ESSURE
Report
- Report Number
- 2951250-2016-00682
- Event Type
- Injury
- Date Received
- May 24, 2016
- Date of Event
- October 30, 2012
- Report Date
- May 10, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("DEVICE BREAKAGE"), DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA- ABDOMINAL/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA-ABDOMINAL"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), GASTROINTESTINAL INJURY ("A HOLE IS MY INTESTINE DUE TO ESSURE COIL RUBBING UP AGAINST / THAT THE COIL WAS IMBEDED IN MY BOWEL"), PELVIC PAIN ("PAIN PELVIC PAIN"), POST PROCEDURAL HAEMORRHAGE ("I WAS BLEEDING ON INSIDE, SHE SAID IT WAS FROM MY STITCHES") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL),") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "THERE WAS TWO COILS IN MY RIGHT". MEDICAL CONDITIONS: SHA HAD NO ANY ESSURE CONFIRMATION TEST WERE PERFORMED (B)(6) 2012: PREGNANCY URINE HCG TEST WAS NEGATIVE. (B)(6) 2012: FINAL PATHOLOGIC DIAGNOSIS: TWO SEGMENT OF FALLOPIAN TUBE, BOTH WITH FULL CROSS SECTION IDENTIFIED. BOTH FALLOPIAN TUBE WITH FOREIGN MATERIAL CONSISTENT WITH MEDICAL DEVICES. (B)(6) 2012: GROSS DESCRIPTION: RECEIVED ARE TWO SIMILAR APPEARING FALLOPIAN TUBES AVERAGING 8CM IN LENGTH AND 0.4CM IN DIAMETER. EACH TUBE HAS A PARTIALLY INSERTED FINE COILED WIRE WITH A COARSE OUTER COILED WIRE. THE SEROSAL SURFACES ARE SMOOTH AND PINK-RED TO WHITE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: BIRTH CONTROL. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY, KIDNEY STONES, ENVIRONMENTAL ALLERGY, PELVIC ADHESIONS, MELANOMA, POST-TRAUMATIC STRESS DISORDER AND SEASONAL ALLERGY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL AS WELL AS CODEINE, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET). IN 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND MOOD SWINGS ("MOOD SWINGS"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), RASH ERYTHEMATOUS ("RED RASH THAT WAS SCABBY ON HIPS AND THIGHS") AND PROCEDURAL PAIN ("ON (B)(6) 2012 PLACED THE LEFT ESSURE AGAIN AND THE PAIN WAS UNBEARABLE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPEPSIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS") AND BURNING MOUTH SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND VISION BLURRED ("VISION/EYE PROBLEMS: BLURRY VISION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), POST PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), INFECTION ("INFECTION (OTHER)"), MIGRAINE ("MIGRAINES / HEADACHES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM CONDITION TYPE OF DISORDER OR CONDITION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY 0N (B)(6) 2012, HYSTEROSCOPY ON (B)(6) 2015: UNABLE TO PERFORM ABLATION; HYSTERECTOMY WITH UNILATERAL OOPHORECTOMY AND SHE HAD ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, GASTROINTESTINAL INJURY, PELVIC PAIN, POST PROCEDURAL HAEMORRHAGE, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, INFECTION, MIGRAINE, BLADDER DISORDER, URINARY TRACT DISORDER, REPRODUCTIVE TRACT DISORDER, NAUSEA, TOOTH DISORDER, AMNESIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, WEIGHT INCREASED, MOOD SWINGS, RASH ERYTHEMATOUS, FATIGUE, DYSPEPSIA, BURNING MOUTH SYNDROME, DYSFUNCTIONAL UTERINE BLEEDING AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSFUNCTIONAL UTERINE BLEEDING WITH ESSURE. THE REPORTER CONSIDERED AMNESIA, BLADDER DISORDER, BURNING MOUTH SYNDROME, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL INJURY, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, POST PROCEDURAL HAEMORRHAGE, PROCEDURAL PAIN, RASH ERYTHEMATOUS, REPRODUCTIVE TRACT DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL DETAILS (MEDICAL RECORDS): (B)(6) 2012: ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE. FINDINGS: ADHESIONS OF THE RIGHT ADNEXA TO THE PERICOLONIC FAT WITH AN INTRAABDOMINAL PLACEMENT OF AN ESSURE COIL. NORMAL OVARIES BILATERALLY, NORMAL APPEARING UTERUS. PROCEDURE: INSPECTION OF THE PELVIS NOTED THE ESSURE COIL INTO THE PERICOLONIC FAT ADJACENT TO THE COLON, SO WE PROCEEDED WITH REMOVAL OF THE RIGHT AND LEFT ADNEXA INCLUDING THE COMPLETE REMOVAL OF THE ESSURE COILS, AT WHICH POINT IN TIME INTRAOPERATIVE CONSULT WITH DR. WAS PERFORMED AND HE PROCEEDED TO VISUALIZE THE COIL AND FELT THAT IT COULD BE REMOVED WITHOUT SURGICAL EXCISION OF THE BOWEL. THIS WAS REMOVED BY TEASING OUT THE COIL DEVICE AND FOLLOWING COMPLETE REMOVAL, DR. VISUALLY LOOKED AT THE AREA NEAR THE COLON SEROSA AND FOUND TO BE WITHIN NORMAL LIMITS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS MAINTAINED IN STABLE CONDITION IN THE POSTANESTHESIA CARE UNIT (P ACU). HYSTERECTOMY ON (B)(6) 2015 (MEDICAL RECORDS): FINAL PATHOLOGIC DIAGNOSIS: UTERUS, CERVIX AND RIGHT OVARY, HYSTERECTOMY AND RIGHT OOPHORECTOMY: CERVIX: NO SIGNIFICANT PATHOLOGIC ABNORMALITY ENDOMETRIUM: WEAKLY PROLIFERATIVE PATTERN. MYOMETRIUM: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. SEROSA: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. OVARY: RARE SURFACE ADHESIONS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: DEVICE DISLOCATION, PELVIC PAIN, ABNORMAL BLEEDING, DYSMENORRHEA. AND THE FOLLOWING ONE WAS DESCRIBED IN MEDICAL RECORDS: DYSFUNCTIONAL UTERINE BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN PELVIC PAIN"), DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA- ABDOMINAL/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA-ABDOMINAL"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)"), DEVICE BREAKAGE ("DEVICE BREAKAGE"), GASTROINTESTINAL INJURY ("A HOLE IS MY INTESTINE DUE TO ESSURE COIL RUBBING UP AGAINST / THAT THE COIL WAS "IMBEDDED" IN MY BOWEL"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL),"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND POST PROCEDURAL HAEMORRHAGE ("I WAS BLEEDING ON INSIDE, SHE SAID IT WAS FROM MY STITCHES") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "THERE WAS TWO COILS IN MY RIGHT". MEDICAL CONDITIONS: SHA HAD NO ANY ESSURE CONFIRMATION TEST WERE PERFORMED. (B)(6) 2012: PREGNANCY URINE HCG TEST WAS NEGATIVE. (B)(6) 2012: FINAL PATHOLOGIC DIAGNOSIS: TWO SEGMENT OF FALLOPIAN TUBE, BOTH WITH FULL CROSS SECTION IDENTIFIED. BOTH FALLOPIAN TUBE WITH FOREIGN MATERIAL CONSISTENT WITH MEDICAL DEVICES. (B)(6) 2012: GROSS DESCRIPTION: RECEIVED ARE TWO SIMILAR APPEARING FALLOPIAN TUBES AVERAGING 8CM IN LENGTH AND 0.4CM IN DIAMETER. EACH TUBE HAS A PARTIALLY INSERTED FINE COILED WIRE WITH A COARSE OUTER COILED WIRE. THE SEROSAL SURFACES ARE SMOOTH AND PINK-RED TO WHITE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: BIRTH CONTROL. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY, KIDNEY STONES, ENVIRONMENTAL ALLERGY, PELVIC ADHESIONS, MELANOMA, POST-TRAUMATIC STRESS DISORDER AND SEASONAL ALLERGY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL AS WELL AS CODEINE, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET). IN 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND MOOD SWINGS ("MOOD SWINGS"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), RASH ERYTHEMATOUS ("RED RASH THAT WAS SCABBY ON HIPS AND THIGHS") AND PROCEDURAL PAIN ("ON (B)(6) 2012 PLACED THE LEFT ESSURE AGAIN AND THE PAIN WAS UNBEARABLE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPEPSIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS") AND BURNING MOUTH SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND VISION BLURRED ("VISION/EYE PROBLEMS: BLURRY VISION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), INFECTION ("INFECTION (OTHER)"), MIGRAINE ("MIGRAINES / HEADACHES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM CONDITION TYPE OF DISORDER OR CONDITION"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") AND POST PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY ON (B)(6) 2012, HYSTEROSCOPY ON (B)(6) 2015: UNABLE TO PERFORM ABLATION; HYSTERECTOMY WITH UNILATERAL OOPHORECTOMY AND SHE HAD ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GASTROINTESTINAL INJURY, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, INFECTION, MIGRAINE, BLADDER DISORDER, URINARY TRACT DISORDER, REPRODUCTIVE TRACT DISORDER, NAUSEA, TOOTH DISORDER, AMNESIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, WEIGHT INCREASED, MOOD SWINGS, RASH ERYTHEMATOUS, FATIGUE, DYSPEPSIA, BURNING MOUTH SYNDROME, DYSFUNCTIONAL UTERINE BLEEDING, PROCEDURAL PAIN AND POST PROCEDURAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSFUNCTIONAL UTERINE BLEEDING WITH ESSURE. THE REPORTER CONSIDERED AMNESIA, BLADDER DISORDER, BURNING MOUTH SYNDROME, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL INJURY, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, POST PROCEDURAL HAEMORRHAGE, PROCEDURAL PAIN, RASH ERYTHEMATOUS, REPRODUCTIVE TRACT DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL DETAILS (MEDICAL RECORDS): (B)(6) 2012: ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE. FINDINGS: ADHESIONS OF THE RIGHT ADNEXA TO THE PERICOLONIC FAT WITH AN INTRAABDOMINAL PLACEMENT OF AN ESSURE COIL. NORMAL OVARIES BILATERALLY, NORMAL APPEARING UTERUS. PROCEDURE: INSPECTION OF THE PELVIS NOTED THE ESSURE COIL INTO THE PERICOLONIC FAT ADJACENT TO THE COLON, SO WE PROCEEDED WITH REMOVAL OF THE RIGHT AND LEFT ADNEXA INCLUDING THE COMPLETE REMOVAL OF THE ESSURE COILS, AT WHICH POINT IN TIME INTRAOPERATIVE CONSULT WITH DR. WAS PERFORMED AND HE PROCEEDED TO VISUALIZE THE COIL AND FELT THAT IT COULD BE REMOVED WITHOUT SURGICAL EXCISION OF THE BOWEL. THIS WAS REMOVED BY TEASING OUT THE COIL DEVICE AND FOLLOWING COMPLETE REMOVAL, DR. VISUALLY LOOKED AT THE AREA NEAR THE COLON SEROSA AND FOUND TO BE WITHIN NORMAL LIMITS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS MAINTAINED IN STABLE CONDITION IN THE POSTANESTHESIA CARE UNIT (P ACU). HYSTERECTOMY ON (B)(6) 2015 (MEDICAL RECORDS): FINAL PATHOLOGIC DIAGNOSIS: UTERUS, CERVIX AND RIGHT OVARY, HYSTERECTOMY AND RIGHT OOPHORECTOMY: CERVIX: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. ENDOMETRIUM: WEAKLY PROLIFERATIVE PATTERN. MYOMETRIUM: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. SEROSA: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. OVARY: RARE SURFACE ADHESIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: DEVICE DISLOCATION, PELVIC PAIN, ABNORMAL BLEEDING, DYSMENORRHEA. AND THE FOLLOWING ONE WAS DESCRIBED IN MEDICAL RECORDS: DYSFUNCTIONAL UTERINE BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA- ABDOMINAL/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA-ABDOMINAL,") AND DEVICE BREAKAGE ("DEVICE BREAKAGE") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: (B)(6) HAD NO ANY ESSURE CONFIRMATION TEST WERE PERFORMED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: BIRTH CONTROL. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY, KIDNEY STONES, ENVIRONMENTAL ALLERGY, PELVIC ADHESIONS AND MELANOMA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), INFECTION ("INFECTION (OTHER)"), MIGRAINE ("MIGRAINES / HEADACHES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM CONDITION TYPE OF DISORDER OR CONDITION"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), PELVIC PAIN ("PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), EYE DISORDER ("VISION/EYE PROBLEMS"), WEIGHT ABNORMAL ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE") AND GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, HORMONE LEVEL ABNORMAL, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, INFECTION, MIGRAINE, BLADDER DISORDER, URINARY TRACT DISORDER, REPRODUCTIVE TRACT DISORDER, NAUSEA, TOOTH DISORDER, NERVOUS SYSTEM DISORDER, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN, VAGINAL DISCHARGE, EYE DISORDER, WEIGHT ABNORMAL AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, REPRODUCTIVE TRACT DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT ABNORMAL TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET, NEW REPORTER INFORMATION, PATIENT DEMOGRAPHIC INFORMATION, CONCOMITANT CONDITION, PATIENT RELEVANT HISTORY AND CONCURRENT CONDITION,ESSURE INDICATION PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES, LOT NUMBER ,START, STOP DATES, THE EVENT MEDICAL DVICE REMOVED AND COMPLICATION WERE REPLACED WITH HORMONAL CHANGES DESCRIBE, ABNORMAL BLEEDING, ALLERGIC OR HYPERSENSITIVITY REACTION TYPE, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) , APAREUNIA, INFECTION (OTHER), MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA- ABDOMINAL, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA-ABDOMINAL,, MIGRAINES / HEADACHES, BLADDER OR URINARY PROBLEMS OR CHANGES, REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION, NAUSEA, DENTAL PROBLEMS, NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE ,DEVICE BREAKAGE, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PAIN. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN PELVIC PAIN"), DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA- ABDOMINAL/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA-ABDOMINAL"), GASTROINTESTINAL INJURY ("A HOLE IS MY INTESTINE DUE TO ESSURE COIL RUBBING UP AGAINST / THAT THE COIL WAS IMBEDED IN MY BOWEL"), DEVICE BREAKAGE ("DEVICE BREAKAGE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL),") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "THERE WAS TWO COILS IN MY RIGHT". MEDICAL CONDITIONS: SHA HAD NO ANY ESSURE CONFIRMATION TEST WERE PERFORMED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: BIRTH CONTROL. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY, KIDNEY STONES, ENVIRONMENTAL ALLERGY, PELVIC ADHESIONS, MELANOMA, POST-TRAUMATIC STRESS DISORDER AND SEASONAL ALLERGY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL AS WELL AS CODEINE, IBUPROFEN, OXYCOCET (PERCOCET) AND VICODIN. IN 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND MOOD SWINGS ("MOOD SWINGS"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND RASH ERYTHEMATOUS ("RED RASH THAT WAS SCABBY ON HIPS AND THIGHS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPEPSIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS") AND BURNING MOUTH SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISION BLURRED ("VISION/EYE PROBLEMS: BLURRY VISION") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), INFECTION ("INFECTION (OTHER)"), MIGRAINE ("MIGRAINES / HEADACHES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM CONDITION TYPE OF DISORDER OR CONDITION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY 0N (B)(6) 2012), SURGERY (SHE HAD ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE), SURGERY, SURGERY AND SURGERY (HYSTEROSCOPY ON (B)(6) 2015: UNABLE TO PERFORM ABLATION). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, GASTROINTESTINAL INJURY, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, INFECTION, MIGRAINE, BLADDER DISORDER, URINARY TRACT DISORDER, REPRODUCTIVE TRACT DISORDER, NAUSEA, TOOTH DISORDER, AMNESIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, WEIGHT INCREASED, MOOD SWINGS, RASH ERYTHEMATOUS, FATIGUE, DYSPEPSIA, BURNING MOUTH SYNDROME AND DYSFUNCTIONAL UTERINE BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSFUNCTIONAL UTERINE BLEEDING WITH ESSURE. THE REPORTER CONSIDERED AMNESIA, BLADDER DISORDER, BURNING MOUTH SYNDROME, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL INJURY, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH ERYTHEMATOUS, REPRODUCTIVE TRACT DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL DETAILS (MEDICAL RECORDS): (B)(6) 2012: ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE. FINDINGS: ADHESIONS OF THE RIGHT ADNEXA TO THE PERICOLONIC FAT WITH AN INTRAABDOMINAL PLACEMENT OF AN ESSURE COIL. NORMAL OVARIES BILATERALLY, NORMAL APPEARING UTERUS. PROCEDURE: INSPECTION OF THE PELVIS NOTED THE ESSURE COIL INTO THE PERICOLONIC FAT ADJACENT TO THE COLON, SO WE PROCEEDED WITH REMOVAL OF THE RIGHT AND LEFT ADNEXA INCLUDING THE COMPLETE REMOVAL OF THE ESSURE COILS, AT WHICH POINT IN TIME INTRAOPERATIVE CONSULT WITH DR. WAS PERFORMED AND HE PROCEEDED TO VISUALIZE THE COIL AND FELT THAT IT COULD BE REMOVED WITHOUT SURGICAL EXCISION OF THE BOWEL. THIS WAS REMOVED BY TEASING OUT THE COIL DEVICE AND FOLLOWING COMPLETE REMOVAL, DR. VISUALLY LOOKED AT THE AREA NEAR THE COLON SEROSA AND FOUND TO BE WITHIN NORMAL LIMITS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS MAINTAINED IN STABLE CONDITION IN THE POSTANESTHESIA CARE UNIT (P ACU). HYSTERECTOMY ON (B)(6) 2015 (MEDICAL RECORDS): FINAL PATHOLOGIC DIAGNOSIS: UTERUS, CERVIX AND RIGHT OVARY, HYSTERECTOMY AND RIGHT OOPHORECTOMY: CERVIX: NO SIGNIFICANT PATHOLOGIC ABNORMALITY ENDOMETRIUM: WEAKLY PROLIFERATIVE PATTERN. MYOMETRIUM: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. SEROSA: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. OVARY: RARE SURFACE ADHESIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. (B)(6) 2012: PREGNANCY URINE HCG TEST WAS NEGATIVE. (B)(6) 2012: FINAL PATHOLOGIC DIAGNOSIS: TWO SEGMENT OF FALLOPIAN TUBE, BOTH WITH FULL CROSS SECTION IDENTIFIED. BOTH FALLOPIAN TUBE WITH FOREIGN MATERIAL CONSISTENT WITH MEDICAL DEVICES. (B)(6) 2012: GROSS DESCRIPTION: RECEIVED ARE TWO SIMILAR APPEARING FALLOPIAN TUBES AVERAGING 8CM IN LENGTH AND 0.4CM IN DIAMETER. EACH TUBE HAS A PARTIALLY INSERTED FINE COILED WIRE WITH A COARSE OUTER COILED WIRE. THE SEROSAL SURFACES ARE SMOOTH AND PINK-RED TO WHITE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: DEVICE DISLOCATION, PELVIC PAIN, ABNORMAL BLEEDING, DYSMENORRHEA. AND THE FOLLOWING ONE WAS DESCRIBED IN MEDICAL RECORDS: DYSFUNCTIONAL UTERINE BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN PELVIC PAIN"), DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA- ABDOMINAL/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA-ABDOMINAL"), GASTROINTESTINAL INJURY ("A HOLE IS MY INTESTINE DUE TO ESSURE COIL RUBBING UP AGAINST / THAT THE COIL WAS IMBEDED IN MY BOWEL"), DEVICE BREAKAGE ("DEVICE BREAKAGE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL),") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "THERE WAS TWO COILS IN MY RIGHT". MEDICAL CONDITIONS: SHA HAD NO ANY ESSURE CONFIRMATION TEST WERE PERFORMED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: BIRTH CONTROL. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY, KIDNEY STONES, ENVIRONMENTAL ALLERGY, PELVIC ADHESIONS, MELANOMA, POST-TRAUMATIC STRESS DISORDER AND SEASONAL ALLERGY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL AS WELL AS CODEINE, IBUPROFEN, OXYCOCET (PERCOCET) AND VICODIN. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND RASH ERYTHEMATOUS ("RED RASH THAT WAS SCABBY ON HIPS AND THIGHS"). IN 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND MOOD SWINGS ("MOOD SWINGS"). ON (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6)2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2013, THE PATIENT EXPERIENCED DYSPEPSIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS") AND BURNING MOUTH SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISION BLURRED ("VISION/EYE PROBLEMS: BLURRY VISION") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), INFECTION ("INFECTION (OTHER)"), MIGRAINE ("MIGRAINES / HEADACHES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM CONDITION TYPE OF DISORDER OR CONDITION"), TOOTH DISORDER ("DENTAL PROBLEMS") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY 0N (B)(6)2012), SURGERY (SHE HAD ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE), SURGERY, SURGERY AND SURGERY (HYSTEROSCOPY ON (B)(6)2015: UNABLE TO PERFORM ABLATION). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, GASTROINTESTINAL INJURY, DEVICE BREAKAGE, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, INFECTION, MIGRAINE, BLADDER DISORDER, URINARY TRACT DISORDER, REPRODUCTIVE TRACT DISORDER, NAUSEA, TOOTH DISORDER, AMNESIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, WEIGHT INCREASED, MOOD SWINGS, RASH ERYTHEMATOUS, FATIGUE, DYSPEPSIA, BURNING MOUTH SYNDROME AND DYSFUNCTIONAL UTERINE BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSFUNCTIONAL UTERINE BLEEDING WITH ESSURE. THE REPORTER CONSIDERED AMNESIA, BLADDER DISORDER, BURNING MOUTH SYNDROME, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL INJURY, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH ERYTHEMATOUS, REPRODUCTIVE TRACT DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL DETAILS (MEDICAL RECORDS): (B)(6)2012: ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE. FINDINGS: ADHESIONS OF THE RIGHT ADNEXA TO THE PERICOLONIC FAT WITH AN INTRAABDOMINAL PLACEMENT OF AN ESSURE COIL. NORMAL OVARIES BILATERALLY, NORMAL APPEARING UTERUS. PROCEDURE: INSPECTION OF THE PELVIS NOTED THE ESSURE COIL INTO THE PERICOLONIC FAT ADJACENT TO THE COLON, SO WE PROCEEDED WITH REMOVAL OF THE RIGHT AND LEFT ADNEXA INCLUDING THE COMPLETE REMOVAL OF THE ESSURE COILS, AT WHICH POINT IN TIME INTRAOPERATIVE CONSULT WITH DR. WAS PERFORMED AND HE PROCEEDED TO VISUALIZE THE COIL AND FELT THAT IT COULD BE REMOVED WITHOUT SURGICAL EXCISION OF THE BOWEL. THIS WAS REMOVED BY TEASING OUT THE COIL DEVICE AND FOLLOWING COMPLETE REMOVAL, DR. VISUALLY LOOKED AT THE AREA NEAR THE COLON SEROSA AND FOUND TO BE WITHIN NORMAL LIMITS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS MAINTAINED IN STABLE CONDITION IN THE POSTANESTHESIA CARE UNIT (P ACU). HYSTERECTOMY ON(B)(6)2015 (MEDICAL RECORDS): FINAL PATHOLOGIC DIAGNOSIS: UTERUS, CERVIX AND RIGHT OVARY, HYSTERECTOMY AND RIGHT OOPHORECTOMY: CERVIX: NO SIGNIFICANT PATHOLOGIC ABNORMALITY ENDOMETRIUM: WEAKLY PROLIFERATIVE PATTERN. MYOMETRIUM: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. SEROSA: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. OVARY: RARE SURFACE ADHESIONS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. (B)(6)2012: PREGNANCY URINE HCG TEST WAS NEGATIVE. (B)(6)2012: FINAL PATHOLOGIC DIAGNOSIS: TWO SEGMENT OF FALLOPIAN TUBE, BOTH WITH FULL CROSS SECTION IDENTIFIED. BOTH FALLOPIAN TUBE WITH FOREIGN MATERIAL CONSISTENT WITH MEDICAL DEVICES. (B)(6)2012: GROSS DESCRIPTION: RECEIVED ARE TWO SIMILAR APPEARING FALLOPIAN TUBES AVERAGING 8CM IN LENGTH AND 0.4CM IN DIAMETER. EACH TUBE HAS A PARTIALLY INSERTED FINE COILED WIRE WITH A COARSE OUTER COILED WIRE. THE SEROSAL SURFACES ARE SMOOTH AND PINK-RED TO WHITE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: DEVICE DISLOCATION, PELVIC PAIN, ABNORMAL BLEEDING, DYSMENORRHEA. AND THE FOLLOWING ONE WAS DESCRIBED IN MEDICAL RECORDS: DYSFUNCTIONAL UTERINE BLEEDING. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: INFORMATION FROM PFS AND MR. NEW REPORTERS ADDED. CASE MEDICALLY CONFIRMED. PATIENT¿S DEMOGRAPHICS ADDED. HISTORICAL AND CONCOMITANT CONDITIONS AND DRUGS ADDED. NEW EVENTS ADDED: MOOD SWINGS, RED RASH THAT WAS SCABBY ON HIPS, A HOLE IS MY INTESTINE DUE TO ESSURE COIL RUBBING UP AGAINST, FATIGUE, COIL WAS IMBEDDED IN MY BOWEL, THERE WAS TWO COILS IN MY RIGHT. EVENTS UPDATED: MEMORY LOSS, BLURRY VISION, WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS, DYSFUNCTIONAL UTERINE BLEEDING. ON (B)(6)2018: LEGAL CASE EXTRACTION FORM RECEIVED: UNSTRUCTURED RELEVANT TEST UPDATED: FINAL PATHOLOGIC DIAGNOSIS AND GROSS DESCRIPTION. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN PELVIC PAIN"), DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA- ABDOMINAL/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INTRA-ABDOMINAL"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)"), DEVICE BREAKAGE ("DEVICE BREAKAGE"), GASTROINTESTINAL INJURY ("A HOLE IS MY INTESTINE DUE TO ESSURE COIL RUBBING UP AGAINST / THAT THE COIL WAS IMBEDED IN MY BOWEL"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL),"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND POST PROCEDURAL HAEMORRHAGE ("I WAS BLEEDING ON INSIDE, SHE SAID IT WAS FROM MY STITCHES") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "THERE WAS TWO COILS IN MY RIGHT". MEDICAL CONDITIONS: SHA HAD NO ANY ESSURE CONFIRMATION TEST WERE PERFORMED (B)(6)2012: PREGNANCY URINE HCG TEST WAS NEGATIVE. (B)(6)2012: FINAL PATHOLOGIC DIAGNOSIS: TWO SEGMENT OF FALLOPIAN TUBE, BOTH WITH FULL CROSS SECTION IDENTIFIED. BOTH FALLOPIAN TUBE WITH FOREIGN MATERIAL CONSISTENT WITH MEDICAL DEVICES. (B)(6)2012: GROSS DESCRIPTION: RECEIVED ARE TWO SIMILAR APPEARING FALLOPIAN TUBES AVERAGING 8CM IN LENGTH AND 0.4CM IN DIAMETER. EACH TUBE HAS A PARTIALLY INSERTED FINE COILED WIRE WITH A COARSE OUTER COILED WIRE. THE SEROSAL SURFACES ARE SMOOTH AND PINK-RED TO WHITE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: BIRTH CONTROL. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY, KIDNEY STONES, ENVIRONMENTAL ALLERGY, PELVIC ADHESIONS, MELANOMA, POST-TRAUMATIC STRESS DISORDER AND SEASONAL ALLERGY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL AS WELL AS CODEINE, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET). IN 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND MOOD SWINGS ("MOOD SWINGS"). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), RASH ERYTHEMATOUS ("RED RASH THAT WAS SCABBY ON HIPS AND THIGHS") AND PROCEDURAL PAIN ("ON (B)(6)2012 PLACED THE LEFT ESSURE AGAIN AND THE PAIN WAS UNBEARABLE"). ON (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6)2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2013, THE PATIENT EXPERIENCED DYSPEPSIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS") AND BURNING MOUTH SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: PROBLEMS WITH DIGESTION AND HAVING BMS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND VISION BLURRED ("VISION/EYE PROBLEMS: BLURRY VISION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE"), CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE"), INFECTION ("INFECTION (OTHER)"), MIGRAINE ("MIGRAINES / HEADACHES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM CONDITION TYPE OF DISORDER OR CONDITION"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") AND POST PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY 0N (B)(6)2012, HYSTEROSCOPY ON (B)(6)2015: UNABLE TO PERFORM ABLATION; HYSTERECTOMY WITH UNILATERAL OOPHORECTOMY AND SHE HAD ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, GASTROINTESTINAL INJURY, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, INFECTION, MIGRAINE, BLADDER DISORDER, URINARY TRACT DISORDER, REPRODUCTIVE TRACT DISORDER, NAUSEA, TOOTH DISORDER, AMNESIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VISION BLURRED, WEIGHT INCREASED, MOOD SWINGS, RASH ERYTHEMATOUS, FATIGUE, DYSPEPSIA, BURNING MOUTH SYNDROME, DYSFUNCTIONAL UTERINE BLEEDING, PROCEDURAL PAIN AND POST PROCEDURAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DYSFUNCTIONAL UTERINE BLEEDING WITH ESSURE. THE REPORTER CONSIDERED AMNESIA, BLADDER DISORDER, BURNING MOUTH SYNDROME, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL INJURY, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, POST PROCEDURAL HAEMORRHAGE, PROCEDURAL PAIN, RASH ERYTHEMATOUS, REPRODUCTIVE TRACT DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL DETAILS (MEDICAL RECORDS): (B)(6)2012: ROBOTIC-ASSISTED BILATERAL SALPINGECTOMY, RETRIEVAL OF ESSURE DEVICE. FINDINGS: ADHESIONS OF THE RIGHT ADNEXA TO THE PERICOLONIC FAT WITH AN INTRAABDOMINAL PLACEMENT OF AN ESSURE COIL. NORMAL OVARIES BILATERALLY, NORMAL APPEARING UTERUS. PROCEDURE: INSPECTION OF THE PELVIS NOTED THE ESSURE COIL INTO THE PERICOLONIC FAT ADJACENT TO THE COLON, SO WE PROCEEDED WITH REMOVAL OF THE RIGHT AND LEFT ADNEXA INCLUDING THE COMPLETE REMOVAL OF THE ESSURE COILS, AT WHICH POINT IN TIME INTRAOPERATIVE CONSULT WITH DR. WAS PERFORMED AND HE PROCEEDED TO VISUALIZE THE COIL AND FELT THAT IT COULD BE REMOVED WITHOUT SURGICAL EXCISION OF THE BOWEL. THIS WAS REMOVED BY TEASING OUT THE COIL DEVICE AND FOLLOWING COMPLETE REMOVAL, DR. VISUALLY LOOKED AT THE AREA NEAR THE COLON SEROSA AND FOUND TO BE WITHIN NORMAL LIMITS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS MAINTAINED IN STABLE CONDITION IN THE POSTANESTHESIA CARE UNIT (P ACU). HYSTERECTOMY ON (B)(6)2015 (MEDICAL RECORDS): FINAL PATHOLOGIC DIAGNOSIS: UTERUS, CERVIX AND RIGHT OVARY, HYSTERECTOMY AND RIGHT OOPHORECTOMY: CERVIX: NO SIGNIFICANT PATHOLOGIC ABNORMALITY ENDOMETRIUM: WEAKLY PROLIFERATIVE PATTERN. MYOMETRIUM: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. SEROSA: NO SIGNIFICANT PATHOLOGIC ABNORMALITY. OVARY: RARE SURFACE ADHESIONS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: DEVICE DISLOCATION, PELVIC PAIN, ABNORMAL BLEEDING, DYSMENORRHEA. AND THE FOLLOWING ONE WAS DESCRIBED IN MEDICAL RECORDS: DYSFUNCTIONAL UTERINE BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2019: EVENTS- "PERFORATION (FALLOPIAN TUBE), ON (B)(6)2012 PLACED THE LEFT ESSURE AGAIN AND THE PAIN WAS UNBEARABLE, I WAS BLEEDING ON INSIDE, SHE SAID IT WAS FROM MY STITCHES" ADDED FROM PFS. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED ON 04-MAY-2016 FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A FEMALE PLAINTIFF OF UNSPECIFIED AGE IN UNITED STATES WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR PERMANENT STERILIZATION. THE PLAINTIFF WAS IMPLANTED WITH ESSURE AND SUBSEQUENTLY HAD THE DEVICE REMOVED DUE TO COMPLICATIONS. FOLLOW-UP RECEIVED ON 20-MAY-2016: QUALITY SAFETY EVALUATION OF PTC. (B)(4). FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS RECEIVED FROM A LAWYER ON BEHALF OF A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) REMOVED DUE TO COMPLICATIONS. THESE EVENTS ARE LISTED ACCORDING TO ESSURES REFERENCE SAFETY INFORMATION. THIS CASE WAS RECEIVED THROUGH A LEGAL CLAIM WHICH INCLUDED SEVERAL PLAINTIFFS; THE ADVERSE EVENTS/COMPLICATIONS EACH INDIVIDUAL PLAINTIFF EXPERIENCED WERE NOT SPECIFIED. DESPITE OF THE LACK OF DETAILS FOR A COMPREHENSIVE CAUSALITY ASSESSMENT, CONSIDERING ESSURE REMOVAL WAS REQUIRED, CAUSALITY WITH THE SUSPECT DEVICE CANNOT BE EXCLUDED. THEREFORE, THIS CASE WAS REGARDED AS INCIDENT. A PRODUCT TECHNICAL COMPLAINT INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330425 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | CODEINE| CODEINE| CODEINE| CODEINE| CODEINE| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| PERCOCET| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| VICODIN| VICODIN| VICODIN| VICODIN| VICODIN |