ESSURE
Report
- Report Number
- 2951250-2017-07445
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- April 1, 2016
- Report Date
- July 24, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION OF ORGANS/ PERFORATION (UTERUS)"), DEVICE DISLOCATION ("MIGRATION OF IMPLANT/ MIGRATION OF DEVICE: BOWELS/ESSURE LOGED IN BOWEL/I COULD FEEL THE COILS COMING OUT AND I WAS FEELING AIR BUBBLES AS IF I WAS GOIVING BIRTH TO IT") AND URETHRAL STENOSIS ("URETHRAL METALSTENOSIS") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OVERACTIVE BLADDER, PAIN OF LOWER EXTREMITIES, ADHESIOLYSIS, POST-TRAUMATIC STRESS DISORDER, ORTHOGNATHIC SURGERY AND SMOKER. CONCURRENT CONDITIONS INCLUDED BLOOD LOSS OF (NOS), ANEMIA, LEFT LOWER QUADRANT PAIN, PAIN INJECTION SITE, PAIN IN EXTREMITY, TINGLING, DISCOLORATION SKIN, MUSCLE SPASM, PAIN NECK, DRUG ALLERGY (CAUSES NAUSEA /VOMITING), GROIN ABSCESS, PAIN IN HIP, KNEE PAIN, FALL, DYSFUNCTIONAL UTERINE BLEEDING, TENDERNESS, CHEST PAIN, NAUSEA, DIVERTICULUM AND EXTERNAL HEMORRHOIDS. CONCOMITANT PRODUCTS INCLUDED DICYCLOVERINE (DICYCLOMINE), FLUNISOLIDE (AEROBID INHALER), GABAPENTIN, GABAPENTIN (NEURONTIN), MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERON), MELOXICAM, OXYBUTYNIN, PARA-SELTZER (EXCEDRIN) AND SERTRALINE (ZOLOFT). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA/CRAMPING") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN 2013, THE PATIENT EXPERIENCED VULVOVAGINAL RASH ("RASHES /SKIN CONDITIONS: VAGINAL AREA") AND GENITAL RASH ("RASHES OR SKIN CONDITION: TYPE; TAILBONE TO MY PUBIC AREA"). IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND TOOTH LOSS ("TEETH WOULD FALL OUT"). IN 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("MENORRHAGIA"). IN 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), DIARRHOEA ("CONSTANT LOOSE AND UNFORMED STOOL"), WEIGHT INCREASED ("WEIGHT GAIN"), THE FIRST EPISODE OF ABDOMINAL PAIN LOWER ("PAIN LOWER ABDOMINAL AND PUBIC AREA TO MY TAILBONE"), ANXIETY ("HORMONAL CHANGES: ANXIETY"), HYPOAESTHESIA ("ARMS AND LEGS NUMB"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATED") AND COLITIS ("COLITIS"). IN 2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2017, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS /CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS /CONDITIONS"), URINARY INCONTINENCE ("URINARY INCONTINENCE") AND URETHRAL STENOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL: IRREGULAR BOWEL SYNDROME"), MOOD ALTERED ("HORMONAL CHANGES: GRUMPY"), DECREASED INTEREST ("NO INTEREST"), BACTERIAL VULVOVAGINITIS ("INFECTION: BACTERIAL INFECTION IN VAGINA"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("INSIDE LOWER BELLY"), UTERINE PAIN ("WOMB PAIN"), BLADDER PAIN ("BLADDER PAIN"), SWELLING ("SWELLING") AND THE SECOND EPISODE OF ABDOMINAL PAIN LOWER ("PAIN LOWER ABDOMEN"). THE PATIENT WAS TREATED WITH OXYCOCET (PERCOCET), AMPICILLIN, ONDANSETRON (ZOFRAN), LOPERAMIDE HYDROCHLORIDE (IMODIUM), VICODIN (LORTAB), METHOCARBAMOL (ROBAXIN), SURGERY (HAD SURGERY TO REMOVE THE ESSURE IMPLANT) AND SURGERY (SCHEDULED DATE: (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, URINARY TRACT DISORDER, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, DIARRHOEA, MOOD ALTERED, DECREASED INTEREST, BACTERIAL VULVOVAGINITIS, MIGRAINE, HEADACHE, NAUSEA, ALLERGY TO METALS, VULVOVAGINAL RASH, VAGINAL DISCHARGE, WEIGHT INCREASED, BACK PAIN, ABDOMINAL PAIN, UTERINE PAIN, BLADDER PAIN, GENITAL RASH, ANXIETY, URINARY INCONTINENCE, URETHRAL STENOSIS, TOOTH LOSS, HYPOAESTHESIA, WEIGHT FLUCTUATION, COLITIS, SWELLING AND THE LAST EPISODE OF ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, BACK PAIN, BACTERIAL VULVOVAGINITIS, BLADDER DISORDER, BLADDER PAIN, COLITIS, DECREASED INTEREST, DEVICE DISLOCATION, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL RASH, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, SWELLING, TOOTH LOSS, URETHRAL STENOSIS, URINARY INCONTINENCE, URINARY TRACT DISORDER, UTERINE PAIN, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL RASH, WEIGHT FLUCTUATION, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL PAIN LOWER AND THE SECOND EPISODE OF ABDOMINAL PAIN LOWER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2012: TRAILING COILS LEFT: 2, RIGHT: 0. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BILATERAL ESSURE TUBAL CLOSURE DEVICES WITH NO EVI. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE DESCRIBED: PELVIC PAIN, DYSMENORRHOEA, URINARY INCONTINENCE, ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT) 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION OF ORGANS/ PERFORATION (UTERUS)"), EMBEDDED DEVICE ("MIGRATION OF IMPLANT/ MIGRATION OF DEVICE: BOWELS/ESSURE LOGGED IN BOWEL/I COULD FEEL THE COILS COMING OUT AND I WAS FEELING AIR BUBBLES AS IF I WAS GIVING BIRTH TO IT") AND URETHRAL STENOSIS ("URETHRAL METALSTENOSIS") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OVERACTIVE BLADDER, PAIN OF LOWER EXTREMITIES, ADHESIOLYSIS, POST-TRAUMATIC STRESS DISORDER, ORTHOGNATHIC SURGERY AND SMOKER. CONCURRENT CONDITIONS INCLUDED BLOOD LOSS OF (NOS), ANEMIA, LEFT LOWER QUADRANT PAIN, PAIN INJECTION SITE, PAIN IN EXTREMITY, TINGLING, DISCOLORATION SKIN, MUSCLE SPASM, PAIN NECK, DRUG ALLERGY (CAUSES NAUSEA /VOMITING), GROIN ABSCESS, PAIN IN HIP, KNEE PAIN, FALL, DYSFUNCTIONAL UTERINE BLEEDING, TENDERNESS, CHEST PAIN, NAUSEA, DIVERTICULUM AND EXTERNAL HEMORRHOIDS. CONCOMITANT PRODUCTS INCLUDED DICYCLOVERINE (DICYCLOMINE), FLUNISOLIDE (AEROBID INHALER), GABAPENTIN, GABAPENTIN (NEURONTIN), MEDROXYPROGESTERONE ACETATE (MEDROXY PROGESTERON), MELOXICAM, OXYBUTYNIN, PARA-SELTZER (EXCEDRIN) AND SERTRALINE (ZOLOFT). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA/CRAMPING") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN 2013, THE PATIENT EXPERIENCED VULVOVAGINAL RASH ("RASHES /SKIN CONDITIONS: VAGINAL AREA") AND GENITAL RASH ("RASHES OR SKIN CONDITION: TYPE; TAILBONE TO MY PUBIC AREA"). IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND TOOTH LOSS ("TEETH WOULD FALL OUT"). IN 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("MENORRHAGIA"). IN 2016, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), DIARRHOEA ("CONSTANT LOOSE AND UNFORMED STOOL"), WEIGHT INCREASED ("WEIGHT GAIN"), PUBIC PAIN ("PAIN LOWER ABDOMINAL AND PUBIC AREA TO MY TAILBONE"), ANXIETY ("HORMONAL CHANGES: ANXIETY"), HYPOAESTHESIA ("ARMS AND LEGS NUMB"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATED") AND COLITIS ("COLITIS"). IN 2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2017, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS /CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS /CONDITIONS"), URINARY INCONTINENCE ("URINARY INCONTINENCE") AND URETHRAL STENOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"), BOWEL MOVEMENT IRREGULARITY ("GASTROINTESTINAL: IRREGULAR BOWEL SYNDROME"), MOOD ALTERED ("HORMONAL CHANGES: GRUMPY"), DECREASED INTEREST ("NO INTEREST"), BACTERIAL VULVOVAGINITIS ("INFECTION: BACTERIAL INFECTION IN VAGINA"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("INSIDE LOWER BELLY"), UTERINE PAIN ("WOMB PAIN"), BLADDER PAIN ("BLADDER PAIN"), SWELLING ("SWELLING") AND ABDOMINAL PAIN LOWER ("PAIN LOWER ABDOMEN"). THE PATIENT WAS TREATED WITH OXYCOCET (PERCOCET), AMPICILLIN, ONDANSETRON (ZOFRAN), LOPERAMIDE HYDROCHLORIDE (IMODIUM), VICODIN (LORTAB), METHOCARBAMOL (ROBAXIN), SURGERY (HAD SURGERY TO REMOVE THE ESSURE IMPLANT) AND SURGERY (SCHEDULED DATE: (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, EMBEDDED DEVICE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, URINARY TRACT DISORDER, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, BOWEL MOVEMENT IRREGULARITY, DIARRHOEA, MOOD ALTERED, DECREASED INTEREST, BACTERIAL VULVOVAGINITIS, MIGRAINE, HEADACHE, NAUSEA, ALLERGY TO METALS, VULVOVAGINAL RASH, VAGINAL DISCHARGE, WEIGHT INCREASED, BACK PAIN, ABDOMINAL PAIN, UTERINE PAIN, BLADDER PAIN, GENITAL RASH, PUBIC PAIN, ANXIETY, URINARY INCONTINENCE, URETHRAL STENOSIS, TOOTH LOSS, HYPOAESTHESIA, WEIGHT FLUCTUATION, COLITIS, SWELLING AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ANXIETY, BACK PAIN, BACTERIAL VULVOVAGINITIS, BLADDER DISORDER, BLADDER PAIN, BOWEL MOVEMENT IRREGULARITY, COLITIS, DECREASED INTEREST, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL RASH, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, PUBIC PAIN, SWELLING, TOOTH LOSS, URETHRAL STENOSIS, URINARY INCONTINENCE, URINARY TRACT DISORDER, UTERINE PAIN, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL RASH, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2012: TRAILING COILS LEFT: 2, RIGHT: 0. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BILATERAL ESSURE TUBAL CLOSURE DEVICES WITH NO EVI. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE DESCRIBED: PELVIC PAIN, DYSMENORRHOEA, URINARY INCONTINENCE, ABDOMINAL PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. REPORTER INFORMATION, PATIENT¿S DEMOGRAPHIC INFORMATION, OTHER RELEVANT HISTORY AND LAB DATA UPDATED. ESSURE LOT NUMBER, INDICATION FEMALE STERILIZATION AND REMOVAL DATE WAS ADDED. EVENTS WERE CLUBBED WITH PREVIOUSLY REPORTED EVENTS. EVENTS: VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, URINARY TRACT INFECTION, BLADDER INFECTION, TOOTH DISORDER, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, BOWEL MOVEMENT IRREGULARITY, DIARRHEA, MOOD ALTERED, DECREASE INTEREST, BACTERIAL VULVOVAGINITIS, MIGRAINE, HEADACHE, NAUSEA, ALLERGY TO METALS, VULVOVAGINAL RASH, VAGINAL DISCHARGE, WEIGHT DECREASED, BACK PAIN, ABDOMINAL PAIN, UTERINE PAIN, BLADDER PAIN, GENITAL RASH, COCCYDYNIA, PUBIC RASH, ANXIETY, URINARY INCONTINENCE, URETHRAL STENOSIS, TOOTH LOSS, HYPOAESTHESIA, WEIGHT FLUCTUATION, COLITIS, SWELLING, INFECTION, ABDOMINAL PAIN LOWER WERE NEWLY ADDED. 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 UTERINE PERFORATION ('PERFORATION OF ORGANS/ PERFORATION (UTERUS)'), LARGE INTESTINE PERFORATION ('MY COLON IS HURTING DUE TO ESSURE PUNCTURING IT'), DEVICE DISLOCATION ('MIGRATION OF IMPLANT/ MIGRATION OF DEVICE: BOWELS/ESSURE LOGGED IN BOWEL/I COULD FEEL THE COILS COMING OUT AND I WAS FEELING AIR BUBBLES AS IF I WAS GIVING BIRTH TO IT/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: BOWELS'), DEVICE EXPULSION ('I TOLD HER ABOUT THE COIL COMING THROUGH') AND URETHRAL STENOSIS ('URETHRAL METALSTENOSIS) IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERACTIVE BLADDER, PAIN OF LOWER EXTREMITIES, ADHESIOLYSIS, POST-TRAUMATIC STRESS DISORDER, ORTHOGNATHIC SURGERY, SMOKER, RIGHT UPPER QUADRANT PAIN, ULTRASOUND BILIARY TRACT AND D & C. CONCURRENT CONDITIONS INCLUDED DEPRESSION SINCE 1999, BLOOD LOSS OF (NOS), ANEMIA, LEFT LOWER QUADRANT PAIN, PAIN INJECTION SITE, PAIN IN EXTREMITY, TINGLING, DISCOLORATION SKIN, MUSCLE SPASM, PAIN NECK, DRUG ALLERGY (CAUSES NAUSEA /VOMITING), GROIN ABSCESS, PAIN IN HIP, KNEE PAIN, FALL, DYSFUNCTIONAL UTERINE BLEEDING, TENDERNESS, CHEST PAIN, NAUSEA, DIVERTICULUM, EXTERNAL HEMORRHOIDS, CERVIX DISORDER AND CERVIX DISORDER. CONCOMITANT PRODUCTS INCLUDED AMITRIPTYLINE FROM (B)(6) 2017 TO (B)(6) 2018, CAFFEINE;PARACETAMOL (EXCEDRIN), DICYCLOVERINE (DICYCLOMINE) SINCE (B)(6) 2017, FLUNISOLIDE (AEROBID), GABAPENTIN (NEURONTIN), GABAPENTIN FROM 2013 TO 2017, IBUPROFEN FROM (B)(6) 2014 TO (B)(6) 2014, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE), MELOXICAM FROM 2015 TO 2017, OMEPRAZOLE SINCE (B)(6) 2018, OXYBUTYNIN FROM 2015 TO 2017, PANTOPRAZOLE SINCE (B)(6) 2018, RANITIDINE SINCE (B)(6) 2018 AND SERTRALINE HYDROCHLORIDE (ZOLOFT). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA/CRAMPING/DYSMENORRHEA(CRAMPING)") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2013, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND ABDOMINAL PAIN LOWER ("PAIN LOWER ABDOMINAL AND PUBIC AREA TO MY TAILBONE/PAIN TOWARDS MY RIGHT BELLY BUTTON"). IN 2013, THE PATIENT EXPERIENCED VULVOVAGINAL RASH ("RASHES /SKIN CONDITIONS: VAGINAL AREA") AND RASH ("RASHES OR SKIN CONDITION: TYPE; TAILBONE TO MY PUBIC