ESSURE
Report
- Report Number
- 2951250-2025-00629
- Event Type
- Injury
- Date Received
- October 27, 2025
- Report Date
- November 4, 2025
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BAYER CASE NUMBER: (B)(4) IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES. [FALLOPIAN TUBE PERFORATION], PHYSICAL PAIN [PELVIC PAIN FEMALE] , EMOTIONAL ANGUISH [ANGUISH] , DISCOMFORT [DISCOMFORT] , QUALITY OF LIFE [IMPAIRED QUALITY OF LIFE], EMOTIONAL DISTRESS [EMOTIONAL DISTRESS] , ENDOMETRIOSIS [ENDOMETRIOSIS] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES.") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 4. CONCURRENT CONDITIONS WERE LISTED AS DYSPNEA AND SINUS ARRHYTHMIA. IN 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017 SHE EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), ANXIETY ("EMOTIONAL ANGUISH"), DISCOMFORT ("DISCOMFORT"), IMPAIRED QUALITY OF LIFE ("QUALITY OF LIFE"), EMOTIONAL DISTRESS ("EMOTIONAL DISTRESS") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). ESSURE WAS REMOVED IN (B)(6) 2025. ON UNKNOWN DATE SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH AMITRIPTYLINE (AMITRIPTYLINE PAMOATE), CLONAZEPAM-R AND GLIFAGE (METFORMIN) AS WELL AS SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE PELVIC PAIN, ANXIETY, DISCOMFORT, IMPAIRED QUALITY OF LIFE, EMOTIONAL DISTRESS AND ENDOMETRIOSIS HAD NOT RESOLVED. THE OUTCOME OF FALLOPIAN TUBE PERFORATION WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DISCOMFORT, EMOTIONAL DISTRESS, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, IMPAIRED QUALITY OF LIFE AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ABOUT SIX MONTHS AFTER THE IMPLEMENTATION OF ESSURE, THE PATIENT BEGAN TO HAVE SERIOUS AND PERSISTENT GYNECOLOGICAL PROBLEMS WHICH LED HER TO SEEK NUMEROUS MEDICAL CARES AND TO FACE CONSTANT AND GROWING SUFFERING. THE SYMPTOMS, WHICH MANIFESTED THEMSELVES IN AN INTENSE AND DEBILITATING WAY, SIGNIFICANTLY COMPROMISED THE PATIENT¿S QUALITY OF LIFE, CAUSING HER PHYSICAL PAIN, DISCOMFORT AND EMOTIONAL ANGUISH. THE SITUATION HAS WORSENED TO THE POINT OF REQUIRING THE CONSTANT SEARCH FOR MEDICAL ASSISTANCE, WITH TRIPS TO HOSPITALS AND CLINICS, TO FIND AN ACCURATE DIAGNOSIS AND AN EFFECTIVE TREATMENT TO ALLEVIATE THEIR SUFFERING. THE PATIENT RETURNED TO THE (B)(6) HOSPITAL, WHERE SHE CLAIMS THAT SHE WAS NEGLECTED AND DISCOVERED THAT THE STATE ITSELF HAD RECOGNIZED THE ERROR IN THE PROCEDURE AND HAD DECIDED TO REMOVE THE ESSURE. THE PATIENT EXPERIENCED A PROLONGED PERIOD OF PHYSICAL AND PSYCHOLOGICAL SUFFERING. DESPITE THE REMOVAL OF ESSURE AND BILATERAL SALPINGECTOMY PERFORMED ON (B)(6) 2025, SHE CONTINUED TO FEEL THE SAME SYMPTOMS THAT HAD PLAGUED HER SINCE THE INSERTION OF ESSURE. PAIN, DISCOMFORT AND ANGUISH PERSIST, FORCING HER TO KEEP MEDICAL APPOINTMENTS AND NOT BE DISCHARGED. SHE FEELS NEGLECTED BY THE MANUFACTURER AND SUPPLIER OF ESSURE AND BY THE HOSPITAL. THE CONDUCT OF THE DEFENDANTS VIOLATED THE MOST ELEMENTARY TECHNICAL AND SCIENTIFIC KNOWLEDGE, DEMONSTRATING NEGLIGENCE AND DISREGARD FOR THE PATIENT¿S HEALTH AND WELL-BEING. ALTHOUGH THE PROCEDURE FOR THE IMPLANTATION OF THE ESSURE DEVICE TOOK PLACE IN 2016, THE PATIENT WAS FULLY AWARE OF THE DAMAGE AND OF ITS AUTHORSHIP LATER. THE SUSPENSION OF THE USE OF THE DEVICE BY 2017 DDED TO THE NEED FOR REMOVAL SURGERY SCHEDULED FOR (B)(6) 2025, DEMONSTRATES THE RECOGNITION OF THE PROBLEM BY THE STATE AND THE CONSOLIDATION OF THE DAMAGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD CREATINE] (DATE UNKNOWN): 1.0 [BLOOD GLUCOSE] (DATE UNKNOWN): 91 [BLOOD UREA] (DATE UNKNOWN): 25 [CHEST X-RAY] (DATE UNKNOWN): PRESERVED LUNG TRANSPARENCY. MEDIASTINUM CENTERED. PRESERVED AORTA. NORMAL HEART AREA. FREE COSTOPHRENIC BREASTS. [COAGULATION TEST] (DATE UNKNOWN): NORMAL [HAEMATOCRIT] (DATE UNKNOWN): 35.9 [HAEMOGLOBIN] (DATE UNKNOWN): 12.2 [HIV TEST] IN (B)(6) 2024: NON-REACTIVE [ULTRASOUND ABDOMEN] (DATE UNKNOWN): NORMAL-SIZED LIVER, REGULAR CONTOURS, AND HOMOGENEOUS PARENCHYMAL TEXTURE, WITH NO EVIDENCE OF TUMOR LESION. NORMAL CALIBER PORT VEIN. ABSENCE OF DILATATION OF THE INTRA- AND EXTRAHEPATIC BILIARY SYSTEM. COMMON BILE DUCT OF NORMAL CALIBER. GALLBLADDER WITH LITTLE DISTENDEDNESS, APPARENTLY WITHOUT ECHOES INSIDE. PANCREAS WITH PRESERVED ANATOMICAL ASPECT. TOPICAL KIDNEYS OF NORMAL DIMENSIONS, REGULAR CONTOURS AND HOMOGENEOUS PARENCHYMAL TEXTURE. ABSENCE OF DILATION OF PYELOCALICEAL SYSTEMS. WE DID NOT SHOW STONES OR TUMOR LESIONS. SPLEEN OF NORMAL VOLUME WITH HOMOGENEOUS PARENCHYMAL TEXTURE. ABDOMINAL AORTA AND INFERIOR VENA CAVA WITH NORMAL APPEARANCE. FULL BLADDER, WITH THIN WALLS, REGULAR CONTOURS AND ANECHOIC CONTENT. ABSENCE OF FREE FLUID IN THE ABDOMINAL CAVITY. TRANSVERSE IMAGES OF THE UTERINE HORNS WITH IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES [ULTRASOUND SCAN VAGINA] ON (B)(6) 2024: THE UTERUS WAS ANTEVERSE-FLEXION, WITH A REGULAR CONTOUR AND HOMOGENEOUS TEXTURE. UTERUS MEASUREMENTS: 77 X 42 X 41 MM (W X D X T) VOL.: 71 CM³. CENTERED ENDOMETRIUM, MEASURING 9.9 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE. RIGHT OVARY MEASURING 23 X 16 X 15 MM (VOL: 3.0 CM³). LEFT OVARY MEASURING 27 X 15 X 12 MM (VOL: 2.6 CM3 ). TRANSVERSE IMAGES OF THE HORNS WITH IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES [WHITE BLOOD CELL COUNT] (DATE UNKNOWN): 4.590. 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: 29-OCT-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: 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. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
BAYER CASE NUMBER: (B)(4). IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES. [FALLOPIAN TUBE PERFORATION]. PHYSICAL PAIN [PELVIC PAIN FEMALE]. EMOTIONAL ANGUISH [ANGUISH]. DISCOMFORT [DISCOMFORT]. QUALITY OF LIFE [IMPAIRED QUALITY OF LIFE]. EMOTIONAL DISTRESS [EMOTIONAL DISTRESS]. ENDOMETRIOSIS [ENDOMETRIOSIS]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES.") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 4. CONCURRENT CONDITIONS WERE LISTED AS DYSPNEA AND SINUS ARRHYTHMIA. IN 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017 SHE EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), ANXIETY ("EMOTIONAL ANGUISH"), DISCOMFORT ("DISCOMFORT"), IMPAIRED QUALITY OF LIFE ("QUALITY OF LIFE"), EMOTIONAL DISTRESS ("EMOTIONAL DISTRESS") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). ESSURE WAS REMOVED IN (B)(6) 2025. ON UNKNOWN DATE SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH AMITRIPTYLINE (AMITRIPTYLINE PAMOATE), CLONAZEPAM-R AND GLIFAGE (METFORMIN) AS WELL AS SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE PELVIC PAIN, ANXIETY, DISCOMFORT, IMPAIRED QUALITY OF LIFE, EMOTIONAL DISTRESS AND ENDOMETRIOSIS HAD NOT RESOLVED. THE OUTCOME OF FALLOPIAN TUBE PERFORATION WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DISCOMFORT, EMOTIONAL DISTRESS, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, IMPAIRED QUALITY OF LIFE AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ABOUT SIX MONTHS AFTER THE IMPLEMENTATION OF ESSURE, THE PATIENT BEGAN TO HAVE SERIOUS AND PERSISTENT GYNECOLOGICAL PROBLEMS WHICH LED HER TO SEEK NUMEROUS MEDICAL CARES AND TO FACE CONSTANT AND GROWING SUFFERING. THE SYMPTOMS, WHICH MANIFESTED THEMSELVES IN AN INTENSE AND DEBILITATING WAY, SIGNIFICANTLY COMPROMISED THE PATIENT¿S QUALITY OF LIFE, CAUSING HER PHYSICAL PAIN, DISCOMFORT AND EMOTIONAL ANGUISH. THE SITUATION HAS WORSENED TO THE POINT OF REQUIRING THE CONSTANT SEARCH FOR MEDICAL ASSISTANCE, WITH TRIPS TO HOSPITALS AND CLINICS, TO FIND AN ACCURATE DIAGNOSIS AND AN EFFECTIVE TREATMENT TO ALLEVIATE THEIR SUFFERING. THE PATIENT RETURNED TO THE WOMEN'S HOSPITAL, WHERE SHE CLAIMS THAT SHE WAS NEGLECTED AND DISCOVERED THAT THE STATE ITSELF HAD RECOGNIZED THE ERROR IN THE PROCEDURE AND HAD DECIDED TO REMOVE THE ESSURE. THE PATIENT EXPERIENCED A PROLONGED PERIOD OF PHYSICAL AND PSYCHOLOGICAL SUFFERING. DESPITE THE REMOVAL OF ESSURE AND BILATERAL SALPINGECTOMY PERFORMED ON (B)(6) 2025, SHE CONTINUED TO FEEL. THE SAME SYMPTOMS THAT HAD PLAGUED HER SINCE THE INSERTION OF ESSURE. PAIN, DISCOMFORT AND ANGUISH PERSIST, FORCING HER TO KEEP MEDICAL APPOINTMENTS AND NOT BE DISCHARGED. SHE FEELS NEGLECTED BY THE MANUFACTURER AND SUPPLIER OF ESSURE AND BY THE HOSPITAL. THE CONDUCT OF THE DEFENDANTS VIOLATED THE MOST ELEMENTARY TECHNICAL AND SCIENTIFIC KNOWLEDGE, DEMONSTRATING NEGLIGENCE AND DISREGARD FOR THE PATIENT¿S HEALTH AND WELL-BEING. ALTHOUGH THE PROCEDURE FOR THE IMPLANTATION OF THE ESSURE DEVICE TOOK PLACE IN 2016, THE PATIENT WAS FULLY AWARE OF THE DAMAGE AND OF ITS AUTHORSHIP LATER. THE SUSPENSION OF THE USE OF THE DEVICE BY 2017 DDED TO THE NEED FOR REMOVAL SURGERY SCHEDULED FOR (B)(6) 2025, DEMONSTRATES THE RECOGNITION OF THE PROBLEM BY THE STATE AND THE CONSOLIDATION OF THE DAMAGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD CREATINE] (DATE UNKNOWN): 1.0. [BLOOD GLUCOSE] (DATE UNKNOWN): 91. [BLOOD UREA] (DATE UNKNOWN): 25. [CHEST X-RAY] (DATE UNKNOWN): PRESERVED LUNG TRANSPARENCY. MEDIASTINUM CENTERED. PRESERVED AORTA. NORMAL HEART AREA. FREE COSTOPHRENIC BREASTS. [COAGULATION TEST] (DATE UNKNOWN): NORMAL. [HAEMATOCRIT] (DATE UNKNOWN): 35.9. [HAEMOGLOBIN] (DATE UNKNOWN): 12.2. [HIV TEST] IN (B)(6) 2024: NON-REACTIVE. [ULTRASOUND ABDOMEN] (DATE UNKNOWN): NORMAL-SIZED LIVER, REGULAR CONTOURS, AND HOMOGENEOUS PARENCHYMAL TEXTURE, WITH NO EVIDENCE OF TUMOR LESION. NORMAL CALIBER PORT VEIN. ABSENCE OF DILATATION OF THE INTRA- AND EXTRAHEPATIC BILIARY SYSTEM. COMMON BILE DUCT OF NORMAL CALIBER. GALLBLADDER WITH LITTLE DISTENDEDNESS, APPARENTLY WITHOUT ECHOES INSIDE. PANCREAS WITH PRESERVED ANATOMICAL ASPECT. TOPICAL KIDNEYS OF NORMAL DIMENSIONS, REGULAR CONTOURS AND HOMOGENEOUS. PARENCHYMAL TEXTURE. ABSENCE OF DILATION OF PYELOCALICEAL SYSTEMS. WE DID NOT SHOW STONES OR TUMOR LESIONS. SPLEEN OF NORMAL VOLUME WITH HOMOGENEOUS PARENCHYMAL TEXTURE. ABDOMINAL AORTA AND INFERIOR VENA CAVA WITH NORMAL APPEARANCE. FULL BLADDER, WITH THIN WALLS, REGULAR CONTOURS AND ANECHOIC CONTENT. ABSENCE OF FREE FLUID IN THE ABDOMINAL CAVITY. TRANSVERSE IMAGES OF THE UTERINE HORNS WITH IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES [ULTRASOUND SCAN VAGINA] ON (B)(6) 2024: THE UTERUS WAS ANTEVERSE-FLEXION, WITH A REGULAR CONTOUR AND HOMOGENEOUS TEXTURE. UTERUS MEASUREMENTS: 77 X 42 X 41 MM (W X D X T) VOL.: 71 CM³. CENTERED ENDOMETRIUM, MEASURING 9.9 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE. RIGHT OVARY MEASURING 23 X 16 X 15 MM (VOL: 3.0 CM³). LEFT OVARY MEASURING 27 X 15 X 12 MM (VOL: 2.6 CM3 ). TRANSVERSE IMAGES OF THE HORNS WITH IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES. [WHITE BLOOD CELL COUNT] (DATE UNKNOWN): 4.590. 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: (B)(6) 2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: 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. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
BAYER CASE NUMBER: (B)(4) IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES. [FALLOPIAN TUBE PERFORATION] , PHYSICAL PAIN [PELVIC PAIN FEMALE], EMOTIONAL ANGUISH [ANGUISH] , DISCOMFORT [DISCOMFORT] , QUALITY OF LIFE [IMPAIRED QUALITY OF LIFE] , EMOTIONAL DISTRESS [EMOTIONAL DISTRESS] , ENDOMETRIOSIS [ENDOMETRIOSIS] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES.") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 4. CONCURRENT CONDITIONS WERE LISTED AS DYSPNEA AND SINUS ARRHYTHMIA. IN 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017 SHE EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN"), ANXIETY ("EMOTIONAL ANGUISH"), DISCOMFORT ("DISCOMFORT"), IMPAIRED QUALITY OF LIFE ("QUALITY OF LIFE"), EMOTIONAL DISTRESS ("EMOTIONAL DISTRESS") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). ON UNKNOWN DATE SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH AMITRIPTYLINE (AMITRIPTYLINE PAMOATE), CLONAZEPAM-R AND GLIFAGE (METFORMIN) AS WELL AS SURGERY (TO REMOVE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2025. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ANXIETY, DISCOMFORT, IMPAIRED QUALITY OF LIFE, EMOTIONAL DISTRESS AND ENDOMETRIOSIS HAD NOT RESOLVED. THE OUTCOME OF FALLOPIAN TUBE PERFORATION WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DISCOMFORT, EMOTIONAL DISTRESS, ENDOMETRIOSIS, FALLOPIAN TUBE PERFORATION, IMPAIRED QUALITY OF LIFE AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ABOUT SIX MONTHS AFTER THE IMPLEMENTATION OF ESSURE, THE PATIENT BEGAN TO HAVE SERIOUS AND PERSISTENT GYNECOLOGICAL PROBLEMS WHICH LED HER TO SEEK NUMEROUS MEDICAL CARES AND TO FACE CONSTANT AND GROWING SUFFERING. THE SYMPTOMS, WHICH MANIFESTED THEMSELVES IN AN INTENSE AND DEBILITATING WAY, SIGNIFICANTLY COMPROMISED THE PATIENT¿S QUALITY OF LIFE, CAUSING HER PHYSICAL PAIN, DISCOMFORT AND EMOTIONAL ANGUISH. THE SITUATION HAS WORSENED TO THE POINT OF REQUIRING THE CONSTANT SEARCH FOR MEDICAL ASSISTANCE, WITH TRIPS TO HOSPITALS AND CLINICS, TO FIND AN ACCURATE DIAGNOSIS AND AN EFFECTIVE TREATMENT TO ALLEVIATE THEIR SUFFERING. THE PATIENT RETURNED TO THE WOMEN'S HOSPITAL, WHERE SHE CLAIMS THAT SHE WAS NEGLECTED AND DISCOVERED THAT THE STATE ITSELF HAD RECOGNIZED THE ERROR IN THE PROCEDURE AND HAD DECIDED TO REMOVE THE ESSURE. THE PATIENT EXPERIENCED A PROLONGED PERIOD OF PHYSICAL AND PSYCHOLOGICAL SUFFERING. DESPITE THE REMOVAL OF ESSURE AND BILATERAL SALPINGECTOMY PERFORMED ON (B)(6) 2025, SHE CONTINUED TO FEEL. THE SAME SYMPTOMS THAT HAD PLAGUED HER SINCE THE INSERTION OF ESSURE. PAIN, DISCOMFORT AND ANGUISH PERSIST, FORCING HER . TO KEEP MEDICAL APPOINTMENTS AND NOT BE DISCHARGED. SHE FEELS