ESSURE
Report
- Report Number
- 2951250-2018-01691
- Event Type
- Injury
- Date Received
- April 11, 2018
- Date of Event
- May 25, 2012
- Report Date
- May 29, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), PELVIC PAIN ("PELVIC PAIN/WORSENING OF BOWEL SYSTEM PELVIC PAIN / PAIN"), PELVIC INFLAMMATORY DISEASE ("INFECTIONS: I HAD PELVIC INFLAMMATION/PELVIC INFLAMMATORY SYNDROME") AND ENDOMETRIOSIS ABLATION ("LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS") IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114- NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX LOW, ABDOMINAL PAIN LOWER, PSYCHOLOGICAL DISORDER NOS, BLADDER DISORDER NOS, URINARY TRACT DISORDER, NICKEL SENSITIVITY, ANXIETY, ABDOMINAL PAIN, BLADDER INFECTION, URINARY RETENTION, CONSTIPATION AND MENSES IRREGULAR. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM) SINCE 2017 AND LISDEXAMFETAMINE MESILATE (VYVANSE) SINCE 2017. ON (B)(6) 20112, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 24 DAYS AFTER INSERTION OF ESSURE. IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), RASH ("RASHES"), ALLERGY TO METALS ("NICKEL ALLERGY/ALWAYS WAS ALLERGIC TO NICKEL"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE/MORE DISCHARGE"), FATIGUE ("FATIGUE/THE PAIN I WAS EXPERIENCING ESPECIALLY WITH LOSS OF WEIGHT MADE ME TIRED"), URINARY TRACT INFECTION ("URINARY PROBLEMS OR BLADDER CHANGES: MORE BLADDER INFECTION UTI"), CYSTITIS ("URINARY PROBLEMS OR BLADDER CHANGES: MORE BLADDER INFECTION UTI") AND FEEDING DISORDER ("COULDN'T EAT HAD METALLIC TASTE PAIN WAS SO BAD I DIDN'T EAT"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN: ABDOMINAL PAIN"). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS/MY HAIR FALLS OUT AND IS THIN"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) DUE TO SEVERE PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/MY STOMACH ALWAYS CRAMPED LIKE PERIOD CRAMPS WHERE MY TUBES"). IN MAY 2014, THE PATIENT EXPERIENCED PRURITUS GENERALISED ("CONSTANT ITCHING OF MY SKIN UNTIL I WOULD SCAR MY BODY"). IN 2014, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: UNSPECIFIED"). IN 2016, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS/I WAS 180 IN 2013 I WENT DOWN TO 92 POUNDS IN DEC-2017"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("LOSING MY HORMONES HAS MADE MY WHOLE LIFE CHANGE! I DEALT WITH PAIN AND NOW I HAVE TO BE ON HORMONE PILLS THAT IF I MISS A DAY I WANT TO NOT LEAVE MY BED") AND EXPERIENCED MENTAL DISORDER ("LOSING MY OVARIES MADE MY MENTAL ILLNESS WORSE"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED HEADACHE ("HEADACHES"), DYSGEUSIA ("METAL TASTE IN MY MOUTH"), COITAL BLEEDING ("WOULD BLEED AND HURT WHEN HAVING SEX") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN/ I COULD FEEL MY TUBES THROB"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PELVIC PAIN, PELVIC INFLAMMATORY DISEASE, ENDOMETRIOSIS ABLATION, ALOPECIA, HEADACHE, NAUSEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, PRURITUS GENERALISED, DYSGEUSIA, FEMALE SEXUAL DYSFUNCTION, HORMONE LEVEL ABNORMAL, RASH, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, ABDOMINAL PAIN, MENTAL DISORDER, URINARY TRACT INFECTION, CYSTITIS, FEEDING DISORDER, COITAL BLEEDING, GASTROINTESTINAL DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, COITAL BLEEDING, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS ABLATION, FATIGUE, FEEDING DISORDER, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENTAL DISORDER, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PRURITUS GENERALISED, RASH, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 130 LBS. FU: (B)(6) 2019, ESSURE INSERTION DATE DISCREPANCY: 25MAY2012 (PREVIOUSLY REPORTED AS 1-MAY-2012). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 15.8 KG/SQM. NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2016: THE PATIENT DOES NOT HAVE AN INTRAUTERINE DEVICE. THE PATIENT IS STATUS POST ESSURE PLACEMENT IN THE FALLOPIAN TUBES BILATERALLY FOR TUBAL OCCLUSION. THERE IS A SMALL NABOTHIAN CYST IN THE CERVIX. OTHERWISE ,NEGATIVE MRI STUDY OF THE PELVIS.. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: ABDOMINAL PAIN, PELVIC PAIN, UTERINE PERFORATION, ENDOMETRIOSIS, VAGINAL DISCHARGE, PID (PELVIC INFLAMMATORY DISEASE), NAUSEA AND WEIGHT LOSS." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-FEB-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID) INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 UTERINE PERFORATION ("PERFORATION (UTERUS)"), PELVIC PAIN ("PELVIC PAIN/WORSENING OF BOWEL SYSTEM PELVIC PAIN / PAIN"), PELVIC INFLAMMATORY DISEASE ("INFECTIONS: I HAD PELVIC INFLAMMATION/PELVIC INFLAMMATORY SYNDROME") AND ENDOMETRIOSIS ABLATION ("LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS") IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX LOW, ABDOMINAL PAIN LOWER, PSYCHOLOGICAL DISORDER NOS, BLADDER DISORDER NOS, URINARY TRACT DISORDER, NICKEL SENSITIVITY, ANXIETY, ABDOMINAL PAIN, BLADDER INFECTION, URINARY RETENTION, CONSTIPATION AND MENSES IRREGULAR. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM) SINCE 2017 AND LISDEXAMFETAMINE MESILATE (VYVANSE) SINCE 2017. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 24 DAYS AFTER INSERTION OF ESSURE. IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), RASH ("RASHES"), ALLERGY TO METALS ("NICKEL ALLERGY/ALWAYS WAS ALLERGIC TO NICKEL"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE/MORE DISCHARGE"), FATIGUE ("FATIGUE/THE PAIN I WAS EXPERIENCING ESPECIALLY WITH LOSS OF WEIGHT MADE ME TIRED"), URINARY TRACT INFECTION ("URINARY PROBLEMS OR BLADDER CHANGES: MORE BLADDER INFECTION UTI"), CYSTITIS ("URINARY PROBLEMS OR BLADDER CHANGES: MORE BLADDER INFECTION UTI") AND FEEDING DISORDER ("COULDN'T EAT HAD METALLIC TASTE PAIN WAS SO BAD I DIDN'T EAT"). ON (B)(6)2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN: ABDOMINAL PAIN"). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS/MY HAIR FALLS OUT AND IS THIN"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) DUE TO SEVERE PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/MY STOMACH ALWAYS CRAMPED LIKE PERIOD CRAMPS WHERE MY TUBES"). IN (B)(6)2014, THE PATIENT EXPERIENCED PRURITUS GENERALISED ("CONSTANT ITCHING OF MY SKIN UNTIL I WOULD SCAR MY BODY"). IN 2014, THE PATIENT EXPERIENCED GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: UNSPECIFIED"). IN 2016, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS/I WAS 180 IN 2013 I WENT DOWN TO 92 POUNDS IN (B)(6)2017"). ON (B)(6)2017, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("LOSING MY HORMONES HAS MADE MY WHOLE LIFE CHANGE! I DEALT WITH PAIN AND NOW I HAVE TO BE ON HORMONE PILLS THAT IF I MISS A DAY I WANT TO NOT LEAVE MY BED") AND EXPERIENCED MENTAL DISORDER ("LOSING MY OVARIES MADE MY MENTAL ILLNESS WORSE"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED HEADACHE ("HEADACHES"), DYSGEUSIA ("METAL TASTE IN MY MOUTH"), COITAL BLEEDING ("WOULD BLEED AND HURT WHEN HAVING SEX") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN/ I COULD FEEL MY TUBES THROB"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PELVIC PAIN, PELVIC INFLAMMATORY DISEASE, ENDOMETRIOSIS ABLATION, ALOPECIA, HEADACHE, NAUSEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, PRURITUS GENERALISED, DYSGEUSIA, FEMALE SEXUAL DYSFUNCTION, HORMONE LEVEL ABNORMAL, RASH, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, ABDOMINAL PAIN, MENTAL DISORDER, URINARY TRACT INFECTION, CYSTITIS, FEEDING DISORDER, COITAL BLEEDING, GASTROINTESTINAL DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, COITAL BLEEDING, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS ABLATION, FATIGUE, FEEDING DISORDER, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENTAL DISORDER, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PRURITUS GENERALISED, RASH, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 130 LBS. FU: (B)(6)2019, ESSURE INSERTION DATE DISCREPANCY: (B)(6)2012 (PREVIOUSLY REPORTED AS (B)(6)2012). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 15.8 KG/SQM. NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6)2016: THE PATIENT DOES NOT HAVE AN INTRAUTERINE DEVICE. THE PATIENT IS STATUS POST ESSURE PLACEMENT IN THE FALLOPIAN TUBES BILATERALLY FOR TUBAL OCCLUSION. THERE IS A SMALL NABOTHIAN CYST IN THE CERVIX. OTHERWISE ,NEGATIVE MRI STUDY OF THE PELVIS.. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: ABDOMINAL PAIN, PELVIC PAIN, UTERINE PERFORATION, ENDOMETRIOSIS, VAGINAL DISCHARGE, PID (PELVIC INFLAMMATORY DISEASE), NAUSEA AND WEIGHT LOSS." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-FEB-2019: REPORTER INFORMATION WAS ADDED. THIS CASE IS MEDICALLY CONFIRMED. THIS CASE CONCERNS 26 YEAR OLD PATIENT. HER DEMOGRAPHIC WAS UPDATED. ESSURE INDICATION WAS ADDED. ESSURE LOT NUMBER WAS ADDED. HER HISTORICAL AND CONCURRENT CONDITIONS WERE ADDED. PER PLAINTIFF FACT SHEET FOLLOWING EVENTS: UTERINE PERFORATION, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), METAL TASTE IN MY MOUTH, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) DUE TO SEVERE PAIN, LOSING MY HORMONES HAS MADE MY WHOLE LIFE CHANGE! I DEALT WITH PAIN AND NOW I HAVE TO BE ON HORMONE PILLS THAT IF I MISS A DAY I WANT TO NOT LEAVE MY BED, RASHES, NICKEL ALLERGY/ALWAYS WAS ALLERGIC TO NICKEL, DYSMENORRHEA (CRAMPING)/MY STOMACH ALWAYS CRAMPED LIKE PERIOD CRAMPS WHERE MY TUBES, LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE/MORE DISCHARGE, FATIGUE/THE PAIN I WAS EXPERIENCING ESPECIALLY WITH LOSS OF WEIGHT MADE ME TIRED, WEIGHT LOSS/I WAS 180 IN 2013 I WENT DOWN TO 92 POUNDS IN (B)(6)2017, PAIN: ABDOMINAL PAIN, LOSING MY OVARIES MADE MY MENTAL ILLNESS WORSE, URINARY PROBLEMS OR BLADDER CHANGES: MORE BLADDER INFECTION UTI, URINARY PROBLEMS OR BLADDER CHANGES: MORE BLADDER INFECTION UTI, COULDN'T EAT HAD METALLIC TASTE PAIN WAS SO BAD I DIDN'T EAT, WOULD BLEED AND HURT WHEN HAVING SEX, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: UNSPECIFIED, LOWER ABDOMINAL PAIN/ I COULD FEEL MY TUBES THROB WERE 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 UTERINE PERFORATION ('PERFORATION (UTERUS)'), PELVIC PAIN ('PELVIC PAIN/WORSENING OF BOWEL SYSTEM PELVIC PAIN / PAIN'), PELVIC INFLAMMATORY DISEASE ('INFECTIONS: I HAD PELVIC INFLAMMATION/PELVIC INFLAMMATORY SYNDROME'), ENDOMETRIOSIS ABLATION ('LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS') AND GENITAL HAEMORRHAGE ('BLEEDING ISSUES') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114- NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL IN 2014, BODY MASS INDEX LOW, ABDOMINAL PAIN LOWER, PSYCHOLOGICAL DISORDER NOS, BLADDER DISORDER NOS, URINARY TRACT DISORDER, NICKEL SENSITIVITY, ANXIETY, ABDOMINAL PAIN, BLADDER INFECTION, URINARY RETENTION, CONSTIPATION AND MENSES IRREGULAR. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM) SINCE 2017, ETONOGESTREL (IMPLANON) AND LISDEXAMFETAMINE MESILATE (VYVANSE) SINCE 2017. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 24 DAYS AFTER INSERTION OF ESSURE. IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), RASH ("RASHES"), ALLERGY TO METALS ("NICKEL ALLERGY/ALWAYS WAS ALLERGIC TO NICKEL"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE/MORE DISCHARGE"), FATIGUE ("FATIGUE/THE PAIN I WAS EXPERIENCING ESPECIALLY WITH LOSS OF WEIGHT MADE ME TIRED"), URINARY TRACT INFECTION ("URINARY PROBLEMS OR BLADDER CHANGES: MORE BLADDER INFECTION UTI"), CYSTITIS ("URINARY PROBLEMS OR BLADDER CHANGES: MORE BLADDER INFECTION UTI") AND FEEDING DISORDER ("COULDN'T EAT HAD METALLIC TASTE PAIN WAS SO BAD I DIDN'T EAT"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN: ABDOMINAL PAIN"). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS/MY HAIR FALLS OUT AND IS THIN"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE) DUE TO SEVERE PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/MY STOMACH ALWAYS CRAMPED LIKE PERIOD CRAMPS WHERE MY TUBES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PRURITUS GENERALISED ("CONSTANT ITCHING OF MY SKIN UNTIL I WOULD SCAR MY BODY"). IN 2014, THE PATIENT EXPERIENCED GASTRIC DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: UNSPECIFIED/GASTRIC PROBLEMS"). IN 2016, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS/I WAS 180 IN 2013 I WENT DOWN TO 92 POUNDS IN (B)(6) 2017"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("LOSING MY HORMONES HAS MADE MY WHOLE LIFE CHANGE! I DEALT WITH PAIN AND NOW I HAVE TO BE ON HORMONE PILLS THAT IF I MISS A DAY I WANT TO NOT LEAVE MY BED") AND EXPERIENCED MENTAL DISORDER ("LOSING MY OVARIES MADE MY MENTAL ILLNESS WORSE"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES"), DYSGEUSIA ("METAL TASTE IN MY MOUTH"), COITAL BLEEDING ("WOULD BLEED AND HURT WHEN HAVING SEX") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN/ I COULD FEEL MY TUBES THROB"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND LAPAROSCOPIC SURGERY FOR ENDOMETRIOSIS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, PELVIC PAIN, PELVIC INFLAMMATORY DISEASE, ENDOMETRIOSIS ABLATION, GENITAL HAEMORRHAGE, ALOPECIA, HEADACHE, NAUSEA, VAGINAL HAEMORRHAGE, MENORRHAGIA, PRURITUS GENERALISED, DYSGEUSIA, FEMALE SEXUAL DYSFUNCTION, HORMONE LEVEL ABNORMAL, RASH, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT DECREASED, ABDOMINAL PAIN, MENTAL DISORDER, URINARY TRACT INFECTION, CYSTITIS, FEEDING DISORDER, COITAL BLEEDING, GASTRIC DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, COITAL BLEEDING, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS ABLATION, FATIGUE, FEEDING DISORDER, FEMALE SEXUAL DYSFUNCTION, GASTRIC DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENTAL DISORDER, NAUSEA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PRURITUS GENERALISED, RASH, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 130 LBS. FU: (B)(6) 2019, ESSURE INSERTION DATE DISCREPANCY: (B)(6) 2012 (PREVIOUSLY REPORTED AS (B)(6) 2012). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 15.8 KG/SQM. NUCLEAR MAGNETIC RESONANCE IMAGING ON (B)(6) 2016: THE PATIENT DOES NOT HAVE AN INTRAUTERINE DEVICE. THE PATIENT IS STATUS POST ESSURE PLACEMENT IN THE FALLOPIAN TUBES BILATERALLY FOR TUBAL OCCLUSION. THERE IS A SMALL NABOTHIAN CYST IN THE CERVIX. OTHERWISE, NEGATIVE MRI STUDY OF THE PELVIS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: ABDOMINAL PAIN, PELVIC PAIN, UTERINE PERFORATION, ENDOMETRIOSIS, VAGINAL DISCHARGE, PID (PELVIC INFLAMMATORY DISEASE), NAUSEA AND WEIGHT LOSS." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAY-2019: PFS RECEIVED. REPORTER INFORMATION WERE ADDED. MEDICAL HISTORY AND CONCOMITANT DRUG WERE ADDED. EVENT VERBATIM AND PT WERE UPDATED FOR PREVIOUSLY REPORTED EVENT GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: UNSPECIFIED/GASTRIC PROBLEM. EVENT : BLEEDING ISSUES WERE ADDED. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND PELVIC INFECTION ("INFECTIONS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE COILS REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC INFECTION, ALOPECIA, HEADACHE, NAUSEA AND PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, HEADACHE, NAUSEA, PAIN, PELVIC INFECTION AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. 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 ("PELVIC PAIN") AND PELVIC INFECTION ("INFECTIONS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE COILS REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PELVIC INFECTION, ALOPECIA, HEADACHE, NAUSEA AND PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, HEADACHE, NAUSEA, PAIN, PELVIC INFECTION AND PELVIC PAIN TO BE RELATED TO ESSURE. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER, LAWYER, LAWYER OR LAWYER IS NOT POSSIBLE. 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 |
|---|---|---|---|---|---|---|---|
| 265302 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 962114- NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | IMPLANON| VALIUM| VALIUM| VALIUM| VYVANSE| VYVANSE| VYVANSE |