AREA"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND TOOTH LOSS ("TEETH WOULD FALL OUT"). IN 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/NOT BEING ABLE TO HAVE SEX AND HOE IT HURT"), FATIGUE ("FATIGUE"), DIARRHOEA ("CONSTANT LOOSE AND UNFORMED STOOL,DIARRHEA"), BACTERIAL VULVOVAGINITIS ("INFECTION: BACTERIAL INFECTION IN VAGINA"), ANXIETY ("HORMONAL CHANGES: ANXIETY"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATED"), COLITIS ("COLITIS/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION-TYPE: COLITIS") AND MOOD SWINGS ("MOOD SWINGS"). IN 2016, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2016, THE PATIENT EXPERIENCED THE FIRST EPISODE OF HYPOAESTHESIA ("ARMS AND LEGS NUMB/ARMS AND LEGS WOULD GO NUMB") AND THE SECOND EPISODE OF HYPOAESTHESIA ("ARMS AND LEGS NUMB/ARMS AND LEGS WOULD GO NUMB"). IN (B)(6) 2017, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2017, THE PATIENT EXPERIENCED URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS /CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS /CONDITIONS"), URINARY INCONTINENCE ("URINARY INCONTINENCE") AND URETHRAL STENOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH GASTROINTESTINAL PAIN, DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING/STOMACH IS SWOLLEN"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL: IRREGULAR BOWEL SYNDROME"), MOOD ALTERED ("HORMONAL CHANGES: GRUMPY"), DECREASED INTEREST ("NO INTEREST"), BACK PAIN ("BACK PAIN/LOWER BACK PAIN"), ABDOMINAL PAIN ("INSIDE LOWER BELLY ABDOMINAL HURT SO BAD"), UTERINE PAIN ("WOMB PAIN"), BLADDER PAIN ("BLADDER PAIN"), SWELLING ("SWELLING"), PARAESTHESIA ("TINGLING IN MY LEGS AND ARMS/MY LEGS ARE DEAD WEIGHT AND TINGLING TO MY TOES"), GENITAL PAIN ("PAIN AT THE MIDDLE OF PRIVATE AREA UPWARDS"), MUSCULOSKELETAL CHEST PAIN ("PAIN TOWARDS MY RIGHT MY RIGHT BELLY BUTTON TO RIBS HURTS"), LIMB DISCOMFORT ("CAN'T WALK MY LEGS ARE HEAVY"), PAIN IN EXTREMITY ("I HAVE SHARP PAINS THAT SHOOT TO MY TOES"), PRURITUS ("ITCHING") AND ABDOMINAL MASS ("ABDOMINAL MASS"). THE PATIENT WAS TREATED WITH AMPICILLIN, ANTIBIOTICS, HYDROCODONE BITARTRATE;PARACETAMOL (LORTAB), LOPERAMIDE HYDROCHLORIDE (IMODIUM), METHOCARBAMOL (ROBAXIN), ONDANSETRON (ZOFRAN), OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) AND SURGERY (HAD SURGERY TO REMOVE THE ESSURE IMPLANT/HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND SCHEDULED DATE: (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, LARGE INTESTINE PERFORATION, DEVICE DISLOCATION, DEVICE EXPULSION, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, URINARY TRACT DISORDER, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, DIARRHOEA, MOOD ALTERED, DECREASED INTEREST, BACTERIAL VULVOVAGINITIS, MIGRAINE, HEADACHE, NAUSEA, ALLERGY TO METALS, VULVOVAGINAL RASH, VAGINAL DISCHARGE, WEIGHT INCREASED, BACK PAIN, ABDOMINAL PAIN, UTERINE PAIN, BLADDER PAIN, RASH, ABDOMINAL PAIN LOWER, ANXIETY, URINARY INCONTINENCE, URETHRAL STENOSIS, TOOTH LOSS, WEIGHT FLUCTUATION, COLITIS, SWELLING, MOOD SWINGS, PARAESTHESIA, GENITAL PAIN, MUSCULOSKELETAL CHEST PAIN, PAIN IN EXTREMITY, PRURITUS, ABDOMINAL MASS AND THE LAST EPISODE OF HYPOAESTHESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL MASS, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ANXIETY, BACK PAIN, BACTERIAL VULVOVAGINITIS, BLADDER DISORDER, BLADDER PAIN, COLITIS, DECREASED INTEREST, DEVICE DISLOCATION, DEVICE EXPULSION, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL PAIN, HEADACHE, LARGE INTESTINE PERFORATION, LIMB DISCOMFORT, MENORRHAGIA, MIGRAINE, MOOD ALTERED, MOOD SWINGS, MUSCULOSKELETAL CHEST PAIN, NAUSEA, PAIN IN EXTREMITY, PARAESTHESIA, PRURITUS, RASH, SWELLING, TOOTH LOSS, URETHRAL STENOSIS, URINARY INCONTINENCE, URINARY TRACT DISORDER, UTERINE PAIN, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL RASH, WEIGHT FLUCTUATION, WEIGHT INCREASED AND THE FIRST EPISODE OF HYPOAESTHESIA TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: ON (B)(6) 2012: TRAILING COILS LEFT: 2, RIGHT: 0. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: BILATERAL ESSURE TUBAL CLOSURE DEVICES WITH NO EVIDENCE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WAS/WERE DESCRIBED: PELVIC PAIN, DYSMENORRHOEA, URINARY INCONTINENCE, ABDOMINAL PAIN, NECK PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONCE WERE ADDED FROM SOCIAL MEDIA: PARAESTHESIA, GENITAL PAIN, MUSCULOSKELETAL CHEST PAIN, LIMB DISCOMFORT, PAIN IN EXTREMITY, GASTROINTESTINAL PAIN, PRURITUS, ABDOMINAL MASS, DEVICE EXPULSION, LARGE INTESTINE PERFORATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET AND SOCIAL MEDIA RECEIVED. EVENTS: TINGLING IN MY LEGS AND ARMS, MOOD SWINGS, PAIN AT THE MIDDLE OF PRIVATE AREA UP WORDS, PAIN TOWARDS MY RIGHT BELLY BUTTON TO RIBS HURTS, CAN'T WALK MY LEGS ARE HEAVY, I HAVE SHARP PAINS THAT SHOOT TO MY TOES,MY COLON IS HURTING DUE TO ESSURE PUNCTURING IT, I TOLD HER ABOUT THE COIL COMING THROUGH, ITCHING, ABDOMINAL MASS WERE ADDED. CONCOMITANT DRUGS, CONDITION AND REPORTER'S INFORMATION WAS ADDED. INCIDENT: 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS") AND DEVICE DISLOCATION ("MIGRATION OF IMPLANT") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (HAD SURGERY TO REMOVE THE ESSURE IMPLANT) AND SURGERY (HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, DEVICE DISLOCATION AND PERFORATION TO BE RELATED TO ESSURE. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835563 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | AEROBID| AEROBID INHALER| AEROBID INHALER| AMITRIPTYLINE| DEPO PROVERA| DICYCLOMINE| DICYCLOMINE| DICYCLOMINE [DICYCLOVERINE]| EXCEDRIN [CAFFEINE,PARACETAMOL]| EXCEDRIN [CAFFEINE,PARACETAMOL]| EXCEDRIN [CAFFEINE,PARACETAMOL]| GABAPENTIN| GABAPENTIN| GABAPENTIN| IBUPROFEN| MEDROXYPROGESTERON| MEDROXYPROGESTERON| MEDROXYPROGESTERON| MELOXICAM| MELOXICAM| MELOXICAM| NEURONTIN| NEURONTIN| NEURONTIN| NEURONTIN| NEURONTIN| NEURONTIN| OMEPRAZOLE| OXYBUTYNIN| OXYBUTYNIN| OXYBUTYNIN| PANTOPRAZOLE| RANITIDINE| ZOLOFT| ZOLOFT| ZOLOFT |