ESSURE
Report
- Report Number
- 2951250-2021-00945
- Event Type
- Injury
- Date Received
- March 23, 2021
- Date of Event
- January 1, 2009
- Report Date
- March 24, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626976) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY, GALLSTONES, THYROID DISORDER, THYROIDECTOMY, DRY EYE SYNDROME, NABOTHIAN CYST, ADENOMYOSIS, LEIOMYOMA NOS, PARATUBAL CYST, DYSMENORRHEA, MENOMETRORRHAGIA AND CYSTOSCOPY. ON (B)(6) 2016: WITHOUT THYROTOXIC STORM E05.00, NO SIGNS OF CORNEAL EXPOSURE OR OPTIC NERVE DISEASE. CONCURRENT CONDITIONS INCLUDED EPIGASTRIC PAIN, CHEST PAIN, CHOLELITHIASIS, CHOLECYSTITIS, THYROID CANCER, DRUG ALLERGY, GRAVES' DISEASE, NUMBNESS IN LEG, GROIN PAIN, CHEST PAIN, HAEMORRHAGIC ANAEMIA, HYPOXIA, ALCOHOL USE, MYOCARDIAL INFARCTION, MORBID OBESITY (BMI 43.474), UTERINE BLEEDING, PERINEAL PAIN, PHOTOPHOBIA, SNORING, COLD INTOLERANCE, BLURRY VISION (THE PATIENT COMPLAINS OF BLURRY VISION IN BOTH EYES FOR SEVERAL MONTHS. THE PATIENT STATES IT CAUSES FUZZY VISION AND IT IS LIMITING PATIENT'S HOBBIES.), PAIN IN LIMB, PLANTAR FASCIAL FIBROMATOSIS, PAIN IN EXTREMITY, EXTREMITIES BURNING SENSATION OF, AMBLYOPIA, ASTIGMATISM, THYROTOXICOSIS WITH GOITRE, PROPTOSIS, MYOPIA, DRY EYE SYNDROME, TYPE II DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, NUMBNESS AND LEG CRAMPS. FAMILY HISTORY INCLUDED LUNG CANCER (SISTER). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2008 TO (B)(6) 2008, METHYLPREDNISOLONE ACETATE (METHYLPREDNIS), SUMATRIPTAN AND TIZANIDINE. IN 2008, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN UP TO APPROX 300LBS") AND EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/DECREASE IN SEX DRIVE"), THE FIRST EPISODE OF DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED LIBIDO DECREASED ("DECREASE IN SEX DRIVE"), TEMPERATURE INTOLERANCE ("HEAT SENSITIVITY") AND HOT FLUSH ("HOT FLASHES"). IN (B)(6) 2008, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), URINARY INCONTINENCE ("INCONTINENCE,URINE LEAKING"), HYPOAESTHESIA ("HIPS AND BOTH LEFT AND RIGHT LEGS GO NUMB AND IT ALSO HAPPENS WHEN SITTING/HIPS AND LEGS NUMB"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL,") AND BLADDER DISORDER ("BLADDER PROBLEM"). IN 2010, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND VAGINAL INFECTION ("VAGINAL INFECTION"). IN 2011, THE PATIENT EXPERIENCED VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: WEAR GLASSES/VISION GETTING WORSE"). IN 2012, THE PATIENT EXPERIENCED TOOTH FRACTURE ("DENTAL PROBLEMS/TEETH CHIPPING 6 EXTRACTIONS"). IN 2013, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("HYPERTHYROIDISM"), BASEDOW'S DISEASE ("GRAVE'S DISEASE"), FATIGUE ("FATIGUE"), PARAESTHESIA ("TINGLING IN LEGS AND HANDS") AND DIZZINESS ("DIZZINESS"). IN 2014, THE PATIENT EXPERIENCED CARDIAC FLUTTER ("HEART FLUTTERING"), ANAEMIA ("ANEMIA") AND ANXIETY ("ANXIETY"). IN (B)(6) 2015, THE PATIENT EXPERIENCED TREMOR ("TREMORS"). IN 2015, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL") AND GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN FEBRUARY 2017, THE PATIENT EXPERIENCED DERMATITIS ("DERMATITIS"). IN 2017, THE PATIENT EXPERIENCED DIARRHOEA ("DIARRHEA") AND OVARIAN CYST ("CYSTS ON MY OVARIES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SLEEP APNOEA SYNDROME ("OTHER INJURIES OR COMPLICATIONS: SLEEP APNEA"). IN (B)(6) 2018, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS") AND EXPERIENCED GROIN PAIN ("GROIN PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/ CRAMPING/PAIN"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN/PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), PAIN ("SHARP PAINS WHEN WALKING"), THE SECOND EPISODE OF DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PAIN IN EXTREMITY ("HIPS AND LEGS PAIN"), ARTHRALGIA ("HIPS AND LEGS PAIN"), NECK PAIN ("NECK PAIN") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH ALPRAZOLAM, CEFALEXIN (CEPHALEXIN), ERGOCALCIFEROL, FERROUS SULFATE (FERROUS SULPHATE), GABAPENTIN, HYDROCHLOROTHIAZIDE;PROPRANOLOL HYDROCHLORIDE (HYDROCHLOROTHIAZIDE;PROPRANOLOL HCL), IBUPROFEN, IRON, LEVOTHYROXINE, METFORMIN, OMEPRAZOLE, ONDANSETRON, OXYCODONE, PARACETAMOL (ACETAM), SUMATRIPTAN (IMITREX), TOPIRAMATE, MACROGOL 3350 (MIRALAX) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HYPERTHYROIDISM, WEIGHT INCREASED, WEIGHT DECREASED, FEMALE SEXUAL DYSFUNCTION, LIBIDO DECREASED, TOOTH FRACTURE, ALOPECIA, TEMPERATURE INTOLERANCE, VISUAL IMPAIRMENT, IRRITABLE BOWEL SYNDROME, DIARRHOEA, URINARY INCONTINENCE, URINARY TRACT INFECTION, GROIN PAIN, HYPOAESTHESIA, TREMOR, BASEDOW'S DISEASE, CARDIAC FLUTTER, ANAEMIA, NAUSEA, FATIGUE, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ABDOMINAL PAIN LOWER, PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE, HOT FLUSH, DEPRESSION, ANXIETY, DERMATITIS, BLADDER DISORDER, PARAESTHESIA, THE LAST EPISODE OF DYSMENORRHOEA, GASTROOESOPHAGEAL REFLUX DISEASE, AMNESIA, OVARIAN CYST, DIZZINESS, PAIN IN EXTREMITY, ARTHRALGIA, NECK PAIN, BACK PAIN AND SLEEP APNOEA SYNDROME OUTCOME WAS UNKNOWN AND THE MIGRAINE, HEADACHE AND VAGINAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANAEMIA, ANXIETY, ARTHRALGIA, BACK PAIN, BASEDOW'S DISEASE, BLADDER DISORDER, CARDIAC FLUTTER, DEPRESSION, DERMATITIS, DIARRHOEA, DIZZINESS, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, GROIN PAIN, HEADACHE, HOT FLUSH, HYPERTHYROIDISM, HYPOAESTHESIA, IRRITABLE BOWEL SYNDROME, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, NAUSEA, NECK PAIN, OVARIAN CYST, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, SLEEP APNOEA SYNDROME, TEMPERATURE INTOLERANCE, TOOTH FRACTURE, TREMOR, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF DYSMENORRHOEA AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE OF BIRTH AS PER MR IS (B)(6) 1977. PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL. CURRENT WEIGHT: 197 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2008: RESULTS: TOTAL BILATERAL OCCLUSION. X-RAY - ON (B)(6) 2008: RESULTS: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2008, PROCEDURE: ESSURE STERILIZATION, HYSTERESCOPIC WITH ESSURE OCCLUSION OF BILATERAL FALLOPIAN TUBE. FINDINGS: THE PATIENT HAS AN ANTEVERTED NORMAL SIZE UTERUS. ON VISUALIZATION OF THE ENDOMETRIAL CAVITY, IT WAS FOUND TO BE SLIGHTLY FLUFFY. THE BILATERAL TUBAL OSTIA WERE VISUALIZED AND TWO COILS REMAIN IN THE CAVITY BILATERALLY. ON (B)(6) 2008, HYSTEROSALPINGOGRAM, IMPRESSION: SATISFACTORY POSITION OF ESSURE FALLOPIAN WIRES. OCCLUDED FALLOPIAN TUBES. ON (B)(6) 2017, FINDINGS. SMALL ENDPLATE OSTEOPHYTES. MODERATE NARROWING OF THE L5-S1 DISC SPACE. VERTEBRAL BODY HEIGHT, ALIGNMENT AND DENSITY NORMAL. NO FRACTURE. NO LYTIC OR BLASTIC LESION. NO ENDPLATE DESTRUCTION. NORMAL FACET JOINTS. NO SPONDYLOLYSIS. NO OTHER FINDING. IMPRESSION: MODERATE L5-S1 DEGENERATIVE DISC DISEASE. NO ACUTE FINDING. ON (B)(6) 2017, COMPARISON: CT ABDOMEN AND PELVIS WITH CONTRAST (B)(6) 2015, IMPRESSION: 1. MILDLY ENLARGED UTERUS WHICH MAY BE NORMAL FOR MULTIGRAVID UTERUS. NO DISCRETE UTERINE MASS WAS IDENTIFIED. 2. THERE WAS A 2.2 CM FOLLICULAR CYST IN THE LEFT OVARY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: HYPOAESTHESIA, PELVIC PAIN, MENORRHAGIA, IRRITABLE BOWEL SYNDROME, ABDOMINAL PAIN, HYPERTHYROIDISM, TREMOR, ANAEMIA, BASEDOW'S DISEASE, MIGRAINE, HEADACHE,VISUAL IMPAIREMENT. LOT NUMBER: 626976 MANUFACTURING DATE: 2008/04 EXPIRATION DATE: 2010/04. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-MAR-2021: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626976) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY, GALLSTONES, THYROID DISORDER, THYROIDECTOMY, DRY EYE SYNDROME, NABOTHIAN CYST, ADENOMYOSIS, LEIOMYOMA NOS, PARATUBAL CYST, DYSMENORRHEA, MENOMETRORRHAGIA AND CYSTOSCOPY. ON (B)(6) 2016: WITHOUT THYROTOXIC STORM E05.00, NO SIGNS OF CORNEAL EXPOSURE OR OPTIC NERVE DISEASE. CONCURRENT CONDITIONS INCLUDED EPIGASTRIC PAIN, CHEST PAIN, CHOLELITHIASIS, CHOLECYSTITIS, THYROID CANCER, DRUG ALLERGY, GRAVES' DISEASE, NUMBNESS IN LEG, GROIN PAIN, CHEST PAIN, HAEMORRHAGIC ANAEMIA, HYPOXIA, ALCOHOL USE, MYOCARDIAL INFARCTION, MORBID OBESITY (BMI 43.474), UTERINE BLEEDING, PERINEAL PAIN, PHOTOPHOBIA, SNORING, COLD INTOLERANCE, BLURRY VISION (THE PATIENT COMPLAINS OF BLURRY VISION IN BOTH EYES FOR SEVERAL MONTHS. THE PATIENT STATES IT CAUSES FUZZY VISION AND IT IS LIMITING PATIENT'S HOBBIES.), PAIN IN LIMB, PLANTAR FASCIAL FIBROMATOSIS, PAIN IN EXTREMITY, EXTREMITIES BURNING SENSATION OF, AMBLYOPIA, ASTIGMATISM, THYROTOXICOSIS WITH GOITRE, PROPTOSIS, MYOPIA, DRY EYE SYNDROME, TYPE II DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, NUMBNESS AND LEG CRAMPS. FAMILY HISTORY INCLUDED LUNG CANCER (SISTER). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2008 TO (B)(6) 2008, METHYLPREDNISOLONE ACETATE (METHYLPREDNIS), SUMATRIPTAN AND TIZANIDINE. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2008, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN UP TO APPROX 300LBS") AND EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/DECREASE IN SEX DRIVE"), THE FIRST EPISODE OF DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2008, THE PATIENT EXPERIENCED LIBIDO DECREASED ("DECREASE IN SEX DRIVE"), TEMPERATURE INTOLERANCE ("HEAT SENSITIVITY") AND HOT FLUSH ("HOT FLASHES"). IN (B)(6) 2008, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), URINARY INCONTINENCE ("INCONTINENCE,URINE LEAKING"), HYPOAESTHESIA ("HIPS AND BOTH LEFT AND RIGHT LEGS GO NUMB AND IT ALSO HAPPENS WHEN SITTING/HIPS AND LEGS NUMB"), MENORRHAGIA ("SEVERE MENSTRUAL FLOW/ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL,") AND BLADDER DISORDER ("BLADDER PROBLEM"). IN 2010, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND VAGINAL INFECTION ("VAGINAL INFECTION"). IN 2011, THE PATIENT EXPERIENCED VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: WEAR GLASSES/VISION GETTING WORSE"). IN 2012, THE PATIENT EXPERIENCED TOOTH FRACTURE ("DENTAL PROBLEMS/TEETH CHIPPING 6 EXTRACTIONS"). IN 2013, THE PATIENT EXPERIENCED HYPERTHYROIDISM ("HYPERTHYROIDISM"), BASEDOW'S DISEASE ("GRAVE'S DISEASE"), FATIGUE ("FATIGUE"), PARAESTHESIA ("TINGLING IN LEGS AND HANDS") AND DIZZINESS ("DIZZINESS"). IN 2014, THE PATIENT EXPERIENCED CARDIAC FLUTTER ("HEART FLUTTERING"), ANAEMIA ("ANEMIA") AND ANXIETY ("ANXIETY"). IN (B)(6) 2015, THE PATIENT EXPERIENCED TREMOR ("TREMORS"). IN 2015, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL") AND GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DERMATITIS ("DERMATITIS"). IN 2017, THE PATIENT EXPERIENCED DIARRHOEA ("DIARRHEA") AND OVARIAN CYST ("CYSTS ON MY OVARIES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SLEEP APNOEA SYNDROME ("OTHER INJURIES OR COMPLICATIONS: SLEEP APNEA"). IN (B)(6) 2018, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS") AND EXPERIENCED GROIN PAIN ("GROIN PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/ CRAMPING/PAIN"), ABDOMINAL PAIN UPPER ("UPPER ABDOMINAL PAIN/PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), PAIN ("SHARP PAINS WHEN WALKING"), THE SECOND EPISODE OF DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PAIN IN EXTREMITY ("HIPS AND LEGS PAIN"), ARTHRALGIA ("HIPS AND LEGS PAIN"), NECK PAIN ("NECK PAIN") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH ALPRAZOLAM, CEFALEXIN (CEPHALEXIN), ERGOCALCIFEROL, FERROUS SULFATE (FERROUS SULPHATE), GABAPENTIN, HYDROCHLOROTHIAZIDE;PROPRANOLOL HYDROCHLORIDE (HYDROCHLOROTHIAZIDE;PROPRANOLOL HCL), IBUPROFEN, IRON, LEVOTHYROXINE, METFORMIN, OMEPRAZOLE, ONDANSETRON, OXYCODONE, PARACETAMOL (ACETAM), SUMATRIPTAN (IMITREX), TOPIRAMATE, MACROGOL 3350 (MIRALAX) AND SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HYPERTHYROIDISM, WEIGHT INCREASED, WEIGHT DECREASED, FEMALE SEXUAL DYSFUNCTION, LIBIDO DECREASED, TOOTH FRACTURE, ALOPECIA, TEMPERATURE INTOLERANCE, VISUAL IMPAIRMENT, IRRITABLE BOWEL SYNDROME, DIARRHOEA, URINARY INCONTINENCE, URINARY TRACT INFECTION, GROIN PAIN, HYPOAESTHESIA, TREMOR, BASEDOW'S DISEASE, CARDIAC FLUTTER, ANAEMIA, NAUSEA, FATIGUE, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ABDOMINAL PAIN LOWER, PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE, HOT FLUSH, DEPRESSION, ANXIETY, DERMATITIS, BLADDER DISORDER, PARAESTHESIA, THE LAST EPISODE OF DYSMENORRHOEA, GASTROOESOPHAGEAL REFLUX DISEASE, AMNESIA, OVARIAN CYST, DIZZINESS, PAIN IN EXTREMITY, ARTHRALGIA, NECK PAIN, BACK PAIN AND SLEEP APNOEA SYNDROME OUTCOME WAS UNKNOWN AND THE MIGRAINE, HEADACHE AND VAGINAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANAEMIA, ANXIETY, ARTHRALGIA, BACK PAIN, BASEDOW'S DISEASE, BLADDER DISORDER, CARDIAC FLUTTER, DEPRESSION, DERMATITIS, DIARRHOEA, DIZZINESS, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, GROIN PAIN, HEADACHE, HOT FLUSH, HYPERTHYROIDISM, HYPOAESTHESIA, IRRITABLE BOWEL SYNDROME, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, NAUSEA, NECK PAIN, OVARIAN CYST, PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, SLEEP APNOEA SYNDROME, TEMPERATURE INTOLERANCE, TOOTH FRACTURE, TREMOR, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF DYSMENORRHOEA AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE OF BIRTH AS PER MR IS (B)(6) 1977. PLAINTIFF CURRENTLY PLANNING FOR ESSURE REMOVAL. CURRENT WEIGHT: 197 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2008: RESULTS: TOTAL BILATERAL OCCLUSION. X-RAY - ON (B)(6) 2008: RESULTS: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2008, PROCEDURE: ESSURE STERILIZATION, HYSTERESCOPIC WITH ESSURE OCCLUSION OF BILATERAL FALLOPIAN TUBE. FINDINGS: THE PATIENT HAS AN ANTEVERTED NORMAL SIZE UTERUS. ON VISUALIZATION OF THE ENDOMETRIAL CAVITY, IT WAS FOUND TO BE SLIGHTLY FLUFFY. THE BILATERAL TUBAL OSTIA WERE VISUALIZED AND TWO COILS REMAIN IN THE CAVITY BILATERALLY. ON (B)(6)2008, HYSTEROSALPINGOGRAM, IMPRESSION: SATISFACTORY POSITION OF ESSURE FALLOPIAN WIRES. OCCLUDED FALLOPIAN TUBES. ON (B)(6) 2017, FINDINGS. SMALL ENDPLATE OSTEOPHYTES. MODERATE NARROWING OF THE L5-S1 DISC SPACE. VERTEBRAL BODY HEIGHT, ALIGNMENT AND DENSITY NORMAL. NO FRACTURE. NO LYTIC OR BLASTIC LESION. NO ENDPLATE DESTRUCTION. NORMAL FACET JOINTS. NO SPONDYLOLYSIS. NO OTHER FINDING. IMPRESSION: MODERATE L5-S1 DEGENERATIVE DISC DISEASE. NO ACUTE FINDING. ON (B)(6) 2017, COMPARISON: CT ABDOMEN AND PELVIS WITH CONTRAST (B)(6) 2015, IMPRESSION: MILDLY ENLARGED UTERUS WHICH MAY BE NORMAL FOR MULTIGRAVID UTERUS. NO DISCRETE UTERINE MASS WAS IDENTIFIED. THERE WAS A 2.2 CM FOLLICULAR CYST IN THE LEFT OVARY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: HYPOAESTHESIA, PELVIC PAIN, MENORRHAGIA, IRRITABLE BOWEL SYNDROME, ABDOMINAL PAIN, HYPERTHYROIDISM, TREMOR, ANAEMIA, BASEDOW'S DISEASE, MIGRAINE, HEADACHE,VISUAL IMPAIREMENT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2021: MR RECEIVED: PREVIOUSLY REPORTED EVENT PELVIC PAIN MADE MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED DUE TO SURGERY. CASE CATEGORY UPDATED TO SERIOUS INCIDENT. REPORTER, MEDICAL HISTORY AND ESSURE REMOVAL DATE ADDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 453434 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 626976 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| METHYLPREDNIS| METHYLPREDNIS| SUMATRIPTAN| SUMATRIPTAN| TIZANIDINE| TIZANIDINE |