ESSURE
Report
- Report Number
- 2951250-2017-01580
- Event Type
- Injury
- Date Received
- April 21, 2017
- Report Date
- January 7, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VAGINAL CUFF DEHISCENCE ("CUFF REPAIR") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CERVICAL DYSPLASIA IN 2001. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, HYPOTHYROIDISM, DYSFUNCTIONAL UTERINE BLEEDING AND MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX) AND LEVOTHYROXINE SINCE (B)(6) 2011. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS / TEETH REMOVED:2 CROWNS : 1 CROWN NEEDED"). ON (B)(6) 2013, 2 YEARS 10 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE,") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2014, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BVD"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA") AND DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL CUFF DEHISCENCE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPS"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSGEUSIA ("METAL TASTE"), THYROID DISORDER ("THYROID ISSUES") AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2015, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY.) AND SURGERY (CUFF REPAIR). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL CUFF DEHISCENCE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED, ALOPECIA, ABDOMINAL PAIN, ABDOMINAL DISTENSION AND BACTERIAL VAGINOSIS OUTCOME WAS UNKNOWN, THE DYSGEUSIA AND VULVOVAGINAL MYCOTIC INFECTION HAD RESOLVED AND THE THYROID DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, BACTERIAL VAGINOSIS, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, THYROID DISORDER, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL CUFF DEHISCENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL PROCEDURE PERFORMED WITHOUT COMPLICATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, ABDOMINAL PAIN, VAGINAL DISCHARGE,¿ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2018: PFS AND MEDICAL RECORD RECEIVED. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. CONCOMITANT DISEASE, LAB DATA WERE ADDED. UPDATED SUSPECT DRUG INDICATION. EVENTS BLOATING AND BVD ADDED. THE PREVIOUS REPORTED EVENT "CUFF REPAIR" WAS RECODED TO VAGINAL CUFF DEHISCENCE (TREATMENT: REPAIR). 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND ROTATOR CUFF REPAIR ("CUFF REPAIR") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CERVICAL DYSPLASIA IN 2001. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND HYPOTHYROIDISM. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX) AND LEVOTHYROXINE SINCE AUGUST 2011. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ROTATOR CUFF REPAIR (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPS"), VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE,"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS"), ALOPECIA ("HAIR LOSS"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSGEUSIA ("METAL TASTE"), THYROID DISORDER ("THYROID ISSUES") AND FUNGAL INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ROTATOR CUFF REPAIR, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED, ALOPECIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE DYSGEUSIA AND FUNGAL INFECTION HAD RESOLVED AND THE THYROID DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FUNGAL INFECTION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, ROTATOR CUFF REPAIR, THYROID DISORDER, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. CONCOMITANT DISEASE, CONCOMITANT DRUGS, HISTORICAL CONDITION WERE ADDED. UPDATED SUSPECT DRUG INDICATION. EVENTS VAGINAL BLEEDING, MENORRHAGIA, BLADDER INFECTION, URINARY TRACT INFECTION, VAGINAL INFECTION, DENTAL PROBLEMS, DYSMENORRHEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, WEIGHT LOSS, HAIR LOSS, ABDOMINAL PAIN, METAL TASTE, THYROID ISSUES, YEAST INFECTION AND CUFF REPAIR ADDED. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND VAGINAL CUFF DEHISCENCE ("CUFF REPAIR") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CERVICAL DYSPLASIA IN 2001. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, HYPOTHYROIDISM, DYSFUNCTIONAL UTERINE BLEEDING AND MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX) AND LEVOTHYROXINE SINCE (B)(6) 2011. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT UNDERWENT TOOTH EXTRACTION ("DENTAL PROBLEMS / TEETH REMOVED:2 CROWNS : 1 CROWN NEEDED"). ON (B)(6) 2013, 2 YEARS 10 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE,") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2014, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BVD"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA") AND DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL CUFF DEHISCENCE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPS"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSGEUSIA ("METAL TASTE"), THYROID DISORDER ("THYROID ISSUES") AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2015, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY.) AND SURGERY (CUFF REPAIR). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL CUFF DEHISCENCE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, TOOTH EXTRACTION, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED, ALOPECIA, ABDOMINAL PAIN, ABDOMINAL DISTENSION AND BACTERIAL VAGINOSIS OUTCOME WAS UNKNOWN, THE DYSGEUSIA AND VULVOVAGINAL MYCOTIC INFECTION HAD RESOLVED AND THE THYROID DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, BACTERIAL VAGINOSIS, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, THYROID DISORDER, TOOTH EXTRACTION, URINARY TRACT INFECTION, VAGINAL CUFF DEHISCENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL PROCEDURE PERFORMED WITHOUT COMPLICATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, ABDOMINAL PAIN, VAGINAL DISCHARGE,¿ QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') AND VAGINAL CUFF DEHISCENCE ('CUFF REPAIR') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICAL DYSPLASIA IN 2001. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, HYPOTHYROIDISM, DYSFUNCTIONAL UTERINE BLEEDING AND MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEBREX), LEVOTHYROXINE SINCE ON (B)(6) 2011 AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT UNDERWENT TOOTH EXTRACTION ("DENTAL PROBLEMS / TEETH REMOVED: 2 CROWNS : 1 CROWN NEEDED"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), 2 YEARS 10 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE,") AND ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING/ TUMMY BEING SWOLLEN"). ON (B)(6) 2014, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BVD"). ON (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLEEDING/SPOTTING") AND MENORRHAGIA ("MENORRHAGIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA") AND DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6)2015, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL CUFF DEHISCENCE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), ABDOMINAL PAIN LOWER ("CRAMPS"), CYSTITIS ("BLADDER INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSGEUSIA ("METAL TASTE"), HYPOTHYROIDISM ("THYROID ISSUES/ I HAVE HYPOTHYROIDISM"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"), PYREXIA ("FEVER OF 100.4"), ANAEMIA ("I AM VERY ANEMIC"), NEPHROLITHIASIS ("HAD SURGERY TODAY FOR KIDNEY STONE") AND BREAST PAIN ("BOOBS HAVE BEEN SORE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND UTERINE LEIOMYOMA ("THEY FOUND FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2015, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY., CUFF REPAIR AND REMOVED KIDNEY STONE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL CUFF DEHISCENCE, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, TOOTH EXTRACTION, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED, ALOPECIA, ABDOMINAL PAIN, ABDOMINAL DISTENSION, BACTERIAL VAGINOSIS, ANAEMIA, NEPHROLITHIASIS, UTERINE LEIOMYOMA AND BREAST PAIN OUTCOME WAS UNKNOWN, THE DYSGEUSIA AND VULVOVAGINAL MYCOTIC INFECTION HAD RESOLVED AND THE HYPOTHYROIDISM WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANAEMIA, BACTERIAL VAGINOSIS, BREAST PAIN, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HYPOTHYROIDISM, MENORRHAGIA, NEPHROLITHIASIS, PELVIC PAIN, PYREXIA, TOOTH EXTRACTION, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL CUFF DEHISCENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL MYCOTIC INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL PROCEDURE PERFORMED WITHOUT COMPLICATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST: ON AN UNKNOWN DATE: RESULTS: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, ABDOMINAL PAIN, VAGINAL DISCHARGE,HYPOTHYROIDISM, FEVER, KIDNEY STONE, FIBROIDS, BREAST PAIN, ANEMIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-DEC-2019: PFS+ SOCIAL MEDIA RECEIVED- NEW EVENT FEVER OF 100.4, I AM VERY ANEMIC, HAD SURGERY TODAY FOR KIDNEY STONE, THEY FOUND FIBROIDS, BOOBS HAVE BEEN SORE WERE ADDED. EVENT THYROID DISORDER UPDATED TO HYPOTHYROIDISM, NEW REPORTERS, CONCOMITANT DRUG WERE ADDED. INCIDENT: 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") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("CRAMPS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, ESSURE REMOVAL ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORDS. 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. A PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAY-2017: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2010 AND REPORTED ADVERSE EVENTS INCLUDING PAIN (UNDERSTOOD AS PELVIC PAIN) AND HEAVY BLEEDING (UNDERSTOOD AS GENITAL HAEMORRHAGE). ON (B)(6) 2015 PLAINTIFF UNDERWENT SURGERY AND ESSURE WAS REMOVED. PELVIC PAIN AND HAEMORRHAGE ARE HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS CASE NO ALTERNATIVE EXPLANATION WAS GIVEN FOR THE EVENTS. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE HAVE BEEN PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("CRAMPS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, ESSURE REMOVAL ON (B)(6) 2015). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2010 AND REPORTED ADVERSE EVENTS INCLUDING PAIN (UNDERSTOOD AS PELVIC PAIN) AND HEAVY BLEEDING (UNDERSTOOD AS GENITAL HAEMORRHAGE). ON (B)(6) 2015 PLAINTIFF UNDERWENT SURGERY AND ESSURE WAS REMOVED. PELVIC PAIN AND HAEMORRHAGE ARE HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS CASE NO ALTERNATIVE EXPLANATION WAS GIVEN FOR THE EVENTS. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292353 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other| R | CELEBREX| CELEBREX| CELEBREX| CELEBREX| DEPO PROVERA| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE |