ESSURE
Report
- Report Number
- 2951250-2018-04117
- Event Type
- Injury
- Date Received
- September 25, 2018
- Date of Event
- January 7, 2005
- Report Date
- September 26, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4) ON (B)(6) 2018. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("INTENSE BACK ACHES") AND THE FIRST EPISODE OF FATIGUE ("ABNORMAL EXHAUSTION FOR NEARLY 14 YEARS") IN A 59-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12263379) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY (POSSIBLE ALLERGY OR NICKEL INTOLERANCE). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, 23 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF FATIGUE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MYALGIA ("VIOLENT MUSCLE AND JOINT PAIN THROUGHOUT MY BODY"), ARTHRALGIA ("VIOLENT MUSCLE AND JOINT PAIN THROUGHOUT MY BODY"), THE SECOND EPISODE OF FATIGUE ("FAIRLY SUDDEN EXHAUSTION, LIKE A REALLY BAD FLU BUT WITHOUT THE FEVER"), INFLUENZA LIKE ILLNESS ("FAIRLY SUDDEN EXHAUSTION, LIKE A REALLY BAD FLU BUT WITHOUT THE FEVER"), DIZZINESS ("DIZZINESS THAT MADE ME HOLD ONTO WALLS"), MUSCLE SPASMS ("UNTIMELY CRAMPS"), MUSCLE TWITCHING ("UNCONTROLLABLE TWITCHING OF MUSCLES OR NERVES"), PARAESTHESIA ("PINS AND NEEDLES IN LIMBS AND HEAD"), TINNITUS ("CRACKLING IN HEAD AND MOUTH WITH ELECTRICITY IN THE MOUTH (FAINT LIGHT)"), PARAESTHESIA ORAL ("CRACKLING IN HEAD AND MOUTH WITH ELECTRICITY IN THE MOUTH (FAINT LIGHT)"), HEAD DISCOMFORT ("HEAD HEAVINESS"), MEMORY IMPAIRMENT ("REDUCED MEMORY AND FORGETTING WORDS"), AUDITORY DISORDER ("MESSED UP HEARING"), VISION BLURRED ("BLURRY VISION"), PAROSMIA ("DISTURBED SENSE OF SMELL AND TASTE (ODOR AND FLAVOR OF ¿TIN¿)"), DYSGEUSIA ("DISTURBED SENSE OF SMELL AND TASTE (ODOR AND FLAVOR OF ¿TIN¿)"), DYSPNOEA ("SHORTNESS OF BREATH AND RACING HEART, EVEN WHEN LYING DOWN"), PALPITATIONS ("SHORTNESS OF BREATH AND RACING HEART, EVEN WHEN LYING DOWN"), ATONIC URINARY BLADDER ("BLADDER ATONY WITH SLOW URINATION AND STRONG SMELLING URINE"), URINE FLOW DECREASED ("BLADDER ATONY WITH SLOW URINATION AND STRONG SMELLING URINE"), URINE ODOUR ABNORMAL ("BLADDER ATONY WITH SLOW URINATION AND STRONG SMELLING URINE"), DECREASED APPETITE ("DISTURBED APPETITE, LIKE BEING ASLEEP (WANTING TO EAT SOMETHING BUT IMPOSSIBLE TO SWALLOW IT)"), NONINFECTIVE GINGIVITIS ("GUMS LIKE THEY ARE BURNT"), WEIGHT DECREASED ("WEIGHT LOSS"), ASTHENIA ("DIMINISHED STRENGTH"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("DESIRE TO ENGAGE IN SIMPLE BASIC ACTIVITIES BUT BODY UNWILLING"), HYPERSOMNIA ("HYPERSOMNIA WHICH TAKES OVER HUNGER"), SKIN BURNING SENSATION ("ENIGMATIC SKIN CHANGES: BURNS MOSTLY OF THE FACE AND NECK WITH RED SKIN THAT SHEDS IN YELLOW GRANULE"), RASH ERYTHEMATOUS ("ENIGMATIC SKIN CHANGES: BURNS MOSTLY OF THE FACE AND NECK WITH RED SKIN THAT SHEDS IN YELLOW GRANULE"), SKIN EXFOLIATION ("ENIGMATIC SKIN CHANGES: BURNS MOSTLY OF THE FACE AND NECK WITH RED SKIN THAT SHEDS IN YELLOW GRANULE"), PRURITUS GENERALISED ("UNTIMELY SKIN ITCHINESS (NOSE, EAR CANAL, HEAD AND FACE, LEGS, BACK AND THORAX)") AND RASH PUSTULAR ("AGGLUTINATED MICROCYSTS OF THE BACK AND FACE THAT ITCH"). ON (B)(6) 2018, THE PATIENT EXPERIENCED GASTROINTESTINAL MOTILITY DISORDER ("COLON VARYING BETWEEN ASTONISHING SLUGGISHNESS AND ASTONISHING RAPIDITY (CONSTIPATION AND DIARRHEA)"). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE BACK PAIN, MYALGIA, ARTHRALGIA, THE LAST EPISODE OF FATIGUE, INFLUENZA LIKE ILLNESS, DIZZINESS, MUSCLE SPASMS, MUSCLE TWITCHING, PARAESTHESIA, TINNITUS, PARAESTHESIA ORAL, HEAD DISCOMFORT, MEMORY IMPAIRMENT, AUDITORY DISORDER, VISION BLURRED, PAROSMIA, DYSGEUSIA, DYSPNOEA, PALPITATIONS, ATONIC URINARY BLADDER, URINE FLOW DECREASED, URINE ODOUR ABNORMAL, GASTROINTESTINAL MOTILITY DISORDER, DECREASED APPETITE, NONINFECTIVE GINGIVITIS, WEIGHT DECREASED, ASTHENIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, HYPERSOMNIA, SKIN BURNING SENSATION, RASH ERYTHEMATOUS, SKIN EXFOLIATION, PRURITUS GENERALISED AND RASH PUSTULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, ASTHENIA, ATONIC URINARY BLADDER, AUDITORY DISORDER, BACK PAIN, DECREASED APPETITE, DIZZINESS, DYSGEUSIA, DYSPNOEA, GASTROINTESTINAL MOTILITY DISORDER, HEAD DISCOMFORT, HYPERSOMNIA, INFLUENZA LIKE ILLNESS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MEMORY IMPAIRMENT, MUSCLE SPASMS, MUSCLE TWITCHING, MYALGIA, NONINFECTIVE GINGIVITIS, PALPITATIONS, PARAESTHESIA, PARAESTHESIA ORAL, PAROSMIA, PRURITUS GENERALISED, RASH ERYTHEMATOUS, RASH PUSTULAR, SKIN BURNING SENSATION, SKIN EXFOLIATION, TINNITUS, URINE FLOW DECREASED, URINE ODOUR ABNORMAL, VISION BLURRED, WEIGHT DECREASED, THE FIRST EPISODE OF FATIGUE AND THE SECOND EPISODE OF FATIGUE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: PATIENT¿S CURRENT CONDITION: ABNORMAL EXHAUSTION, BUT CONDITION IMPROVED AFTER ESSURE REMOVAL. SKIN ITCHING AND BURNING DISAPPEARED THE DAY AFTER REMOVAL. NO LONGER BEDRIDDEN. LETHARGY DISAPPEARED, MEMORY IS MUCH BETTER. SHE KNEW THAT I COULDN'T TOLERATE JEWELRY CONTAINING NICKEL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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 IN A SUPPLEMENTAL REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 21-SEP-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("INTENSE BACK ACHES") AND THE FIRST EPISODE OF FATIGUE ("ABNORMAL EXHAUSTION FOR NEARLY 14 YEARS") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12263379) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY (POSSIBLE ALLERGY OR NICKEL INTOLERANCE). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, 23 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF FATIGUE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MYALGIA ("VIOLENT MUSCLE AND JOINT PAIN THROUGHOUT MY BODY"), ARTHRALGIA ("VIOLENT MUSCLE AND JOINT PAIN THROUGHOUT MY BODY"), THE SECOND EPISODE OF FATIGUE ("FAIRLY SUDDEN EXHAUSTION, LIKE A REALLY BAD FLU BUT WITHOUT THE FEVER"), INFLUENZA LIKE ILLNESS ("FAIRLY SUDDEN EXHAUSTION, LIKE A REALLY BAD FLU BUT WITHOUT THE FEVER"), DIZZINESS ("DIZZINESS THAT MADE ME HOLD ONTO WALLS"), MUSCLE SPASMS ("UNTIMELY CRAMPS"), MUSCLE TWITCHING ("UNCONTROLLABLE TWITCHING OF MUSCLES OR NERVES"), PARAESTHESIA ("PINS AND NEEDLES IN LIMBS AND HEAD"), TINNITUS ("CRACKLING IN HEAD AND MOUTH WITH ELECTRICITY IN THE MOUTH (FAINT LIGHT)"), PARAESTHESIA ORAL ("CRACKLING IN HEAD AND MOUTH WITH ELECTRICITY IN THE MOUTH (FAINT LIGHT)"), HEAD DISCOMFORT ("HEAD HEAVINESS"), MEMORY IMPAIRMENT ("REDUCED MEMORY AND FORGETTING WORDS"), AUDITORY DISORDER ("MESSED UP HEARING"), VISION BLURRED ("BLURRY VISION"), PAROSMIA ("DISTURBED SENSE OF SMELL AND TASTE (ODOR AND FLAVOR OF ¿TIN¿)"), DYSGEUSIA ("DISTURBED SENSE OF SMELL AND TASTE (ODOR AND FLAVOR OF ¿TIN¿)"), DYSPNOEA ("SHORTNESS OF BREATH AND RACING HEART, EVEN WHEN LYING DOWN"), PALPITATIONS ("SHORTNESS OF BREATH AND RACING HEART, EVEN WHEN LYING DOWN"), ATONIC URINARY BLADDER ("BLADDER ATONY WITH SLOW URINATION AND STRONG SMELLING URINE"), URINE FLOW DECREASED ("BLADDER ATONY WITH SLOW URINATION AND STRONG SMELLING URINE"), URINE ODOUR ABNORMAL ("BLADDER ATONY WITH SLOW URINATION AND STRONG SMELLING URINE"), DECREASED APPETITE ("DISTURBED APPETITE, LIKE BEING ASLEEP (WANTING TO EAT SOMETHING BUT IMPOSSIBLE TO SWALLOW IT)"), NONINFECTIVE GINGIVITIS ("GUMS LIKE THEY ARE BURNT"), WEIGHT DECREASED ("WEIGHT LOSS"), ASTHENIA ("DIMINISHED STRENGTH"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("DESIRE TO ENGAGE IN SIMPLE BASIC ACTIVITIES BUT BODY UNWILLING"), HYPERSOMNIA ("HYPERSOMNIA WHICH TAKES OVER HUNGER"), SKIN BURNING SENSATION ("ENIGMATIC SKIN CHANGES: BURNS MOSTLY OF THE FACE AND NECK WITH RED SKIN THAT SHEDS IN YELLOW GRANULE"), RASH ERYTHEMATOUS ("ENIGMATIC SKIN CHANGES: BURNS MOSTLY OF THE FACE AND NECK WITH RED SKIN THAT SHEDS IN YELLOW GRANULE"), SKIN EXFOLIATION ("ENIGMATIC SKIN CHANGES: BURNS MOSTLY OF THE FACE AND NECK WITH RED SKIN THAT SHEDS IN YELLOW GRANULE"), PRURITUS GENERALISED ("UNTIMELY SKIN ITCHINESS (NOSE, EAR CANAL, HEAD AND FACE, LEGS, BACK AND THORAX)") AND RASH PUSTULAR ("AGGLUTINATED MICROCYSTS OF THE BACK AND FACE THAT ITCH"). ON (B)(6) 2018, THE PATIENT EXPERIENCED GASTROINTESTINAL MOTILITY DISORDER ("COLON VARYING BETWEEN ASTONISHING SLUGGISHNESS AND ASTONISHING RAPIDITY (CONSTIPATION AND DIARRHEA)"). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE BACK PAIN, MYALGIA, ARTHRALGIA, THE LAST EPISODE OF FATIGUE, INFLUENZA LIKE ILLNESS, DIZZINESS, MUSCLE SPASMS, MUSCLE TWITCHING, PARAESTHESIA, TINNITUS, PARAESTHESIA ORAL, HEAD DISCOMFORT, MEMORY IMPAIRMENT, AUDITORY DISORDER, VISION BLURRED, PAROSMIA, DYSGEUSIA, DYSPNOEA, PALPITATIONS, ATONIC URINARY BLADDER, URINE FLOW DECREASED, URINE ODOUR ABNORMAL, GASTROINTESTINAL MOTILITY DISORDER, DECREASED APPETITE, NONINFECTIVE GINGIVITIS, WEIGHT DECREASED, ASTHENIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, HYPERSOMNIA, SKIN BURNING SENSATION, RASH ERYTHEMATOUS, SKIN EXFOLIATION, PRURITUS GENERALISED AND RASH PUSTULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, ASTHENIA, ATONIC URINARY BLADDER, AUDITORY DISORDER, BACK PAIN, DECREASED APPETITE, DIZZINESS, DYSGEUSIA, DYSPNOEA, GASTROINTESTINAL MOTILITY DISORDER, HEAD DISCOMFORT, HYPERSOMNIA, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MEMORY IMPAIRMENT, MUSCLE SPASMS, MUSCLE TWITCHING, MYALGIA, NONINFECTIVE GINGIVITIS, PALPITATIONS, PARAESTHESIA, PARAESTHESIA ORAL, PAROSMIA, PRURITUS GENERALISED, RASH PUSTULAR, SKIN BURNING SENSATION, TINNITUS, URINE ODOUR ABNORMAL, VISION BLURRED, WEIGHT DECREASED, THE FIRST EPISODE OF FATIGUE AND THE SECOND EPISODE OF FATIGUE TO BE RELATED TO ESSURE (ESS205). NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PATIENT¿S CURRENT CONDITION: ABNORMAL EXHAUSTION, BUT CONDITION IMPROVED AFTER ESSURE REMOVAL. SKIN ITCHING AND BURNING DISAPPEARED THE DAY AFTER REMOVAL. NO LONGER BEDRIDDEN. LETHARGY DISAPPEARED, MEMORY IS MUCH BETTER. SHE KNEW THAT I COULDN¿T TOLERATE JEWELRY CONTAINING NICKEL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6). FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. 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 IN A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748789 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12263379 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other| R |