ESSURE
Report
- Report Number
- 2951250-2018-00209
- Event Type
- Injury
- Date Received
- January 8, 2018
- Report Date
- July 3, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5032895) ON (B)(6) 2014. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), CHOLELITHIASIS ("GALLSTONES"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), THROMBOSIS ("MANY BLOOD CLOTS IN MY BODY/ BLOOD CLOTS, PFO HEART CONDITION AND SPLENETIC INFRACT'S"), SPLENIC INFARCTION ("SPLENETIC INFRACTIONS"), SEIZURE ("SEIZURES"), LOSS OF CONSCIOUSNESS ("BLACK OUTS WITH NO RECOLLECTION OF OCCURENCE") AND CARDIAC DISORDER ("HOLE IN MY HEART/ HEART ISSUES") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 (DATE OF BIRTHS:(B)(6) 2008,(B)(6) 2011, (B)(6) 2011). IN 2011, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN"), VISION BLURRED ("BLURRED VISION"), LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("LOWER AND UPPER BACK PAIN"), FATIGUE ("FATIGUE") AND DYSGEUSIA ("CONSTANT METAL TASTE IN MY MOUTH/ SENSITIVITY TO TASTE"). IN JUNE 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN 2011, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN"), VISION BLURRED ("BLURRED VISION"), LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("LOWER AND UPPER BACK PAIN"), FATIGUE ("FATIGUE") AND DYSGEUSIA ("CONSTANT METAL TASTE IN MY MOUTH/ SENSITIVITY TO TASTE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED AND REMOVED ON (B)(6) 2013. A NEW ESSURE WAS INSERTED ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED CHOLELITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THROMBOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SPLENIC INFARCTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("SEVERE MIGRAINES / MIGRAINE HEADACHES"), MYALGIA ("MUSCLE PAIN / MUSCLE SPASMS"), PARAESTHESIA ("ELECTRIC SHOCK WHEN I TOUCHED ANYTHING"), HYPERTHYROIDISM ("HYPERACTIVE THYROID"), HYPERTENSION ("HIGH BLOOD PRESSURE"), DEPRESSION ("DEPRESSION"), CARDIAC DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("YEAR AND A HALF OF UNBEARABLE PAIN / SORENESS"), ALLERGY TO METALS ("ALLERGIC TO NICKEL"), DYSPEPSIA ("DIGESTIVE PROBLEMS/ DIGESTION AND COLON ISSUES/ DIGESTIVE ISSUES"), ABDOMINAL DISTENSION ("BLOATING"), TENDERNESS ("SENSITIVITY TO TOUCH"), PHOTOPHOBIA ("LIGHT SENSITIVITY"), IRRITABILITY ("IRRITABILITY"), ANXIETY ("ANXIETY"), HYPERVENTILATION ("HYPERVENTILATION "), DYSPNOEA ("TROUBLE BREATHING"), NAUSEA ("NAUSEA"), TOOTH LOSS ("TEETH LOSS"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL CYCLE"), ALOPECIA ("HAIR LOSS"), BALANCE DISORDER ("LOSS OF BALANCE"), DIZZINESS ("DIZZY SPELLS, DIZZINESS"), DYSPAREUNIA ("PAINFUL INTERCOURSE/LACK OF INTIMACY"), FEELING ABNORMAL ("BRAIN FOG") AND PREMATURE MENOPAUSE ("EARLY ONSET MENOPAUSE SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY) AND SURGERY (GALLBLADDER REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CHOLELITHIASIS, THROMBOSIS, SPLENIC INFARCTION, SEIZURE, MIGRAINE, ABDOMINAL PAIN, MYALGIA, ARTHRALGIA, VISION BLURRED, BACK PAIN, FATIGUE, PARAESTHESIA, HYPERTHYROIDISM, HYPERTENSION, DEPRESSION, CARDIAC DISORDER, PAIN, ALLERGY TO METALS, DYSPEPSIA, TENDERNESS, PHOTOPHOBIA, IRRITABILITY, ANXIETY, HYPERVENTILATION, NAUSEA, TOOTH LOSS, MENSTRUAL DISORDER, ALOPECIA, BALANCE DISORDER, DIZZINESS, DYSPAREUNIA, FEELING ABNORMAL AND PREMATURE MENOPAUSE HAD NOT RESOLVED, THE GENITAL HAEMORRHAGE, DYSGEUSIA AND ABDOMINAL DISTENSION HAD RESOLVED AND THE LOSS OF CONSCIOUSNESS AND DYSPNOEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR HYPERTENSION, HYPERTHYROIDISM, LOSS OF CONSCIOUSNESS AND PARAESTHESIA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BALANCE DISORDER, CARDIAC DISORDER, CHOLELITHIASIS, DEPRESSION, DIZZINESS, DYSGEUSIA, DYSPAREUNIA, DYSPEPSIA, DYSPNOEA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HYPERVENTILATION, IRRITABILITY, MENSTRUAL DISORDER, MIGRAINE, MYALGIA, NAUSEA, PAIN, PELVIC PAIN, PHOTOPHOBIA, PREMATURE MENOPAUSE, SEIZURE, SPLENIC INFARCTION, TENDERNESS, THROMBOSIS, TOOTH LOSS AND VISION BLURRED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE CONFIRMATION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT 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 ON A SUPPLEMENTAL REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FOOD AND DRUG ADMINISTRATION (REFERENCE NUMBER: MW5032895) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEEDING"), THROMBOSIS ("MANY BLOOD CLOTS IN MY BODY/ BLOOD CLOTS, PFO HEART CONDITION AND SPLENETIC INFRACTS"), LOSS OF CONSCIOUSNESS ("BLACK OUTS WITH NO RECOLLECTION OF OCCURENCE"), CHOLELITHIASIS (¿GALLSTONES¿), CARDIAC DISORDER ("HOLE IN MY HEART/ HEART ISSUES"), SPLENIC INFARCTION (¿SPLENETIC INFRACTIONS¿) AND SEIZURES (¿SEIZURES¿) IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 (DATE OF BIRTHS: (B)(6) 2008, (B)(6) 2011). IN 2011, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN"), VISION BLURRED ("BLURRED VISION"), LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("LOWER AND UPPER BACK PAIN"), FATIGUE ("FATIGUE") AND DYSGEUSIA ("CONSTANT METAL TASTE IN MY MOUTH/ SENSITIVITY TO TASTE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THROMBOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("SEVERE MIGRAINES / MIGRAINE HEADACHES"), MYALGIA ("MUSCLE PAIN / MUSCLE SPASMS"), CARDIAC DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("YEAR AND A HALF OF UNBEARABLE PAIN / SORENESS"), DYSPEPSIA ("DIGESTIVE PROBLEMS/ DIGESTION AND COLON ISSUES/ DIGESTIVE ISSUES"), ABDOMINAL DISTENSION ("BLOATING"), TENDERNESS ("SENSITIVITY TO TOUCH") AND PHOTOPHOBIA ("LIGHT SENSITIVITY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PARAESTHESIA ("ELECTRIC SHOCK WHEN I TOUCHED ANYTHING"), HYPERTHYROIDISM ("HYPERACTIVE THYROID"), HYPERTENSION ("HIGH BLOOD PRESSURE"), DEPRESSION ("DEPRESSION") AND ALLERGY TO METALS ("ALLERGIC TO NICKEL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THROMBOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("SEVERE MIGRAINES / MIGRAINE HEADACHES"), MYALGIA ("MUSCLE PAIN / MUSCLE SPASMS"), CARDIAC DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("YEAR AND A HALF OF UNBEARABLE PAIN / SORENESS"), DYSPEPSIA ("DIGESTIVE PROBLEMS/ DIGESTION AND COLON ISSUES/ DIGESTIVE ISSUES"), ABDOMINAL DISTENSION ("BLOATING"), TENDERNESS ("SENSITIVITY TO TOUCH") AND PHOTOPHOBIA ("LIGHT SENSITIVITY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PARAESTHESIA ("ELECTRIC SHOCK WHEN I TOUCHED ANYTHING"), HYPERTHYROIDISM ("HYPERACTIVE THYROID"), HYPERTENSION ("HIGH BLOOD PRESSURE"), DEPRESSION ("DEPRESSION") IRRITABILITY (¿IRRITABILITY¿), ANXIETY (¿ANXIETY¿), HYPERVENTILATION (¿HYPERVENTILATION/ TROUBLE BREATHING¿), NAUSEA (¿NAUSEA¿), SPLENIC INFARCTION (SERIOUS CRITERION MEDICALLY SIGNIFICANT), TOOTH LOSS (¿TEETH LOSS¿), MENSTRUAL DISORDER (¿ABNORMAL MENSTRUAL CYCLE¿), SEIZURES (SERIOUS CRITERION MEDICALLY SIGNIFICANT), ALOPECIA (¿HAIR LOSS¿), BALANCE DISORDER (¿LOSS OF BALANCE¿), DIZZINESS (¿DIZZY SPELLS, DIZZINESS¿), DYSPAREUNIA (¿PAINFUL INTERCOURSE/LACK OF INTIMACY¿), FEELING ABNORMAL (¿BRAIN FOG¿), PREMATURE MENOPAUSE (¿EARLY ONSET MENOPAUSE SYMPTOMS¿) AND ALLERGY TO METALS ("ALLERGIC TO NICKEL"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY) (GALLBLADDER REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, THROMBOSIS, ABDOMINAL PAIN, LOSS OF CONSCIOUSNESS, CARDIAC DISORDER, PAIN, TENDERNESS AND PHOTOPHOBIA OUTCOME WAS UNKNOWN, THE MIGRAINE, MYALGIA, ARTHRALGIA, VISION BLURRED, DYSPEPSIA, BACK PAIN, FATIGUE, PARAESTHESIA, HYPERTHYROIDISM, HYPERTENSION, DEPRESSION IRRITABILITY, ANXIETY, HYPERVENTILATION, NAUSEA, SPLENIC INFARCTION, TOOTH LOSS, CHOLELITHIASIS, MENSTRUAL DISORDER, SEIZURES, ALOPECIA, BALANCE DISORDER, DIZZINESS, DYSPAREUNIA, FEELING ABNORMAL AND PREMATURE MENOPAUSE IRRITABILITY, ANXIETY, HYPERVENTILATION, NAUSEA, SPLENIC INFARCTION, TOOTH LOSS, CHOLELITHIASIS, MENSTRUAL DISORDER, SEIZURES, ALOPECIA, BALANCE DISORDER, DIZZINESS, DYSPAREUNIA, FEELING ABNORMAL AND PREMATURE MENOPAUSE AND ALLERGY TO METALS OUTCOME WAS NOT RECOVERED/NOT RESOLVED AND GENITAL HAEMORRHAGE, DYSGEUSIA, ABDOMINAL DISTENSION OUTCOME WAS RECOVERED/RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ARTHRALGIA, BACK PAIN, CARDIAC DISORDER, DEPRESSION, DYSGEUSIA, DYSPEPSIA, FATIGUE, GENITAL HAEMORRHAGE, MIGRAINE, MYALGIA, PAIN, PELVIC PAIN, PHOTOPHOBIA, TENDERNESS, THROMBOSIS IRRITABILITY, ANXIETY, HYPERVENTILATION, NAUSEA, SPLENIC INFARCTION, TOOTH LOSS, CHOLELITHIASIS, MENSTRUAL DISORDER, SEIZURES, ALOPECIA, BALANCE DISORDER, DIZZINESS, DYSPAREUNIA, FEELING ABNORMAL AND PREMATURE MENOPAUSE AND VISION BLURRED TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR HYPERTENSION, HYPERTHYROIDISM, LOSS OF CONSCIOUSNESS AND PARAESTHESIA WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: ESSURE CONFIRMATION. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT. NO LOT NUMBER PROVIDED; THEREFORE, NO LOT HISTORY RECORD (LHR) REVIEW COULD BE DONE. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSIONS CAN BE DRAWN. NO CAPA INVESTIGATION IS REQUIRED PER CRITERIA ESTABLISHED IN WI-(B)(4), ¿PROCESSING ESSURE CASES IN DEV@COM.¿ (B)(4). MEDICAL ASSESSMENT. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE FOR A QUALITY DEFICIT PER SE. THE MEDICAL EVENTS WERE REPORTED WITH AN OCCURRENCE OVER A PERIOD OF 2,5 YEARS AND ARE OF BROAD NATURE. THE MAJORITY OF THE REPORTED MEDICAL EVENTS WAS ASSESSED AS UNRELATED TO THE PRODUCT. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. AT TIME OF THIS MEDICAL EVALUATION THE TECHNICAL INVESTIGATION CONCLUDED ¿UNCONFIRMED QUALITY DEFECT¿. IN SUMMARY, BASED ON THE AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: NEW REPORTERS AND HISTORICAL CONDITIONS ADDED. NEW EVENTS ADDED: BLOATING, SENSITIVITY TO TOUCH, LIGHT SENSITIVITY, IRRITABILITY, ANXIETY, HYPERVENTILATION, TROUBLE BREATHING, NAUSEA, SPLENETIC INFRACTIONS, TEETH LOSS, GALLSTONES, ABNORMAL MENSTRUAL CYCLE, SEIZURES, HAIR LOSS, LOSS OF BALANCE, DIZZINESS, PAINFUL INTERCOURSE/LACK OF INTIMACY, BRAIN FOG, EARLY ONSET MENOPAUSE SYMPTOMS. 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. THIS SPONTANEOUS CASE REFERS TO A FEMALE CONSUMER OF NOT REPORTED AGE WHO RECEIVED ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND EXPERIENCED BLACK OUTS WITH NO RECOLLECTION OF OCCURRENCE, HOLE IN MY HEART, AND MANY BLOOD CLOTS IN MY BODY. THIS CASE IS NOT MEDICALLY CONFIRMED. ALL EVENTS ARE UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE AND CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND REGARDED AS INCIDENT. CONSIDERING THE PATHOPHYSIOLOGY OF EVENTS BLACK OUTS WITH NO RECOLLECTION OF OCCURRENCE, HOLE IN MY HEART, AND MANY BLOOD CLOTS IN MY BODY AND THE LOCAL ACTION OF ESSURE, CAUSALITY IS ASSESSED AS UNRELATED. THE CONSUMER HAD A HYSTERECTOMY TO HAVE COILS REMOVED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED: SEVERE MIGRAINES, PELVIC PAIN, ABDOMINAL PAIN, MUSCLE PAIN, JOINT PAIN, BLURRED VISION, LOWER AND UPPER BACK PAIN, FATIGUE, CONSTANT METAL TASTE IN MY MOUTH, ELECTRIC SHOCK WHEN I TOUCHED ANYTHING, HYPERACTIVE THYROID, HIGH BLOOD PRESSURE, DEPRESSION, YEAR AND A HALF OF UNBEARABLE PAIN, ALLERGIC TO NICKEL, AND DIGESTIVE PROBLEMS. PRODUCT TECHNICAL COMPLAINT INVESTIGATION RECEIVED: BASED ON THE AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT QUALITY DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17044 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |