ESSURE
Report
- Report Number
- 2951250-2018-00658
- Event Type
- Injury
- Date Received
- February 15, 2018
- Report Date
- April 19, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: (B)(4)) ON 20-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 19-JUL-2018 THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("ESSURE MIGHT HAVE HAVE SIDELINED ME WITH CONSTANT PAIN") AND AUTOIMMUNE DISORDER ("ESSURE CAUSES AUTOIMMUNE DISORDERS") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS, MULTI GRAVIDA, PARITY 3 ((B)(6) 1996; (B)(6) 2007; (B)(6) 2011) AND ABORTION INDUCED. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY AND OBESITY. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE (CELEXA) FROM 2015 TO 2017, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) SINCE 2012, LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY) SINCE 2012, MONTELUKAST (SINGULAIR) SINCE 2012, TRAMADOL HYDROCHLORIDE (TAMADOL) FROM 2016 TO 2017 AND VICODIN (LORTAB) FROM 2015 TO 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA/SEVERE MENSTRUAL PERIODS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION-BLOATING EVERY TIME I ATE"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES (SEVERE MIGRAINES AT LEAST ONE WEEK)") AND WEIGHT INCREASED ("WEIGHT GAIN/, ESSURE MIGHT HAVE HAVE SIDELINED ME WITH 30 LBS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND FATIGUE ("TIRED ALL THE TIME/FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING SEX /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2016, THE PATIENT EXPERIENCED DRUG DEPENDENCE ("OPIOD DEPENDENCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SINGLE MOST PAINFUL EXPERIENCE, DAILY ABDOMINAL PAIN, PINCHING &OR STABBING FEELINGS/SEVERE AND PERSISTENT ABDOMINAL PAIN"), DEPRESSION ("CLINICAL DEPRESSION"), DIZZINESS ("DIZZINESS"), CHEST PAIN ("CHEST PAINS"), DYSURIA ("PAIN WHILE URINATING"), PAIN ("PHYSICAL PAIN"), SEASONAL ALLERGY ("SEASONAL ALLERGIES GOT WORSE"), URTICARIA ("GOT HIVES"), NAUSEA ("NAUSEA"), ANXIETY ("ANXIETY"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VULVOVAGINAL PAIN ("MILD VAGINAL PAIN"), GENERAL PHYSICAL HEALTH DETERIORATION ("ESSURE HAS CAUSED DEBILITATING SIDE EFFECTS IN MY LIFE"), ABDOMINAL PAIN UPPER ("PAINS IN MY STOMACH"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("CRAMPING") AND FEAR OF PREGNANCY ("SCARED OF BEING PREGNANT"). THE PATIENT WAS TREATED WITH SURGERY (IN 2016-2017, UNDERWENT HYSTERECTOMY TO REMOVE THE ESSURE). ESSURE WAS REMOVED IN 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, SEASONAL ALLERGY, URTICARIA, URINARY TRACT DISORDER, BLADDER DISORDER, DYSMENORRHOEA, MIGRAINE, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED, DRUG DEPENDENCE, VULVOVAGINAL PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, ABDOMINAL PAIN UPPER AND FEAR OF PREGNANCY OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, ALOPECIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, ANXIETY, HEADACHE AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE ABDOMINAL DISTENSION, DIZZINESS, CHEST PAIN, DYSPAREUNIA AND DYSURIA HAD NOT RESOLVED AND THE DEPRESSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BLADDER DISORDER, CHEST PAIN, DEPRESSION, DIZZINESS, DRUG DEPENDENCE, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FEAR OF PREGNANCY, FEMALE SEXUAL DYSFUNCTION, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, SEASONAL ALLERGY, URINARY TRACT DISORDER, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD USED CONDOMS APPROX. 2007-2011 FOR BIRTH CONTROL. IN APPROX. 2016-2017, UNDERWENT HYSTERECTOMY TO REMOVE THE ESSURE. IN SOCIAL MEDIA POST, SHE STATED THAT ESSURE PROBLEMS GET WORST FOR HER BUT SHE WAS SCARED TO GO VISIT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.3 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA POST: ¿PELVIC PAIN, WEIGHT GAIN AND AUTOIMMUNE DIORDER." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-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.
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: FDA-2014-N-0736-1507) ON (B)(6) 2015. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("ESSURE MIGHT HAVE HAVE SIDELINED ME WITH CONSTANT PAIN") AND AUTOIMMUNE DISORDER ("ESSURE CAUSES AUTOIMMUNE DISORDERS") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS, MULTI GRAVIDA, PARITY 3 ((B)(6) 1996; (B)(6) 2007; (B)(6) 2011) AND ABORTION INDUCED. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY AND OBESITY. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE (CELEXA) FROM 2015 TO 2017, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) SINCE 2012, LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY) SINCE 2012, MONTELUKAST (SINGULAIR) SINCE 2012, TRAMADOL HYDROCHLORIDE (TAMADOL) FROM 2016 TO 2017 AND VICODIN (LORTAB) FROM 2015 TO 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN AUGUST 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA/SEVERE MENSTRUAL PERIODS"). IN SEPTEMBER 2012, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION-BLOATING EVERY TIME I ATE"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/SEVERE MENSTUAL PERIODS PAIN"). IN OCTOBER 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES (SEVERE MIGRAINES AT LEAST ONE WEEK)") AND WEIGHT INCREASED ("WEIGHT GAIN/, ESSURE MIGHT HAVE HAVE SIDELINED ME WITH 30 LBS"). IN JUNE 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND FATIGUE ("TIRED ALL THE TIME/FATIGUE"). IN AUGUST 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING SEX /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2016, THE PATIENT EXPERIENCED DRUG DEPENDENCE ("OPIOD DEPENDENCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SINGLE MOST PAINFUL EXPERIENCE, DAILY ABDOMINAL PAIN, PINCHING &OR STABBING FEELINGS/SEVERE AND PERSISTENT ABDOMINAL PAIN"), DEPRESSION ("CLINICAL DEPRESSION"), DIZZINESS ("DIZZINESS"), CHEST PAIN ("CHEST PAINS"), DYSURIA ("PAIN WHILE URINATING"), PAIN ("PHYSICAL PAIN"), SEASONAL ALLERGY ("SEASONAL ALLERGIES GOT WORSE"), URTICARIA ("GOT HIVES"), NAUSEA ("NAUSEA"), ANXIETY ("ANXIETY"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VULVOVAGINAL PAIN ("MILD VAGINAL PAIN"), GENERAL PHYSICAL HEALTH DETERIORATION ("ESSURE HAS CAUSED DEBILITATING SIDE EFFECTS IN MY LIFE"), ABDOMINAL PAIN UPPER ("PAINS IN MY STOMACH"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("CRAMPING") AND FEAR OF PREGNANCY ("SCARED OF BEING PREGNANT"). THE PATIENT WAS TREATED WITH SURGERY (IN 2016-2017, UNDERWENT HYSTERECTOMY TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, SEASONAL ALLERGY, URTICARIA, URINARY TRACT DISORDER, BLADDER DISORDER, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED, DRUG DEPENDENCE, VULVOVAGINAL PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, ABDOMINAL PAIN UPPER AND FEAR OF PREGNANCY OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, FATIGUE, DEPRESSION, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, ANXIETY AND HEADACHE WAS RESOLVING, THE ABDOMINAL DISTENSION, DIZZINESS, CHEST PAIN, DYSPAREUNIA, DYSURIA AND MIGRAINE HAD NOT RESOLVED AND THE ALOPECIA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BLADDER DISORDER, CHEST PAIN, DEPRESSION, DIZZINESS, DRUG DEPENDENCE, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FEAR OF PREGNANCY, FEMALE SEXUAL DYSFUNCTION, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, SEASONAL ALLERGY, URINARY TRACT DISORDER, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD USED CONDOMS APPROX. 2007-2011 FOR BIRTH CONTROL. IN APPROX. 2016-2017, UNDERWENT HYSTERECTOMY TO REMOVE THE ESSURE. IN SOCIAL MEDIA POST, SHE STATED THAT ESSURE PROBLEMS GET WORST FOR HER BUT SHE WAS SCARED TO GO VISIT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.3 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA POST: ¿PELVIC PAIN, WEIGHT GAIN AND AUTOIMMUNE DIORDER." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED : OUTCOMES OF EVENTS, " ABDOMINAL PAIN, DEPRESSION, ANXIETY, FATIGUE, HEADACHE,CRAMPING AND APAREUNIA ." WERE UPDATED. DATE OF ESSURE REMOVAL 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.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: FDA-2014-N-0736-1507) 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 ("ESSURE MIGHT HAVE HAVE SIDELINED ME WITH CONSTANT PAIN/PELVIC PAIN") AND AUTOIMMUNE DISORDER ("ESSURE CAUSES AUTOIMMUNE DISORDERS") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS, MULTI GRAVIDA, PARITY 3 ((B)(6)1996; (B)(6)2007; (B)(6)2011), ABORTION INDUCED AND HELICOBACTER PYLORI ASSOCIATED GASTROINTESTINAL DISEASE. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY, OBESITY, CRYING ABNORMAL, VAGINAL DISCHARGE, INSOMNIA, EYE ITCHING, EYE REDNESS, CONJUNCTIVITIS, STRESS, URINARY TRACT INFECTION, URINARY FREQUENCY, BREAST PAIN, HOT FLASHES, VERTIGO, EYE PAIN, URINATION PAIN, BLURRED VISION, IRRITABILITY AND RASH. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE (CELEXA) FROM (B)(6) TO (B)(6), CORTISONE, DIPHENHYDRAMINE HYDROCHLORIDE SINCE 2012, HYDROCODONE BITARTRATE;PARACETAMOL (LORTAB) FROM (B)(6) TO (B)(6), IBUPROFEN (MOTRIN IB), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY) SINCE 2012, MONTELUKAST SODIUM (SINGULAIR) SINCE 2012 AND TRAMADOL HYDROCHLORIDE (TAMADOL) FROM (B)(6)TO (B)(6). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA/SEVERE MENSTRUAL PERIODS"), SEASONAL ALLERGY ("SEASONAL ALLERGIES GOT WORSE"), URTICARIA ("GOT HIVES"), NAUSEA ("NAUSEA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VULVOVAGINAL PAIN ("MILD VAGINAL PAIN") AND BACK PAIN ("LOWER BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/, ESSURE MIGHT HAVE HAVE SIDELINED ME WITH 30 LBS"). IN (B)(6)2012, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION-BLOATING EVERY TIME I ATE"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/SEVERE MENSTUAL PERIODS PAIN"). IN (B)(6)2012, THE PATIENT EXPERIENCED DEPRESSION ("CLINICAL DEPRESSION/DEPRESSION"), MIGRAINE ("MIGRAINES/HEADACHES (SEVERE MIGRAINES AT LEAST ONE WEEK)") AND ANXIETY ("ANXIETY"). IN (B)(6)2013, THE PATIENT EXPERIENCED FATIGUE ("TIRED ALL THE TIME/FATIGUE"). IN 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6)2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING SEX /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), THE FIRST EPISODE OF FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND THE SECOND EPISODE OF FEMALE SEXUAL DYSFUNCTION ("APAREUNIA(INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2016, THE PATIENT EXPERIENCED DRUG DEPENDENCE ("OPIOD DEPENDENCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SINGLE MOST PAINFUL EXPERIENCE, DAILY ABDOMINAL PAIN, PINCHING &OR STABBING FEELINGS/SEVERE AND PERSISTENT ABDOMINAL PAIN"), DIZZINESS ("DIZZINESS"), CHEST PAIN ("CHEST PAINS"), DYSURIA ("PAIN WHILE URINATING"), PAIN ("PHYSICAL PAIN"), GENERAL PHYSICAL HEALTH DETERIORATION ("ESSURE HAS CAUSED DEBILITATING SIDE EFFECTS IN MY LIFE"), ABDOMINAL PAIN UPPER ("PAINS IN MY STOMACH"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("CRAMPING") AND FEAR OF PREGNANCY ("SCARED OF BEING PREGNANT"). THE PATIENT WAS TREATED WITH PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL COMPLETE FORMULA CAPLETS) AND SURGERY ((B)(6)2017, TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY, DA VINCI PLATFORM). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, FATIGUE, DEPRESSION, DYSMENORRHOEA, ANXIETY, HEADACHE AND THE LAST EPISODE OF FEMALE SEXUAL DYSFUNCTION WAS RESOLVING, THE AUTOIMMUNE DISORDER, PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, SEASONAL ALLERGY, URTICARIA, URINARY TRACT DISORDER, BLADDER DISORDER, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED, DRUG DEPENDENCE, VULVOVAGINAL PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, ABDOMINAL PAIN UPPER, FEAR OF PREGNANCY AND BACK PAIN OUTCOME WAS UNKNOWN, THE ABDOMINAL DISTENSION, DIZZINESS, CHEST PAIN, DYSPAREUNIA, DYSURIA AND MIGRAINE HAD NOT RESOLVED AND THE ALOPECIA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, BLADDER DISORDER, CHEST PAIN, DEPRESSION, DIZZINESS, DRUG DEPENDENCE, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FEAR OF PREGNANCY, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, SEASONAL ALLERGY, URINARY TRACT DISORDER, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF FEMALE SEXUAL DYSFUNCTION AND THE SECOND EPISODE OF FEMALE SEXUAL DYSFUNCTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD USED CONDOMS APPROX. (B)(6)-(B)(6) FOR BIRTH CONTROL. IN APPROX. (B)(6)-(B)(6), UNDERWENT HYSTERECTOMY TO REMOVE THE ESSURE. IN SOCIAL MEDIA POST, SHE STATED THAT ESSURE PROBLEMS GET WORST FOR HER BUT SHE WAS SCARED TO GO VISIT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.3 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6)2016: IMPRESSION: NORMAL PELVIC SONO. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA POST: ¿PELVIC PAIN, WEIGHT GAIN AND AUTOIMMUNE DISORDER." CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: LOWER ABDOMINAL PAIN, VAGINAL BLEEDING, ANXIETY, DEPRESSION, DYSPAREUNIA, DYSMENORRHEA, PELVIC PAIN, BLOATING, MENSTRUAL BLEEDING, BACK PAIN, FATIGUE, WEIGHT GAIN, MENORRHAGIA, HEADACHES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-APR-2019: PFS & MEDICAL RECORD RECEIVED: NEW EVENT - LOWER BACK PAIN, FEMALE SEXUAL DYSFUNCTION ADDED. REPORTERS' INFORMATION, MEDICAL HISTORY, LAB DATA, CONCOMITANT DRUGS WERE ADDED. OUTCOME OF THE EVENT PELVIC PAIN AND APAREUNIA WAS UPDATED. THE SEVERITY OF EVENT LOW BACK PAIN 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: FDA-2014-N-0736-1507) ON 20-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-FEB-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("ESSURE MIGHT HAVE SIDELINED ME WITH CONSTANT PAIN") AND AUTOIMMUNE DISORDER ("ESSURE CAUSES AUTOIMMUNE DISORDERS") IN A (B)(6)FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS, MULTI GRAVIDA, MULTIPAROUS ((B)(6) 1996; (B)(6) 2007; (B)(6) 2011) AND ABORTION. CONCURRENT CONDITIONS INCLUDED DEPRESSION, ANXIETY AND OBESITY. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE (CELEXA) FROM 2015 TO 2017, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) SINCE 2012, LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY) SINCE 2012, MONTELUKAST (SINGULAIR) SINCE 2012, TRAMADOL HYDROCHLORIDE (TAMADOL) FROM 2016 TO 2017 AND VICODIN (LORTAB) FROM 2015 TO 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA/SEVERE MENSTRUAL PERIODS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION-BLOATING EVERY TIME I ATE"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER PROBLEMS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES (SEVERE MIGRAINES AT LEAST ONE WEEK)") AND WEIGHT INCREASED ("WEIGHT GAIN/, ESSURE MIGHT HAVE SIDELINED ME WITH 30 LBS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND FATIGUE ("TIRED ALL THE TIME/FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING SEX /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2016, THE PATIENT EXPERIENCED DRUG DEPENDENCE ("OPIOID DEPENDENCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SINGLE MOST PAINFUL EXPERIENCE, DAILY ABDOMINAL PAIN, PINCHING &OR STABBING FEELINGS/SEVERE AND PERSISTENT ABDOMINAL PAIN"), DEPRESSION ("CLINICAL DEPRESSION"), DIZZINESS ("DIZZINESS"), CHEST PAIN ("CHEST PAINS"), DYSURIA ("PAIN WHILE URINATING"), PAIN ("PHYSICAL PAIN"), SEASONAL ALLERGY ("SEASONAL ALLERGIES GOT WORSE"), URTICARIA ("GOT HIVES"), NAUSEA ("NAUSEA"), ANXIETY ("ANXIETY"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VULVOVAGINAL PAIN ("MILD VAGINAL PAIN"), GENERAL PHYSICAL HEALTH DETERIORATION ("ESSURE HAS CAUSED DEBILITATING SIDE EFFECTS IN MY LIFE"), ABDOMINAL PAIN UPPER ("PAINS IN MY STOMACH"), HEADACHE ("HEADACHES"), ABDOMINAL PAIN LOWER ("CRAMPING") AND FEAR OF PREGNANCY ("SCARED OF BEING PREGNANT"). THE PATIENT WAS TREATED WITH SURGERY (IN 2016-2017, UNDERWENT HYSTERECTOMY TO REMOVE THE ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, SEASONAL ALLERGY, URTICARIA, URINARY TRACT DISORDER, BLADDER DISORDER, DYSMENORRHOEA, MIGRAINE, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED, DRUG DEPENDENCE, VULVOVAGINAL PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, ABDOMINAL PAIN UPPER AND FEAR OF PREGNANCY OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, ALOPECIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, ANXIETY, HEADACHE AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE ABDOMINAL DISTENSION, DIZZINESS, CHEST PAIN, DYSPAREUNIA AND DYSURIA HAD NOT RESOLVED AND THE DEPRESSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BLADDER DISORDER, CHEST PAIN, DEPRESSION, DIZZINESS, DRUG DEPENDENCE, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, FATIGUE, FEAR OF PREGNANCY, FEMALE SEXUAL DYSFUNCTION, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, SEASONAL ALLERGY, URINARY TRACT DISORDER, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD USED CONDOMS APPROX. 2007-2011 FOR BIRTH CONTROL. IN APPROX. 2016-2017, UNDERWENT HYSTERECTOMY TO REMOVE THE ESSURE. IN SOCIAL MEDIA POST, SHE STATED THAT ESSURE PROBLEMS GET WORST FOR HER BUT SHE WAS SCARED TO GO VISIT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA POST: ¿PELVIC PAIN, WEIGHT GAIN AND AUTOIMMUNE DISORDER." FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-FEB-2018: PLAINTIFF FACT SHEET AND SOCIAL MEDIA POST RECEIVED. REPORTERS ADDED, PATIENT DEMOGRAPHICS WERE UPDATED, EVENTS VAGINAL BLEEDING, MENORRHAGIA, SEASONAL ALLERGIES GOT WORSE, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), MIGRAINES / HEADACHES (SEVERE MIGRAINES AT LEAST ONCE A WEEK.), NAUSEA, ANXIETY, WEIGHT GAIN, VAGINAL DISCHARGE, HEADACHES, CRAMPING AND ESSURE CONFIRMATION TEST: NO WAS ADDED FROM PFS AND EVENTS ESSURE HAS CAUSED DEBILITATING SIDE EFFECTS IN MY LIFE, ABDOMINAL PAIN UPPER, ESSURE MIGHT HAVE SIDELINED ME WITH CONSTANT PAIN, ESSURE MIGHT HAVE SIDELINED ME WITH 30 LBS AND ESSURE CAUSES AUTOIMMUNE DISORDERS AND FEAR OF PREGNANCY ADDED FROM SOCIAL MEDIA POST. CONCOMITANT MEDICATION ADDED, HISTORICAL CONDITION ADDED, INTERVENTION WAS TICKED FOR EVENT PELVIC PAIN AND HYSTERECTOMY WAS ADDED. DISABILITY WAS ADDED FOR EVENT PELVIC PAIN. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118184 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R| S | BENADRYL| BENADRYL| BENADRYL| CELEXA| CELEXA| CELEXA| CELEXA| CLARITIN-D ALLERGY| CLARITIN-D ALLERGY| CLARITIN-D ALLERGY| CLARITIN-D ALLERGY| CORTISONE| DIPHENHYDRAMINE HYDROCHLORIDE| LORTAB| LORTAB| LORTAB| LORTAB [HYDROCODONE BITARTRATE,PARACETAMOL]| MOTRIN IB| SINGULAIR| SINGULAIR| SINGULAIR| SINGULAIR| TAMADOL| TAMADOL| TAMADOL| TAMADOL| BENADRYL| CELEXA| CLARITIN-D ALLERGY| LORTAB| SINGULAIR| TAMADOL |