ESSURE
Report
- Report Number
- 2951250-2018-01366
- Event Type
- Injury
- Date Received
- March 31, 2018
- Report Date
- April 16, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CRUSHING PELVIC PAIN/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN PELVIS") AND GENITAL HAEMORRHAGE ("CONSTANT HEAVY BLEEDING FOR 10 MONTHS WITH ONLY A BRIEF BREAK WHILE TAKING PROGESTERONE AND A FEW DAYS EVERY NOW AND AGAIN REDUCED TO SPOTTING") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CYST BREAST AND HYPERTENSION. CONCURRENT CONDITIONS INCLUDED BLADDER PROLAPSE. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2011, MORPHINE SULFATE AND PARACETAMOL (ACETAMINOPHEN). IN 2011, THE PATIENT EXPERIENCED WEIGHT INCREASED ("GAIN WITH BLOATING"), ABDOMINAL DISTENSION ("GAIN WITH BLOATING") AND PYREXIA ("INTERMITTENT LOW GRADE FEVER"). IN OCTOBER 2011, THE PATIENT EXPERIENCED HYPOAESTHESIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS"), PARALYSIS ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") AND PARAESTHESIA ("TINGLING REACHED DOWN INTO FEET"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). IN NOVEMBER 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN DECEMBER 2011, THE PATIENT EXPERIENCED ARTHRALGIA ("IT HAD GONE INTO MY HIP JOINTS TO THE POINT WHERE I COULDN'T WALK / JOINT ACHES/ JOINT PAIN/ WRIST PAIN/ CONSTANT JOINT PAIN IN HIPS, ELBOWS, KNEES"), FATIGUE ("EXTREME FATIGUE/ FATIGUE") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN JANUARY 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), CHEST PAIN ("CHEST PAIN/ CHEST PAINS DID OCCUR FREQUENTLY") AND ABDOMINAL PAIN LOWER ("CRAMPING"). IN FEBRUARY 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND VERTIGO ("VERTIGO"). IN MARCH 2012, THE PATIENT EXPERIENCED EYE MOVEMENT DISORDER ("EYE TWITCHING"), VISION BLURRED ("BLURRY VISION") AND BLOOD PRESSURE FLUCTUATION ("CHANGE IN BLOOD PRESSURE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK ACHES/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN BACK"), QUALITY OF LIFE DECREASED ("MY LIFE SLOWLY BECAME CRIPPLING"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), TYPE IV HYPERSENSITIVITY REACTION ("IMMUNOLOGIC REACTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND PAIN IN EXTREMITY ("PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN DOWN LEGS"). THE PATIENT WAS TREATED WITH OTHER ANTIINFLAMMATORY AGENTS IN COMB. AND SURGERY (BILATERAL SALPINGECTOMY (ASSISTED WITH HYSTERSCOPE) PORTIONS OF TUBES REMOVED /D&C HYSTEROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2012. IN 2012, THE PELVIC PAIN, BACK PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, GENITAL HAEMORRHAGE, TYPE IV HYPERSENSITIVITY REACTION, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA, HYPOAESTHESIA, PARALYSIS, PARAESTHESIA, ANXIETY, EYE MOVEMENT DISORDER, VISION BLURRED, WEIGHT INCREASED, ABDOMINAL DISTENSION, VERTIGO, PYREXIA, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER HAD RESOLVED. AT THE TIME OF THE REPORT, THE ARTHRALGIA, FATIGUE AND QUALITY OF LIFE DECREASED HAD RESOLVED AND THE COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PARAESTHESIA, PARALYSIS, PELVIC PAIN, PYREXIA, QUALITY OF LIFE DECREASED, TYPE IV HYPERSENSITIVITY REACTION, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE STATED THAT HER LIFE SLOWLY BECAME CRIPPLING. ESSURE WAS REMOVED AND THE CONSUMER INFORMED THAT WITHIN WEEKS SHE WAS PERFECTLY FINE AGAIN. DURING ESSURE INSERTION ON (B)(6) 2011, SHE HAD COMPLICATIONS, HER LEFT TUBE WAS TOO FLUFFY. WAS NOT QUITE RECEIVED AS COMPLICATION BUT WAS TOLD IT WAS THE REASON FOR EXCRUCIATING SUDDEN SHARP, PIERCING PAIN UPON INITIAL INSERTION OF LEFT TUBE. DOCTOR ADVISED TO GIVE HER MORE PAIN MEDICATION, LEFT, THEN RETURNED 5-10 MINUTES LATER WITH A SEALED MEDICAL COMPONENT. ESSURE MICRO INSERTS PLACEMENT, TRAILING COILS BOTH RIGHT AND LEFT TUBES. PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: RADIOPAQUE COILS PREVIOUSLY ARE NOTED NOT VISIBLE THE CONSUMER UNDERWENT A SCAN ON AN UNSPECIFIED DATE WHICH SHOWED ESSURE WERE IMPLANTED CORRECTLY AND NEVER MIGRATED. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT: 120-125 LBS. CURRENT WEIGHT AS OF (B)(6) 2018: 100 LBS. HYSTEROSALPINGOGRAM ON (B)(6) 2012, THE RESULTS OF ESSURE CONFIRMATION TEST WAS OCCLUDED, ESSURE SUCCESSFUL WITH NO EVIDENCE OF SPILLAGE. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMAING PELVIC PAIN MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: MEDICAL RECORDS RECEIVED: REPORTER ADDED, HISTORICAL CONDITION AND CONCOMITANT DRUG 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CRUSHING PELVIC PAIN/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN PELVIS"), GENITAL HAEMORRHAGE ("CONSTANT HEAVY BLEEDING FOR 10 MONTHS WITH ONLY A BRIEF BREAK WHILE TAKING PROGESTERONE AND A FEW DAYS EVERY NOW AND AGAIN REDUCED TO SPOTTING") AND DIPLEGIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CYST BREAST AND HYPERTENSION. CONCURRENT CONDITIONS INCLUDED BLADDER PROLAPSE. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2011, MORPHINE SULFATE AND PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED WEIGHT INCREASED ("GAIN WITH BLOATING"), ABDOMINAL DISTENSION ("GAIN WITH BLOATING") AND PYREXIA ("INTERMITTENT LOW GRADE FEVER"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DIPLEGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPOAESTHESIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") AND PARAESTHESIA ("TINGLING REACHED DOWN INTO FEET"). ON THE SAME DAY, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ARTHRALGIA ("IT HAD GONE INTO MY HIP JOINTS TO THE POINT WHERE I COULDN'T WALK / JOINT ACHES/ JOINT PAIN/ WRIST PAIN/ CONSTANT JOINT PAIN IN HIPS, ELBOWS, KNEES"), FATIGUE ("EXTREME FATIGUE/ FATIGUE") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), CHEST PAIN ("CHEST PAIN/ CHEST PAINS DID OCCUR FREQUENTLY") AND ABDOMINAL PAIN LOWER ("CRAMPING"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND VERTIGO ("VERTIGO"). IN (B)(6) 2012, THE PATIENT EXPERIENCED EYE MOVEMENT DISORDER ("EYE TWITCHING"), VISION BLURRED ("BLURRY VISION") AND BLOOD PRESSURE FLUCTUATION ("CHANGE IN BLOOD PRESSURE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK ACHES/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN BACK"), QUALITY OF LIFE DECREASED ("MY LIFE SLOWLY BECAME CRIPPLING"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HYPERSENSITIVITY ("IMMUNOLOGIC REACTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PAIN IN EXTREMITY ("PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN DOWN LEGS"), PROCEDURAL PAIN ("PAIN DURING PLACEMENT ") AND MALAISE ("SICKNESS"). THE PATIENT WAS TREATED WITH OTHER ANTIINFLAMMATORY AGENTS IN COMB. AND SURGERY (BILATERAL SALPINGECTOMY (ASSISTED WITH HYSTERSCOPE) PORTIONS OF TUBES REMOVED /D&C HYSTEROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2012. IN 2012, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DIPLEGIA, BACK PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA, HYPOAESTHESIA, PARAESTHESIA, ANXIETY, EYE MOVEMENT DISORDER, VISION BLURRED, WEIGHT INCREASED, ABDOMINAL DISTENSION, VERTIGO, PYREXIA, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER HAD RESOLVED. AT THE TIME OF THE REPORT, THE ARTHRALGIA, FATIGUE AND QUALITY OF LIFE DECREASED HAD RESOLVED AND THE COMPLICATION OF DEVICE INSERTION, PROCEDURAL PAIN AND MALAISE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, DIPLEGIA, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, HYPOAESTHESIA, MALAISE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PROCEDURAL PAIN, PYREXIA, QUALITY OF LIFE DECREASED, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE STATED THAT HER LIFE SLOWLY BECAME CRIPPLING. ESSURE WAS REMOVED AND THE CONSUMER INFORMED THAT WITHIN WEEKS SHE WAS PERFECTLY FINE AGAIN. DURING ESSURE INSERTION ON (B)(6) 2011, SHE HAD COMPLICATIONS, HER LEFT TUBE WAS TOO FLUFFY. WAS NOT QUITE RECEIVED AS COMPLICATION BUT WAS TOLD IT WAS THE REASON FOR EXCRUCIATING SUDDEN SHARP, PIERCING PAIN UPON INITIAL INSERTION OF LEFT TUBE. DOCTOR ADVISED TO GIVE HER MORE PAIN MEDICATION, LEFT, THEN RETURNED 5-10 MINUTES LATER WITH A SEALED MEDICAL COMPONENT. ESSURE MICRO INSERTS PLACEMENT, TRAILING COILS BOTH RIGHT AND LEFT TUBES. PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: RADIOPAQUE COILS PREVIOUSLY ARE NOTED NOT VISIBLE THE CONSUMER UNDERWENT A SCAN ON AN UNSPECIFIED DATE WHICH SHOWED ESSURE WERE IMPLANTED CORRECTLY AND NEVER MIGRATED. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT: 120-125 LBS. CURRENT WEIGHT AS OF (B)(6) 2018: 100 LBS. HYSTEROSALPINGOGRAM ON (B)(6) 2012, THE RESULTS OF ESSURE CONFIRMATION TEST WAS OCCLUDED, ESSURE SUCCESSFUL WITH NO EVIDENCE OF SPILLAGE. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMING PELVIC PAIN AND VIA PER SOCIAL MEDIA EVENT: PAIN DURING PLACEMENT WAS ADDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("TWO FRAGMENTS OF METAL INNER COIL"), PELVIC PAIN ("CRUSHING PELVIC PAIN/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN PELVIS"), GENITAL HAEMORRHAGE ("CONSTANT HEAVY BLEEDING FOR 10 MONTHS WITH ONLY A BRIEF BREAK WHILE TAKING PROGESTERONE AND A FEW DAYS EVERY NOW AND AGAIN REDUCED TO SPOTTING") AND DIPLEGIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CYST BREAST, HYPERTENSION, MIGRAINE AND HEADACHE. CONCURRENT CONDITIONS INCLUDED BLADDER PROLAPSE, ROOT CANAL PROCEDURE AND IRREGULAR MENSTRUAL CYCLE. CONCOMITANT PRODUCTS INCLUDED DIPHENHYDRAMINE CITRATE;IBUPROFEN (MOTRIN PM), ESTRADIOL (ESTRACE) FROM (B)(6) 2012 TO (B)(6) 2012, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE(B)(6)2011, MORPHINE SULFATE, NAPROXEN SODIUM (ANAPROX), NORETHISTERONE ACETATE (AYGESTIN) FROM (B)(6) 2012 TO (B)(6) 2012, PARACETAMOL (TYLENOL), PARACETAMOL;TRAMADOL HYDROCHLORIDE (ULTRACET) FROM (B)(6) 2012 TO (B)(6)2012, PREDNISONE FROM (B)(6) 2012 TO (B)(6) 2012 AND TYLOX (PERCOCET [OXYCODONE HYDROCHLORIDE,OXYCODONE TEREPHTHALATE,PARACETAMOL]) FROM (B)(6) 2012 TO (B)(6) 2012. IN 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("GAIN WITH BLOATING") AND EXPERIENCED ABDOMINAL DISTENSION ("WEIGHT GAIN WITH BLOATING") AND PYREXIA ("INTERMITTENT LOW GRADE FEVER"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DIPLEGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPOAESTHESIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") AND PARAESTHESIA ("TINGLING REACHED DOWN INTO FEET"). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)/HEAVY VAGINAL BLEEDING") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). IN (B)(6)2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6)2011, THE PATIENT EXPERIENCED ARTHRALGIA ("IT HAD GONE INTO MY HIP JOINTS TO THE POINT WHERE I COULDN'T WALK / JOINT ACHES/ JOINT PAIN/ WRIST PAIN/ CONSTANT JOINT PAIN IN HIPS, ELBOWS, KNEES"), FATIGUE ("EXTREME FATIGUE/ FATIGUE") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6)2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), CHEST PAIN ("CHEST PAIN/ CHEST PAINS DID OCCUR FREQUENTLY") AND ABDOMINAL PAIN LOWER ("CRAMPING"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND VERTIGO ("VERTIGO"). IN (B)(6) 2012, THE PATIENT EXPERIENCED EYE MOVEMENT DISORDER ("EYE TWITCHING"), VISION BLURRED ("BLURRY VISION") AND BLOOD PRESSURE FLUCTUATION ("CHANGE IN BLOOD PRESSURE/ BLOOD PRESSURE CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK ACHES/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN BACK"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HYPERSENSITIVITY ("LEERGIC REACTION/HYPERSENSITIVITY, IMMUNOLOGIC REACTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PAIN IN EXTREMITY ("PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN DOWN LEGS"), PROCEDURAL PAIN ("PAIN DURING PLACEMENT ") AND MALAISE ("SICKNESS") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("MY LIFE SLOWLY BECAME CRIPPLING"). THE PATIENT WAS TREATED WITH OTHER ANTIINFLAMMATORY AGENTS IN COMB. AND SURGERY (BILATERAL SALPINGECTOMY (ASSISTED WITH HYSTERSCOPE) PORTIONS OF TUBES REMOVED /D&C HYSTEROSCOPY). ESSURE WAS REMOVED ON(B)(6)2012. IN (B)(6), THE PELVIC PAIN, GENITAL HAEMORRHAGE, DIPLEGIA, BACK PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA, HYPOAESTHESIA, PARAESTHESIA, ANXIETY, EYE MOVEMENT DISORDER, VISION BLURRED, WEIGHT INCREASED, ABDOMINAL DISTENSION, VERTIGO, PYREXIA, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, COMPLICATION OF DEVICE INSERTION, PROCEDURAL PAIN AND MALAISE OUTCOME WAS UNKNOWN AND THE ARTHRALGIA, FATIGUE AND QUALITY OF LIFE DECREASED HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, DEVICE BREAKAGE, DIPLEGIA, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, HYPOAESTHESIA, MALAISE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PROCEDURAL PAIN, PYREXIA, QUALITY OF LIFE DECREASED, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE STATED THAT HER LIFE SLOWLY BECAME CRIPPLING. ESSURE WAS REMOVED AND THE CONSUMER INFORMED THAT WITHIN WEEKS SHE WAS PERFECTLY FINE AGAIN. DURING ESSURE INSERTION ON (B)(6)2011, SHE HAD COMPLICATIONS, HER LEFT TUBE WAS TOO FLUFFY. WAS NOT QUITE RECEIVED AS COMPLICATION BUT WAS TOLD IT WAS THE REASON FOR EXCRUCIATING SUDDEN SHARP, PIERCING PAIN UPON INITIAL INSERTION OF LEFT TUBE. DOCTOR ADVISED TO GIVE HER MORE PAIN MEDICATION, LEFT, THEN RETURNED 5-10 MINUTES LATER WITH A SEALED MEDICAL COMPONENT. ESSURE MICRO INSERTS PLACEMENT, TRAILING COILS BOTH RIGHT AND LEFT TUBES. PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS (B)(6)2011,(B)(6)2011 (DISCREPANCY NOTED) IN DATE OF PLACEMENT OF ESSURE. CURRENT WEIGHT AS OF (B)(6)2018: 100 LBS APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT: 120-125 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6)2012: RESULTS: RADIOPAQUE COILS PREVIOUSLY ARE NOTED NOT VISIBLE. CULTURE URINE - ON(B)(6)2012: MULTIPLE ORGANISMS PRESENT EACH LESS THAN 10,000 CFU/ML THESE ORGANISMS COMMONLY FOUND ON EXTERNAL AND INTERNAL GENITALIA, ARE CONSIDERED TO BE COLONIZERS, NO FURTHER TESTING PERFORMED. HYSTEROSALPINGOGRAM - ON (B)(6)2012: TOTAL BILATERAL OCCLUSION; ON (B)(6)2012: NO FREE SPILL. PATHOLOGY TEST - ON (B)(6)2012: THERE IS A SEGMENT OF METAL OUTER COIL MEASURING 4 CM IN LENGTH AND 0.2 CM IN DIAMETER AND TWO FRAGMENTS OF METAL INNER COIL MEASURING 1 X 0.1 CM AND 3 X 0.1 CM. THE SHORTER FRAGMENT HAS A METAL BALL SHAPE END, WHICH MEASURES 0.1 CM IN DIAMETER. SURROUNDING THE SHORTER FRAGMENT OF COIL IS A PORTION OF SOFT TISSUE MEASURING 0.4 CM IN LENGTH AND 0.3 CM IN DIAMETER. THE LONGER FRAGMENT OF INNER COIL IS SURROUNDED BY WHITE THIN MEMBRANOUS MATERIAL MEASURING 1.5 CM IN LENGTH AND LESS THAN 0.1 CM IN THICKNESS. SECTIONS OF THE FALLOPIAN TUBE SHOWED PATENT LUMEN (THE LUMEN CAN BE PROBED) AND GROSSLY NORMAL MUCOSA. PHOTOGRAPH IS TAKEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO CASSETTES AS FOLLOWS: 1 A LONGER SEGMENT OF FALLOPIAN TUBE 1B BISECTED AND ENTIRELY SUBMITTED POSSIBLE SHORTER SEGMENT OF FALLOPIAN TUBE.. ULTRASOUND PELVIS - ON (B)(6)2012: UTERUS: MEASURES 92 X 49 X 68 MM. THE UTERUS IS RETROVERTED. THE ENDOMETRIUM MEASURES 10.2 MM THICKNESS. THERE IS A HYPOECHOIC AREA NOTED NEAR THE FUNDAL REGION OF THE ENDOMETRIAL STRIPE THIS MEASURES 1 0 X 5 MM. THIS COULD REPRESENT BLOOD CLOT BUT THE POSSIBILITY OF ENDOMETRIAL HYPERPLASTIC LESION OR A SUBMUCOSAL FIBROID CANNOT BE EXCLUDED. RIGHT OVARY: MEASURES 31 X 14 X 28 MM. IT DOES NOT CONTAIN ANY SUSPICIOUS LESIONS. LEFT OVARY: MEASURES 40 X 26 X 39 MM. A CYST WITH SEPTATION MEASURES 26 X 20 X 29 MILLIMETER.. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: BLEEDING , CRAMPING, ANXIETY , VAGINAL BLEEDING ,VERTIGO ,NAUSEA. , BLEEDING AND LOW BACK PAIN AND THIGH PAIN CONFIRMAING PELVIC PAIN AND VIA PER SOCIAL MEDIA EVENT: PAIN DURING PLACEMENT WAS ADDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-APR-2019: PFS AND MR RECEIVED. REPORTERS INFORMATION UPDATED. EVENT: DEVICE BREAKAGE WERE ADDED.MEDICAL HISTORY , CONCOMITANT DRUG , LAB DATA WERE ADDED. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("TWO FRAGMENTS OF METAL INNER COIL"), PELVIC PAIN ("CRUSHING PELVIC PAIN/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN PELVIS"), GENITAL HAEMORRHAGE ("CONSTANT HEAVY BLEEDING FOR 10 MONTHS WITH ONLY A BRIEF BREAK WHILE TAKING PROGESTERONE AND A FEW DAYS EVERY NOW AND AGAIN REDUCED TO SPOTTING") AND DIPLEGIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CYST BREAST, HYPERTENSION, MIGRAINE AND HEADACHE. CONCURRENT CONDITIONS INCLUDED BLADDER PROLAPSE, ROOT CANAL PROCEDURE AND IRREGULAR MENSTRUAL CYCLE. CONCOMITANT PRODUCTS INCLUDED DIPHENHYDRAMINE CITRATE;IBUPROFEN (MOTRIN PM), ESTRADIOL (ESTRACE) FROM (B)(6) 2012 TO (B)(6) 2012, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6)2011, MORPHINE SULFATE, NAPROXEN SODIUM (ANAPROX), NORETHISTERONE ACETATE (AYGESTIN) FROM (B)(6) 2012 TO (B)(6)2012, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) FROM (B)(6)2012 TO (B)(6)2012, PARACETAMOL (TYLENOL), PARACETAMOL;TRAMADOL HYDROCHLORIDE (ULTRACET) FROM (B)(6)2012 TO (B)(6)2012 AND PREDNISONE FROM (B)(6)2012 TO (B)(6)2012. IN 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("GAIN WITH BLOATING") AND EXPERIENCED ABDOMINAL DISTENSION ("WEIGHT GAIN WITH BLOATING") AND PYREXIA ("INTERMITTENT LOW GRADE FEVER"). IN (B)(6)2011, THE PATIENT EXPERIENCED DIPLEGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPOAESTHESIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") AND PARAESTHESIA ("TINGLING REACHED DOWN INTO FEET"). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)/HEAVY VAGINAL BLEEDING") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). IN (B)(6)2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6)2011, THE PATIENT EXPERIENCED ARTHRALGIA ("IT HAD GONE INTO MY HIP JOINTS TO THE POINT WHERE I COULDN'T WALK / JOINT ACHES/ JOINT PAIN/ WRIST PAIN/ CONSTANT JOINT PAIN IN HIPS, ELBOWS, KNEES"), FATIGUE ("EXTREME FATIGUE/ FATIGUE") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6)2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), CHEST PAIN ("CHEST PAIN/ CHEST PAINS DID OCCUR FREQUENTLY") AND ABDOMINAL PAIN LOWER ("CRAMPING"). IN (B)(6)2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND VERTIGO ("VERTIGO"). IN (B)(6)2012, THE PATIENT EXPERIENCED EYE MOVEMENT DISORDER ("EYE TWITCHING"), VISION BLURRED ("BLURRY VISION") AND BLOOD PRESSURE FLUCTUATION ("CHANGE IN BLOOD PRESSURE/ BLOOD PRESSURE CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK ACHES/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN BACK"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HYPERSENSITIVITY ("LEERGIC REACTION/HYPERSENSITIVITY, IMMUNOLOGIC REACTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PAIN IN EXTREMITY ("PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN DOWN LEGS"), PROCEDURAL PAIN ("PAIN DURING PLACEMENT ") AND MALAISE ("SICKNESS") AND WAS FOUND TO HAVE QUALITY OF LIFE DECREASED ("MY LIFE SLOWLY BECAME CRIPPLING"). THE PATIENT WAS TREATED WITH OTHER ANTIINFLAMMATORY AGENTS IN COMB. AND SURGERY (BILATERAL SALPINGECTOMY (ASSISTED WITH HYSTERSCOPE) PORTIONS OF TUBES REMOVED /D&C HYSTEROSCOPY). ESSURE WAS REMOVED ON (B)(6)2012. IN 2012, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DIPLEGIA, BACK PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA, HYPOAESTHESIA, PARAESTHESIA, ANXIETY, EYE MOVEMENT DISORDER, VISION BLURRED, WEIGHT INCREASED, ABDOMINAL DISTENSION, VERTIGO, PYREXIA, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, COMPLICATION OF DEVICE INSERTION, PROCEDURAL PAIN AND MALAISE OUTCOME WAS UNKNOWN AND THE ARTHRALGIA, FATIGUE AND QUALITY OF LIFE DECREASED HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, DEVICE BREAKAGE, DIPLEGIA, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, HYPOAESTHESIA, MALAISE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PROCEDURAL PAIN, PYREXIA, QUALITY OF LIFE DECREASED, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE STATED THAT HER LIFE SLOWLY BECAME CRIPPLING. ESSURE WAS REMOVED AND THE CONSUMER INFORMED THAT WITHIN WEEKS SHE WAS PERFECTLY FINE AGAIN. DURING ESSURE INSERTION ON (B)(6)2011, SHE HAD COMPLICATIONS, HER LEFT TUBE WAS TOO FLUFFY. WAS NOT QUITE RECEIVED AS COMPLICATION BUT WAS TOLD IT WAS THE REASON FOR EXCRUCIATING SUDDEN SHARP, PIERCING PAIN UPON INITIAL INSERTION OF LEFT TUBE. DOCTOR ADVISED TO GIVE HER MORE PAIN MEDICATION, LEFT, THEN RETURNED 5-10 MINUTES LATER WITH A SEALED MEDICAL COMPONENT. ESSURE MICRO INSERTS PLACEMENT, TRAILING COILS BOTH RIGHT AND LEFT TUBES. PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS (B)(6)2011,(B)(6)2011 (DISCREPANCY NOTED) IN DATE OF PLACEMENT OF ESSURE. CURRENT WEIGHT AS OF (B)(6)2018: 100 LBS APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT: 120-125 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6)2012: RESULTS: RADIOPAQUE COILS PREVIOUSLY ARE NOTED NOT VISIBLE. CULTURE URINE - ON (B)(6)2012: MULTIPLE ORGANISMS PRESENT EACH LESS THAN 10,000 CFU/ML THESE ORGANISMS COMMONLY FOUND ON EXTERNAL AND INTERNAL GENITALIA, ARE CONSIDERED TO BE COLONIZERS, NO FURTHER TESTING PERFORMED. HYSTEROSALPINGOGRAM - ON (B)(6)2012: TOTAL BILATERAL OCCLUSION; ON (B)(6)2012: NO FREE SPILL. PATHOLOGY TEST - ON (B)(6)2012: THERE IS A SEGMENT OF METAL OUTER COIL MEASURING 4 CM IN LENGTH AND 0.2 CM IN DIAMETER AND TWO FRAGMENTS OF METAL INNER COIL MEASURING 1 X 0.1 CM AND 3 X 0.1 CM. THE SHORTER FRAGMENT HAS A METAL BALL SHAPE END, WHICH MEASURES 0.1 CM IN DIAMETER. SURROUNDING THE SHORTER FRAGMENT OF COIL IS A PORTION OF SOFT TISSUE MEASURING 0.4 CM IN LENGTH AND 0.3 CM IN DIAMETER. THE LONGER FRAGMENT OF INNER COIL IS SURROUNDED BY WHITE THIN MEMBRANOUS MATERIAL MEASURING 1.5 CM IN LENGTH AND LESS THAN 0.1 CM IN THICKNESS. SECTIONS OF THE FALLOPIAN TUBE SHOWED PATENT LUMEN (THE LUMEN CAN BE PROBED) AND GROSSLY NORMAL MUCOSA. PHOTOGRAPH IS TAKEN. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO CASSETTES AS FOLLOWS: 1 A LONGER SEGMENT OF FALLOPIAN TUBE 1B BISECTED AND ENTIRELY SUBMITTED POSSIBLE SHORTER SEGMENT OF FALLOPIAN TUBE.. ULTRASOUND PELVIS - ON (B)(6)2012: UTERUS: MEASURES 92 X 49 X 68 MM. THE UTERUS IS RETROVERTED. THE ENDOMETRIUM MEASURES 10.2 MM THICKNESS. THERE IS A HYPOECHOIC AREA NOTED NEAR THE FUNDAL REGION OF THE ENDOMETRIAL STRIPE THIS MEASURES 1 0 X 5 MM. THIS COULD REPRESENT BLOOD CLOT BUT THE POSSIBILITY OF ENDOMETRIAL HYPERPLASTIC LESION OR A SUBMUCOSAL FIBROID CANNOT BE EXCLUDED. RIGHT OVARY: MEASURES 31 X 14 X 28 MM. IT DOES NOT CONTAIN ANY SUSPICIOUS LESIONS. LEFT OVARY: MEASURES 40 X 26 X 39 MM. A CYST WITH SEPTATION MEASURES 26 X 20 X 29 MILLIMETER.. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: BLEEDING , CRAMPING, ANXIETY , VAGINAL BLEEDING ,VERTIGO ,NAUSEA. , BLEEDING AND LOW BACK PAIN AND THIGH PAIN CONFIRMAING PELVIC PAIN AND VIA PER SOCIAL MEDIA EVENT: PAIN DURING PLACEMENT WAS ADDED. BATCH NUMBER: 822365 MANUFACTURE DATE: 2011-01 EXPIRATION DATE:2014-01 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-APR-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CRUSHING PELVIC PAIN/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN PELVIS") AND GENITAL HAEMORRHAGE ("CONSTANT HEAVY BLEEDING FOR 10 MONTHS WITH ONLY A BRIEF BREAK WHILE TAKING PROGESTERONE AND A FEW DAYS EVERY NOW AND AGAIN REDUCED TO SPOTTING") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CYST BREAST AND HYPERTENSION. CONCURRENT CONDITIONS INCLUDED BLADDER PROLAPSE. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2011, MORPHINE SULFATE AND PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED WEIGHT INCREASED ("GAIN WITH BLOATING"), ABDOMINAL DISTENSION ("GAIN WITH BLOATING") AND PYREXIA ("INTERMITTENT LOW GRADE FEVER"). IN (B)(6) 2011, THE PATIENT EXPERIENCED HYPOAESTHESIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS"), DIPLEGIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") AND PARAESTHESIA ("TINGLING REACHED DOWN INTO FEET"). ON THE SAME DAY, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ARTHRALGIA ("IT HAD GONE INTO MY HIP JOINTS TO THE POINT WHERE I COULDN'T WALK / JOINT ACHES/ JOINT PAIN/ WRIST PAIN/ CONSTANT JOINT PAIN IN HIPS, ELBOWS, KNEES"), FATIGUE ("EXTREME FATIGUE/ FATIGUE") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), CHEST PAIN ("CHEST PAIN/ CHEST PAINS DID OCCUR FREQUENTLY") AND ABDOMINAL PAIN LOWER ("CRAMPING"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND VERTIGO ("VERTIGO"). IN (B)(6) 2012, THE PATIENT EXPERIENCED EYE MOVEMENT DISORDER ("EYE TWITCHING"), VISION BLURRED ("BLURRY VISION") AND BLOOD PRESSURE FLUCTUATION ("CHANGE IN BLOOD PRESSURE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK ACHES/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN BACK"), QUALITY OF LIFE DECREASED ("MY LIFE SLOWLY BECAME CRIPPLING"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HYPERSENSITIVITY ("IMMUNOLOGIC REACTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PAIN IN EXTREMITY ("PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN DOWN LEGS") AND PROCEDURAL PAIN ("PAIN DURING PLACEMENT "). THE PATIENT WAS TREATED WITH OTHER ANTIINFLAMMATORY AGENTS IN COMB. AND SURGERY (BILATERAL SALPINGECTOMY (ASSISTED WITH HYSTEROSCOPE) PORTIONS OF TUBES REMOVED /D&C HYSTEROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2012. IN 2012, THE PELVIC PAIN, GENITAL HAEMORRHAGE, BACK PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA, HYPOAESTHESIA, DIPLEGIA, PARAESTHESIA, ANXIETY, EYE MOVEMENT DISORDER, VISION BLURRED, WEIGHT INCREASED, ABDOMINAL DISTENSION, VERTIGO, PYREXIA, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER HAD RESOLVED. AT THE TIME OF THE REPORT, THE ARTHRALGIA, FATIGUE AND QUALITY OF LIFE DECREASED HAD RESOLVED AND THE COMPLICATION OF DEVICE INSERTION AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, DIPLEGIA, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, PROCEDURAL PAIN, PYREXIA, QUALITY OF LIFE DECREASED, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE STATED THAT HER LIFE SLOWLY BECAME CRIPPLING. ESSURE WAS REMOVED AND THE CONSUMER INFORMED THAT WITHIN WEEKS SHE WAS PERFECTLY FINE AGAIN. DURING ESSURE INSERTION ON (B)(6) 2011, SHE HAD COMPLICATIONS, HER LEFT TUBE WAS TOO FLUFFY. WAS NOT QUITE RECEIVED AS COMPLICATION BUT WAS TOLD IT WAS THE REASON FOR EXCRUCIATING SUDDEN SHARP, PIERCING PAIN UPON INITIAL INSERTION OF LEFT TUBE. DOCTOR ADVISED TO GIVE HER MORE PAIN MEDICATION, LEFT, THEN RETURNED 5-10 MINUTES LATER WITH A SEALED MEDICAL COMPONENT. ESSURE MICRO INSERTS PLACEMENT, TRAILING COILS BOTH RIGHT AND LEFT TUBES. PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM PELVIS - ON (B)(6) 2012: RADIOPAQUE COILS PREVIOUSLY ARE NOTED NOT VISIBLE. THE CONSUMER UNDERWENT A SCAN ON AN UNSPECIFIED DATE WHICH SHOWED ESSURE WERE IMPLANTED CORRECTLY AND NEVER MIGRATED. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT: 120-125 LBS. CURRENT WEIGHT AS OF (B)(6) 2018: 100 LBS. HYSTEROSALPINGOGRAM ON (B)(6) 2012, THE RESULTS OF ESSURE CONFIRMATION TEST WAS OCCLUDED, ESSURE SUCCESSFUL WITH NO EVIDENCE OF SPILLAGE. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMING PELVIC PAIN AND VIA PER SOCIAL MEDIA EVENT: PAIN DURING PLACEMENT WAS ADDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUN-2018: PER SOCIAL MEDIA EVENT: PAIN DURING PLACEMENT 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CRUSHING PELVIC PAIN/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN PELVIS") AND GENITAL HAEMORRHAGE ("CONSTANT HEAVY BLEEDING FOR 10 MONTHS WITH ONLY A BRIEF BREAK WHILE TAKING PROGESTERONE AND A FEW DAYS EVERY NOW AND AGAIN REDUCED TO SPOTTING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BLADDER PROLAPSE. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE (B)(6) 2011. IN 2011, THE PATIENT EXPERIENCED WEIGHT INCREASED ("GAIN WITH BLOATING"), ABDOMINAL DISTENSION ("GAIN WITH BLOATING") AND PYREXIA ("INTERMITTENT LOW GRADE FEVER"). IN (B)(6) 2011, THE PATIENT EXPERIENCED HYPOAESTHESIA ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS"), PARALYSIS ("LEGS GOING NUMB WITH BRIEF PERIODS OF PARALYSIS") AND PARAESTHESIA ("TINGLING REACHED DOWN INTO FEET"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ARTHRALGIA ("IT HAD GONE INTO MY HIP JOINTS TO THE POINT WHERE I COULDN'T WALK / JOINT ACHES/ JOINT PAIN/ WRIST PAIN/ CONSTANT JOINT PAIN IN HIPS, ELBOWS, KNEES"), FATIGUE ("EXTREME FATIGUE/ FATIGUE") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), CHEST PAIN ("CHEST PAIN/ CHEST PAINS DID OCCUR FREQUENTLY") AND ABDOMINAL PAIN LOWER ("CRAMPING"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND VERTIGO ("VERTIGO"). IN (B)(6) 2012, THE PATIENT EXPERIENCED EYE MOVEMENT DISORDER ("EYE TWITCHING"), VISION BLURRED ("BLURRY VISION") AND BLOOD PRESSURE FLUCTUATION ("CHANGE IN BLOOD PRESSURE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK ACHES/ PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN BACK"), QUALITY OF LIFE DECREASED ("MY LIFE SLOWLY BECAME CRIPPLING"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), TYPE IV HYPERSENSITIVITY REACTION ("IMMUNOLOGIC REACTION"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND PAIN IN EXTREMITY ("PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN DOWN LEGS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY (ASSISTED WITH HYSTEROSCOPE) PORTIONS OF TUBES REMOVED WITH ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2012. IN 2012, THE PELVIC PAIN, BACK PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, GENITAL HAEMORRHAGE, TYPE IV HYPERSENSITIVITY REACTION, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA, HYPOAESTHESIA, PARALYSIS, PARAESTHESIA, ANXIETY, EYE MOVEMENT DISORDER, VISION BLURRED, WEIGHT INCREASED, ABDOMINAL DISTENSION, VERTIGO, PYREXIA, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, PAIN IN EXTREMITY AND ABDOMINAL PAIN LOWER HAD RESOLVED. AT THE TIME OF THE REPORT, THE ARTHRALGIA, FATIGUE AND QUALITY OF LIFE DECREASED HAD RESOLVED AND THE COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PARAESTHESIA, PARALYSIS, PELVIC PAIN, PYREXIA, QUALITY OF LIFE DECREASED, TYPE IV HYPERSENSITIVITY REACTION, VAGINAL HAEMORRHAGE, VERTIGO, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE STATED THAT HER LIFE SLOWLY BECAME CRIPPLING. ESSURE WAS REMOVED AND THE CONSUMER INFORMED THAT WITHIN WEEKS SHE WAS PERFECTLY FINE AGAIN. DURING ESSURE INSERTION ON (B)(6) 2011, SHE HAD COMPLICATIONS, HER LEFT TUBE WAS TOO FLUFFY. WAS NOT QUITE RECEIVED AS COMPLICATION BUT WAS TOLD IT WAS THE REASON FOR EXCRUCIATING SUDDEN SHARP, PIERCING PAIN UPON INITIAL INSERTION OF LEFT TUBE. DOCTOR ADVISED TO GIVE HER MORE PAIN MEDICATION, LEFT, THEN RETURNED 5-10 MINUTES LATER WITH A SEALED MEDICAL COMPONENT. DIAGNOSTIC RESULTS: THE CONSUMER UNDERWENT A SCAN ON AN UNSPECIFIED DATE WHICH SHOWED ESSURE WERE IMPLANTED CORRECTLY AND NEVER MIGRATED. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT: (B)(6). CURRENT WEIGHT AS OF (B)(6) 2018: (B)(6). HYSTEROSALPINGOGRAM ON (B)(6) 2012, THE RESULTS OF ESSURE CONFIRMATION TEST WAS OCCLUDED, ESSURE SUCCESSFUL WITH NO EVIDENCE OF SPILLAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION, PATIENT¿S DEMOGRAPHIC INFORMATION, RELEVANT HISTORY AND LAB DATA UPDATED. ESSURE LOT NUMBER AND REMOVAL DATE (B)(6) 2012 WAS ADDED. ESSURE START DATE UPDATED FROM (B)(6) 2011 TO (B)(6) 2011. EVENTS FATIGUE, JOINT PAIN/ WRIST PAIN/ CONSTANT JOINT PAIN IN HIPS, ELBOWS, KNEES, PAIN SEVERE, PERSISTENT, WITH STABBING FREQUENTLY IN PELVIS, BACK WERE CLUBBED WITH PREVIOUSLY REPORTED EVENTS. EVENTS VAGINAL HAEMORRHAGE, MENORRHAGIA, GENITAL HAEMORRHAGE, TYPE IV HYPERSENSITIVITY REACTION, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, ALOPECIA, MIGRAINE, HEADACHE, NAUSEA, HYPOAESTHESIA, PARALYSIS, PARAESTHESIA, ANXIETY, EYE MOVEMENT DISORDER, VISION BLURRED, WEIGHT INCREASED, ABDOMINAL DISTENSION, VERTIGO, PYREXIA, BLOOD PRESSURE FLUCTUATION, CHEST PAIN, PAIN IN EXTREMITY, ABDOMINAL PAIN LOWER, COMPLICATION OF DEVICE INSERTION WERE NEWLY ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230276 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R | ACETAMINOPHEN| ANAPROX| ANAPROX| AYGESTIN| AYGESTIN| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| ESTRACE| ESTRACE| MORPHINE SULFATE| MORPHINE SULFATE| MORPHINE SULFATE| MORPHINE SULFATE| MORPHINE SULFATE| MOTRIN PM| MOTRIN PM| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PREDNISONE| PREDNISONE| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]| ULTRACET| ULTRACET |