ESSURE
Report
- Report Number
- 2951250-2017-07802
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- January 1, 2012
- Report Date
- April 9, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: FDA-(B)(4)) ON 24-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-JUN-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/CHRONIC PELVIC PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VERTIGO ("VERTIGO INTERFERES WITH DAILY LIFE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 1 IN (B)(6) 2011, GONORRHEA, GRAVIDA II, PARITY 3 AND ABDOMINAL HERNIA REPAIR (2012) IN 1995. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL IRRITATION, CHRONIC CERVICITIS AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. IN 2011, THE PATIENT EXPERIENCED ALOPECIA ("MY HAIR IS CONSTANTLY FALLING OUT/HAIR LOSS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VERTIGO (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("MESSED WITH MY HORMONES"), WEIGHT LOSS POOR ("CAN NOT LOSE WEIGHT"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CAN NOT CONCENTRATE"), MOTOR DYSFUNCTION ("MY MOTOR SKITTS ARE DECLINING"), HEADACHE ("HEADACHE"), DIZZINESS ("CONSTANT DIZZINESS"), DEPRESSED MOOD ("FEEL DEPRESSED"), ANGER ("ANGRY AT THE WORLD"), APATHY ("SEVERE LACK OF MOTIVATION"), ABDOMINAL DISTENSION ("EXCESSIVE BLOATING/BLOATING"), ABDOMINAL PAIN ("SEVERE CRAMPS"), MENORRHAGIA ("MY BLOOD FLOW IS SO HEAVY MASSIVE SIZED DOTS / ABNORMAL BLEEDING(MENORRHAGIA)"), ARTHRALGIA ("JOINT PAIN"), RESTLESS LEGS SYNDROME ("RESTLESS LEG SYNDROME"), ABDOMINAL PAIN UPPER ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), MUSCLE TWITCHING ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), DISCOMFORT ("UNCOMFORTABLE"), FEELING ABNORMAL ("FEEL SO HORRIBLE"), INFLAMMATION ("CONSTANT INFLAMMATORY RESPONSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("FIRST PANIC ATTACK"), FATIGUE ("EXHAUSTED, CHRONIC FATIGUE / FATIGUE") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL LACERATION ("VAGINAL LACERATION"), URINARY TRACT INFECTION ("UTI"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), UTERINE CERVICAL PAIN ("CERVIX PAIN"), DYSMENORRHOEA ("MENSTRUAL CRAMP") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE DEVICE REMOVAL /HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VERTIGO, HORMONE LEVEL ABNORMAL, WEIGHT LOSS POOR, ALOPECIA, AMNESIA, DISTURBANCE IN ATTENTION, MOTOR DYSFUNCTION, HEADACHE, DIZZINESS, DEPRESSED MOOD, ANGER, APATHY, ABDOMINAL PAIN, MENORRHAGIA, RESTLESS LEGS SYNDROME, ABDOMINAL PAIN UPPER, MUSCLE TWITCHING, DISCOMFORT, FEELING ABNORMAL, INFLAMMATION, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, VAGINAL LACERATION, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL PAIN, UTERINE CERVICAL PAIN, DYSMENORRHOEA AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN, THE PANIC ATTACK AND ANXIETY WAS RESOLVING AND THE FATIGUE, ABDOMINAL DISTENSION AND ARTHRALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANGER, ANXIETY, APATHY, ARTHRALGIA, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEPRESSED MOOD, DISCOMFORT, DISTURBANCE IN ATTENTION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, INFLAMMATION, MENORRHAGIA, MOTOR DYSFUNCTION, MUSCLE TWITCHING, PANIC ATTACK, PELVIC PAIN, RESTLESS LEGS SYNDROME, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE CERVICAL PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, VULVOVAGINAL PAIN AND WEIGHT LOSS POOR TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. UNKNOWN DATE: TESTS: ALL NORMAL. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED. MOREOVER, THE REPORTED MEDICAL EVENT(S) ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. A BATCH REVIEW OF SIMILAR CASES IS NOT APPLICABLE AS NO BATCH NUMBER WAS REPORTED. IN SUMMARY, BASED ON THE AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN REPORTED MEDICAL EVENT (S) AND QUALITY DEFECT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2018: PFS RECEIVED - NEW EVENTS "ABNORMAL BLEEDING (VAGINAL), ANXIETY, BLADDER PROBLEMS OR CHANGE, URINARY PROBLEMS OR CHANGES, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, VAGINAL LACERATION, UTI, BACTERIAL VAGINOSIS, VAGINAL PAIN, CERVIX PAIN, MENSTRUAL CRAMP, LOWER ABDOMINAL PAIN" WERE ADDED. LOT NUMBER WAS ADDED. NEW REPORTER WERE ADDED. PRODUCT IMPLANT DATE WAS UPDATED. 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.
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: FDA-2014-N-0736-1625) ON 24-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 28-AUG-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/CHRONIC PELVIC PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VERTIGO ("VERTIGO INTERFERES WITH DAILY LIFE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 1 IN (B)(6) 2011, GONORRHEA, MULTIGRAVIDA, PARITY 3 AND ABDOMINAL HERNIA REPAIR (2012) IN 1995. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL IRRITATION, CHRONIC CERVICITIS AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ALOPECIA ("MY HAIR IS CONSTANTLY FALLING OUT/HAIR LOSS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VERTIGO (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("MESSED WITH MY HORMONES"), WEIGHT LOSS POOR ("CAN NOT LOSE WEIGHT"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CAN NOT CONCENTRATE"), MOTOR DYSFUNCTION ("MY MOTOR SKITTS ARE DECLINING"), HEADACHE ("HEADACHE"), DIZZINESS ("CONSTANT DIZZINESS"), DEPRESSED MOOD ("FEEL DEPRESSED"), ANGER ("ANGRY AT THE WORLD"), APATHY ("SEVERE LACK OF MOTIVATION"), ABDOMINAL DISTENSION ("EXCESSIVE BLOATING/BLOATING"), ABDOMINAL PAIN ("SEVERE CRAMPS"), MENORRHAGIA ("MY BLOOD FLOW IS SO HEAVY MASSIVE SIZED DOTS / ABNORMAL BLEEDING(MENORRHAGIA)"), ARTHRALGIA ("JOINT PAIN"), RESTLESS LEGS SYNDROME ("RESTLESS LEG SYNDROME"), ABDOMINAL PAIN UPPER ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), MUSCLE TWITCHING ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), DISCOMFORT ("UNCOMFORTABLE"), FEELING ABNORMAL ("FEEL SO HORRIBLE"), INFLAMMATION ("CONSTANT INFLAMMATORY RESPONSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("FIRST PANIC ATTACK"), FATIGUE ("EXHAUSTED, CHRONIC FATIGUE / FATIGUE") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL LACERATION ("VAGINAL LACERATION"), URINARY TRACT INFECTION ("UTI"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), UTERINE CERVICAL PAIN ("CERVIX PAIN"), DYSMENORRHOEA ("MENSTRUAL CRAMP") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE DEVICE REMOVAL /HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VERTIGO, HORMONE LEVEL ABNORMAL, WEIGHT LOSS POOR, ALOPECIA, AMNESIA, DISTURBANCE IN ATTENTION, MOTOR DYSFUNCTION, HEADACHE, DIZZINESS, DEPRESSED MOOD, ANGER, APATHY, ABDOMINAL PAIN, MENORRHAGIA, RESTLESS LEGS SYNDROME, ABDOMINAL PAIN UPPER, MUSCLE TWITCHING, DISCOMFORT, FEELING ABNORMAL, INFLAMMATION, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, VAGINAL LACERATION, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL PAIN, UTERINE CERVICAL PAIN, DYSMENORRHOEA AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN, THE PANIC ATTACK AND ANXIETY WAS RESOLVING AND THE FATIGUE, ABDOMINAL DISTENSION AND ARTHRALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANGER, ANXIETY, APATHY, ARTHRALGIA, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEPRESSED MOOD, DISCOMFORT, DISTURBANCE IN ATTENTION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, INFLAMMATION, MENORRHAGIA, MOTOR DYSFUNCTION, MUSCLE TWITCHING, PANIC ATTACK, PELVIC PAIN, RESTLESS LEGS SYNDROME, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE CERVICAL PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, VULVOVAGINAL PAIN AND WEIGHT LOSS POOR TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. UNKNOWN DATE: TESTS: ALL NORMAL. 