NEGLECTED BY THE MANUFACTURER AND SUPPLIER OF ESSURE . AND BY THE HOSPITAL. THE CONDUCT OF THE DEFENDANTS VIOLATED THE MOST ELEMENTARY TECHNICAL AND SCIENTIFIC KNOWLEDGE, DEMONSTRATING NEGLIGENCE AND DISREGARD FOR THE PATIENT¿S HEALTH AND WELL-BEING. ALTHOUGH THE PROCEDURE FOR THE IMPLANTATION OF THE ESSURE DEVICE TOOK PLACE IN 2016, THE PATIENT WAS FULLY AWARE OF THE DAMAGE AND OF ITS AUTHORSHIP LATER. THE SUSPENSION OF THE USE OF THE DEVICE BY 2017 DDED TO THE NEED FOR REMOVAL SURGERY SCHEDULED FOR (B)(6) 2025, DEMONSTRATES THE RECOGNITION OF THE PROBLEM BY THE STATE AND THE CONSOLIDATION OF THE DAMAGE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD CREATINE] (DATE UNKNOWN): 1.0, [BLOOD GLUCOSE] (DATE UNKNOWN): 91, [BLOOD UREA] (DATE UNKNOWN): 25, [CHEST X-RAY] (DATE UNKNOWN): PRESERVED LUNG TRANSPARENCY. MEDIASTINUM CENTERED. PRESERVED AORTA. NORMAL HEART AREA. FREE COSTOPHRENIC. BREASTS. [COAGULATION TEST] (DATE UNKNOWN): NORMAL [HAEMATOCRIT] (DATE UNKNOWN): 35.9, [HAEMOGLOBIN] (DATE UNKNOWN): 12.2, [HIV TEST] IN AUGUST 2024: NON-REACTIVE, [ULTRASOUND ABDOMEN] (DATE UNKNOWN): NORMAL-SIZED LIVER, REGULAR CONTOURS, AND HOMOGENEOUS PARENCHYMAL TEXTURE, WITH NO EVIDENCE OF TUMOR LESION. NORMAL CALIBER PORT VEIN. ABSENCE OF DILATATION OF THE INTRA- AND EXTRAHEPATIC BILIARY SYSTEM. COMMON BILE DUCT OF NORMAL CALIBER. GALLBLADDER WITH LITTLE DISTENDEDNESS, APPARENTLY WITHOUT ECHOES INSIDE. PANCREAS WITH PRESERVED ANATOMICAL ASPECT. TOPICAL KIDNEYS OF NORMAL DIMENSIONS, REGULAR CONTOURS AND HOMOGENEOUS PARENCHYMAL TEXTURE. ABSENCE OF DILATION OF PYELOCALICEAL SYSTEMS. WE DID NOT SHOW STONES OR TUMOR LESIONS. SPLEEN OF NORMAL VOLUME WITH HOMOGENEOUS PARENCHYMAL TEXTURE. ABDOMINAL AORTA AND INFERIOR VENA CAVA WITH NORMAL APPEARANCE. FULL BLADDER, WITH THIN WALLS, REGULAR CONTOURS AND ANECHOIC CONTENT. ABSENCE OF FREE FLUID IN THE ABDOMINAL CAVITY. TRANSVERSE IMAGES OF THE UTERINE HORNS WITH IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES [ULTRASOUND SCAN VAGINA] ON (B)(6) 2024: THE UTERUS WAS ANTEVERSE-FLEXION, WITH A REGULAR CONTOUR AND HOMOGENEOUS TEXTURE. UTERUS MEASUREMENTS: 77 X 42 X 41 MM (W X D X T) VOL.: 71 CM³. CENTERED ENDOMETRIUM, MEASURING 9.9 MM THICK. OVARIES OF NORMAL SHAPE, VOLUME AND TEXTURE. RIGHT OVARY MEASURING 23 X 16 X 15 MM (VOL: 3.0 CM³). LEFT OVARY MEASURING 27 X 15 X 12 MM (VOL: 2.6 CM3 ). TRANSVERSE IMAGES OF THE HORNS WITH IDENTIFICATION OF THE DEVICES IN THEIR LINEAR AXES, INCLUDING THE PROXIMAL END THAT CROSSES THE MYOMETRIUM IN THE INTERSTITIAL PORTION OF THE RIGHT AND LEFT TUBES [WHITE BLOOD CELL COUNT] (DATE UNKNOWN): 4.590. CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2734816 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |