ESSURE
Report
- Report Number
- 2951250-2018-02087
- Event Type
- Injury
- Date Received
- May 7, 2018
- Report Date
- April 22, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), INFLAMMATION ("INFLAMMATION"), FATIGUE ("FATIGUE") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE IMPLANT REMOVAL). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALOPECIA, MIGRAINE, INFLAMMATION, FATIGUE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, FATIGUE, INFLAMMATION, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). 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: 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 622309) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CYSTOCELE AND DYSPAREUNIA. CONCURRENT CONDITIONS INCLUDED OBESITY AND GENITAL HAEMORRHAGE. CONCOMITANT PRODUCTS INCLUDED METHYLPHENIDATE HYDROCHLORIDE (RITALIN) FROM 2012 TO 2013 FOR ADHD AS WELL AS AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) SINCE 2013, FLUOXETINE FROM 2008 TO 2009 AND LEVONORGESTREL (MIRENA) FROM (B)(6) 2016. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2007, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), INFLAMMATION ("INFLAMMATION / OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: FULL BODY INFLAMMATION / AUTOIMMUNE DISORDER - TYPE OF DISORDER: FULL BODY INFLAMMATION"), FATIGUE ("AUTOIMMUNE DISORDER TYPE OF DISORDER: CHRONIC FATIGUE"), HEADACHE ("HEADACHES"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS / PROGRESSIVELY GOT WORSE WHEN THEY STARTED") AND IMMUNE SYSTEM DISORDER ("DEVELOPED IMMUNE ISSUES"). IN (B)(6) 2007, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN WITHIN MONTHS AFTER HAVING ESSURE IMPLANTED"). IN (B)(6) 2007, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS CLUMPS OF HAIR LOSS THROUGHOUT THE YEARS"). IN (B)(6) 2007, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH BELOW MY NECK"), ARTHRALGIA ("JOINT, HIPS, KNEES, ANKLES PAIN"), UTERINE PAIN ("UTERUS PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2008, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND NIGHT SWEATS ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: NIGHT SWEATS"). IN JANUARY 2009, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL PROBLEMS ONGOING TOOTH DECAY LEADING TO ROOT CANALS AND CROWNS ON DIFFERENT DATES OVER THE YEARS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED DRASTICALLY / VISION/EYE PROBLEMS TYPE: RAPID DECLINE IN VISION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PALPITATIONS ("BLOOD OR HEART DISORDER/CONDITION TYPE: HEART PALPITATIONS"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINITIS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE THROUGHOUT THE YEARS"), DYSPLASIA ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: DYSPLASIA") AND CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER INFECTION"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MENOPAUSE ("HORMONAL CHANGES DESCRIBE: EARLY PERI-MENOPAUSE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DRY SKIN ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: PATCHES ON SKIN BUT ARE GONE NOW AFTER REMOVAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), ADNEXA UTERI PAIN ("BILATERALLY WHERE THE COILS WHERE IN THE FALLOPIAN TUBES"), HOT FLUSH ("HOT FLASHES") AND OVARIAN CYST ("OVARIAN CYST"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN SUCCINATE (IMITREX DF) AND SURGERY (ESSURE IMPLANT REMOVAL, HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTOMY AND SURGERY (OTHER) TYPE OF SURGERY: ROOT CANALS). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, ANXIETY, MENORRHAGIA, VAGINAL HAEMORRHAGE, DRY SKIN, PALPITATIONS, DENTAL CARIES, MENOPAUSE, URINARY TRACT INFECTION, HEADACHE, AMNESIA, DEPRESSION, RASH, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, DYSPLASIA, ARTHRALGIA, UTERINE PAIN, ABDOMINAL PAIN, CYSTITIS, IMMUNE SYSTEM DISORDER, ADNEXA UTERI PAIN AND OVARIAN CYST OUTCOME WAS UNKNOWN, THE ALOPECIA, INFLAMMATION AND WEIGHT INCREASED WAS RESOLVING AND THE DYSMENORRHOEA, VAGINAL INFECTION, NIGHT SWEATS AND HOT FLUSH HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, CYSTITIS, DENTAL CARIES, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPLASIA, FATIGUE, HEADACHE, HOT FLUSH, IMMUNE SYSTEM DISORDER, INFLAMMATION, MENOPAUSE, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, OVARIAN CYST, PALPITATIONS, PELVIC PAIN, RASH, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE KIDNEYS AND BLADDER VVERE EVALUATED. THE RIGHT KIDNEY MEASURES 9.5 CM, WHILE THE LEFT MEASURES 10.3 CM IN THEIR GREATEST LENGTHS DISCREPANCY TO BE NOTED IN ESSURE INSERTION DATE AS PREVIOUSLY MENTIONED IN PFS (B)(6) 1971. CURRENT WEIGHT 180 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.3 KG/SQM. COLPOSCOPY - ON AN UNKNOWN DATE: DYSPLASIA. HAV HAD ABNORMAL CELLS AT THROUGHOUT THE YEARS.. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: ESSURE COILS WITHIN THE FALLOPIAN TUBES.. ULTRASOUND SCAN - ON AN UNKNOWN DATE: CRAMPING, HAD OVARIAN CYSTS THROUGHOUT THE YEARS.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2017: NORMAL APPEARING UTERINE CAVITY, LACK OF OPACIFICATION OF THE FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAY-2019: PFS RECEIVED: PATIENTS BIRTH DATE WAS UPDATED. EVENTS TOOTH DISORDER WAS UPDATED AS TOOTH DECAY. NEW EVENT OVARIAN CYST WAS ADDED. EVENT ONSET DATE WERE UPDATED. REPORTER CAUSALITY COMMENT WAS ADDED. EVENT OUTCOME OF NIGHT SWEATS WAS UPDATED. 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 PELVIC PAIN ('PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 622309) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CYSTOCELE AND DYSPAREUNIA. CONCURRENT CONDITIONS INCLUDED OBESITY AND GENITAL HAEMORRHAGE. CONCOMITANT PRODUCTS INCLUDED METHYLPHENIDATE HYDROCHLORIDE (RITALIN) FROM 2012 TO 2013 FOR ADHD AS WELL AS AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) SINCE 2013, FLUOXETINE FROM 2008 TO 2009 AND LEVONORGESTREL (MIRENA) FROM (B)(6) 2016 TO (B)(6) 2016. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2007, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), INFLAMMATION ("INFLAMMATION / OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: FULL BODY INFLAMMATION / AUTOIMMUNE DISORDER - TYPE OF DISORDER: FULL BODY INFLAMMATION"), FATIGUE ("AUTOIMMUNE DISORDER TYPE OF DISORDER: CHRONIC FATIGUE"), HEADACHE ("HEADACHES"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS / PROGRESIVELY GOT WORSE WHEN THEY STARTED") AND IMMUNE SYSTEM DISORDER ("DEVELOPED IMMUNE ISSUES"). IN (B)(6) 2007, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN WITHIN MONTHS AFTER HAVING ESSURE IMPALTED"). IN (B)(6) 2007, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS CLUMPS OF HAIR LOSS THROUGHOUT THE YEARS"). IN (B)(6) 2007, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH BELOW MY NECK"), ARTHRALGIA ("JOINT, HIPS, KNEES, ANKLES PAIN"), UTERINE PAIN ("UTERUS PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2008, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND NIGHT SWEATS ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: NIGHT SWEATS"). IN (B)(6) 2009, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL PROBLEMS ONGOING TOOTH DECAY LEADING TO ROOT CANALS AND CROWNS ON DIFFERENT DATES OVER THE YEARS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED DRASTICALLY / VISION/EYE PROBLEMS TYPE: RAPID DECLINE IN VISION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PALPITATIONS ("BLOOD OR HEART DISORDER/CONDITION TYPE: HEART PALPITATIONS"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINITIS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE THROUGHOUT THE YEARS"), DYSPLASIA ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: DYSPLASIA") AND CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER INFECTION"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MENOPAUSE ("HORMONAL CHANGES DESCRIBE: EARLY PERI-MENOPAUSE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DRY SKIN ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: PATCHES ON SKIN BUT ARE GONE NOW AFTER REMOVAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), ADNEXA UTERI PAIN ("BILATERALLY WHERE THE COILS WHERE IN THE FALLOPIAN TUBES"), HOT FLUSH ("HOT FLASHES"), OVARIAN CYST ("OVARIAN CYST"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS/"), FLUID RETENTION ("FLUID RETENTION") AND AMENORRHOEA ("HAVE ONLY HAD 2 THIS YEAR") AND WAS FOUND TO HAVE BLOOD FOLLICLE STIMULATING HORMONE INCREASED ("I JUST LOOKED AT MY FSH NUMBERS AND THEY ARE HIGH"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN SUCCINATE (IMITREX DF) AND SURGERY (ESSURE IMPLANT REMOVAL, HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTOMY AND SURGERY (OTHER) TYPE OF SURGERY: ROOT CANALS). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, ANXIETY, MENORRHAGIA, VAGINAL HAEMORRHAGE, DRY SKIN, PALPITATIONS, DENTAL CARIES, MENOPAUSE, URINARY TRACT INFECTION, HEADACHE, AMNESIA, DEPRESSION, RASH, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, DYSPLASIA, ARTHRALGIA, UTERINE PAIN, ABDOMINAL PAIN, CYSTITIS, IMMUNE SYSTEM DISORDER, ADNEXA UTERI PAIN, OVARIAN CYST, MENSTRUATION IRREGULAR, AMENORRHOEA AND BLOOD FOLLICLE STIMULATING HORMONE INCREASED OUTCOME WAS UNKNOWN, THE ALOPECIA, INFLAMMATION, WEIGHT INCREASED AND FLUID RETENTION WAS RESOLVING AND THE DYSMENORRHOEA, VAGINAL INFECTION, NIGHT SWEATS AND HOT FLUSH HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, AMENORRHOEA, AMNESIA, ANXIETY, ARTHRALGIA, BLOOD FOLLICLE STIMULATING HORMONE INCREASED, CYSTITIS, DENTAL CARIES, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPLASIA, FATIGUE, FLUID RETENTION, HEADACHE, HOT FLUSH, IMMUNE SYSTEM DISORDER, INFLAMMATION, MENOPAUSE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, NIGHT SWEATS, OVARIAN CYST, PALPITATIONS, PELVIC PAIN, RASH, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE KIDNEYS AND BLADDER VVERE EVALUATED. THE RIGHT KIDNEY MEASURES 9.5 CM, WHILE THE LEFT MEASURES 10.3 CM IN THEIR GREATEST LENGTHS DISCREPANCY TO BE NOTED IN ESSURE INSERTION DATE AS PREVIOUSLY MENTIONED IN PFS 13-SEP-1971. CURRENT WEIGHT 180 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.3 KG/SQM. COLPOSCOPY - ON AN UNKNOWN DATE: DYSPLASIA. HAV HAD ABNORMAL CELLS AT THROUGHOUT THE YEARS.. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: ESSURE COILS WITHIN THE FALLOPIAN TUBES.. ULTRASOUND SCAN - ON AN UNKNOWN DATE: CRAMPING, HAD OVARIAN CYSTS THROUGHOUT THE YEARS.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2017: NORMAL APPEARING UTERINE CAVITY, LACK OF OPACIFICATION OF THE FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA: MENSTRUATION IRREGULAR, FLUID RETENTION, FOLLITROPIN HIGH, AMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-SEP-2019: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION UPDATED. NEW EVENTS: "IRREGULAR PERIODS, HAVE HAD ONLY 2 THIS YEAR, FLUID RETENTION, HAVE ONLY HAD 2 THIS YEAR, I JUST LOOKED AT MY FSH NUMBERS AND THEY ARE HIGH" WERE ADDED. ON 1-OCT-2019: SOCIAL MEDIA RECEIVED. NO NEW SIGNIFICANT INFORMATION ADDED. 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 PELVIC PAIN ("PAIN") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 622309) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, CYSTOCELE AND DYSPAREUNIA. CONCURRENT CONDITIONS INCLUDED GENITAL HAEMORRHAGE. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE; DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) SINCE 2013, FLUOXETINE FROM 2008 TO 2009, LEVONORGESTREL (MIRENA) FROM (B)(6) 2016 TO (B)(6) 2016 AND METHYLPHENIDATE HYDROCHLORIDE (RITALIN) FROM 2012 TO 2013. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2007, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), IRIDOCYCLITIS ("INFLAMMATION / OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: FULL BODY INFLAMMATION"), FATIGUE ("AUTOIMMUNE DISORDER TYPE OF DISORDER: CHRONIC FATIGUE"), HEADACHE ("HEADACHES"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH BELOW MY NECK"), ARTHRALGIA ("JOINT, HIPS, KNEES, ANKLES PAIN"), UTERINE PAIN ("UTERUS PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND IMMUNE SYSTEM DISORDER ("DEVELOPED IMMUNE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN 2008, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). IN 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED DRASTICALLY"). IN 2012, THE PATIENT EXPERIENCED PALPITATIONS ("BLOOD OR HEART DISORDER/CONDITION TYPE: HEART PALPITATIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DYSPLASIA ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: DYSPLASIA") AND CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER INFECTION"). IN 2014, THE PATIENT EXPERIENCED MENOPAUSE ("HORMONAL CHANGES DESCRIBE: EARLY PERI-MENOPAUSE"). IN 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS CLUMPS OF HAIR LOSS THROUGHOUT THE YEARS"), DRY SKIN ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: PATCHES ON SKIN BUT ARE GONE NOW AFTER REMOVAL"), TOOTH DISORDER ("DENTAL PROBLEMS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), VULVOVAGINITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINITIS"), NIGHT SWEATS ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: NIGHT SWEATS"), ADNEXA UTERI PAIN ("BILATERALLY WHERE THE COILS WHERE IN THE FALLOPIAN TUBES") AND HOT FLUSH ("HOT FLASHES"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN SUCCINATE (IMITREX DF) AND SURGERY (ESSURE IMPLANT REMOVAL, HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTOMY AND SURGERY (OTHER) TYPE OF SURGERY: ROOT CANALS). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, ANXIETY, MENORRHAGIA, VAGINAL HAEMORRHAGE, DRY SKIN, PALPITATIONS, TOOTH DISORDER, MENOPAUSE, URINARY TRACT INFECTION, HEADACHE, AMNESIA, DEPRESSION, RASH, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, DYSPLASIA, ARTHRALGIA, UTERINE PAIN, ABDOMINAL PAIN, CYSTITIS, IMMUNE SYSTEM DISORDER, NIGHT SWEATS AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN, THE ALOPECIA, IRIDOCYCLITIS AND WEIGHT INCREASED WAS RESOLVING AND THE DYSMENORRHOEA, VULVOVAGINITIS AND HOT FLUSH HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, CYSTITIS, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPLASIA, FATIGUE, HEADACHE, HOT FLUSH, IMMUNE SYSTEM DISORDER, IRIDOCYCLITIS, MENOPAUSE, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PALPITATIONS, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT, VULVOVAGINITIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE KIDNEYS AND BLADDER WERE EVALUATED. THE RIGHT KIDNEY MEASURES 9.5 CM, WHILE THE LEFT MEASURES 10.3 CM IN THEIR GREATEST LENGTHS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: ESSURE COILS WITHIN THE FALLOPIAN TUBES.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2017: NORMAL APPEARING UTERINE CAVITY, LACK OF OPACIFICATION OF THE FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-FEB-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. LOT NUMBER ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: PATCHES ON SKIN BUT ARE GONE NOW AFTER REMOVAL, BLOOD OR HEART DISORDER/CONDITION TYPE: HEART PALPITATIONS, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), HORMONAL CHANGES DESCRIBE: EARLY PERI-MENOPAUSE, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINITIS, URINARY TRACT INFECTIONS, HEADACHES, NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, RASHES OR SKIN CONDITIONS TYPE: RASH BELOW MY NECK, VAGINAL DISCHARGE, VISION/EYE PROBLEMS TYPE: VISION DETERIORATED DRASTICALLY, WEIGHT GAIN, OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: DYSPLASIA, JOINT, HIPS, KNEES, ANKLES PAIN, UTERUS PAIN, ABDOMINAL PAIN, BLADDER INFECTION, DEVELOPED IMMUNE ISSUES, NIGHT SWEATS, BILATERALLY WHERE THE COILS WHERE IN THE FALLOPIAN TUBES, HOT FLASHES. EVENT INFLAMMATION UPDATED TO IRIDOCYCLITIS. OUTCOME OF EVENT IRIDOCYCLITIS AND ALOPECIA WERE UPDATED. TREATMENT AND CONCOMITANT DRUG, LAB DATA, MEDICAL HISTORY, REPORTER INFORMATION, AKA NAME 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 PELVIC PAIN ('PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 622309) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, CYSTOCELE AND DYSPAREUNIA. CONCURRENT CONDITIONS INCLUDED GENITAL HAEMORRHAGE. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) SINCE 2013, FLUOXETINE FROM 2008 TO 2009, LEVONORGESTREL (MIRENA) FROM (B)(6) 2016 TO (B)(6) 2016 AND METHYLPHENIDATE HYDROCHLORIDE (RITALIN) FROM 2012 TO 2013. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2007, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), IRIDOCYCLITIS ("INFLAMMATION / OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: FULL BODY INFLAMMATION"), FATIGUE ("AUTOIMMUNE DISORDER TYPE OF DISORDER: CHRONIC FATIGUE"), HEADACHE ("HEADACHES"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH BELOW MY NECK"), ARTHRALGIA ("JOINT, HIPS, KNEES, ANKLES PAIN"), UTERINE PAIN ("UTERUS PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND IMMUNE SYSTEM DISORDER ("DEVELOPED IMMUNE ISSUES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN 2008, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). IN 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED DRASTICALLY"). IN 2012, THE PATIENT EXPERIENCED PALPITATIONS ("BLOOD OR HEART DISORDER/CONDITION TYPE: HEART PALPITATIONS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DYSPLASIA ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: DYSPLASIA") AND CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER INFECTION"). IN 2014, THE PATIENT EXPERIENCED MENOPAUSE ("HORMONAL CHANGES DESCRIBE: EARLY PERI-MENOPAUSE"). IN 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS CLUMPS OF HAIR LOSS THROUGHOUT THE YEARS"), DRY SKIN ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: PATCHES ON SKIN BUT ARE GONE NOW AFTER REMOVAL"), TOOTH DISORDER ("DENTAL PROBLEMS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINITIS"), NIGHT SWEATS ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: NIGHT SWEATS"), ADNEXA UTERI PAIN ("BILATERALLY WHERE THE COILS WHERE IN THE FALLOPIAN TUBES") AND HOT FLUSH ("HOT FLASHES"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN SUCCINATE (IMITREX DF) AND SURGERY (ESSURE IMPLANT REMOVAL, HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTOMY AND SURGERY (OTHER) TYPE OF SURGERY: ROOT CANALS). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, ANXIETY, MENORRHAGIA, VAGINAL HAEMORRHAGE, DRY SKIN, PALPITATIONS, TOOTH DISORDER, MENOPAUSE, URINARY TRACT INFECTION, HEADACHE, AMNESIA, DEPRESSION, RASH, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, DYSPLASIA, ARTHRALGIA, UTERINE PAIN, ABDOMINAL PAIN, CYSTITIS, IMMUNE SYSTEM DISORDER, NIGHT SWEATS AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN, THE ALOPECIA, IRIDOCYCLITIS AND WEIGHT INCREASED WAS RESOLVING AND THE DYSMENORRHOEA, VAGINAL INFECTION AND HOT FLUSH HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, CYSTITIS, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPLASIA, FATIGUE, HEADACHE, HOT FLUSH, IMMUNE SYSTEM DISORDER, IRIDOCYCLITIS, MENOPAUSE, MENORRHAGIA, MIGRAINE, NIGHT SWEATS, PALPITATIONS, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE KIDNEYS AND BLADDER VVERE EVALUATED. THE RIGHT KIDNEY MEASURES 9.5 CM, WHILE THE LEFT MEASURES 10.3 CM IN THEIR GREATEST LENGTHS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: ESSURE COILS WITHIN THE FALLOPIAN TUBES.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2017: NORMAL APPEARING UTERINE CAVITY, LACK OF OPACIFICATION OF THE FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF PTC. (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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 622309) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CYSTOCELE, DYSPAREUNIA AND ADHD. CONCURRENT CONDITIONS INCLUDED OBESITY AND GENITAL HAEMORRHAGE. CONCOMITANT PRODUCTS INCLUDED METHYLPHENIDATE HYDROCHLORIDE (RITALIN) FROM 2012 TO 2013 FOR ADHD AS WELL AS AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL) SINCE 2013, FLUOXETINE FROM 2008 TO 2009 AND LEVONORGESTREL (MIRENA) FROM (B)(6) 2016 TO (B)(6) 2016. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2007, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), INFLAMMATION ("INFLAMMATION / OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: FULL BODY INFLAMMATION / AUTOIMMUNE DISORDER - TYPE OF DISORDER: FULL BODY INFLAMMATION"), FATIGUE ("AUTOIMMUNE DISORDER TYPE OF DISORDER: CHRONIC FATIGUE"), HEADACHE ("HEADACHES"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS / PROGRESIVELY GOT WORSE WHEN THEY STARTED") AND IMMUNE SYSTEM DISORDER ("DEVELOPED IMMUNE ISSUES"). IN (B)(6) 2007, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN WITHIN MONTHS AFTER HAVING ESSURE IMPALTED"). IN (B)(6) 2007, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS CLUMPS OF HAIR LOSS THROUGHOUT THE YEARS"). IN (B)(6) 2007, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH BELOW MY NECK"), ARTHRALGIA ("JOINT, HIPS, KNEES, ANKLES PAIN"), UTERINE PAIN ("UTERUS PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2008, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND NIGHT SWEATS ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: NIGHT SWEATS"). IN (B)(6) 2009, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL PROBLEMS ONGOING TOOTH DECAY LEADING TO ROOT CANALS AND CROWNS ON DIFFERENT DATES OVER THE YEARS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED DRASTICALLY / VISION/EYE PROBLEMS TYPE: RAPID DECLINE IN VISION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PALPITATIONS ("BLOOD OR HEART DISORDER/CONDITION TYPE: HEART PALPITATIONS"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINITIS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE THROUGHOUT THE YEARS"), DYSPLASIA ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: DYSPLASIA") AND CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER INFECTION"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MENOPAUSE ("HORMONAL CHANGES DESCRIBE: EARLY PERI-MENOPAUSE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DRY SKIN ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: PATCHES ON SKIN BUT ARE GONE NOW AFTER REMOVAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), ADNEXA UTERI PAIN ("BILATERALLY WHERE THE COILS WHERE IN THE FALLOPIAN TUBES"), HOT FLUSH ("HOT FLASHES"), OVARIAN CYST ("OVARIAN CYST"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS/"), FLUID RETENTION ("FLUID RETENTION"), AMENORRHOEA ("HAVE ONLY HAD 2 THIS YEAR") AND MYALGIA ("SORE MUSCLES") AND WAS FOUND TO HAVE BLOOD FOLLICLE STIMULATING HORMONE INCREASED ("I JUST LOOKED AT MY FSH NUMBERS AND THEY ARE HIGH"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SUMATRIPTAN SUCCINATE (IMITREX DF) AND SURGERY (ESSURE IMPLANT REMOVAL, HYSTERECTOMY (PARTIAL) WITH BILATERAL SALPINGECTOMY AND SURGERY (OTHER) TYPE OF SURGERY: ROOT CANALS). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, ANXIETY, MENORRHAGIA, VAGINAL HAEMORRHAGE, DRY SKIN, PALPITATIONS, DENTAL CARIES, MENOPAUSE, URINARY TRACT INFECTION, HEADACHE, AMNESIA, DEPRESSION, RASH, VAGINAL DISCHARGE, VISUAL IMPAIRMENT, DYSPLASIA, ARTHRALGIA, UTERINE PAIN, ABDOMINAL PAIN, CYSTITIS, IMMUNE SYSTEM DISORDER, ADNEXA UTERI PAIN, OVARIAN CYST, MENSTRUATION IRREGULAR, AMENORRHOEA AND BLOOD FOLLICLE STIMULATING HORMONE INCREASED OUTCOME WAS UNKNOWN, THE ALOPECIA, INFLAMMATION, WEIGHT INCREASED AND FLUID RETENTION WAS RESOLVING AND THE DYSMENORRHOEA, VAGINAL INFECTION, NIGHT SWEATS AND HOT FLUSH HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, AMENORRHOEA, AMNESIA, ANXIETY, ARTHRALGIA, BLOOD FOLLICLE STIMULATING HORMONE INCREASED, CYSTITIS, DENTAL CARIES, DEPRESSION, DRY SKIN, DYSMENORRHOEA, DYSPLASIA, FATIGUE, FLUID RETENTION, HEADACHE, HOT FLUSH, IMMUNE SYSTEM DISORDER, INFLAMMATION, MENOPAUSE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MYALGIA, NIGHT SWEATS, OVARIAN CYST, PALPITATIONS, PELVIC PAIN, RASH, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THE KIDNEYS AND BLADDER VVERE EVALUATED. THE RIGHT KIDNEY MEASURES 9.5 CM, WHILE THE LEFT MEASURES 10.3 CM IN THEIR GREATEST LENGTHS DISCREPANCY TO BE NOTED IN ESSURE INSERTION DATE AS PREVIOUSLY MENTIONED IN PFS 13-SEP-1971. CURRENT WEIGHT 180 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.3 KG/SQM. COLPOSCOPY - ON AN UNKNOWN DATE: DYSPLASIA. HAV HAD ABNORMAL CELLS AT THROUGHOUT THE YEARS. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: ESSURE COILS WITHIN THE FALLOPIAN TUBES.. ULTRASOUND SCAN - ON AN UNKNOWN DATE: CRAMPING, HAD OVARIAN CYSTS THROUGHOUT THE YEARS. ULTRASOUND SCAN VAGINA - ON (B)(6) 2017: NORMAL APPEARING UTERINE CAVITY, LACK OF OPACIFICATION OF THE FALLOPIAN TUBES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA: MENSTRUATION IRREGULAR, FLUID RETENTION, FOLLITROPIN HIGH, AMENORRHEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION WAS ADDED. EVENTS: SORE MUSCLES WAS ADDED. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), INFLAMMATION ("INFLAMMATION "), FATIGUE ("FATIGUE") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE IMPLANT REMOVAL). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALOPECIA, MIGRAINE, INFLAMMATION, FATIGUE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, FATIGUE, INFLAMMATION, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). 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 |
|---|---|---|---|---|---|---|---|
| 334350 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 622309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | ADDERALL| ADDERALL| ADDERALL| ADDERALL| ADDERALL| FLUOXETINE| FLUOXETINE| FLUOXETINE| FLUOXETINE| FLUOXETINE| MIRENA| MIRENA| MIRENA| MIRENA| MIRENA| RITALIN| RITALIN| RITALIN| RITALIN| RITALIN |