ESSURE
Report
- Report Number
- 2951250-2020-02528
- Event Type
- Injury
- Date Received
- March 18, 2020
- Date of Event
- January 1, 2013
- Report Date
- January 31, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN WITH RADIATION TO LEGS') IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO RELEVANT MEDICAL HISTORY AND CONCOMITANT DISEASE. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE / EXTREME AND CHRONIC FATIGUE") AND ASTHENIA ("NO ENERGY"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATED FEELING"), PAIN ("PAIN ALL OVER THE BODY"), VITAMIN B12 DEFICIENCY ("VITAMIN B-12 DEFICIENCY"), MYOPIA ("POOR DISTANCE VISION"), HAIR GROWTH ABNORMAL ("HAIR ON SCALP HAS STOPPED GROWING/IS NOT GROWING ANYMORE, OR IS HARDLY GROWING"), HYPOAESTHESIA ("LITTLE SENSATION ON SKIN"), DIZZINESS ("DIZZINESS"), INSOMNIA ("INSOMNIA") AND MEMORY IMPAIRMENT ("FORGETFULNESS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE CHRONIC PAIN IN THE ABDOMEN"), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS") AND DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. IN 2014, THE VITAMIN B12 DEFICIENCY HAD RESOLVED. IN 2016, THE HAIR GROWTH ABNORMAL AND DIZZINESS HAD RESOLVED. ON (B)(6) 2016, THE PELVIC PAIN HAD RESOLVED. ON (B)(6) 2016, THE HYPOAESTHESIA HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, HEAVY MENSTRUAL BLEEDING, MENSTRUATION IRREGULAR, HEADACHE, HORMONE LEVEL ABNORMAL, ASTHENIA, AMNESIA, ARTHRALGIA AND DISTURBANCE IN ATTENTION OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION, PAIN, FATIGUE, MYOPIA, INSOMNIA AND MEMORY IMPAIRMENT HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, ASTHENIA, BACK PAIN, DISTURBANCE IN ATTENTION, DIZZINESS, FATIGUE, HAIR GROWTH ABNORMAL, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, HYPOAESTHESIA, INSOMNIA, MEMORY IMPAIRMENT, MENSTRUATION IRREGULAR, MYOPIA, PAIN, PELVIC PAIN AND VITAMIN B12 DEFICIENCY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER ESSURE IMPLANTATION, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFERED DAMAGE. SHE WAS NOT TREATED AND NOT HOSPITALIZED. REMOVAL WAS PERFORMED AT PATIENT'S REQUEST. THE SYMPTOMS DECREASED WHEN THE ESSURE WAS REMOVED AND ALL OF THE COMPLAINTS DISAPPEARED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.9 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAY-2021: THE FOLLOWING INFORMATION WAS UPDATED: PRIMARY REPORTER AND NEW EVENTS (MEMORY LOSS, CHRONIC ABDOMINAL PAIN, CHRONIC BACK PAIN, PAIN IN HIP, HEADACHE, CONCENTRATION IMPAIRMENT, MENSTRUATION IRREGULAR, BLEEDING MENSTRUAL HEAVY, HORMONAL IMBALANCE). WE RECEIVED A LOT NUMBER IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN WITH RADIATION TO LEGS') IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO RELEVANT MEDICAL HISTORY AND CONCOMITANT DISEASE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ASTHENIA ("NO ENERGY"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATED FEELING"), PAIN ("PAIN ALL OVER THE BODY"), INSOMNIA ("INSOMNIA"), VITAMIN B12 DEFICIENCY ("VITAMIN B-12 DEFICIENCY"), MEMORY IMPAIRMENT ("FORGETFULNESS"), MYOPIA ("POOR DISTANCE VISION"), HAIR GROWTH ABNORMAL ("HAIR ON SCALP HAS STOPPED GROWING/IS NOT GROWING ANYMORE, OR IS HARDLY GROWING"), HYPOAESTHESIA ("LITTLE SENSATION ON SKIN") AND DIZZINESS ("DIZZINESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. IN 2014, THE VITAMIN B12 DEFICIENCY HAD RESOLVED. IN 2016, THE HAIR GROWTH ABNORMAL AND DIZZINESS HAD RESOLVED. ON (B)(6) 2016, THE PELVIC PAIN HAD RESOLVED. ON (B)(6) 2016, THE HYPOAESTHESIA HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL DISTENSION, PAIN, FATIGUE, INSOMNIA, MEMORY IMPAIRMENT AND MYOPIA HAD NOT RESOLVED AND THE ASTHENIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ASTHENIA, DIZZINESS, FATIGUE, HAIR GROWTH ABNORMAL, HYPOAESTHESIA, INSOMNIA, MEMORY IMPAIRMENT, MYOPIA, PAIN, PELVIC PAIN AND VITAMIN B12 DEFICIENCY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER ESSURE IMPLANTATION, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFERED DAMAGE. SHE WAS NOT TREATED AND NOT HOSPITALIZED. ESSURE WAS REMOVED. SHE HAS NOT RECOVERED. REMOVAL WAS PERFORMED AT PATIENT'S REQUEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.9 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JUN-2020: ESSURE DEVICE REMOVAL QUESTIONNAIRE WAS RECEIVED. PATIENT'S WEIGHT AND HEIGHT PROVIDED; NEW EVENT NO ENERGY ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN WITH RADIATION TO LEGS') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATED FEELING"), PAIN ("PAIN ALL OVER THE BODY"), FATIGUE ("FATIGUE"), INSOMNIA ("INSOMNIA"), VITAMIN B12 DEFICIENCY ("VITAMIN B-12 DEFICIENCY"), MEMORY IMPAIRMENT ("FORGETFULNESS"), MYOPIA ("POOR DISTANCE VISION"), HAIR GROWTH ABNORMAL ("HAIR ON SCALP HAS STOPPED GROWING/IS NOT GROWING ANYMORE, OR IS HARDLY GROWING"), HYPOAESTHESIA ("LITTLE SENSATION ON SKIN") AND DIZZINESS ("DIZZINESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON 17-(B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. IN 2014, THE VITAMIN B12 DEFICIENCY HAD RESOLVED. IN 2016, THE HAIR GROWTH ABNORMAL AND DIZZINESS HAD RESOLVED. ON (B)(6) 2016, THE PELVIC PAIN HAD RESOLVED. ON (B)(6) 2016, THE HYPOAESTHESIA HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL DISTENSION, PAIN, FATIGUE, INSOMNIA, MEMORY IMPAIRMENT AND MYOPIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, DIZZINESS, FATIGUE, HAIR GROWTH ABNORMAL, HYPOAESTHESIA, INSOMNIA, MEMORY IMPAIRMENT, MYOPIA, PAIN, PELVIC PAIN AND VITAMIN B12 DEFICIENCY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER ESSURE IMPLANTATION, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFERED DAMAGE. SHE WAS NOT TREATED AND NOT HOSPITALIZED. ESSURE WAS REMOVED. SHE HAS NOT RECOVERED QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC WE RECEIVED A LOT NUMBER IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN WITH RADIATION TO LEGS') IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATED FEELING"), PAIN ("PAIN ALL OVER THE BODY"), FATIGUE ("FATIGUE"), INSOMNIA ("INSOMNIA"), VITAMIN B12 DEFICIENCY ("VITAMIN B-12 DEFICIENCY"), MEMORY IMPAIRMENT ("FORGETFULNESS"), MYOPIA ("POOR DISTANCE VISION"), HAIR GROWTH ABNORMAL ("HAIR ON SCALP HAS STOPPED GROWING/IS NOT GROWING ANYMORE, OR IS HARDLY GROWING"), HYPOAESTHESIA ("LITTLE SENSATION ON SKIN") AND DIZZINESS ("DIZZINESS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. IN 2014, THE VITAMIN B12 DEFICIENCY HAD RESOLVED. IN 2016, THE HAIR GROWTH ABNORMAL AND DIZZINESS HAD RESOLVED. ON (B)(6) 2016, THE PELVIC PAIN HAD RESOLVED. ON (B)(6) 2016, THE HYPOAESTHESIA HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL DISTENSION, PAIN, FATIGUE, INSOMNIA, MEMORY IMPAIRMENT AND MYOPIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, DIZZINESS, FATIGUE, HAIR GROWTH ABNORMAL, HYPOAESTHESIA, INSOMNIA, MEMORY IMPAIRMENT, MYOPIA, PAIN, PELVIC PAIN AND VITAMIN B12 DEFICIENCY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER ESSURE IMPLANTATION, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFERED DAMAGE. SHE WAS NOT TREATED AND NOT HOSPITALIZED. ESSURE WAS REMOVED. SHE HAS NOT RECOVERED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-APR-2020: PATIENT ANSWERED TO FOLLOW UP REQUEST: BIRTH DATE / AGE WAS PROVIDED. ESSURE (LOT# 945067) WAS USED FOR STERILIZATION (INDICATION AND START DATE ADDED/AMENDED). DATE OF ESSURE REMOVAL: (B)(6) 2016. EVENTS WERE REPORTED (PREVIOUSLY ONLY ESSURE REMOVAL REPORTED AS EVENT). PATIENT WAS NOT HOSPITALIZED. SHE GAVE CONSENT TO CONTACT TREATING PHYSICIAN. WE RECEIVED A LOT NUMBER IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN WITH RADIATION TO LEGS / PAIN') IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945067) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO RELEVANT MEDICAL HISTORY AND CONCOMITANT DISEASE. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE / EXTREME AND CHRONIC FATIGUE") AND ASTHENIA ("NO ENERGY"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 YEARS 8 MONTHS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATED FEELING"), PAIN ("PAIN ALL OVER THE BODY"), VITAMIN B12 DEFICIENCY ("VITAMIN B-12 DEFICIENCY"), MYOPIA ("POOR DISTANCE VISION"), HAIR GROWTH ABNORMAL ("HAIR ON SCALP HAS STOPPED GROWING/IS NOT GROWING ANYMORE, OR IS HARDLY GROWING"), HYPOAESTHESIA ("LITTLE SENSATION ON SKIN"), DIZZINESS ("DIZZINESS"), INSOMNIA ("INSOMNIA") AND MEMORY IMPAIRMENT ("FORGETFULNESS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE CHRONIC PAIN IN THE ABDOMEN"), BACK PAIN ("SEVERE CHRONIC PAIN IN THE BACK"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), HEAVY MENSTRUAL BLEEDING ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), MENSTRUATION IRREGULAR ("CHANGE IN THEIR MENSTRUATION CYCLE / ABNORMALLY LARGE AMOUNT OF BLOOD LOSS"), HEADACHE ("SEVERE CHRONIC PAIN IN THE HEAD"), AMNESIA ("MEMORY LOSS"), ARTHRALGIA ("SEVERE CHRONIC PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), BLADDER DISORDER ("BLADDER PROBLEMS") AND FEELING ABNORMAL ("BRAIN FOG") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. IN 2014, THE VITAMIN B12 DEFICIENCY HAD RESOLVED. IN 2016, THE HAIR GROWTH ABNORMAL AND DIZZINESS HAD RESOLVED. ON (B)(6) 2016, THE PELVIC PAIN HAD RESOLVED. ON (B)(6) 2016, THE HYPOAESTHESIA HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY, HEAVY MENSTRUAL BLEEDING, MENSTRUATION IRREGULAR, HEADACHE, HORMONE LEVEL ABNORMAL, ASTHENIA, AMNESIA, ARTHRALGIA, DISTURBANCE IN ATTENTION, GENITAL HAEMORRHAGE, BLADDER DISORDER AND FEELING ABNORMAL OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION, PAIN, FATIGUE, MYOPIA, INSOMNIA AND MEMORY IMPAIRMENT HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, ASTHENIA, BACK PAIN, BLADDER DISORDER, DISTURBANCE IN ATTENTION, DIZZINESS, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HAIR GROWTH ABNORMAL, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, HYPOAESTHESIA, INSOMNIA, MEMORY IMPAIRMENT, MENSTRUATION IRREGULAR, MYOPIA, PAIN, PELVIC PAIN AND VITAMIN B12 DEFICIENCY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER ESSURE IMPLANTATION, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFERED DAMAGE. SHE WAS NOT TREATED AND NOT HOSPITALIZED. REMOVAL WAS PERFORMED AT PATIENT'S REQUEST. THE SYMPTOMS DECREASED WHEN THE ESSURE WAS REMOVED AND ALL OF THE COMPLAINTS DISAPPEARED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.9 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JAN-2022: NEW ADVERSE EVENTS ADDED: ABNORMAL BLEEDING, BLADDER PROBLEMS AND BRAIN FOG. WE RECEIVED A LOT NUMBER IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN MATERIAL WAS REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THE TREATMENT, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFERED DAMAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-APR-2020: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN MATERIAL WAS REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER THE TREATMENT, VARIOUS PHYSICAL SYMPTOMS DEVELOPED. AS A RESULT OF THE SYMPTOMS, SHE WAS HINDERED IN HER NORMAL DAILY FUNCTIONING AND SHE SUFFERED DAMAGE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311033 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 945067 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Required Intervention| O |