLY INFORMED THAT ESSURE WAS AN INFALLIBLE METHOD AND HAD NO NEGATIVE EFFECTS ON THE WOMAN'S HEALTH. THERE WAS A DEFICIT IN THE HEALTHCARE PROVIDED TO THE PATIENT, AS THERE WAS NO INFORMED CONSENT FOR ANY OF THE MEDICAL/HEALTH PROCEDURES PERFORMED ON THE PATIENT, EITHER FOR THE IMPLANTATION OF THE ESSURE DEVICE OR FOR ITS REMOVAL. THE PATIENT WAS A VICTIM OF THE PASSIVE AND ROUTINE ACTIONS OF THE MEDICAL PROFESSIONALS WHO WERE SUPPOSED TO LOOK AFTER HER HEALTH. ESSURE IS PLACED WITHOUT DIFFICULTY, 5 RINGS REMAIN IN THE RIGHT OSTIUM AND 4 IN THE LEFT OSTIUM. PAIN 0 ON THE VISUAL ANALOGUE PAIN SCALE CONCLUSIONS: THE HEALTHCARE PROVIDED BY THE GYNECOLOGY AND OBSTETRICS DEPARTMENT WAS ADEQUATE AND IN ACCORDANCE WITH THE SCIENTIFIC KNOWLEDGE AT THE TIME. THE STERILIZATION SHE HAD REQUESTED WAS PERFORMED, WITH THE METHOD SHE HAD CHOSEN, AFTER BEING INFORMED, AMONG THE DIFFERENT OPTIONS OFFERED AND AFTER SIGNING AN INFORMED CONSENT. THE SURGICAL TECHNIQUE WAS PERFORMED AS PLANNED. THE PROTOCOLIZED POSTOPERATIVE CONTROLS WERE CARRIED OUT. UNTIL 2016, THERE ARE NO SYMPTOMS THAT INDICATED ANY COMPLICATIONS. FOLLOWING THE PATIENT'S REQUEST, BILATERAL SALPINGECTOMY IS PERFORMED TO REMOVE THE MATERIAL, AFTER SIGNING AN INFORMED CONSENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALANINE AMINOTRANSFERASE (5- 33 U/L)] ON (B)(6) 2023: 47 [BLOOD BICARBONATE (22- 26 MMOL/L)] ON (B)(6) 2023: 26.30 [BLOOD FIBRINOGEN (150- 450 MG/DL)] ON (B)(6) 2023: 702 [BLOOD TESTOSTERONE (0.22- 1.14 NG/ML)] ON (B)(6) 2016: 0.04 [CYTOLOGY] ON (B)(6) 2023: MICROSCOPIC DESCRIPTION: CYTOLOGICAL SAMPLE SUITABLE FOR EVALUATION, INCLUDING ENDOCERVICAL COMPONENT AND TRANSFORMATION ZONE. THE CELLULASE CORRESPONDS TO TROPHIC EPITHELIUM FROM INTERMEDIATE AND SUPERFICIAL STRATA, WITH OCCASIONAL GROUPINGS OF ENDOCERVICAL EPITHELIUM. THE FLORA CORRESPONDS ENTIRELY TO DODERLEIN BACILLI. THE BACKGROUND OF THE SAMPLE PRESENTS POLYMORPHONUCLEAR ELEMENTS AND HISTIOCYTES IN SMALL QUANTITIES. NO ATYPICAL CELLS ARE OBSERVED. DIAGNOSIS: NEGATIVE [HAEMATOCRIT (36- 48 %)] ON (B)(6) 2016: 33.3 [HAEMOGLOBIN (12- 16 G/DL)] ON (B)(6) 2016: 11.1; ON (B)(6) 2020: 11.60; ON (B)(6) 2022: 11.90 [LYMPHOCYTE COUNT (15- 48 %)] ON (B)(6) 2022: 52.10 [MEAN CELL HAEMOGLOBIN (27- 31 PG)] ON (B)(6) 2016: 26.4 [MEAN PLATELET VOLUME (8- 12 FL)] ON (B)(6) 2020: 12.60 [NEUTROPHIL COUNT (1.80- 7.0 10*3/UL)] ON (B)(6) 2020: 1.71 [OESTRADIOL (39- 189 PG/ML)] ON (B)(6) 2016: 26.34 [PATHOLOGY TEST] ON (B)(6) 2023: TWO TUBULOAMPULLARY SEGMENTS OF FALLOPIAN TUBES WERE RECEIVED, PATENT, MEASURING 4.7X0.4 AND 3.8X0.6, WITHOUT MACROSCOPIC ALTERATIONS. THEY INCLUDE FIMBRIAE. 2 SUB CENTIMETER METALLIC SEGMENTS COMPATIBLE WITH ESSURE WERE IDENTIFIED. NO DYSPLASTIC FEATURES OF THE TUBAL EPITHELIUM WERE OBSERVED. NON-FUNCTIONING ENDOMETRIAL POLYP; (DATE UNKNOWN): - ENDOMETRIUM (POLYPECTOMY): NON-FUNCTIONING ENDOMETRIAL POLYP. TWO INTRATUBAL METALLIC FRAGMENTS COMPATIBLE WITH ESSURES. UTERINE TUBES (BILATERAL SALPINGECTOMY): PATENT FALLOPIAN TUBES, WITHOUT SPECIAL FEATURES. NO DYSPLASTIC FEATURES OF THE TUBAL EPITHELIUM HAVE BEEN SEEN. [PHYSICAL EXAMINATION] (DATE UNKNOWN): SYMMETRICAL BREASTS WITH A FIBROCYSTIC CONSISTENCY. SMALL NODULES OF MORE THAN 1 CM IN SIZE ARE PALPATED IN THE UPPER EXTERNAL QUADRANT OF THE LEFT BREAST, SUGGESTING SMALL CYSTS THAT ARE PAINFUL TO PALPATION. THE NIPPLE-AREOLA COMPLEX IS NORMAL. THE RIGHT BREAST IS NORMAL, WITHOUT NODULES. SIMILAR CONSISTENCY. CLINICAL JUDGMENT: LEFT-SIDED MASTALGIA [SERUM FERRITIN (13- 150 NG/ML)] ON (B)(6) 2016: 6 [ULTRASOUND SCAN VAGINA] ON (B)(6) 2012: BOTH DEVICES ARE IDENTIFIED NORMALLY INSERTED. DISTANCE BETWEEN PROXIMAL ENDS 27MM. ESSURE NORMALLY INSERTED; ON (B)(6) 2012: -UTERUS: SIZE 67X48X47MM. SHAPE: NORMAL. POSITION: RETROVERSION. ENDOMETRIUM: 8MM. FINDINGS: BOTH DEVICES ARE IDENTIFIED NORMALLY INSERTED. DISTANCE BETWEEN PROXIMAL ENDS 27MM. RIGHT ADNEXA: 24MM, NORMAL. LEFT ADNEXA: 30MM, NORMAL. PELVIS PLATE: ESSURE NORMALLY INSERTED; (DATE UNKNOWN): IRREGULAR UTERUS MEASURING 88X59MM, TYPE 4 INTRAMURAL MYOMA ON THE ANTERIOR SURFACE MEASURING 41 X 43MM WITH PERIPHERAL DOPPLER UPTAKE. OVARIES OF NORMAL SIZE AND ECHO STRUCTURE. (B)(6). PATIENT DESIRES HORMONAL CONTRACEPTION. CLINICAL JUDGMENT: URINARY URGENCY AND URINARY INCONTINENCE. MYOMATOUS UTERUS. [VENOUS OXYGEN PARTIAL PRESSURE (30- 50 MMHG)] ON (B)(6) 2023: 27.20 [WHITE BLOOD CELL COUNT (4- 10 10*3/UL)] ON (B)(6) 2020: 3.72 [X-RAY] ON (B)(6) 2012: ESSURE CONTROL ABDOMINAL PLATE. BATCH: 852527 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 25-SEP-2024: QUALITY SAFETY EVALUATION OF PTC. CASE COMMENTS: WE RECEIVED AN INVALID LOT NUMBER IN THIS CASE. 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.
BAYER CASE NUMBER: (B)(4) SINCE THE DEVICES ARE ANCHORED AND EMBEDDED IN THE TISSUES [EMBEDDED DEVICE] TWO INTRATUBAL METALLIC FRAGMENTS COMPATIBLE WITH ESSURES [DEVICE BREAKAGE] SINCE IMPLANTATION, THE PATIENT NOTICED CHANGES IN MENSTRUATION, BECOMING MORE PAINFUL AND WITH ABUNDANT CLOTS [PERIOD PAINS] SINCE IMPLANTATION, THE PATIENT NOTICED CHANGES IN MENSTRUATION, BECOMING MORE PAINFUL AND WITH ABUNDANT CLOTS [MENSTRUAL CLOTS] ALLERGIC REACTION [ALLERGIC REACTION] PELVIC PAIN [PELVIC PAIN FEMALE] ABDOMINAL CRAMP [ABDOMINAL CRAMP] EXCESSIVE BLEEDING [GENITAL BLEEDING] INTENSE HEADACHES [FREQUENT HEADACHES] EXTREME FATIGUE [FATIGUE EXTREME] HAIR LOSS [HAIR LOSS] ANXIETY [ANXIETY] DEPRESSION [DEPRESSION] WHICH INEVITABLY LEADS TO IMMENSE EMOTIONAL SUFFERING. [EMOTIONAL SUFFERING] CASE NARRATIVE: 0FETHIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("SINCE THE DEVICES ARE ANCHORED AND EMBEDDED IN THE TISSUES"), DEVICE BREAKAGE ("TWO INTRATUBAL METALLIC FRAGMENTS COMPATIBLE WITH ESSURES"), DYSMENORRHOEA ("SINCE IMPLANTATION, THE PATIENT NOTICED CHANGES IN MENSTRUATION, BECOMING MORE PAINFUL AND WITH ABUNDANT CLOTS") AND MENSTRUAL CLOTS ("SINCE IMPLANTATION, THE PATIENT NOTICED CHANGES IN MENSTRUATION, BECOMING MORE PAINFUL AND WITH ABUNDANT CLOTS") IN A 35 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 852527) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF MENSTRUAL DISORDER, BACTERIAL VAGINOSIS, HYPOTENSION, DISCOMFORT, CESAREAN SECTION, PARITY 1, ABORTION, MULTIGRAVIDA, HYPOGASTRIC PAIN, POST COITAL BLEEDING AND METRORRHAGIA. THE PATIENT, WITH NO RELEVANT PERSONAL MEDICAL HISTORY AT THE TIME OF THE EVENTS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CERAZET. CONCURRENT CONDITIONS WERE LISTED AS FIBROIDS, GENITAL BLEEDING, ABDOMINAL PAIN, OVERACTIVE BLADDER, ABNORMAL UTERINE BLEEDING, URINARY INCONTINENCE, URINARY URGENCY, VERTIGO, NAUSEA, DIZZINESS, HYPERMENORRHEA, ENDOCERVICAL POLYP, INTERMENSTRUAL BLEEDING, BREAST PAIN, VAGINAL ODOR, VAGINAL DISCHARGE AND DYSPAREUNIA. CONCOMITANT PRODUCTS INCLUDED AMCHAFIBRIN (TRANEXAMIC ACID) AND MIRENA (LEVONORGESTREL). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATE SHE EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERION HOSPITALISATION), MENSTRUAL CLOTS (SERIOUSNESS CRITERION HOSPITALISATION), HYPERSENSITIVITY ("ALLERGIC REACTION"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL CRAMP"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), HEADACHE (" INTENSE HEADACHES"), FATIGUE ("EXTREME FATIGUE"), ALOPECIA (" HAIR LOSS"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION") AND EMOTIONAL DISTRESS ("WHICH INEVITABLY LEADS TO IMMENSE EMOTIONAL SUFFERING"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013 LAPAROSCOPIC BILATERAL SALPINGECTOMY AND SURGICAL HYSTEROSCOPY AND HYSTEROCTOMY). ESSURE WAS REMOVED ON (B)(6) 2024. AT THE TIME OF THE REPORT, THE OUTCOMES FOR EMBEDDED DEVICE, DYSMENORRHOEA, MENSTRUAL CLOTS, HYPERSENSITIVITY, PELVIC PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, FATIGUE, ALOPECIA, ANXIETY, DEPRESSION AND EMOTIONAL DISTRESS WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSMENORRHOEA, EMBEDDED DEVICE, EMOTIONAL DISTRESS, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENSTRUAL CLOTS AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE PATIENT'S TEMPORARY DISABILITY REPORTS ARE PROVIDED. THE PATIENT HAS SUFFERED DISPROPORTIONATE HARM BECAUSE OF THE ESSURE IMPLANTATION. ACCORDING TO THE LAWYER, THERE WAS A LACK OF INFORMATION AND INFORMED CONSENT THROUGHOUT THE ENTIRE CARE PROCESS IN THE LEGALLY AND CONSTITUTIONALLY ACCEPTED TERMS. THE PATIENT HAS NOT RECEIVED THE INFORMATION THAT SHOULD HAVE BEEN PROVIDED TO HER IN UNDERSTANDABLE TERMS ABOUT THE MEDICAL, SURGICAL AND OTHER MEDICAL PROCEDURES THAT REQUIRED IT. THERE HAS BEEN HARM, AND THE PATIENT WAS NOT INFORMED OF ANY RISKS IN ANY WAY THAT WOULD AFFECT HER HEALTH. SHE WAS VERBALLY INFORMED THAT ESSURE WAS AN INFALLIBLE METHOD AND HAD NO NEGATIVE EFFECTS ON THE WOMAN'S HEALTH. THERE WAS A DEFICIT IN THE HEALTHCARE PROVIDED TO THE PATIENT, AS THERE WAS NO INFORMED CONSENT FOR ANY OF THE MEDICAL/HEALTH PROCEDURES PERFORMED ON THE PATIENT, EITHER FOR THE IMPLANTATION OF THE ESSURE DEVICE OR FOR ITS REMOVAL. THE PATIENT WAS A VICTIM OF THE PASSIVE AND ROUTINE ACTIONS OF THE MEDICAL PROFESSIONALS WHO WERE SUPPOSED TO LOOK AFTER HER HEALTH. ESSURE IS PLACED WITHOUT DIFFICULTY, 5 RINGS REMAIN IN THE RIGHT OSTIUM AND 4 IN THE LEFT OSTIUM. PAIN 0 ON THE VISUAL ANALOGUE PAIN SCALE. CONCLUSIONS: THE HEALTHCARE PROVIDED BY THE GYNECOLOGY AND OBSTETRICS DEPARTMENT WAS ADEQUATE AND IN ACCORDANCE WITH THE SCIENTIFIC KNOWLEDGE AT THE TIME. THE STERILIZATION SHE HAD REQUESTED WAS PERFORMED, WITH THE METHOD SHE HAD CHOSEN, AFTER BEING INFORMED, AMONG THE DIFFERENT OPTIONS OFFERED AND AFTER SIGNING AN INFORMED CONSENT. THE SURGICAL TECHNIQUE WAS PERFORMED AS PLANNED. THE PROTOCOLIZED POSTOPERATIVE CONTROLS WERE CARRIED OUT. UNTIL 2016, THERE ARE NO SYMPTOMS THAT INDICATED ANY COMPLICATIONS. FOLLOWING THE PATIENT'S REQUEST, BILATERAL SALPINGECTOMY IS PERFORMED TO REMOVE THE MATERIAL, AFTER SIGNING AN INFORMED CONSENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ALANINE AMINOTRANSFERASE ( 5- 33 U/L)] ON (B)(6) 2023: 47. [BLOOD BICARBONATE ( 22- 26 MMOL/L)] ON (B)(6) 2023: 26.30. [BLOOD FIBRINOGEN ( 150- 450 MG/DL)] ON (B)(6) 2023: 702. [BLOOD TESTOSTERONE ( 0.22- 1.14 NG/ML)] ON (B)(6) 2016: 0.04. [CYTOLOGY] ON 1(B)(6) 2023: MICROSCOPIC DESCRIPTION: CYTOLOGICAL SAMPLE SUITABLE FOR EVALUATION, INCLUDING ENDOCERVICAL COMPONENT AND TRANSFORMATION ZONE. THE CELLULASE CORRESPONDS TO TROPHIC EPITHELIUM FROM INTERMEDIATE AND SUPERFICIAL STRATA, WITH OCCASIONAL GROUPINGS OF ENDOCERVICAL EPITHELIUM. THE FLORA CORRESPONDS ENTIRELY TO DODERLEIN BACILLI. THE BACKGROUND OF THE SAMPLE PRESENTS POLYMORPHONUCLEAR ELEMENTS AND HISTIOCYTES IN SMALL QUANTITIES. NO ATYPICAL CELLS ARE OBSERVED. DIAGNOSIS: NEGATIVE [HAEMATOCRIT ( 36- 48 %)] ON (B)(6) 2016: 33.3. [HAEMOGLOBIN ( 12- 16 G/DL)] ON (B)(6)-2016: 11.1; ON (B)(6) 2020: 11.60; ON (B)(6) 2022: 11.90. [LYMPHOCYTE COUNT ( 15- 48 %)] ON (B)(6) 2022: 52.10. [MEAN CELL HAEMOGLOBIN ( 27- 31 PG)] ON (B)(6) 2016: 26.4. [MEAN PLATELET VOLUME ( 8- 12 FL)] ON (B)(6) 2020: 12.60. [NEUTROPHIL COUNT ( 1.80- 7.0 10*3/UL)] ON (B)(6) 2020: 1.71. [OESTRADIOL ( 39- 189 PG/ML)] ON (B)(6) 2016: 26.34. [PATHOLOGY TEST] ON (B)(6) 2023: TWO TUBULOAMPULLARY SEGMENTS OF FALLOPIAN TUBES WERE RECEIVED, PATENT, MEASURING 4.7X0.4 AND 3.8X0.6, WITHOUT MACROSCOPIC ALTERATIONS. THEY INCLUDE FIMBRIAE. 2 SUB CENTIMETER METALLIC SEGMENTS COMPATIBLE WITH ESSURE WERE IDENTIFIED. NO DYSPLASTIC FEATURES OF THE TUBAL EPITHELIUM WERE OBSERVED. NON-FUNCTIONING ENDOMETRIAL POLYP; (DATE UNKNOWN): - ENDOMETRIUM (POLYPECTOMY): NON-FUNCTIONING ENDOMETRIAL POLYP. TWO INTRATUBAL METALLIC FRAGMENTS COMPATIBLE WITH ESSURES. UTERINE TUBES (BILATERAL SALPINGECTOMY): PATENT FALLOPIAN TUBES, WITHOUT SPECIAL FEATURES. NO DYSPLASTIC FEATURES OF THE TUBAL EPITHELIUM HAVE BEEN SEEN. [PHYSICAL EXAMINATION] (DATE UNKNOWN): SYMMETRICAL BREASTS WITH A FIBROCYSTIC CONSISTENCY. SMALL NODULES OF MORE THAN 1 CM IN SIZE ARE PALPATED IN THE UPPER EXTERNAL QUADRANT OF THE LEFT BREAST, SUGGESTING SMALL CYSTS THAT ARE PAINFUL TO PALPATION. THE NIPPLE-AREOLA COMPLEX IS NORMAL. THE RIGHT BREAST IS NORMAL, WITHOUT NODULES. SIMILAR CONSISTENCY. CLINICAL JUDGMENT: LEFT-SIDED MASTALGIA [SERUM FERRITIN ( 13- 150 NG/ML)] ON (B)(6) 2016: 6. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2012: BOTH DEVICES ARE IDENTIFIED NORMALLY INSERTED. DISTANCE BETWEEN PROXIMAL ENDS 27MM. ESSURE NORMALLY INSERTED; ON (B)(6) 2012: -UTERUS: SIZE 67X48X47MM. SHAPE: NORMAL. POSITION: RETROVERSION. ENDOMETRIUM: 8MM. FINDINGS: BOTH DEVICES ARE IDENTIFIED NORMALLY INSERTED. DISTANCE BETWEEN PROXIMAL ENDS 27MM. RIGHT ADNEXA: 24MM, NORMAL. LEFT ADNEXA: 30MM, NORMAL. PELVIS PLATE: ESSURE NORMALLY INSERTED; (DATE UNKNOWN): IRREGULAR UTERUS MEASURING 88X59MM, TYPE 4 INTRAMURAL MYOMA ON THE ANTERIOR SURFACE MEASURING 41 X 43MM WITH PERIPHERAL DOPPLER UPTAKE. OVARIES OF NORMAL SIZE AND ECHO STRUCTURE. FREE DOUGLAS. PATIENT DESIRES HORMONAL CONTRACEPTION. CLINICAL JUDGMENT: URINARY URGENCY AND URINARY INCONTINENCE. MYOMATOUS UTERUS. [VENOUS OXYGEN PARTIAL PRESSURE ( 30- 50 MMHG)] ON (B)(6) 2023: 27.20. [WHITE BLOOD CELL COUNT ( 4- 10 10*3/UL)] ON (B)(6) 2020: 3.72. [X-RAY] ON (B)(6) 2012: ESSURE CONTROL ABDOMINAL PLATE. CASE COMMENTS: 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 |
|---|---|---|---|---|---|---|---|
| 1175609 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 852527 NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H | AMCHAFIBRIN (TRANEXAMIC ACID),| AMCHAFIBRIN (TRANEXAMIC ACID),| MIRENA (LEVONORGESTREL), INTRAUTERINE DELIVERY SYS| MIRENA (LEVONORGESTREL), INTRAUTERINE DELIVERY SYS |