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 28-AUG-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 (FDA, REFERENCE NUMBER: FDA-2014-N-0736-1625) ON 24-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-OCT-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/CHRONIC PELVIC PAIN'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING'), VAGINAL LACERATION ('VAGINAL LACERATION') AND VERTIGO ('VERTIGO INTERFERES WITH DAILY LIFE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 1 (B)(6) 2011, ABDOMINAL HERNIA REPAIR (2012) IN 1995, GONORRHEA, MULTIGRAVIDA AND PARITY 3. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL IRRITATION, CHRONIC CERVICITIS AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. IN 2011, THE PATIENT EXPERIENCED ALOPECIA ("MY HAIR IS CONSTANTLY FALLING OUT/HAIR LOSS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VERTIGO (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT LOSS POOR ("CAN NOT LOSE WEIGHT"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CAN NOT CONCENTRATE"), MOTOR DYSFUNCTION ("MY MOTOR SKITTS ARE DECLINING"), HEADACHE ("HEADACHE"), DIZZINESS ("CONSTANT DIZZINESS"), DEPRESSED MOOD ("FEEL DEPRESSED"), ANGER ("ANGRY AT THE WORLD"), APATHY ("SEVERE LACK OF MOTIVATION"), ABDOMINAL DISTENSION ("EXCESSIVE BLOATING/BLOATING"), ABDOMINAL PAIN ("SEVERE CRAMPS"), MENORRHAGIA ("MY BLOOD FLOW IS SO HEAVY MASSIVE SIZED DOTS / ABNORMAL BLEEDING(MENORRHAGIA)"), ARTHRALGIA ("JOINT PAIN"), RESTLESS LEGS SYNDROME ("RESTLESS LEG SYNDROME"), ABDOMINAL PAIN UPPER ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), MUSCLE TWITCHING ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), DISCOMFORT ("UNCOMFORTABLE"), FEELING ABNORMAL ("FEEL SO HORRIBLE"), INFLAMMATION ("CONSTANT INFLAMMATORY RESPONSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("MESSED WITH MY HORMONES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("FIRST PANIC ATTACK"), FATIGUE ("EXHAUSTED, CHRONIC FATIGUE / FATIGUE") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL LACERATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("UTI"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), UTERINE CERVICAL PAIN ("CERVIX PAIN"), DYSMENORRHOEA ("MENSTRUAL CRAMP"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND LAZINESS ("LAZINESS IS NOT A CHOICE WHEN YOU CANT CONTROL IT. I FIGHT IT EVERY DAY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE DEVICE REMOVAL /HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, HORMONE LEVEL ABNORMAL, WEIGHT LOSS POOR, ALOPECIA, AMNESIA, DISTURBANCE IN ATTENTION, MOTOR DYSFUNCTION, HEADACHE, DIZZINESS, DEPRESSED MOOD, ANGER, APATHY, ABDOMINAL PAIN, MENORRHAGIA, RESTLESS LEGS SYNDROME, ABDOMINAL PAIN UPPER, MUSCLE TWITCHING, DISCOMFORT, FEELING ABNORMAL, INFLAMMATION, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL PAIN, UTERINE CERVICAL PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER AND LAZINESS OUTCOME WAS UNKNOWN, THE PANIC ATTACK AND ANXIETY WAS RESOLVING AND THE FATIGUE, ABDOMINAL DISTENSION AND ARTHRALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANGER, ANXIETY, APATHY, ARTHRALGIA, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEPRESSED MOOD, DISCOMFORT, DISTURBANCE IN ATTENTION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, INFLAMMATION, LAZINESS, MENORRHAGIA, MOTOR DYSFUNCTION, MUSCLE TWITCHING, PANIC ATTACK, PELVIC PAIN, RESTLESS LEGS SYNDROME, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE CERVICAL PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, VULVOVAGINAL PAIN AND WEIGHT LOSS POOR TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. UNKNOWN DATE: TESTS: ALL NORMAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA: LAZINESS. 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 1-OCT-2019: SOCIAL MEDIA: REPORTERS WERE ADDED. NEW EVENT- LAZINESS 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: FDA-2014-N-0736-1625) ON (B)(6) 2015. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/CHRONIC PELVIC PAIN'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING'), VAGINAL LACERATION ('VAGINAL LACERATION') AND VERTIGO ('VERTIGO INTERFERES WITH DAILY LIFE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 1 IN (B)(6) 2011, ABDOMINAL HERNIA REPAIR (2012) IN 1995, GONORRHEA, MULTIGRAVIDA AND PARITY 3. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL IRRITATION, CHRONIC CERVICITIS AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. IN 2011, THE PATIENT EXPERIENCED ALOPECIA ("MY HAIR IS CONSTANTLY FALLING OUT/HAIR LOSS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VERTIGO (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT LOSS POOR ("CAN NOT LOSE WEIGHT"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CAN NOT CONCENTRATE"), MOTOR DYSFUNCTION ("MY MOTOR SKITTS ARE DECLINING"), HEADACHE ("HEADACHE"), DIZZINESS ("CONSTANT DIZZINESS"), DEPRESSED MOOD ("FEEL DEPRESSED"), ANGER ("ANGRY AT THE WORLD"), APATHY ("SEVERE LACK OF MOTIVATION"), ABDOMINAL DISTENSION ("EXCESSIVE BLOATING/BLOATING"), ABDOMINAL PAIN ("SEVERE CRAMPS"), MENORRHAGIA ("MY BLOOD FLOW IS SO HEAVY MASSIVE SIZED DOTS / ABNORMAL BLEEDING(MENORRHAGIA)/ FIRST TWO DAYS ARE SUPER HEAVY"), ARTHRALGIA ("JOINT PAIN"), RESTLESS LEGS SYNDROME ("RESTLESS LEG SYNDROME"), ABDOMINAL PAIN UPPER ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), MUSCLE TWITCHING ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), DISCOMFORT ("UNCOMFORTABLE"), FEELING ABNORMAL ("FEEL SO HORRIBLE"), INFLAMMATION ("CONSTANT INFLAMMATORY RESPONSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("MESSED WITH MY HORMONES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("FIRST PANIC ATTACK"), FATIGUE ("EXHAUSTED, CHRONIC FATIGUE / FATIGUE") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL LACERATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("UTI"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), UTERINE CERVICAL PAIN ("CERVIX PAIN"), DYSMENORRHOEA ("MENSTRUAL CRAMP"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), LAZINESS ("LAZINESS IS NOT A CHOICE WHEN YOU CANT CONTROL IT. I FIGHT IT EVERY DAY"), HYPOTENSION ("LOW BLOOD PRESSURE") AND RASH ("RASH"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE DEVICE REMOVAL /HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, HORMONE LEVEL ABNORMAL, WEIGHT LOSS POOR, ALOPECIA, AMNESIA, DISTURBANCE IN ATTENTION, MOTOR DYSFUNCTION, HEADACHE, DIZZINESS, DEPRESSED MOOD, ANGER, APATHY, ABDOMINAL PAIN, MENORRHAGIA, RESTLESS LEGS SYNDROME, ABDOMINAL PAIN UPPER, MUSCLE TWITCHING, DISCOMFORT, FEELING ABNORMAL, INFLAMMATION, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL PAIN, UTERINE CERVICAL PAIN, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, LAZINESS, HYPOTENSION AND RASH OUTCOME WAS UNKNOWN, THE PANIC ATTACK AND ANXIETY WAS RESOLVING AND THE FATIGUE, ABDOMINAL DISTENSION AND ARTHRALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANGER, ANXIETY, APATHY, ARTHRALGIA, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEPRESSED MOOD, DISCOMFORT, DISTURBANCE IN ATTENTION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPOTENSION, INFLAMMATION, LAZINESS, MENORRHAGIA, MOTOR DYSFUNCTION, MUSCLE TWITCHING, PANIC ATTACK, PELVIC PAIN, RASH, RESTLESS LEGS SYNDROME, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE CERVICAL PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, VULVOVAGINAL PAIN AND WEIGHT LOSS POOR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FOLLOW UP- 9 AND 10 WERE PROCESSED TOGETHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. UNKNOWN DATE: TESTS: ALL NORMAL CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING WERE DESCRIBED IN SOCIAL MEDIA: LAZINESS. 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 10-DEC-2019: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION UPDATED. PRODUCT DETAILS UPDATED. EVENTS: LOW BLOOD PRESSURE, RASH WERE NEWLY ADDED. ON 10-DEC-2019: SOCIAL MEDIA RECEIVED. NO NEW INFORMATION ADDED. 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/CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 1 ON (B)(6) 2011, ABDOMINAL HERNIA REPAIR (2012) IN 1995, GONORRHEA, MULTIGRAVIDA AND PARITY 3. UNKNOWN DATE: TESTS: ALL NORMAL. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL IRRITATION, CHRONIC CERVICITIS AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. IN 2011, THE PATIENT EXPERIENCED ALOPECIA ("MY HAIR IS CONSTANTLY FALLING OUT/HAIR LOSS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VERTIGO ("VERTIGO INTERFERES WITH DAILY LIFE"), WEIGHT LOSS POOR ("CAN NOT LOSE WEIGHT"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CAN NOT CONCENTRATE"), MOTOR DYSFUNCTION ("MY MOTOR SKITTS ARE DECLINING"), HEADACHE ("HEADACHE"), DIZZINESS ("CONSTANT DIZZINESS"), DEPRESSED MOOD ("FEEL DEPRESSED"), ANGER ("ANGRY AT THE WORLD"), APATHY ("SEVERE LACK OF MOTIVATION"), ABDOMINAL DISTENSION ("EXCESSIVE BLOATING/BLOATING"), ABDOMINAL PAIN ("SEVERE CRAMPS"), MENORRHAGIA ("MY BLOOD FLOW IS SO HEAVY MASSIVE SIZED DOTS / ABNORMAL BLEEDING (MENORRHAGIA) / FIRST TWO DAYS ARE SUPER HEAVY"), ARTHRALGIA ("JOINT PAIN"), RESTLESS LEGS SYNDROME ("RESTLESS LEG SYNDROME"), ABDOMINAL PAIN UPPER ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), MUSCLE TWITCHING ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), DISCOMFORT ("UNCOMFORTABLE"), FEELING ABNORMAL ("FEEL SO HORRIBLE"), INFLAMMATION ("CONSTANT INFLAMMATORY RESPONSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("MESSED WITH MY HORMONES"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("FIRST PANIC ATTACK"), FATIGUE ("EXHAUSTED, CHRONIC FATIGUE / FATIGUE") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ BLEEDING LIKE MY PERIODS"), VAGINAL LACERATION ("VAGINAL LACERATION"), URINARY TRACT INFECTION ("UTI"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), UTERINE CERVICAL PAIN ("CERVIX PAIN"), DYSMENORRHOEA ("MENSTRUAL CRAMP/ I DI CRAMP"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), LAZINESS ("LAZINESS IS NOT A CHOICE WHEN YOU CANT CONTROL IT. I FIGHT IT EVERY DAY"), HYPOTENSION ("LOW BLOOD PRESSURE"), RASH ("RASH") AND FUNGAL INFECTION ("YEAST INFECTION") WITH PRURITUS. THE PATIENT WAS TREATED WITH SURGERY (ESSURE DEVICE REMOVAL /HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE, ABDOMINAL DISTENSION, ARTHRALGIA, DYSMENORRHOEA AND FUNGAL INFECTION HAD RESOLVED, THE GENITAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, HORMONE LEVEL ABNORMAL, WEIGHT LOSS POOR, ALOPECIA, AMNESIA, DISTURBANCE IN ATTENTION, MOTOR DYSFUNCTION, HEADACHE, DIZZINESS, DEPRESSED MOOD, ANGER, APATHY, ABDOMINAL PAIN, MENORRHAGIA, RESTLESS LEGS SYNDROME, ABDOMINAL PAIN UPPER, MUSCLE TWITCHING, DISCOMFORT, FEELING ABNORMAL, INFLAMMATION, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL PAIN, UTERINE CERVICAL PAIN, ABDOMINAL PAIN LOWER, LAZINESS, HYPOTENSION AND RASH OUTCOME WAS UNKNOWN AND THE PANIC ATTACK AND ANXIETY WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANGER, ANXIETY, APATHY, ARTHRALGIA, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEPRESSED MOOD, DISCOMFORT, DISTURBANCE IN ATTENTION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPOTENSION, INFLAMMATION, LAZINESS, MENORRHAGIA, MOTOR DYSFUNCTION, MUSCLE TWITCHING, PANIC ATTACK, PELVIC PAIN, RASH, RESTLESS LEGS SYNDROME, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE CERVICAL PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, VULVOVAGINAL PAIN AND WEIGHT LOSS POOR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FOLLOW UP- 9 AND 10 WERE PROCESSED TOGETHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING WERE DESCRIBED IN SOCIAL MEDIA: LAZINESS, YEAST INFECTION, ITCHING. 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 14-JAN-2020: SOCIAL MEDIA RECEIVED- NEW EVENT ITCHED LIKE A YEAST INFECTION WERE ADDED. OUTCOME OF PELVIC PAIN, DYSMENORRHEA UPDATED TO RECOVERED / RESOLVED. NEW REPORTER WERE ADDED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: (B)(4)) ON 24-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 23-MAR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 1 IN (B)(6) 2011, ABDOMINAL HERNIA REPAIR (2012) IN 1995, GONORRHEA, MULTIGRAVIDA AND PARITY 3. UNKNOWN DATE: TESTS: ALL NORMAL. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, VAGINAL IRRITATION, CHRONIC CERVICITIS AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ALOPECIA ("MY HAIR IS CONSTANTLY FALLING OUT/HAIR LOSS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VERTIGO ("VERTIGO INTERFERES WITH DAILY LIFE"), WEIGHT LOSS POOR ("CAN NOT LOSE WEIGHT"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CAN NOT CONCENTRATE"), MOTOR DYSFUNCTION ("MY MOTOR SKITTS ARE DECLINING"), HEADACHE ("HEADACHE"), DIZZINESS ("CONSTANT DIZZINESS"), DEPRESSED MOOD ("FEEL DEPRESSED"), ANGER ("ANGRY AT THE WORLD"), APATHY ("SEVERE LACK OF MOTIVATION"), ABDOMINAL DISTENSION ("EXCESSIVE BLOATING/BLOATING"), ABDOMINAL