ESSURE
Report
- Report Number
- 2951250-2017-11156
- Event Type
- Injury
- Date Received
- December 28, 2017
- Date of Event
- January 1, 2012
- Report Date
- August 19, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5036371) ON 16-JUL-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-FEB-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("INFLAMMATION IN HER PELVIC AREA/ ABDOMEN / RECURRENT PELVIC INFECTIONS / INFECTIONS IN MY PELVIC AND INFECTIONS IN MY ABDOMINAL AREA/I FEEL ARE DUE TO THE INFLAMMATION THAT I ENDURED WHILE I HAD THE ESSURE"), EMBEDDED DEVICE ("EMBEDDING OF THE COILS IN MY TUBES"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE"), MASTITIS ("MASTITIS") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 822368) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA IN 2011, IODINE ALLERGY, MISCARRIAGE, DEPRESSION, ANXIETY, BREAST PAIN, CHOLECYSTECTOMY IN 2006, C-SECTION IN 2007, SCAR ON (B)(6) 2011, MULTIGRAVIDA, SCAR REMOVAL IN 2011, ANAL FISSURE EXCISION IN 2006, PARITY 4 (DATE OF BIRTH: ON (B)(6) 2006, ON (B)(6) 2007, ON (B)(6) 2007, ON (B)(6) 2011), PRE-ECLAMPSIA, NECROTIZING ENTEROCOLITIS (NEC) ON (B)(6) 2011, RIGHT LOWER QUADRANT PAIN ON (B)(6) 2011, MASTITIS ON (B)(6) 2011, MENSES IRREGULAR ON (B)(6) 2011, BLEEDING GENITAL ON (B)(6) 2011, C-SECTION (FOR TWINS), SCIATICA AND DYSURIA (SHE HAS PAIN WITH A FULL BLADDER AND DYSURIA.) ON (B)(6) 2011. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MINI PILL, NUVARING AND MIRENA; FOR DYSTONIA: BACLOFEN AND CARBIDOPA; FOR FIBROMYALGIA: GABAPENTIN; FOR JOINT PAIN: PLAQUENIL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ABDOMINAL PAIN LOWER WITH MIRENA. CONCURRENT CONDITIONS INCLUDED NONSMOKER, NICKEL SENSITIVITY, OBESITY, CERUMEN IMPACTION SINCE ON (B)(6) 2011, SINUSITIS (SINUSITIS (ACUTE)) SINCE ON (B)(6) 2011, COUGHING SINCE ON (B)(6) 2011, BREAST PAIN (RED STREAK RIGHT BREAST. HER RIGHT BREAST HAS BECOME SLIGHTLY SWOLLEN, WARM, TENDER. SHE NOTES SOME MILD RED STREAKING COMING FROM THE NIPPLE.) SINCE ON (B)(6) 2011, IRREGULAR MENSTRUATION SINCE ON (B)(6) 2011, LUMBAGO SINCE ON (B)(6) 2011, BREAST SWELLING SINCE ON (B)(6) 2011, BREAST TENDERNESS SINCE ON (B)(6) 2011, SHAKING SINCE ON (B)(6) 2014, JERKINESS SINCE ON (B)(6) 2014, NIGHTMARES SINCE ON (B)(6) 2014, SHORTNESS OF BREATH SINCE ON (B)(6) 2014 AND BACK PAIN SINCE ON (B)(6) 2011. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D), FISH OIL, HYDROCORTISONE (CORTISOL), LORATADINE (CLARITIN), ORAL CONTRACEPTIVE NOS AND OXYCOCET (PERCOCET). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED INFLAMMATION ("INFLAMMATION /THAT I FEEL ARE DUE TO THE INFLAMMATION"). IN 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) WITH UTERINE SCAR, PELVIC PAIN, ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER, LIBIDO DECREASED ("DESIRE FOR SEX HAS DROPPED"), PAIN ("PAIN / ACHE / DULL ACHE"), CONFUSIONAL STATE ("MENTAL CLARITY BEGAN TO SUFFER"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("MENSTRUAL PERIODS ACCOMPANIED BY SIGNIFICANT PAIN"), ALLERGY TO METALS ("METAL SENSITIVITIES INCREASED / ALLERGIC TO NICKEL / HYPO-ALLERGENIC EARRINGS /HYPERSENSITIVITY REACTION TO NICKEL") WITH INFECTION, RASH AND PRURITUS, VULVOVAGINAL PAIN ("VAGINAL PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), MIGRAINE ("MIGRAINES") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FOOD ALLERGY ("FOOD SENSITIVITIES"), 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE. IN 2015, THE PATIENT EXPERIENCED UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE ("UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER") WITH DYSTONIA AND MUSCLE DISORDER ("MUSCLE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER"). IN 2016, THE PATIENT EXPERIENCED METAL POISONING ("HEAVY METAL POISONING /HEAVY METAL POISONING DUE TO FREQUENT CT SCANS AND MRI'S ORDERED TO DIAGNOSE THESE ISSUES AND RECURRENT INFECTIONS ALL DUE TO THE EFFECTS OF ESSURE"). IN 2017, THE PATIENT EXPERIENCED MOVEMENT DISORDER ("MOVEMENT DISORDER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MASTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ENDOMETRIOSIS ON HER UTERUS/UTERUS HAD SOME POSSIBLE ENDOMETRIOSIS") WITH DYSMENORRHOEA, ABDOMINAL DISTENSION, DYSPAREUNIA AND ABDOMINAL ADHESIONS, SINUSITIS ("SEVERE SINUS INFECTIONS"), ABDOMINAL ADHESIONS ("ADHESIONS FROM MY BOWELS"), MENOPAUSAL SYMPTOMS ("MENOPAUSAL SYMPTOMS") WITH HORMONE LEVEL ABNORMAL, MENORRHAGIA ("HEAVY PERIODS"), ARTHRALGIA ("JOINT PAIN"), NEURALGIA ("NERVE PAIN"), MENTAL DISORDER ("AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), FEELING ABNORMAL ("BRAIN FOG"), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CHEST PAIN ("CHEST PAIN"), DYSPNOEA ("SHORTNESS OF BREATH"), DIZZINESS ("DIZZINESS"), MUSCLE TWITCHING ("MUSCLE TWITCHING"), EYE SWELLING ("SWOLLEN EYE"), MUSCLE CONTRACTIONS INVOLUNTARY ("MUSCLE CONTRACTIONS"), HEADACHE ("HEADACHES"), GINGIVAL RECESSION ("RECEEDED GUMS"), APHTHOUS ULCER ("CANKER SORES"), FEELING DRUNK ("DRUNK LIKE SENSATION"), PARAESTHESIA ("VIBRATING LIKE SENSATIONS"), SKIN DISORDER ("SKIN CHANGES"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), INSOMNIA ("LAST NIGHT WAS ROUGH, COULDN'T SLEEP") AND CALCINOSIS ("I HAVE CALCIUM DEPOSITS ON MY RIGHT HIP") AND WAS FOUND TO HAVE BENIGN FALLOPIAN TUBE NEOPLASM ("BENIGN PARATUBAL CYST"). THE PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2014. THE PATIENT WAS TREATED WITH ANTIBIOTICS, ANTIINFLAMMATORY PREPARATIONS, NON-STEROIDS FOR TOPICAL USE, BACLOFEN, CARBIDOPA, GABAPENTIN, HOMEOPATHICS NOS (DETOX-KIT-HEEL), HYDROXYCHLOROQUINE, IBUPROFEN, LEVODOPA, RIZATRIPTAN BENZOATE (MAXALT), ANTI-INFLAMMATORIES/HERBS, MAXALT, SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY (ON (B)(6) 2014). AND TOTAL HYSTERECTOMYAND BILATERAL SALPINGECTOMY (ON (B)(6) 2014).) AND SAUNA THERAPY,CHANGE IN DIET, DETOX SUPPLEMENTS. ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE HAD RESOLVED, THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, MASTITIS, ADENOMYOSIS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, MENSTRUATION IRREGULAR, DYSMENORRHOEA, ALLERGY TO METALS, SINUSITIS, ABDOMINAL ADHESIONS, MENOPAUSAL SYMPTOMS, VULVOVAGINAL PAIN, FIBROMYALGIA, UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE, MUSCLE DISORDER, METAL POISONING, MENORRHAGIA, MIGRAINE, ARTHRALGIA, NEURALGIA, MENTAL DISORDER, FEELING ABNORMAL, MOVEMENT DISORDER, DYSFUNCTIONAL UTERINE BLEEDING, CHEST PAIN, DYSPNOEA, DIZZINESS, MUSCLE TWITCHING, EYE SWELLING, MUSCLE CONTRACTIONS INVOLUNTARY, HEADACHE, GINGIVAL RECESSION, APHTHOUS ULCER, FEELING DRUNK, PARAESTHESIA, SKIN DISORDER, SYSTEMIC LUPUS ERYTHEMATOSUS, INSOMNIA, CALCINOSIS AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED, LIBIDO DECREASED, PAIN AND INFLAMMATION WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL ADHESIONS, ADENOMYOSIS, ALLERGY TO METALS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, DYSMENORRHOEA, LIBIDO DECREASED, MASTITIS, MENOPAUSAL SYMPTOMS, MENSTRUATION IRREGULAR, PAIN, SINUSITIS AND WEIGHT INCREASED WITH ESSURE. THE REPORTER CONSIDERED APHTHOUS ULCER, ARTHRALGIA, AUTOIMMUNE DISORDER, CALCINOSIS, CHEST PAIN, DIZZINESS, DYSFUNCTIONAL UTERINE BLEEDING, DYSPNOEA, EMBEDDED DEVICE, EYE SWELLING, FEELING ABNORMAL, FEELING DRUNK, FIBROMYALGIA, FOOD ALLERGY, GINGIVAL RECESSION, HEADACHE, INFLAMMATION, INSOMNIA, MENORRHAGIA, MENTAL DISORDER, METAL POISONING, MIGRAINE, MOVEMENT DISORDER, MUSCLE CONTRACTIONS INVOLUNTARY, MUSCLE DISORDER, MUSCLE TWITCHING, NEURALGIA, PARAESTHESIA, PELVIC INFLAMMATORY DISEASE, SKIN DISORDER, SYSTEMIC LUPUS ERYTHEMATOSUS, UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE, URINARY TRACT INFECTION AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: MY PAIN AND RECURRENT INFECTIONS RESOLVED AFTER SURGERY TO REMOVE ESSURE. SINCE THE REMOVAL I HAVE NOT HAD ANY MORE PELVIC INFECTIONS, THE INFLAMMATION HAS DECREASED AND I HAVE NOT HAD ANY MORE ABDOMINAL PAIN. PROCEDURE: PARACERVICAL BLOCK. PROCEDURE DETAILS: USING HYSTEROSCOPIC FLUID BOTH TUBAL OSTIA WERE VISUALIZED. THE ESSURE DEVICE WAS THEN PLACED IN THE FIRST FALLOPIAN TUBE ON THE LEFT SIDE. THE SECOND ESSURE DEVICE WAS PLACED IN THE OPPOSITE TUBE THE EXACT WAY. 2-3 COILS WERE NOTED OUTSIDE EACH TUBE AND ADEQUATE PLACEMENT WAS NOTED OF EACH. THE REST OF THE UTERUS WAS UNREMARKABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. COMPUTERISED TOMOGRAM: ON AN UNKNOWN DATE: RESULTS: PELVIC INFLAMMATORY DISEASE.. HYSTEROSALPINGOGRAM: ON AN UNKNOWN DATE: RESULTS: NOT REPORTED; ON (B)(6) 2011: (AS PER MR) INDICATION: POST ESSURE PROCEDURE FOR TUBAL CLOSURE FINDINGS-SCOUT IMAGE OF THE PELVIS SHOWS LINEAR DENSITIES CONSISTENT WITH HISTORY OF ESSURE TUBAL LIGATION PROCEDURE. ULTRASOUND PELVIS: ON (B)(6) 2011: INDICATION-PELVIC PAIN FOR FOUR YEARS. FINDINGS: TRANSABDOMINAL AND ENDOVAGINAL SONOGRAPHIC EVALUATION OF THE PELVIS SHOWS A NORMAL APPEARING UTERUS MEASURING 9.0 X 5.6 X 4.0 CM. IMPRESSION: NO SONOGRAPHIC ABNORMALITIES ARE IDENTIFIED.; IN 2012: RESULTS: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: RESULTS: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES. ULTRASOUND SCAN: ON AN UNKNOWN DATE: RESULTS: PELVIC INFLAMMATORY DISEASE. URINE ANALYSIS: IN 2012: RESULTS: INCONCLUSIVE. URINALYSIS AND URINE CULTURES, DIAGNOSED WITH URINARY TRACT INFECTION. UROGRAM: IN 2012: RESULTS: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: RESULTS: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, DYSPAREUNIA, ABDOMINAL PAIN AND DYSPNOEA. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES REPORTED VIA SOCIAL MEDIA: LUPUS, LAST NIGHT WAS ROUGH, COULDN'T SLEEP, I HAVE CALCIUM DEPOSITS ON MY RIGHT HIP. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-FEB-2019: PLAINTIFF FACT SHEET RECEIVED. EVENT ADDED FROM SOCIAL MEDIA: LUPUS, LAST NIGHT WAS ROUGH, COULDN'T SLEEP, I HAVE CALCIUM DEPOSITS ON MY RIGHT HIP. EVENT OUTCOME WAS UPDATED FOR THE EVENT: PELVIC INFECTIONS. LAB DATA WAS UPDATED. PLAINTIFF¿S AKA NAME WAS ADDED. REPORTER 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5036371) ON 16-JUL-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 21-MAY-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("INFLAMMATION IN HER PELVIC AREA/ ABDOMEN / RECURRENT PELVIC INFECTIONS / INFECTIONS IN MY PELVIC AND INFECTIONS IN MY ABDOMINAL AREA"), EMBEDDED DEVICE ("EMBEDDING OF THE COILS IN MY TUBES"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE"), MASTITIS ("MASTITIS") AND UTERINE HAEMORRHAGE ("DYSFUNCTIONAL UTERINE BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822368) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA IN 2011, IODINE ALLERGY, MISCARRIAGE, DEPRESSION, ANXIETY, BREAST PAIN, CHOLECYSTECTOMY IN 2006, C-SECTION IN 2007, SCAR IN (B)(6) 2011, MULTIGRAVIDA, SCAR REMOVAL IN 2011, ANAL FISSURE EXCISION IN 2006, PARITY 4 (DATE OF BIRTH: (B)(6) 2006, (B)(6) 2007, (B)(6) 2007, (B)(6) 2011), PRE-ECLAMPSIA, NECROTIZING ENTEROCOLITIS (NEC) ON (B)(6) 2011, RIGHT LOWER QUADRANT PAIN ON (B)(6) 2011, MASTITIS ON (B)(6) 2011, MENSES IRREGULAR WITH EXCESSIVE BLEEDING ON (B)(6) 2011, BLEEDING GENITAL ON (B)(6) 2011, C-SECTION (FOR TWINS), SCIATICA AND DYSURIA (SHE HAS PAIN WITH A FULL BLADDER AND DYSURIA.) ON (B)(6) 2011. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MINI PILL, NUVARING AND MIRENA; FOR DYSTONIA: BACLOFEN AND CARBIDOPA; FOR FIBROMYALGIA: GABAPENTIN; FOR JOINT PAIN: PLAQUENIL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ABDOMINAL PAIN LOWER WITH MIRENA. CONCURRENT CONDITIONS INCLUDED NONSMOKER, NICKEL SENSITIVITY, OBESITY, CERUMEN IMPACTION SINCE (B)(6) 2011, SINUSITIS (SINUSITIS (ACUTE)) SINCE (B)(6) 2011, COUGHING SINCE (B)(6) 2011, BREAST PAIN (RED STREAK RIGHT BREAST HER RIGHT BREAST HAS BECOME SLIGHTLY SWOLLEN, WARM, TENDER. SHE NOTES SOME MILD RED STREAKING COMING FROM THE NIPPLE.) SINCE (B)(6) 2011, IRREGULAR MENSTRUATION SINCE (B)(6) 2011, LUMBAGO SINCE (B)(6) 2011, BREAST SWELLING SINCE (B)(6) 2011, BREAST TENDERNESS SINCE (B)(6) 2011, SHAKING SINCE (B)(6) 2014, JERKINESS SINCE (B)(6) 2014, NIGHTMARES SINCE (B)(6) 2014, SHORTNESS OF BREATH SINCE V2014 AND BACK PAIN SINCE (B)(6) 2011. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D), CONTRACEPTIVES NOS, FISH OIL, HYDROCORTISONE (CORTISOL), LORATADINE (CLARITIN) AND OXYCOCET (PERCOCET). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("VAGINAL PAIN") AND INFLAMMATION ("INFLAMMATION /THAT I FEEL ARE DUE TO THE INFLAMMATION"). IN 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) WITH UTERINE SCAR, PELVIC PAIN, ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER, WEIGHT INCREASED ("WEIGHT GAIN"), LIBIDO DECREASED ("DESIRE FOR SEX HAS DROPPED"), PAIN ("PAIN / ACHE / DULL ACHE"), CONFUSIONAL STATE ("MENTAL CLARITY BEGAN TO SUFFER"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("MENSTRUAL PERIODS ACCOMPANIED BY SIGNIFICANT PAIN"), ALLERGY TO METALS ("METAL SENSITIVITIES INCREASED / ALLERGIC TO NICKEL / HYPO-ALLERGENIC EARRINGS /HYPERSENSITIVITY REACTION TO NICKEL") WITH INFECTION, RASH AND PRURITUS, FIBROMYALGIA ("FIBROMYALGIA") AND MIGRAINE ("MIGRAINES"). IN 2015, THE PATIENT EXPERIENCED CONNECTIVE TISSUE DISORDER ("UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER") WITH DYSTONIA AND MUSCLE DISORDER ("MUSCLE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER"). IN 2016, THE PATIENT EXPERIENCED METAL POISONING ("HEAVY METAL POISONING /HEAVY METAL POISONING DUE TO FREQUENT CT SCANS AND MRI'S ORDERED TO DIAGNOSE THESE ISSUES AND RECURRENT INFECTIONS ALL DUE TO THE EFFECTS OF ESSURE"). IN 2017, THE PATIENT EXPERIENCED MOVEMENT DISORDER ("MOVEMENT DISORDER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MASTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ENDOMETRIOSIS ON HER UTERUS") WITH DYSMENORRHOEA, ABDOMINAL DISTENSION, DYSPAREUNIA AND ABDOMINAL ADHESIONS, BENIGN FALLOPIAN TUBE NEOPLASM ("BENIGN PARATUBAL CYST"), SINUSITIS ("SEVERE SINUS INFECTIONS"), ABDOMINAL ADHESIONS ("ADHESIONS FROM MY BOWELS"), MENOPAUSAL SYMPTOMS ("MENOPAUSAL SYMPTOMS") WITH HORMONE LEVEL ABNORMAL, FOOD ALLERGY ("FOOD SENSITIVITIES"), MENORRHAGIA ("HEAVY PERIODS"), ARTHRALGIA ("JOINT PAIN"), THE FIRST EPISODE OF NEURALGIA ("NERVE PAIN"), MENTAL DISORDER ("AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), FEELING ABNORMAL ("BRAIN FOG"), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CHEST PAIN ("CHEST PAIN"), DYSPNOEA ("SHORTNESS OF BREATH"), DIZZINESS ("DIZZINESS"), MUSCLE TWITCHING ("MUSCLE TWITCHING"), EYE SWELLING ("SWOLLEN EYE"), THE SECOND EPISODE OF NEURALGIA ("NERVE PAIN"), MUSCLE CONTRACTIONS INVOLUNTARY ("MUSCLE CONTRACTIONS"), HEADACHE ("HEADACHES"), GINGIVAL RECESSION ("RECEEDED GUMS"), APHTHOUS ULCER ("CANKER SORES"), FEELING DRUNK ("DRUNK LIKE SENSATION"), PARAESTHESIA ("VIBRATING LIKE SENSATIONS") AND SKIN DISORDER ("SKIN CHANGES"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2014 TO (B)(6) 2014. THE PATIENT WAS TREATED WITH IBUPROFEN, ANTIINFL. PREP., NON-STEROIDS FOR TOPICAL USE, DETOX-KIT-HEEL, HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL), CARBIDOPA, BACLOFEN, RIZATRIPTAN (MAXALT), GABAPENTIN, LEVODOPA, ANTIBIOTICS, AND SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, WEIGHT INCREASED, LIBIDO DECREASED, PAIN AND INFLAMMATION WAS RESOLVING AND THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, MASTITIS, ADENOMYOSIS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, MENSTRUATION IRREGULAR, DYSMENORRHOEA, ALLERGY TO METALS, SINUSITIS, ABDOMINAL ADHESIONS, MENOPAUSAL SYMPTOMS, VULVOVAGINAL PAIN, FIBROMYALGIA, CONNECTIVE TISSUE DISORDER, MUSCLE DISORDER, METAL POISONING, MENORRHAGIA, MIGRAINE, ARTHRALGIA, MENTAL DISORDER, FEELING ABNORMAL, MOVEMENT DISORDER, UTERINE HAEMORRHAGE, CHEST PAIN, DYSPNOEA, DIZZINESS, MUSCLE TWITCHING, EYE SWELLING, THE LAST EPISODE OF NEURALGIA, MUSCLE CONTRACTIONS INVOLUNTARY, HEADACHE, GINGIVAL RECESSION, APHTHOUS ULCER, FEELING DRUNK, PARAESTHESIA AND SKIN DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL ADHESIONS, ADENOMYOSIS, ALLERGY TO METALS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, DYSMENORRHOEA, LIBIDO DECREASED, MASTITIS, MENOPAUSAL SYMPTOMS, MENSTRUATION IRREGULAR, PAIN, SINUSITIS AND WEIGHT INCREASED WITH ESSURE. THE REPORTER CONSIDERED APHTHOUS ULCER, ARTHRALGIA, AUTOIMMUNE DISORDER, CHEST PAIN, CONNECTIVE TISSUE DISORDER, DIZZINESS, DYSPNOEA, EMBEDDED DEVICE, EYE SWELLING, FEELING ABNORMAL, FEELING DRUNK, FIBROMYALGIA, FOOD ALLERGY, GINGIVAL RECESSION, HEADACHE, INFLAMMATION, MENORRHAGIA, MENTAL DISORDER, METAL POISONING, MIGRAINE, MOVEMENT DISORDER, MUSCLE CONTRACTIONS INVOLUNTARY, MUSCLE DISORDER, MUSCLE TWITCHING, PARAESTHESIA, PELVIC INFLAMMATORY DISEASE, SKIN DISORDER, UTERINE HAEMORRHAGE, VULVOVAGINAL PAIN, THE FIRST EPISODE OF NEURALGIA AND THE SECOND EPISODE OF NEURALGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: MY PAIN AND RECURRENT INFECTIONS RESOLVED AFTER SURGERY TO REMOVE ESSURE. SINCE THE REMOVAL I HAVE NOT HAD ANY MORE PELVIC INFECTIONS, THE INFLAMMATION HAS DECREASED AND I HAVE NOT HAD ANY MORE ABDOMINAL PAIN. PROCEDURE- PARACERVICAL BLOCK PROCEDURE DETAILS-USING HYSTEROSCOPIC FLUID BOTH TUBAL OSTIA WERE VISUALIZED. THE ESSURE DEVICE WAS THEN PLACED IN THE FIRST FALLOPIAN TUBE ON THE LEFT SIDE. THE SECOND ESSURE DEVICE WAS PLACED IN THE OPPOSITE TUBE THE EXACT WAY. 2-3 COILS WERE NOTED OUTSIDE EACH TUBE AND ADEQUATE PLACEMENT WAS NOTED OF EACH. THE REST OF THE UTERUS WAS UNREMARKABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: NOT REPORTED HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NOT REPORTED ULTRASOUND PELVIS - IN 2012: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES ULTRASOUND SCAN - ON AN UNKNOWN DATE: NOT REPORTED URINE ANALYSIS - IN 2012: INCONCLUSIVE UROGRAM - IN 2012: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES ON AN UNKNOWN DATE, HYSTEROSALPINGOGRAPHY TEST TO CONFIRM ESSURE PLACEMENT. (B)(6) 2011: UNSPECIFIED TEST - THE COILS HAD INDEED SCARRED HER TUBES. IT WAS UNREMARKABLE. 2012: BLOOD WORK - ELEVATED WHITE BLOOD CELL COUNTS AND OTHER INFLAMMATORY MARKERS. UNSPECIFIED DATE: BLOOD WORK - SIGNIFICANTLY LOW LEVEL OF HORMONES, OVER ALL, IN HER BODY. SHE RAN NUMEROUS TESTS INCLUDING URINALYSIS. CT KUB AND PELVIC ULTRASOUND DETOX SUPPLEMENTS, SAUNA THERAPY, CHANGE IN DIET THIS TREATMENT WAS PRESCRIBED FOR HEAVY METAL POISONING / INJURIES DESCRIBED IN RESPONSE TO QUESTION 1 ABOVE IN 2015. GABAPENTIN AND JOINT PAIN MEDICATION THIS TREATMENT WAS PRESCRIBED FOR FIBROMYALGIA & AUTOIMMUNE ISSUES IN 2016. MUSCLE RELAXER AND MEDICATIONS THIS TREATMENT WAS PRESCRIBED FOR MOVEMENT DISORDER IN 2017. RAN CTS AND MRLS, MADE CHANGES TO DIETS AND GAVE SUPPLEMENTS THIS TREATMENT WAS PRESCRIBED FOR SEVERE AND PERSISTENT ABDOMINAL, PELVIC AND VAGINAL PAIN, INFLAMMATION, MIGRAINES IN 2012. ON (B)(6) 2011, EXAM- PELVIC ULTRASOUND INDICATION-PELVIC PAIN FOR FOUR YEARS. FINDINGS- TRANSABDOMINAL AND ENDOVAGINAL SONOGRAPHIC EVALUATION OF THE PELVIS SHOWS A NORMAL APPEARING UTERUS MEASURING 9.0 X 5.6 X 4.0 CM. IMPRESSION- NO SONOGRAPHIC ABNORMALITIES ARE IDENTIFIED. ON (B)(6) 2011, STOPPED FOR 2 WEEKS THEN RESUMED. PLACED ON NUVA-RING BY PUBLIC HEALTH ON (B)(6) 2011. SHE DID HAVE HER 6 WK POST-PARTUM VISIT BUT NO PELVIC EXAM WAS PERFORMED. SHE IS DUE FOR A PAP SMEAR BUT WANTS TO DEFER DUE TO BLEEDING. ON (B)(6) 2011, HPI- ABNORMAL BLEEDING, PT STOPPED BLEEDING AFTER THE BIRTH OF HER SON AROUND (B)(6) 2014 AND DID NOT BLEED FOR A WEEK AND A HALF. HPI- ABNORMAL BLEEDING, PT STOPPED BLEEDING AFTER THE BIRTH OF HER SON AROUND (B)(6) 2014 AND DID NOT BLEED FOR A WEEK AND A HALF. PT STARTED THE NUVA RING FOR BIRTH CONTROL AND THEN STARTED BLEEDING AGAIN MAR28 AND HAS BEEN BLEEDING HEAVILY SINCE. SHE REMOVED THE NUVA RING AND HAS CONTINUED BLEEDING. SHE ALSO CLO CRAMPING AND SHE DOESN'T NORMALLY CRAMP WITH HER NORMAL MENSES. IMPRESSION AND PLAN- SHE HAS DYSFUNCTIONAL UTERINE BLEEDING MOST LIKELY HORMONAL IN ORIGIN AS SHE IS BREAST FEEDING AND HAVING IRREGULAR BLEEDING. WILL RESTART HER ON A BIRTH CONTROL AFTER HER SURGERY. PT HAS PELVIC PAIN AND DYSPAREUNIA. HAVE RECOMMENDED A DIAGNOSTIC LAPAROSCOPY FOR EVALUATION. ON (B)(6) 2011, HPI- POST OP HISTORY-PT REPORTS THAT SINE THE SURGERY SHE HAS PAIN WITH A FULL BLADDER AND DYSURIA. PRE-OP DIAGNOSIS- PELVIC PAIN POST-OP DIAGNOSIS- PELVIC PAIN WITH PELVIC ADHESIONS PROCEDURE- DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESION AND FINDINGS- SHE HAD SOME ADHESIONS FROM THE ANTERIOR ABDOMINAL WALL TO THE LOWER SEGMENT OF THE UTERUS. ON (B)(6) 2011, THAT PAIN HAS RESOLVED SINCE SURGERY. SHE HAD A LAPAROSCOPY WITH LYSIS OF ADHESIONS RECENTLY. SHE HAS RECOVERED VERY WELL WITH NO PAIN. SHE HAS SOME MILD BLADDER SPASMS WHEN HER BLADDER IS FULL BUT SHE HAS NOTHING ELSE OF SUBSTANTIAL MENTION. SHE IS CONSIDERING A PERMANENT STERILIZATION PROCEDURE ON (B)(6) 2011, HPI-PT. PRESENTS TODAY FOR EVALUATION. SHE HAD AN ESSURE STERILIZATION HERE 2 WEEKS AGO. SHE HAS REPORTED SOME MILD CRAMPING HOWEVER SHE REPORTS THAT SHE HAS DONE WELL AND IS HAPPY WITH THE RESULT. SHE HAD ONE OF HER LEGS GO NUMB FROM THE LOCAL YET SHE RECOVERED FROM THIS BY THE NEXT DAY. NO CURRENT PROBLEMS. ON (B)(6) 2011, LUMBAR SPINE, FIVE VIEWS HISTORY- BACK PAIN AFTER COUGHING. FINDINGS- INCIDENTALLY NOTED ARE ESSURE FALLOPIAN TUBE WIRES IN BOTH SIDES OF THE PELVIS. IMPRESSION- NORMAL LUMBAR SPINE. ON (B)(6) 2011, HPI- SHE WAS HAVING A COUGHING FIT AND THREW HER BACK OUT. SHE NOTES THAT THE PAIN IS RADIATING DOWN INTO BOTH HIPS. PATIENT HAD SOME HYDROCODONE LEFT AT HOME WHICH WAS BARELY TOUCHING THE PAIN. SHE HAS RUN OUT IT NOW. ON (B)(6) 2011, EXAM- BREAST INSPECTION-MILD ERYTHEMATOUS STREAKING IN THE 3 O'CLOCK REGION OF THE RIGHT BREAST BREAST PALPATION-MILD WARMTH, SWELLING, AND TENDERNESS IN THE AFFECTED AREA; NO DISCRETE MASS ON (B)(6) 2014, PT. HAD BEEN LAPAROSCOPE LOA. ON (B)(6) 2014, COMMENTS-PT. HAD SIDE EFFECTS OF PERCOCET AND BM, GROSS DESCRIPTION- 1. DESCRIPTION OF ENDOMETRIUM- GLISTENING TAN. 2. RIGHT FALLOPIAN TUBE-THE PURPLE FIMBRIATED FALLOPIAN TUBE MEASURES 4.0 CM IN LENGTH AND 0.6 CM IN DIAMETER. 3. LEFT FALLOPIAN TUBE- THE PURPLE FIMBRIATED FALLOPIAN TUBE MEASURES 5.0 CM IN LENGTH AND 0.7 CM IN DIAMETER WITH A HYDATID CYST MEASURING 1.5 X 1.2 CM. FINAL DIAGNOSIS- CERVIX AND ENDOCERVIX: NO EVIDENCE OF EPITHELIAL DYSPLASIA. ENDOMETRIUM- SECRETORY PATTERN. THERE IS NO EVIDENCE OF ENDOMETRIAL HYPERPLASIA, A TYPICALITY OR TUMOR. MYOMETRIUM: NO PATHOLOGICAL DIAGNOSIS. RIGHT FALLOPIAN TUBE: NO PATHOLOGICAL DIAGNOSIS LEFT FALLOPIAN TUBE: NO PATHOLOGICAL DIAGNOSIS; BENIGN PARATUBAL CYST. ADDENDUM-PHYSICIAN INDICATES THAT THE LIGATION DEVICES WERE VISIBLE WITHIN THE SPECIMEN. THE GROSS SPECIMEN IS RE-REVIEWED; THE ESSURE LIGATION DEVICES ARE IDENTIFIED WITHIN BOTH FALLOPIAN TUBES. FURTHER SECTIONING THROUGH BOTH FALLOPIAN TUBES REVEALS METALLIC ESSURE LIGATION DEVICES APPROXIMATING 1.5 CM IN LENGTH AND 0.1 CM IN DIAMETER. ON (B)(6) 2014(POST OPERATIVE NOTE)- SUBJECTIVE-PT. WHO PRESENTS FOR A POSTOPERATIVE CHECK FOLLOWING A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY FOR PELVIC PAIN ON (B)(6) 2014. THE PATIENT HAS HAD 3 YEARS OF PELVIC PAIN, WHICH SHE BELIEVED WAS DUE SECONDARY TO ESSURE PLACEMENT. SHE HAD TUBAL OCCLUSION, WHICH WAS CONFIRMED BY HSG BY HER PREVIOUS PROVIDER, BUT HAS HAD PERSISTENT RIGHT-SIDED PELVIC PAIN AND UTERINE PAIN SINCE THE TIME OF PLACEMENT. AT THE TIME OF SURGERY, SHE HAD BILATERAL AREAS OF INFLAMMATION IN THE CORNUAL REGION BUT NO ADHESIONS. THERE WERE SOME FILMY AND 1 THICK BANDS OF ADHESIONS IN THE MID QUADRANT AT A PRIOR LAPAROSCOPY SITE. THESE ADHESIONS WERE TAKEN DOWN IN THEIR ENTIRETY. SURGERY WAS UNCOMPLICATED. PATHOLOGY- PHYSICIAN DID REQUEST AN ADDENDUM TO BE MADE TO CONFIRM ESSURE REMOVAL WITHIN THE FALLOPIAN TUBES. IT WAS REPORTED THAT GADOLINIUM LEVELS OVER 330 UNITS. PATIENT HAVE EXTREMELY LOW NEUROTRANSMITTERS (ASIDE FROM DOPAMINE WHICH WAS NORMAL), PATIENT HAVE JUST STARTED WITH CHELATION. IT WAS REPORTED THAT LEAKY GUT SYNDROM AND GENETIC TESTING HAS HELPED THAT HER LIVER IS UNABLE TO DETOX. THE SKIN IS ONLY OTHER ORGAN THAT DETOXES. ON (B)(6) 2011, HYSTEROSALPINGOGRAPHY (AS PER PFS) (B)(6) 2011(AS PER MR) INDICATION-POST ESSURE PROCEDURE FOR TUBAL CLOSURE FINDINGS-SCOUT IMAGE OF THE PELVIS SHOWS LINEAR DENSITIES CONSISTENT WITH HISTORY OF ESSURE TUBAL LIGATION PROCEDURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, DYSPAREUNIA, ABDOMINAL PAIN AND DYSPNOEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-MAY-2018: PFS AND MR RECEIVED. REPORTERS WERE ADDED. PATIENT¿S HISTORICAL CONDITION, CONCOMITANT DISEASE, CONCOMITANT DRUGS AND UNSTRUCTURED RELEVANT TESTS WERE ADDED. MOVEMENT DISORDER, DYSFUNCTIONAL UTERINE BLEEDING, CHEST PAIN, SHORTNESS OF BREATH, DIZZINESS, MUSCLE TWITCHING, SWOLLEN EYE, NERVE PAIN, MUSCLE CONTRACTIONS, HEADACHES, RECEEDED GUMS, CANKER SORES, DRUNK LIKE SENSATION, VIBRATING LIKE SENSATIONS AND SKIN CHANGES WERE ADDED AS EVENTS. OUTCOME OF INFLAMMATION WAS RESOLVING. ESSURE LOT NUMBER WAS 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.
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW (B)(4)) ON 16-JUL-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 28-AUG-2018. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("INFLAMMATION IN HER PELVIC AREA/ ABDOMEN / RECURRENT PELVIC INFECTIONS / INFECTIONS IN MY PELVIC AND INFECTIONS IN MY ABDOMINAL AREA"), EMBEDDED DEVICE ("EMBEDDING OF THE COILS IN MY TUBES"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE"), MASTITIS ("MASTITIS") AND DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822368) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA IN 2011, IODINE ALLERGY, MISCARRIAGE, DEPRESSION, ANXIETY, BREAST PAIN, CHOLECYSTECTOMY IN 2006, C-SECTION IN 2007, SCAR IN MAY 2011, MULTIGRAVIDA, SCAR REMOVAL IN 2011, ANAL FISSURE EXCISION IN 2006, PARITY 4 (DATE OF BIRTH: (B)(6) 2006, (B)(6) 2007, (B)(6) 2007, (B)(6) 2011), PRE-ECLAMPSIA, NECROTIZING ENTEROCOLITIS (NEC) ON (B)(6) 2011, RIGHT LOWER QUADRANT PAIN ON (B)(6) 2011, MASTITIS ON (B)(6) 2011, MENSES IRREGULAR ON (B)(6) 2011, BLEEDING GENITAL ON (B)(6) 2011, C-SECTION (FOR TWINS), SCIATICA AND DYSURIA (SHE HAS PAIN WITH A FULL BLADDER AND DYSURIA.) ON (B)(6) 2011. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MINI PILL, NUVARING AND MIRENA; FOR DYSTONIA: BACLOFEN AND CARBIDOPA; FOR FIBROMYALGIA: GABAPENTIN; FOR JOINT PAIN: PLAQUENIL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ABDOMINAL PAIN LOWER WITH MIRENA. CONCURRENT CONDITIONS INCLUDED NONSMOKER, NICKEL SENSITIVITY, OBESITY, CERUMEN IMPACTION SINCE (B)(6) 2011, SINUSITIS (SINUSITIS (ACUTE)) SINCE (B)(6) 2011, COUGHING SINCE(B)(6) 2011, BREAST PAIN (RED STREAK RIGHT BREAST HER RIGHT BREAST HAS BECOME SLIGHTLY SWOLLEN, WARM, TENDER. SHE NOTES SOME MILD RED STREAKING COMING FROM THE NIPPLE.) SINCE (B)(6) 2011, IRREGULAR MENSTRUATION SINCE (B)(6) 2011, LUMBAGO SINCE (B)(6) 2011, BREAST SWELLING SINCE (B)(6) 2011, BREAST TENDERNESS SINCE (B)(6) 2011, SHAKING SINCE (B)(6) 2014, JERKINESS SINCE (B)(6) 2014, NIGHTMARES SINCE (B)(6) 2014, SHORTNESS OF BREATH SINCE (B)(6) 2014 AND BACK PAIN SINCE (B)(6) 2011. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D), FISH OIL, HYDROCORTISONE (CORTISOL), LORATADINE (CLARITIN), ORAL CONTRACEPTIVE NOS AND OXYCOCET (PERCOCET). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("VAGINAL PAIN") AND INFLAMMATION ("INFLAMMATION /THAT I FEEL ARE DUE TO THE INFLAMMATION"). IN 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) WITH UTERINE SCAR, PELVIC PAIN, ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER, WEIGHT INCREASED ("WEIGHT GAIN"), LIBIDO DECREASED ("DESIRE FOR SEX HAS DROPPED"), PAIN ("PAIN / ACHE / DULL ACHE"), CONFUSIONAL STATE ("MENTAL CLARITY BEGAN TO SUFFER"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("MENSTRUAL PERIODS ACCOMPANIED BY SIGNIFICANT PAIN"), ALLERGY TO METALS ("METAL SENSITIVITIES INCREASED / ALLERGIC TO NICKEL / HYPO-ALLERGENIC EARRINGS /HYPERSENSITIVITY REACTION TO NICKEL") WITH INFECTION, RASH AND PRURITUS, FIBROMYALGIA ("FIBROMYALGIA") AND MIGRAINE ("MIGRAINES"). IN 2015, THE PATIENT EXPERIENCED UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE ("UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER") WITH DYSTONIA AND MUSCLE DISORDER ("MUSCLE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER"). IN 2016, THE PATIENT EXPERIENCED METAL POISONING ("HEAVY METAL POISONING /HEAVY METAL POISONING DUE TO FREQUENT CT SCANS AND MRI'S ORDERED TO DIAGNOSE THESE ISSUES AND RECURRENT INFECTIONS ALL DUE TO THE EFFECTS OF ESSURE"). IN 2017, THE PATIENT EXPERIENCED MOVEMENT DISORDER ("MOVEMENT DISORDER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MASTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ENDOMETRIOSIS ON HER UTERUS") WITH DYSMENORRHOEA, ABDOMINAL DISTENSION, DYSPAREUNIA AND ABDOMINAL ADHESIONS, BENIGN FALLOPIAN TUBE NEOPLASM ("BENIGN PARATUBAL CYST"), SINUSITIS ("SEVERE SINUS INFECTIONS"), ABDOMINAL ADHESIONS ("ADHESIONS FROM MY BOWELS"), MENOPAUSAL SYMPTOMS ("MENOPAUSAL SYMPTOMS") WITH HORMONE LEVEL ABNORMAL, FOOD ALLERGY ("FOOD SENSITIVITIES"), MENORRHAGIA ("HEAVY PERIODS"), ARTHRALGIA ("JOINT PAIN"), THE FIRST EPISODE OF NEURALGIA ("NERVE PAIN"), MENTAL DISORDER ("AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), FEELING ABNORMAL ("BRAIN FOG"), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CHEST PAIN ("CHEST PAIN"), DYSPNOEA ("SHORTNESS OF BREATH"), DIZZINESS ("DIZZINESS"), MUSCLE TWITCHING ("MUSCLE TWITCHING"), EYE SWELLING ("SWOLLEN EYE"), THE SECOND EPISODE OF NEURALGIA ("NERVE PAIN"), MUSCLE CONTRACTIONS INVOLUNTARY ("MUSCLE CONTRACTIONS"), HEADACHE ("HEADACHES"), GINGIVAL RECESSION ("RECEDED GUMS"), APHTHOUS ULCER ("CANKER SORES"), FEELING DRUNK ("DRUNK LIKE SENSATION"), PARAESTHESIA ("VIBRATING LIKE SENSATIONS") AND SKIN DISORDER ("SKIN CHANGES"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2014. THE PATIENT WAS TREATED WITH IBUPROFEN, ANTIINFL. PREP., NON-STEROIDS FOR TOPICAL USE, DETOX-KIT-HEEL, HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL), CARBIDOPA, BACLOFEN, RIZATRIPTAN (MAXALT), GABAPENTIN, LEVODOPA, ANTIBIOTICS, SURGERY (TOTAL HYSTERECTOMY) AND SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, WEIGHT INCREASED, LIBIDO DECREASED, PAIN AND INFLAMMATION WAS RESOLVING AND THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, MASTITIS, ADENOMYOSIS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, MENSTRUATION IRREGULAR, DYSMENORRHOEA, ALLERGY TO METALS, SINUSITIS, ABDOMINAL ADHESIONS, MENOPAUSAL SYMPTOMS, VULVOVAGINAL PAIN, FIBROMYALGIA, UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE, MUSCLE DISORDER, METAL POISONING, MENORRHAGIA, MIGRAINE, ARTHRALGIA, MENTAL DISORDER, FEELING ABNORMAL, MOVEMENT DISORDER, DYSFUNCTIONAL UTERINE BLEEDING, CHEST PAIN, DYSPNOEA, DIZZINESS, MUSCLE TWITCHING, EYE SWELLING, THE LAST EPISODE OF NEURALGIA, MUSCLE CONTRACTIONS INVOLUNTARY, HEADACHE, GINGIVAL RECESSION, APHTHOUS ULCER, FEELING DRUNK, PARAESTHESIA AND SKIN DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL ADHESIONS, ADENOMYOSIS, ALLERGY TO METALS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, DYSMENORRHOEA, LIBIDO DECREASED, MASTITIS, MENOPAUSAL SYMPTOMS, MENSTRUATION IRREGULAR, PAIN, SINUSITIS AND WEIGHT INCREASED WITH ESSURE. THE REPORTER CONSIDERED APHTHOUS ULCER, ARTHRALGIA, AUTOIMMUNE DISORDER, CHEST PAIN, DIZZINESS, DYSFUNCTIONAL UTERINE BLEEDING, DYSPNOEA, EMBEDDED DEVICE, EYE SWELLING, FEELING ABNORMAL, FEELING DRUNK, FIBROMYALGIA, FOOD ALLERGY, GINGIVAL RECESSION, HEADACHE, INFLAMMATION, MENORRHAGIA, MENTAL DISORDER, METAL POISONING, MIGRAINE, MOVEMENT DISORDER, MUSCLE CONTRACTIONS INVOLUNTARY, MUSCLE DISORDER, MUSCLE TWITCHING, PARAESTHESIA, PELVIC INFLAMMATORY DISEASE, SKIN DISORDER, UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE, VULVOVAGINAL PAIN, THE FIRST EPISODE OF NEURALGIA AND THE SECOND EPISODE OF NEURALGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: MY PAIN AND RECURRENT INFECTIONS RESOLVED AFTER SURGERY TO REMOVE ESSURE. SINCE THE REMOVAL I HAVE NOT HAD ANY MORE PELVIC INFECTIONS, THE INFLAMMATION HAS DECREASED AND I HAVE NOT HAD ANY MORE ABDOMINAL PAIN. PROCEDURE- PARACERVICAL BLOCK. PROCEDURE DETAILS-USING HYSTEROSCOPIC FLUID BOTH TUBAL OSTIA WERE VISUALIZED. THE ESSURE DEVICE WAS THEN PLACED IN THE FIRST FALLOPIAN TUBE ON THE LEFT SIDE. THE SECOND ESSURE DEVICE WAS PLACED IN THE OPPOSITE TUBE THE EXACT WAY. 2-3 COILS WERE NOTED OUTSIDE EACH TUBE AND ADEQUATE PLACEMENT WAS NOTED OF EACH. THE REST OF THE UTERUS WAS UNREMARKABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: NOT REPORTED HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NOT REPORTED ULTRASOUND PELVIS - IN 2012: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES ULTRASOUND SCAN - ON AN UNKNOWN DATE: NOT REPORTED URINE ANALYSIS - IN 2012: INCONCLUSIVE UROGRAM - IN 2012: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES ON AN UNKNOWN DATE, HYSTEROSALPINGOGRAPHY TEST TO CONFIRM ESSURE PLACEMENT. (B)(6) 2011: UNSPECIFIED TEST - THE COILS HAD INDEED SCARRED HER TUBES. IT WAS UNREMARKABLE. 2012: BLOOD WORK - ELEVATED WHITE BLOOD CELL COUNTS AND OTHER INFLAMMATORY MARKERS. UNSPECIFIED DATE: BLOOD WORK - SIGNIFICANTLY LOW LEVEL OF HORMONES, OVER ALL, IN HER BODY. SHE RAN NUMEROUS TESTS INCLUDING URINALYSIS. CT KUB AND PELVIC ULTRASOUND DETOX SUPPLEMENTS, SAUNA THERAPY, CHANGE IN DIET THIS TREATMENT WAS PRESCRIBED FOR HEAVY METAL POISONING / INJURIES DESCRIBED IN RESPONSE TO QUESTION 1 ABOVE IN 2015. GABAPENTIN AND JOINT PAIN MEDICATION THIS TREATMENT WAS PRESCRIBED FOR FIBROMYALGIA & AUTOIMMUNE ISSUES IN 2016. MUSCLE RELAXER AND MEDICATIONS THIS TREATMENT WAS PRESCRIBED FOR MOVEMENT DISORDER IN 2017. RAN CTS AND MRLS, MADE CHANGES TO DIETS AND GAVE SUPPLEMENTS THIS TREATMENT WAS PRESCRIBED FOR SEVERE AND PERSISTENT ABDOMINAL, PELVIC AND VAGINAL PAIN, INFLAMMATION, MIGRAINES IN 2012. ON (B)(6) 2011, EXAM- PELVIC ULTRASOUND INDICATION-PELVIC PAIN FOR FOUR YEARS. FINDINGS- TRANSABDOMINAL AND ENDOVAGINAL SONOGRAPHIC EVALUATION OF THE PELVIS SHOWS A NORMAL APPEARING UTERUS MEASURING 9.0 X 5.6 X 4.0 CM. IMPRESSION- NO SONOGRAPHIC ABNORMALITIES ARE IDENTIFIED. ON (B)(6) 2011, STOPPED FOR 2 WEEKS THEN RESUMED. PLACED ON NUVA-RING BY PUBLIC HEALTH ON (B)(6) 2011. SHE DID HAVE HER 6 WK POST-PARTUM VISIT BUT NO PELVIC EXAM WAS PERFORMED. SHE IS DUE FOR A PAP SMEAR BUT WANTS TO DEFER DUE TO BLEEDING. ON (B)(6) 2011, HPI- ABNORMAL BLEEDING, PT STOPPED BLEEDING AFTER THE BIRTH OF HER SON AROUND (B)(6) 2014 AND DID NOT BLEED FOR A WEEK AND A HALF. HPI- ABNORMAL BLEEDING, PT STOPPED BLEEDING AFTER THE BIRTH OF HER SON AROUND (B)(6) 2014 AND DID NOT BLEED FOR A WEEK AND A HALF. PT STARTED THE NUVA RING FOR BIRTH CONTROL AND THEN STARTED BLEEDING AGAIN MAR28 AND HAS BEEN BLEEDING HEAVILY SINCE. SHE REMOVED THE NUVA RING AND HAS CONTINUED BLEEDING. SHE ALSO CLO CRAMPING AND SHE DOESN'T NORMALLY CRAMP WITH HER NORMAL MENSES. IMPRESSION AND PLAN- SHE HAS DYSFUNCTIONAL UTERINE BLEEDING MOST LIKELY HORMONAL IN ORIGIN AS SHE IS BREAST FEEDING AND HAVING IRREGULAR BLEEDING. WILL RESTART HER ON A BIRTH CONTROL AFTER HER SURGERY. PT HAS PELVIC PAIN AND DYSPAREUNIA. HAVE RECOMMENDED A DIAGNOSTIC LAPAROSCOPY FOR EVALUATION. ON (B)(6) 2011, HPI- POST OP HISTORY-PT REPORTS THAT SINE THE SURGERY SHE HAS PAIN WITH A FULL BLADDER AND DYSURIA. PRE-OP DIAGNOSIS- PELVIC PAIN POST-OP DIAGNOSIS- PELVIC PAIN WITH PELVIC ADHESIONS. PROCEDURE: 1. DIAGNOSTIC LAPAROSCOPY. 2. LYSIS OF ADHESIONS. FINDINGS- SHE HAD SOME ADHESIONS FROM THE ANTERIOR ABDOMINAL WALL TO THE LOWER SEGMENT OF THE UTERUS. ON (B)(6) 2011, THAT PAIN HAS RESOLVED SINCE SURGERY. SHE HAD A LAPAROSCOPY WITH LYSIS OF ADHESIONS RECENTLY. SHE HAS RECOVERED VERY WELL WITH NO PAIN. SHE HAS SOME MILD BLADDER SPASMS WHEN HER BLADDER IS FULL BUT SHE HAS NOTHING ELSE OF SUBSTANTIAL MENTION. SHE IS CONSIDERING A PERMANENT STERILIZATION PROCEDURE. ON (B)(6) 2011, HPI-PT. PRESENTS TODAY FOR EVALUATION. SHE HAD AN ESSURE STERILIZATION HERE 2 WEEKS AGO. SHE HAS REPORTED SOME MILD CRAMPING HOWEVER SHE REPORTS THAT SHE HAS DONE WELL AND IS HAPPY WITH THE RESULT. SHE HAD ONE OF HER LEGS GO NUMB FROM THE LOCAL YET SHE RECOVERED FROM THIS BY THE NEXT DAY. NO CURRENT PROBLEMS. ON (B)(6) 2011, LUMBAR SPINE, FIVE VIEWS. HISTORY- BACK PAIN AFTER COUGHING. FINDINGS- INCIDENTALLY NOTED ARE ESSURE FALLOPIAN TUBE WIRES IN BOTH SIDES OF THE PELVIS. IMPRESSION- NORMAL LUMBAR SPINE. ON (B)(6) 2011, HPI- SHE WAS HAVING A COUGHING FIT AND THREW HER BACK OUT. SHE NOTES THAT THE PAIN IS RADIATING DOWN INTO BOTH HIPS. PATIENT HAD SOME HYDROCODONE LEFT AT HOME WHICH WAS BARELY TOUCHING THE PAIN. SHE HAS RUN OUT IT NOW. ON (B)(6) 2011, EXAM- BREAST INSPECTION-MILD ERYTHEMATOUS STREAKING IN THE 3 O'CLOCK REGION OF THE RIGHT BREAST BREAST PALPATION-MILD WARMTH, SWELLING, AND TENDERNESS IN THE AFFECTED AREA; NO DISCRETE MASS. ON (B)(6) 2014, PT. HAD BEEN LAPAROSCOPE LOA. ON (B)(6) 2014, COMMENTS-PT. HAD SIDE EFFECTS OF PERCOCET AND BM. GROSS DESCRIPTION: 1. DESCRIPTION OF ENDOMETRIUM- GLISTENING TAN. 2. RIGHT FALLOPIAN TUBE-THE PURPLE FIMBRIATED FALLOPIAN TUBE MEASURES 4.0 CM IN LENGTH AND 0.6 CM IN DIAMETER. 3. LEFT FALLOPIAN TUBE- THE PURPLE FIMBRIATED FALLOPIAN TUBE MEASURES 5.0 CM IN LENGTH AND 0.7 CM IN DIAMETER WITH A HYDATID CYST MEASURING 1.5 X 1.2 CM. FINAL DIAGNOSIS: 1. CERVIX AND ENDOCERVIX: NO EVIDENCE OF EPITHELIAL DYSPLASIA. 2. ENDOMETRIUM- SECRETORY PATTERN. THERE IS NO EVIDENCE OF ENDOMETRIAL HYPERPLASIA, A TYPICALITY OR TUMOR. 3. MYOMETRIUM: NO PATHOLOGICAL DIAGNOSIS. 4. RIGHT FALLOPIAN TUBE: NO PATHOLOGICAL DIAGNOSIS. 5. LEFT FALLOPIAN TUBE: NO PATHOLOGICAL DIAGNOSIS; BENIGN PARATUBAL CYST. ADDENDUM-PHYSICIAN INDICATES THAT THE LIGATION DEVICES WERE VISIBLE WITHIN THE SPECIMEN. THE GROSS SPECIMEN IS RE-REVIEWED; THE ESSURE LIGATION DEVICES ARE IDENTIFIED WITHIN BOTH FALLOPIAN TUBES. FURTHER SECTIONING THROUGH BOTH FALLOPIAN TUBES REVEALS METALLIC ESSURE LIGATION DEVICES APPROXIMATING 1.5 CM IN LENGTH AND 0.1 CM IN DIAMETER. ON (B)(6) 2014(POST OPERATIVE NOTE)- SUBJECTIVE-PT. WHO PRESENTS FOR A POSTOPERATIVE CHECK FOLLOWING A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY FOR PELVIC PAIN ON (B)(6) 2014. THE PATIENT HAS HAD 3 YEARS OF PELVIC PAIN, WHICH SHE BELIEVED WAS DUE SECONDARY TO ESSURE PLACEMENT. SHE HAD TUBAL OCCLUSION, WHICH WAS CONFIRMED BY HSG BY HER PREVIOUS PROVIDER, BUT HAS HAD PERSISTENT RIGHT-SIDED PELVIC PAIN AND UTERINE PAIN SINCE THE TIME OF PLACEMENT. AT THE TIME OF SURGERY, SHE HAD BILATERAL AREAS OF INFLAMMATION IN THE CORNUAL REGION BUT NO ADHESIONS. THERE WERE SOME FILMY AND 1 THICK BANDS OF ADHESIONS IN THE MID QUADRANT AT A PRIOR LAPAROSCOPY SITE. THESE ADHESIONS WERE TAKEN DOWN IN THEIR ENTIRETY. SURGERY WAS UNCOMPLICATED. PATHOLOGY- PHYSICIAN DID REQUEST AN ADDENDUM TO BE MADE TO CONFIRM ESSURE REMOVAL WITHIN THE FALLOPIAN TUBES. IT WAS REPORTED THAT GADOLINIUM LEVELS OVER 330 UNITS. PATIENT HAVE EXTREMELY LOW NEUROTRANSMITTERS (ASIDE FROM DOPAMINE WHICH WAS NORMAL), PATIENT HAVE JUST STARTED WITH CHELATION. IT WAS REPORTED THAT LEAKY GUT SYNDROME AND GENETIC TESTING HAS HELPED THAT HER LIVER IS UNABLE TO DETOX. THE SKIN IS ONLY OTHER ORGAN THAT DETOXES. ON (B)(6) 2011, HYSTEROSALPINGOGRAPHY (AS PER PFS). (B)(6) 2011(AS PER MR). INDICATION-POST ESSURE PROCEDURE FOR TUBAL CLOSURE. FINDINGS-SCOUT IMAGE OF THE PELVIS SHOWS LINEAR DENSITIES CONSISTENT WITH HISTORY OF ESSURE TUBAL LIGATION PROCEDURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, DYSPAREUNIA, ABDOMINAL PAIN AND DYSPNOEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5036371) ON 16-JUL-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 14-AUG-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('INFLAMMATION IN HER PELVIC AREA/ ABDOMEN / RECURRENT PELVIC INFECTIONS / INFECTIONS IN MY PELVIC AND INFECTIONS IN MY ABDOMINAL AREA/I FEEL ARE DUE TO THE INFLAMMATION THAT I ENDURED WHILE I HAD THE ESSURE'), EMBEDDED DEVICE ('EMBEDDING OF THE COILS IN MY TUBES'), AUTOIMMUNE DISORDER ('AUTOIMMUNE DISEASE'), MASTITIS ('MASTITIS') AND DYSFUNCTIONAL UTERINE BLEEDING ('DYSFUNCTIONAL UTERINE BLEEDING') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822368) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ERROR IN F_MED_HISTORY:-6502-ORA-06502: PL/SQL: NUMERIC OR VALUE ERROR: CHARACTER STRING BUFFER TOO SMALL. DETAIL: LINE 1. ORA-06512: AT "BBS_OWNER.PKG_CUSTOM_AUTO_NARRATIVE", LINE 3289. ERROR IN F_MED_HISTORY:-6502-ORA-06502: PL/SQL: NUMERIC OR VALUE ERROR: CHARACTER STRING BUFFER TOO SMALL. DETAIL: LINE 1. ORA-06512: AT "BBS_OWNER.PKG_CUSTOM_AUTO_NARRATIVE", LINE 3289. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED INFLAMMATION ("INFLAMMATION /THAT I FEEL ARE DUE TO THE INFLAMMATION"). IN 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) WITH UTERINE SCAR, PELVIC PAIN, ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER, LIBIDO DECREASED ("DESIRE FOR SEX HAS DROPPED"), PAIN ("PAIN / ACHE / DULL ACHE"), CONFUSIONAL STATE ("MENTAL CLARITY BEGAN TO SUFFER"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("MENSTRUAL PERIODS ACCOMPANIED BY SIGNIFICANT PAIN"), ALLERGY TO METALS ("METAL SENSITIVITIES INCREASED / ALLERGIC TO NICKEL / HYPO-ALLERGENIC EARRINGS /HYPERSENSITIVITY REACTION TO NICKEL") WITH INFECTION, RASH AND PRURITUS, VULVOVAGINAL PAIN ("VAGINAL PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), MIGRAINE ("MIGRAINES") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FOOD ALLERGY ("FOOD SENSITIVITIES"), 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE. IN 2015, THE PATIENT EXPERIENCED UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE ("UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER") WITH DYSTONIA AND MUSCLE DISORDER ("MUSCLE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER"). IN 2016, THE PATIENT EXPERIENCED METAL POISONING ("HEAVY METAL POISONING /HEAVY METAL POISONING DUE TO FREQUENT CT SCANS AND MRI'S ORDERED TO DIAGNOSE THESE ISSUES AND RECURRENT INFECTIONS ALL DUE TO THE EFFECTS OF ESSURE"). IN 2017, THE PATIENT EXPERIENCED MOVEMENT DISORDER ("MOVEMENT DISORDER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MASTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ENDOMETRIOSIS ON HER UTERUS/UTERUS HAD SOME POSSIBLE ENDOMETRIOSIS") WITH DYSMENORRHOEA, ABDOMINAL DISTENSION, DYSPAREUNIA AND ABDOMINAL ADHESIONS, SINUSITIS ("SEVERE SINUS INFECTIONS"), ABDOMINAL ADHESIONS ("ADHESIONS FROM MY BOWELS"), MENOPAUSAL SYMPTOMS ("MENOPAUSAL SYMPTOMS") WITH HORMONE LEVEL ABNORMAL, MENORRHAGIA ("HEAVY PERIODS"), ARTHRALGIA ("JOINT PAIN"), NEURALGIA ("NERVE PAIN"), MENTAL DISORDER ("AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), FEELING ABNORMAL ("BRAIN FOG"), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CHEST PAIN ("CHEST PAIN"), DYSPNOEA ("SHORTNESS OF BREATH"), DIZZINESS ("DIZZINESS"), MUSCLE TWITCHING ("MUSCLE TWITCHING"), EYE SWELLING ("SWOLLEN EYE"), MUSCLE CONTRACTIONS INVOLUNTARY ("MUSCLE CONTRACTIONS"), HEADACHE ("HEADACHES"), GINGIVAL RECESSION ("RECEEDED GUMS"), APHTHOUS ULCER ("CANKER SORES"), FEELING DRUNK ("DRUNK LIKE SENSATION"), PARAESTHESIA ("VIBRATING LIKE SENSATIONS"), SKIN DISORDER ("SKIN CHANGES"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), INSOMNIA ("LAST NIGHT WAS ROUGH, COULDN'T SLEEP"), CALCINOSIS ("I HAVE CALCIUM DEPOSITS ON MY RIGHT HIP") AND PELVIC ADHESIONS ("PELVIC ADHESIONS") AND WAS FOUND TO HAVE BENIGN FALLOPIAN TUBE NEOPLASM ("BENIGN PARATUBAL CYST"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2014 TO (B)(6) 2014. THE PATIENT WAS TREATED WITH ANTIBIOTICS, ANTIINFLAMMATORY PREPARATIONS, NON-STEROIDS FOR TOPICAL USE, BACLOFEN, CARBIDOPA, GABAPENTIN, HOMEOPATHICS NOS (DETOX-KIT-HEEL), HYDROXYCHLOROQUINE, IBUPROFEN, LEVODOPA, RIZATRIPTAN BENZOATE (MAXALT), ANTI-INFLAMMATORIES/HERBS, MAXALT, SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY (B)(6)2014). AND TOTAL HYSTERECTOMYAND BILATERAL SALPINGECTOMY (B)(6) 2014).) AND SAUNA THERAPY,CHANGE IN DIET, DETOX SUPPLEMENTS. ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE HAD RESOLVED, THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, MASTITIS, ADENOMYOSIS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, MENSTRUATION IRREGULAR, DYSMENORRHOEA, ALLERGY TO METALS, SINUSITIS, ABDOMINAL ADHESIONS, MENOPAUSAL SYMPTOMS, VULVOVAGINAL PAIN, FIBROMYALGIA, UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE, MUSCLE DISORDER, METAL POISONING, MENORRHAGIA, MIGRAINE, ARTHRALGIA, NEURALGIA, MENTAL DISORDER, FEELING ABNORMAL, MOVEMENT DISORDER, DYSFUNCTIONAL UTERINE BLEEDING, CHEST PAIN, DYSPNOEA, DIZZINESS, MUSCLE TWITCHING, EYE SWELLING, MUSCLE CONTRACTIONS INVOLUNTARY, HEADACHE, GINGIVAL RECESSION, APHTHOUS ULCER, FEELING DRUNK, PARAESTHESIA, SKIN DISORDER, SYSTEMIC LUPUS ERYTHEMATOSUS, INSOMNIA, CALCINOSIS, URINARY TRACT INFECTION AND PELVIC ADHESIONS OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED, LIBIDO DECREASED, PAIN AND INFLAMMATION WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL ADHESIONS, ADENOMYOSIS, ALLERGY TO METALS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, DYSMENORRHOEA, LIBIDO DECREASED, MASTITIS, MENOPAUSAL SYMPTOMS, MENSTRUATION IRREGULAR, PAIN, SINUSITIS AND WEIGHT INCREASED WITH ESSURE. THE REPORTER CONSIDERED APHTHOUS ULCER, ARTHRALGIA, AUTOIMMUNE DISORDER, CALCINOSIS, CHEST PAIN, DIZZINESS, DYSFUNCTIONAL UTERINE BLEEDING, DYSPNOEA, EMBEDDED DEVICE, EYE SWELLING, FEELING ABNORMAL, FEELING DRUNK, FIBROMYALGIA, FOOD ALLERGY, GINGIVAL RECESSION, HEADACHE, INFLAMMATION, INSOMNIA, MENORRHAGIA, MENTAL DISORDER, METAL POISONING, MIGRAINE, MOVEMENT DISORDER, MUSCLE CONTRACTIONS INVOLUNTARY, MUSCLE DISORDER, MUSCLE TWITCHING, NEURALGIA, PARAESTHESIA, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, SKIN DISORDER, SYSTEMIC LUPUS ERYTHEMATOSUS, UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE, URINARY TRACT INFECTION AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: MY PAIN AND RECURRENT INFECTIONS RESOLVED AFTER SURGERY TO REMOVE ESSURE. SINCE THE REMOVAL I HAVE NOT HAD ANY MORE PELVIC INFECTIONS, THE INFLAMMATION HAS DECREASED AND I HAVE NOT HAD ANY MORE ABDOMINAL PAIN. PROCEDURE- PARACERVICAL BLOCK. PROCEDURE DETAILS-USING HYSTEROSCOPIC FLUID BOTH TUBAL OSTIA WERE VISUALIZED. THE ESSURE DEVICE WAS THEN PLACED IN THE FIRST FALLOPIAN TUBE ON THE LEFT SIDE. THE SECOND ESSURE DEVICE WAS PLACED IN THE OPPOSITE TUBE THE EXACT WAY. 2-3 COILS WERE NOTED OUTSIDE EACH TUBE AND ADEQUATE PLACEMENT WAS NOTED OF EACH. THE REST OF THE UTERUS WAS UNREMARKABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: RESULTS: PELVIC INFLAMMATORY DISEASE.. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: NOT REPORTED; ON 15-AUG-2011: (AS PER MR) INDICATION-POST ESSURE PROCEDURE FOR TUBAL CLOSURE FINDINGS-SCOUT IMAGE OF THE PELVIS SHOWS LINEAR DENSITIES CONSISTENT WITH HISTORY OF ESSURE TUBAL LIGATION PROCEDURE.. ULTRASOUND PELVIS - ON (B)(6) 2011: INDICATION-PELVIC PAIN FOR FOUR YEARS. FINDINGS- TRANSABDOMINAL AND ENDOVAGINAL SONOGRAPHIC EVALUATION OF THE PELVIS SHOWS A NORMAL APPEARING UTERUS MEASURING 9.0 X 5.6 X 4.0 CM. IMPRESSION- NO SONOGRAPHIC ABNORMALITIES ARE IDENTIFIED.; IN 2012: RESULTS: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: RESULTS: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULTS: PELVIC INFLAMMATORY DISEASE.. URINE ANALYSIS - IN 2012: RESULTS: INCONCLUSIVE. URINALYSIS AND URINE CULTURES, DIAGNOSED WITH URINARY TRACT INFECTION. UROGRAM - IN 2012: RESULTS: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: RESULTS: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, DYSPAREUNIA, ABDOMINAL PAIN AND DYSPNOEA. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES REPORTED VIA SOCIAL MEDIA: : LUPUS, LAST NIGHT WAS ROUGH, COULDN'T SLEEP, I HAVE CALCIUM DEPOSITS ON MY RIGHT HIP. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2020: QUALITY SAFETY EVALUATION OF PTC. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5036371) ON 16-JUL-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 22-JUL-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('INFLAMMATION IN HER PELVIC AREA/ ABDOMEN / RECURRENT PELVIC INFECTIONS / INFECTIONS IN MY PELVIC AND INFECTIONS IN MY ABDOMINAL AREA/I FEEL ARE DUE TO THE INFLAMMATION THAT I ENDURED WHILE I HAD THE ESSURE'), EMBEDDED DEVICE ('EMBEDDING OF THE COILS IN MY TUBES'), AUTOIMMUNE DISORDER ('AUTOIMMUNE DISEASE'), MASTITIS ('MASTITIS') AND DYSFUNCTIONAL UTERINE BLEEDING ('DYSFUNCTIONAL UTERINE BLEEDING') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822368) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ERROR IN F_MED_HISTORY:-6502-ORA-06502: PL/SQL: NUMERIC OR VALUE ERROR: CHARACTER STRING BUFFER TOO SMALL. DETAIL: LINE 1, ORA-06512: AT "BBS_OWNER.PKG_CUSTOM_AUTO_NARRATIVE", LINE 3289. ERROR IN F_MED_HISTORY:-6502-ORA-06502: PL/SQL: NUMERIC OR VALUE ERROR: CHARACTER STRING BUFFER TOO SMALL. DETAIL: LINE 1, ORA-06512: AT "BBS_OWNER.PKG_CUSTOM_AUTO_NARRATIVE", LINE 3289. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED INFLAMMATION ("INFLAMMATION /THAT I FEEL ARE DUE TO THE INFLAMMATION"). IN 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) WITH UTERINE SCAR, PELVIC PAIN, ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER, LIBIDO DECREASED ("DESIRE FOR SEX HAS DROPPED"), PAIN ("PAIN / ACHE / DULL ACHE"), CONFUSIONAL STATE ("MENTAL CLARITY BEGAN TO SUFFER"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("MENSTRUAL PERIODS ACCOMPANIED BY SIGNIFICANT PAIN"), ALLERGY TO METALS ("METAL SENSITIVITIES INCREASED / ALLERGIC TO NICKEL / HYPO-ALLERGENIC EARRINGS /HYPERSENSITIVITY REACTION TO NICKEL") WITH INFECTION, RASH AND PRURITUS, VULVOVAGINAL PAIN ("VAGINAL PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), MIGRAINE ("MIGRAINES") AND URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FOOD ALLERGY ("FOOD SENSITIVITIES"), 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE. IN 2015, THE PATIENT EXPERIENCED UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE ("UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER") WITH DYSTONIA AND MUSCLE DISORDER ("MUSCLE DISORDER /UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER AND MUSCLE MOVEMENT DISORDER"). IN 2016, THE PATIENT EXPERIENCED METAL POISONING ("HEAVY METAL POISONING /HEAVY METAL POISONING DUE TO FREQUENT CT SCANS AND MRI'S ORDERED TO DIAGNOSE THESE ISSUES AND RECURRENT INFECTIONS ALL DUE TO THE EFFECTS OF ESSURE"). IN 2017, THE PATIENT EXPERIENCED MOVEMENT DISORDER ("MOVEMENT DISORDER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MASTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ENDOMETRIOSIS ON HER UTERUS/UTERUS HAD SOME POSSIBLE ENDOMETRIOSIS") WITH DYSMENORRHOEA, ABDOMINAL DISTENSION, DYSPAREUNIA AND ABDOMINAL ADHESIONS, SINUSITIS ("SEVERE SINUS INFECTIONS"), ABDOMINAL ADHESIONS ("ADHESIONS FROM MY BOWELS"), MENOPAUSAL SYMPTOMS ("MENOPAUSAL SYMPTOMS") WITH HORMONE LEVEL ABNORMAL, MENORRHAGIA ("HEAVY PERIODS"), ARTHRALGIA ("JOINT PAIN"), NEURALGIA ("NERVE PAIN"), MENTAL DISORDER ("AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), FEELING ABNORMAL ("BRAIN FOG"), DYSFUNCTIONAL UTERINE BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CHEST PAIN ("CHEST PAIN"), DYSPNOEA ("SHORTNESS OF BREATH"), DIZZINESS ("DIZZINESS"), MUSCLE TWITCHING ("MUSCLE TWITCHING"), EYE SWELLING ("SWOLLEN EYE"), MUSCLE CONTRACTIONS INVOLUNTARY ("MUSCLE CONTRACTIONS"), HEADACHE ("HEADACHES"), GINGIVAL RECESSION ("RECEDED GUMS"), APHTHOUS ULCER ("CANKER SORES"), FEELING DRUNK ("DRUNK LIKE SENSATION"), PARAESTHESIA ("VIBRATING LIKE SENSATIONS"), SKIN DISORDER ("SKIN CHANGES"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), INSOMNIA ("LAST NIGHT WAS ROUGH, COULDN'T SLEEP"), CALCINOSIS ("I HAVE CALCIUM DEPOSITS ON MY RIGHT HIP") AND PELVIC ADHESIONS ("PELVIC ADHESIONS") AND WAS FOUND TO HAVE BENIGN FALLOPIAN TUBE NEOPLASM ("BENIGN PARATUBAL CYST"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2014. THE PATIENT WAS TREATED WITH ANTIBIOTICS, ANTIINFLAMMATORY PREPARATIONS, NON-STEROIDS FOR TOPICAL USE, BACLOFEN, CARBIDOPA, GABAPENTIN, HOMEOPATHICS NOS (DETOX-KIT-HEEL), HYDROXYCHLOROQUINE, IBUPROFEN, LEVODOPA, RIZATRIPTAN BENZOATE (MAXALT), ANTI-INFLAMMATORIES/HERBS, MAXALT, SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY ((B)(6) 2014). AND TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY ((B)(6) 2014).) AND SAUNA THERAPY,CHANGE IN DIET, DETOX SUPPLEMENTS. ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE HAD RESOLVED, THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, MASTITIS, ADENOMYOSIS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, MENSTRUATION IRREGULAR, DYSMENORRHOEA, ALLERGY TO METALS, SINUSITIS, ABDOMINAL ADHESIONS, MENOPAUSAL SYMPTOMS, VULVOVAGINAL PAIN, FIBROMYALGIA, UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE, MUSCLE DISORDER, METAL POISONING, MENORRHAGIA, MIGRAINE, ARTHRALGIA, NEURALGIA, MENTAL DISORDER, FEELING ABNORMAL, MOVEMENT DISORDER, DYSFUNCTIONAL UTERINE BLEEDING, CHEST PAIN, DYSPNOEA, DIZZINESS, MUSCLE TWITCHING, EYE SWELLING, MUSCLE CONTRACTIONS INVOLUNTARY, HEADACHE, GINGIVAL RECESSION, APHTHOUS ULCER, FEELING DRUNK, PARAESTHESIA, SKIN DISORDER, SYSTEMIC LUPUS ERYTHEMATOSUS, INSOMNIA, CALCINOSIS, URINARY TRACT INFECTION AND PELVIC ADHESIONS OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED, LIBIDO DECREASED, PAIN AND INFLAMMATION WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL ADHESIONS, ADENOMYOSIS, ALLERGY TO METALS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, DYSMENORRHOEA, LIBIDO DECREASED, MASTITIS, MENOPAUSAL SYMPTOMS, MENSTRUATION IRREGULAR, PAIN, SINUSITIS AND WEIGHT INCREASED WITH ESSURE. THE REPORTER CONSIDERED APHTHOUS ULCER, ARTHRALGIA, AUTOIMMUNE DISORDER, CALCINOSIS, CHEST PAIN, DIZZINESS, DYSFUNCTIONAL UTERINE BLEEDING, DYSPNOEA, EMBEDDED DEVICE, EYE SWELLING, FEELING ABNORMAL, FEELING DRUNK, FIBROMYALGIA, FOOD ALLERGY, GINGIVAL RECESSION, HEADACHE, INFLAMMATION, INSOMNIA, MENORRHAGIA, MENTAL DISORDER, METAL POISONING, MIGRAINE, MOVEMENT DISORDER, MUSCLE CONTRACTIONS INVOLUNTARY, MUSCLE DISORDER, MUSCLE TWITCHING, NEURALGIA, PARAESTHESIA, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, SKIN DISORDER, SYSTEMIC LUPUS ERYTHEMATOSUS, UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE, URINARY TRACT INFECTION AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: MY PAIN AND RECURRENT INFECTIONS RESOLVED AFTER SURGERY TO REMOVE ESSURE. SINCE THE REMOVAL I HAVE NOT HAD ANY MORE PELVIC INFECTIONS, THE INFLAMMATION HAS DECREASED AND I HAVE NOT HAD ANY MORE ABDOMINAL PAIN. PROCEDURE- PARACERVICAL BLOCK. PROCEDURE DETAILS-USING HYSTEROSCOPIC FLUID BOTH TUBAL OSTIA WERE VISUALIZED. THE ESSURE DEVICE WAS THEN PLACED IN THE FIRST FALLOPIAN TUBE ON THE LEFT SIDE. THE SECOND ESSURE DEVICE WAS PLACED IN THE OPPOSITE TUBE THE EXACT WAY. 2-3 COILS WERE NOTED OUTSIDE EACH TUBE AND ADEQUATE PLACEMENT WAS NOTED OF EACH. THE REST OF THE UTERUS WAS UNREMARKABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: RESULTS: PELVIC INFLAMMATORY DISEASE. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: NOT REPORTED; ON (B)(6) 2011: (AS PER MR) INDICATION-POST ESSURE PROCEDURE FOR TUBAL CLOSURE. FINDINGS-SCOUT IMAGE OF THE PELVIS SHOWS LINEAR DENSITIES CONSISTENT WITH HISTORY OF ESSURE TUBAL LIGATION PROCEDURE. ULTRASOUND PELVIS - ON (B)(6) 2011: INDICATION-PELVIC PAIN FOR FOUR YEARS. FINDINGS- TRANSABDOMINAL AND ENDOVAGINAL SONOGRAPHIC EVALUATION OF THE PELVIS SHOWS A NORMAL APPEARING UTERUS MEASURING 9.0 X 5.6 X 4.0 CM. IMPRESSION- NO SONOGRAPHIC ABNORMALITIES ARE IDENTIFIED.; IN 2012: RESULTS: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: RESULTS: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULTS: PELVIC INFLAMMATORY DISEASE. URINE ANALYSIS - IN 2012: RESULTS: INCONCLUSIVE. URINALYSIS AND URINE CULTURES, DIAGNOSED WITH URINARY TRACT INFECTION. UROGRAM - IN 2012: RESULTS: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: RESULTS: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, DYSPAREUNIA, ABDOMINAL PAIN AND DYSPNOEA. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES REPORTED VIA SOCIAL MEDIA: : LUPUS, LAST NIGHT WAS ROUGH, COULDN'T SLEEP, I HAVE CALCIUM DEPOSITS ON MY RIGHT HIP. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUL-2020: MEDICAL RECORD WAS RECEIVED. EVENT ADDED FROM MEDICAL RECORD-PELVIC ADHESIONS. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FOOD AND DRUG ADMINISTRATION (REFERENCE NUMBER: MW5036371) ON 16-JUL-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 29-NOV-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("INFLAMMATION IN HER PELVIC AREA/ ABDOMEN / RECURRENT PELVIC INFECTIONS / INFECTIONS IN MY PELVIC AND INFECTIONS IN MY ABDOMINAL AREA"), EMBEDDED DEVICE ("EMBEDDING OF THE COILS IN MY TUBES"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") AND MASTITIS ("MASTITIS") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II IN 2011, IODINE ALLERGY, MISCARRIAGE, DEPRESSION, ANXIETY, BREAST PAIN, CHOLECYSTECTOMY IN 2006, C-SECTION IN (B)(6), SCAR IN (B)(6) 2011, MULTIGRAVIDA, SCAR REMOVAL IN 2011, ANAL FISSURE IN 2006, PARITY 4 (DATE OF BIRTH: (B)(6)) AND PRE-ECLAMPSIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MINI PILL, NUVARING AND MIRENA; FOR DYSTONIA: BACLOFEN AND CARBIDOPA; FOR FIBROMYALGIA: GABAPENTIN; FOR JOINT PAIN: PLAQUENIL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ABDOMINAL PAIN LOWER WITH MIRENA. CONCURRENT CONDITIONS INCLUDED NONSMOKER, NICKEL SENSITIVITY AND OBESITY. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D), FISH OIL AND HYDROCORTISONE (CORTISOL), ANTI-INFLAMMATORIES, DETOX SUPPLEMENTS, PLAQUENIL, CARBIDOPA, BACLOFEN, MAXALT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("VAGINAL PAIN"). IN 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) WITH UTERINE SCAR, PELVIC PAIN, ABDOMINAL PAIN AND ABDOMINAL PAIN LOWER, WEIGHT INCREASED ("WEIGHT GAIN"), LIBIDO DECREASED ("DESIRE FOR SEX HAS DROPPED"), PAIN ("PAIN / ACHE / DULL ACHE"), CONFUSIONAL STATE ("MENTAL CLARITY BEGAN TO SUFFER"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), DYSMENORRHOEA ("MENSTRUAL PERIODS ACCOMPANIED BY SIGNIFICANT PAIN") AND ALLERGY TO METALS ("METAL SENSITIVITIES INCREASED / ALLERGIC TO NICKEL / HYPO-ALLERGENIC EARRINGS /HYPERSENSITIVITY REACTION TO NICKEL") WITH INFECTION, RASH AND PRURITUS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MASTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ADENOMYOSIS ("ENDOMETRIOSIS ON HER UTERUS") WITH DYSMENORRHOEA, ABDOMINAL DISTENSION, DYSPAREUNIA AND ABDOMINAL ADHESIONS, BENIGN FALLOPIAN TUBE NEOPLASM ("BENIGN PARATUBAL CYST"), SINUSITIS ("SEVERE SINUS INFECTIONS"), ABDOMINAL ADHESIONS ("ADHESIONS FROM MY BOWELS"), MENOPAUSAL SYMPTOMS ("MENOPAUSAL SYMPTOMS") WITH HORMONE LEVEL ABNORMAL, FIBROMYALGIA ("FIBROMYALGIA"), CONNECTIVE TISSUE DISORDER ("UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER") WITH DYSTONIA, MUSCLE DISORDER ("MUSCLE DISORDER"), INFLAMMATION ("INFLAMMATION"), METAL POISONING ("HEAVY METAL POISONING"), FOOD ALLERGY ("FOOD SENSITIVITIES"), MENORRHAGIA ("HEAVY PERIODS"), MIGRAINE ("MIGRAINES"), ARTHRALGIA ("JOINT PAIN") AND NEURALGIA ("NERVE PAIN"), AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION AND BRAIN FOG . THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2014 TO (B)(6) 2014. THE PATIENT WAS TREATED WITH IBUPROFEN, SURGERY (TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, WEIGHT INCREASED, LIBIDO DECREASED AND PAIN WAS RESOLVING AND THE EMBEDDED DEVICE, AUTOIMMUNE DISORDER, MASTITIS, ADENOMYOSIS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, MENSTRUATION IRREGULAR, DYSMENORRHOEA, ALLERGY TO METALS, SINUSITIS, ABDOMINAL ADHESIONS, MENOPAUSAL SYMPTOMS, VULVOVAGINAL PAIN, FIBROMYALGIA, CONNECTIVE TISSUE DISORDER, MUSCLE DISORDER, INFLAMMATION, METAL POISONING, MENORRHAGIA, MIGRAINE, ARTHRALGIA AND NEURALGIA AND AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION AND BRAIN FOG OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, AUTOIMMUNE DISORDER, CONNECTIVE TISSUE DISORDER, EMBEDDED DEVICE, FIBROMYALGIA, FOOD ALLERGY, INFLAMMATION, MENORRHAGIA, METAL POISONING, MIGRAINE, MUSCLE DISORDER, NEURALGIA, PELVIC INFLAMMATORY DISEASE AND VULVOVAGINAL PAIN ABDOMINAL ADHESIONS, ADENOMYOSIS, ALLERGY TO METALS, BENIGN FALLOPIAN TUBE NEOPLASM, CONFUSIONAL STATE, DYSMENORRHOEA, LIBIDO DECREASED, MASTITIS, MENOPAUSAL SYMPTOMS, MENSTRUATION IRREGULAR, PAIN, SINUSITIS AND WEIGHT INCREASED AND AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION AND BRAIN FOG TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: MY PAIN AND RECURRENT INFECTIONS RESOLVED AFTER SURGERY TO REMOVE ESSURE. SINCE THE REMOVAL I HAVE NOT HAD ANY MORE PELVIC INFECTIONS, THE INFLAMMATION HAS DECREASED AND I HAVE NOT HAD ANY MORE ABDOMINAL PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.9 KG/SQM. COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: NOT REPORTED. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NOT REPORTED. ULTRASOUND PELVIS - IN 2012: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES. ULTRASOUND SCAN - ON AN UNKNOWN DATE: NOT REPORTED. URINE ANALYSIS - IN 2012: INCONCLUSIVE. UROGRAM - IN 2012: INCONCLUSIVE AND ALL THAT WAS SEEN WAS ESSURE; IN 2014: NOTHING OUT OF PLACE BUT ESSURE IN FALLOP TUBES. ON AN UNKNOWN DATE, HYSTEROSALPINGOGRAPHY TEST TO CONFIRM ESSURE PLACEMENT. (B)(6) 2011: UNSPECIFIED TEST - THE COILS HAD INDEED SCARRED HER TUBES. IT WAS UNREMARKABLE. 2012: BLOOD WORK - ELEVATED WHITE BLOOD CELL COUNTS AND OTHER INFLAMMATORY MARKERS. UNSPECIFIED DATE: BLOOD WORK - SIGNIFICANTLY LOW LEVEL OF HORMONES, OVER ALL, IN HER BODY. SHE RAN NUMEROUS TESTS INCLUDING URINALYSIS. CT KUB AND PELVIC ULTRASOUND. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED ¿UNCONFIRMED QUALITY DEFECT¿. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-NOV-2017: PFS RECEIVED - CASE UPGRADED AS INCIDENT. NEW EVENTS, "SEVERE AND PERSISTENT ABDOMINAL PAIN, VAGINAL PAIN, PAIN DURING SEX, FIBROMYALGIA, UNDIFFERENTIATED CONNECTIVE TISSUE DISORDER, MUSCLE DISORDER, INFLAMMATION, RECURRENT INFECTIONS, AUTOIMMUNE DISEASE, HEAVY METAL POISONING, RASHES, ITCHING, FOOD SENSITIVITIES, HEAVY PERIODS, MIGRAINES, DYSTONIA, JOINT PAIN, NERVE PAIN, AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION AND BRAIN FOG WERE ADDED. NEW REPORTER WAS ADDED. SURGICAL TREATMENT WAS ADDED. PATIENTS INFORMATION WAS UPDATED. HISTORICAL AND CONCOMITANT CONDITIONS AND TREATMENT MEDICATION WERE ADDED. ¿ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC,(B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY". INCIDENT: 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 |
|---|---|---|---|---|---|---|---|
| 930179 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Hospitalization| O| R | CLARITIN| CLARITIN| CONTRACEPTIVES NOS| CORTICOSTEROID NOS| CORTICOSTEROID NOS| CORTICOSTEROID NOS| CORTISOL| CORTISOL| CORTISOL| FISH OIL| FISH OIL| FISH OIL| FISH OIL| FISH OIL| FISH OIL| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| PERCOCET| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| VITAMIN D| VITAMIN D| VITAMIN D| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| CORTISOL| FISH OIL| VITAMIN D |