PAIN ("SEVERE CRAMPS"), MENORRHAGIA ("MY BLOOD FLOW IS SO HEAVY MASSIVE SIZED DOTS / ABNORMAL BLEEDING(MENORRHAGIA)/ FIRST TWO DAYS ARE SUPER HEAVY"), ARTHRALGIA ("JOINT PAIN"), RESTLESS LEGS SYNDROME ("RESTLESS LEG SYNDROME"), ABDOMINAL PAIN UPPER ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), MUSCLE TWITCHING ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), DISCOMFORT ("UNCOMFORTABLE"), FEELING ABNORMAL ("FEEL SO HORRIBLE"), INFLAMMATION ("CONSTANT INFLAMMATORY RESPONSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("MESSED WITH MY HORMONES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("FIRST PANIC ATTACK"), FATIGUE ("EXHAUSTED, CHRONIC FATIGUE / FATIGUE") AND ANXIETY ("ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ BLEEDING LIKE MY PERIODS"), VAGINAL LACERATION ("VAGINAL LACERATION"), URINARY TRACT INFECTION ("UTI"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), UTERINE CERVICAL PAIN ("CERVIX PAIN"), DYSMENORRHOEA ("MENSTRUAL CRAMP/ I DI CRAMP"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), LAZINESS ("LAZINESS IS NOT A CHOICE WHEN YOU CANT CONTROL IT. I FIGHT IT EVERY DAY"), HYPOTENSION ("LOW BLOOD PRESSURE"), RASH ("RASH"), FUNGAL INFECTION ("YEAST INFECTION") WITH PRURITUS, COUGH ("COUGHING") AND DYSPNOEA ("SHORTNESS OF BREATH"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE DEVICE REMOVAL /HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE, ABDOMINAL DISTENSION, ARTHRALGIA, DYSMENORRHOEA AND FUNGAL INFECTION HAD RESOLVED, THE GENITAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, HORMONE LEVEL ABNORMAL, WEIGHT LOSS POOR, ALOPECIA, AMNESIA, DISTURBANCE IN ATTENTION, MOTOR DYSFUNCTION, HEADACHE, DIZZINESS, DEPRESSED MOOD, ANGER, APATHY, ABDOMINAL PAIN, MENORRHAGIA, RESTLESS LEGS SYNDROME, ABDOMINAL PAIN UPPER, MUSCLE TWITCHING, DISCOMFORT, FEELING ABNORMAL, INFLAMMATION, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSPAREUNIA, VAGINAL DISCHARGE, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL PAIN, UTERINE CERVICAL PAIN, ABDOMINAL PAIN LOWER, LAZINESS, HYPOTENSION, RASH, COUGH AND DYSPNOEA OUTCOME WAS UNKNOWN AND THE PANIC ATTACK AND ANXIETY WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COUGH AND DYSPNOEA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANGER, ANXIETY, APATHY, ARTHRALGIA, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEPRESSED MOOD, DISCOMFORT, DISTURBANCE IN ATTENTION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPOTENSION, INFLAMMATION, LAZINESS, MENORRHAGIA, MOTOR DYSFUNCTION, MUSCLE TWITCHING, PANIC ATTACK, PELVIC PAIN, RASH, RESTLESS LEGS SYNDROME, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE CERVICAL PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL LACERATION, VERTIGO, VULVOVAGINAL PAIN AND WEIGHT LOSS POOR TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING WERE DESCRIBED IN SOCIAL MEDIA: LAZINESS, YEAST INFECTION, ITCHING, COUGH, DYSPNOEA. 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 23-MAR-2020: EVENTS ADDED TO THE CASE: "COUGHING"; "SHORTNESS OF BREATH" FROM SOCIAL MEDIA REPORTS ADDED TO CASE. ON 23-MAR-2020: INFORMATION FROM CASE (B)(4) ADDED; NO NEW INFORMATION BESIDES REFERENCE 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.
HOLD - SDA THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING, WHICH TOOK PLACE TAKING PLACE IN (B)(6) 2015 (CASE# (B)(4), AWARENESS DATE (B)(6) 2015). THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/CHRONIC PELVIC PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VERTIGO ("VERTIGO INTERFERES WITH DAILY LIFE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE FERTILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 1 IN (B)(6) 2011. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PANIC ATTACK ("FIRST PANIC ATTACK"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VERTIGO (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("MESSED WITH MY HORMONES"), WEIGHT LOSS POOR ("CAN NOT LOSE WEIGHT"), ALOPECIA ("MY HAIR IS CONSTANTLY FALLING OUT/HAIR LOSS"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("CAN NOT CONCENTRATE"), MOTOR DYSFUNCTION ("MY MOTOR SKITTS ARE DECLINING"), HEADACHE ("HEADACHE"), DIZZINESS ("CONSTANT DIZZINESS"), DEPRESSED MOOD ("FEEL DEPRESSED"), ANGER ("ANGRY AT THE WORLD"), FATIGUE ("EXHAUSTED, CHRONIC FATIGUE"), APATHY ("SEVERE LACK OF MOTIVATION"), ABDOMINAL DISTENSION ("EXCESSIVE BLOATING/BLOATING"), ABDOMINAL PAIN ("SEVERE CRAMPS"), MENORRHAGIA ("MY BLOOD FLOW IS SO HEAVY MASSIVE SIZED DOTS"), ARTHRALGIA ("JOINT PAIN"), RESTLESS LEGS SYNDROME ("RESTLESS LEG SYNDROME"), ABDOMINAL PAIN UPPER ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), MUSCLE TWITCHING ("MUSCLE TWITCHING AND ESPECIALLY WHEN MY INSIDES ARE TWITCHING IN MY STOMACH"), DISCOMFORT ("UNCOMFORTABLE"), FEELING ABNORMAL ("FEEL SO HORRIBLE") AND INFLAMMATION ("CONSTANT INFLAMMATORY RESPONSE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (CHRONIC PELVIC PAIN). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VERTIGO, HORMONE LEVEL ABNORMAL, PANIC ATTACK, WEIGHT LOSS POOR, ALOPECIA, AMNESIA, DISTURBANCE IN ATTENTION, MOTOR DYSFUNCTION, HEADACHE, DIZZINESS, DEPRESSED MOOD, ANGER, FATIGUE, APATHY, ABDOMINAL DISTENSION, ABDOMINAL PAIN, MENORRHAGIA, ARTHRALGIA, RESTLESS LEGS SYNDROME, ABDOMINAL PAIN UPPER, MUSCLE TWITCHING, DISCOMFORT, FEELING ABNORMAL AND INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ALOPECIA, AMNESIA, ANGER, APATHY, ARTHRALGIA, DEPRESSED MOOD, DISCOMFORT, DISTURBANCE IN ATTENTION, DIZZINESS, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, INFLAMMATION, MENORRHAGIA, MOTOR DYSFUNCTION, MUSCLE TWITCHING, PANIC ATTACK, PELVIC PAIN, RESTLESS LEGS SYNDROME, VERTIGO AND WEIGHT LOSS POOR TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: CONFIRMED CLOSURE. UNKNOWN DATE: TESTS: ALL NORMAL. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED. MOREOVER, THE REPORTED MEDICAL EVENT(S) ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. A BATCH REVIEW OF SIMILAR CASES IS NOT APPLICABLE AS NO BATCH NUMBER WAS REPORTED. IN SUMMARY, BASED ON THE AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN REPORTED MEDICAL EVENT (S) AND QUALITY DEFECT FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: SUMMON RECEIVED. CASE WAS UPGRADED IN THE INCIDENT CATEGORY. REPORTER INFORMATION WAS UPDATED. ESSURE EXPLANTATION DATE WAS ADDED. EVENT: BLOATING WAS CLUBBED WITH EXCESSIVE BLOATING, HAIR LOSS WAS CLUBBED WITH MY HAIR IS CONSTANTLY FALLING OUT, CHRONIC PELVIC PAIN WAS CLUBBED WITH PAIN AND HEAVY BLEEDING WAS ADDED. NON DRUG TREATMENT DETAIL OF THE EVENT: CHRONIC PELVIC PAIN WAS UPDATED. EVENT OUTCOME WERE UNKNOWN. THE REPORTER ASSESSED THE EVENTS WERE RELATED TO ESSURE. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, (B)(4) TO BAYER (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¿ 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 |
|---|---|---|---|---|---|---|---|
| 834769 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS |