ESSURE
Report
- Report Number
- 2951250-2018-02362
- Event Type
- Injury
- Date Received
- May 24, 2018
- Date of Event
- June 1, 2011
- Report Date
- March 9, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745, 802746-INVALID) 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 "PLAINTIFF DENIES UNDERGOING AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED IRREGULAR MENSTRUATION AND BLEEDING MENSTRUAL HEAVY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL DISTENSION ("ABNORMAL BLOATING"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), FATIGUE ("FATIGUE / TIRED"), WEIGHT INCREASED ("WEIGHT GAIN / I SEE MYSELF FAT") AND PRURITUS ("RASHES OR SKIN CONDITIONS: ITCHING ON MY FACE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND PELVIC PAIN ("PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), HEADACHE ("HEADACHES;"), BREAST PAIN ("BREAST PAIN"), ANAEMIA ("ANEMIA") AND INFLAMMATION ("I'M ALWAYS SUFFERING INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY PLUS ENDOMETRIAL ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, PRURITUS, HEADACHE, BREAST PAIN, PELVIC PAIN AND INFLAMMATION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, ABDOMINAL DISTENSION, RASH, ALOPECIA, MIGRAINE, DEPRESSION, FATIGUE AND ANAEMIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANAEMIA, BACK PAIN, BREAST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, INFLAMMATION, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PRURITUS, RASH, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT MEDICAL ATTENTION FOR HER SYMPTOMS FROM HEALTHCARE PROVIDER.PATIENT STILL SUFFERS FROM THE ABOVE MENTIONED SYMPTOMS AND IS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 139 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.2 KG/SQM. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: INFLAMMATION NOS. 802745, 802746-INVALID LOT NUMBER:802745 MANUFACTURE DATE:2010/11 EXPIRATION DATE: 2013/11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT NO VALID 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 MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745, 802746(INVALID)) 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 "PLAINTIFF DENIES UNDERGOING AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED IRREGULAR MENSTRUATION AND BLEEDING MENSTRUAL HEAVY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. IN 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL DISTENSION ("ABNORMAL BLOATING"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), FATIGUE ("FATIGUE / TIRED") AND PRURITUS ("RASHES OR SKIN CONDITIONS: ITCHING ON MY FACE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / I SEE MYSELF FAT"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND PELVIC PAIN ("PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), HEADACHE ("HEADACHES;"), BREAST PAIN ("BREAST PAIN"), ANAEMIA ("ANEMIA") AND INFLAMMATION ("I'M ALWAYS SUFFERING INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY PLUS ENDOMETRIAL ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, PRURITUS, HEADACHE, BREAST PAIN, PELVIC PAIN AND INFLAMMATION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, ABDOMINAL DISTENSION, RASH, ALOPECIA, MIGRAINE, DEPRESSION, FATIGUE AND ANAEMIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANAEMIA, BACK PAIN, BREAST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, INFLAMMATION, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PRURITUS, RASH, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT MEDICAL ATTENTION FOR HER SYMPTOMS FROM HEALTHCARE PROVIDER.PATIENT STILL SUFFERS FROM THE ABOVE MENTIONED SYMPTOMS AND IS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 139 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.2 KG/SQM. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: INFLAMMATION NOS. 802745, 802746-INVALID LOT NUMBER:802745 MANUFACTURE DATE:2010/11 EXPIRATION DATE: 2013/11 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . AMENDMENT: THE REPORT WAS AMENDED ON (B)(6) 2019 FOR THE FOLLOWING REASON: INFORMATION AND REFERENCES FROM CASE (B)(4) WERE MIGRATED TO THIS AS IT IS A FOLLOW UP FROM THIS CASE. A NEW REPORTER WAS ADDED AND START DATE OF ESSURE WAS AMENDED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745, 802746(INVALID)) 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 "PLAINTIFF DENIES UNDERGOING AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED IRREGULAR MENSTRUATION AND BLEEDING MENSTRUAL HEAVY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6)2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL DISTENSION ("ABNORMAL BLOATING"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), FATIGUE ("FATIGUE / TIRED") AND PRURITUS ("RASHES OR SKIN CONDITIONS: ITCHING ON MY FACE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / I SEE MYSELF FAT"). IN (B)(6)2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND PELVIC PAIN ("PAIN/PELVIC PAIN"). IN (B)(6)2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), HEADACHE ("HEADACHES;"), BREAST PAIN ("BREAST PAIN"), ANAEMIA ("ANEMIA"), INFLAMMATION ("I'M ALWAYS SUFFERING INFLAMMATION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA") AND GASTROINTESTINAL DISORDER ("GI CONDITIONS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY PLUS ENDOMETRIAL ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, PRURITUS, HEADACHE, BREAST PAIN, PELVIC PAIN, INFLAMMATION, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, ABDOMINAL DISTENSION, RASH, ALOPECIA, MIGRAINE, DEPRESSION, FATIGUE AND ANAEMIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANAEMIA, BACK PAIN, BREAST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, INFLAMMATION, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PRURITUS, RASH, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT MEDICAL ATTENTION FOR HER SYMPTOMS FROM HEALTHCARE PROVIDER. PATIENT STILL SUFFERS FROM THE ABOVE MENTIONED SYMPTOMS AND IS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 139 LBS. PLAINTIFF RECEIVED TREATMENT FOR PAIN. DATE(S) OF INSERTION: (B)(6)2011 (DISCREPANCY NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.2 KG/SQM. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: INFLAMMATION NOS. 802745, 802746-INVALID. LOT NUMBER:802745 MANUFACTURE DATE:2010/11 EXPIRATION DATE: 2013/11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2019: PFS RECEIVED. REPORTER INFORMATION ADDED. EVENT : APAREUNIA, GI CONDITIONS ADDED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745, 802746) 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 "PLAINTIFF DENIES UNDERGOING AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED IRREGULAR MENSTRUATION AND BLEEDING MENSTRUAL HEAVY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL DISTENSION ("ABNORMAL BLOATING"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), FATIGUE ("FATIGUE / TIRED"), WEIGHT INCREASED ("WEIGHT GAIN / I SEE MYSELF FAT") AND PRURITUS ("RASHES OR SKIN CONDITIONS: ITCHING ON MY FACE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND PELVIC PAIN ("PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), HEADACHE ("HEADACHES;"), BREAST PAIN ("BREAST PAIN"), ANAEMIA ("ANEMIA") AND INFLAMMATION ("I'M ALWAYS SUFFERING INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY PLUS ENDOMETRIAL ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, PRURITUS, HEADACHE, BREAST PAIN, PELVIC PAIN AND INFLAMMATION OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, ABDOMINAL DISTENSION, RASH, ALOPECIA, MIGRAINE, DEPRESSION, FATIGUE AND ANAEMIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANAEMIA, BACK PAIN, BREAST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, INFLAMMATION, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PRURITUS, RASH, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: *PATIENT SOUGHT MEDICAL ATTENTION FOR HER SYMPTOMS FROM HEALTHCARE PROVIDER.PATIENT STILL SUFFERS FROM THE ABOVE MENTIONED SYMPTOMS AND IS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 139 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.2 KG/SQM. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: INFLAMMATION NOS . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: SOCIAL MEDIA POST RECEIVED. EVENT INFLAMMATION NOS WAS ADDED. PRODUCT, PATIENT & REPORTER INFORMATION 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745, 802746(NOT VALID)) 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 "PLAINTIFF DENIES UNDERGOING AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED IRREGULAR MENSTRUATION, BLEEDING MENSTRUAL HEAVY, MULTIGRAVIDA, PARITY 3 AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES;"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) , THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN, DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL DISTENSION ("ABNORMAL BLOATING"), RASH ("RASHES, RASHES ON HER FACE AND ARMS"), MIGRAINE ("MIGRAINES"), FATIGUE ("FATIGUE / TIRED") AND PRURITUS ("RASHES OR SKIN CONDITIONS: ITCHING ON MY FACE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / I SEE MYSELF FAT"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND PELVIC PAIN ("PAIN/PELVIC PAIN"). IN 2012, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("VAGINAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) -2019, THE PATIENT EXPERIENCED POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES:FREQUENT URINATION"), 8 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), BREAST PAIN ("BREAST PAIN"), ANAEMIA ("ANEMIA"), INFLAMMATION ("I'M ALWAYS SUFFERING INFLAMMATION"), GASTROINTESTINAL DISORDER ("GI CONDITIONS") AND PAIN IN EXTREMITY ("LEG PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY PLUS ENDOMETRIAL ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, PRURITUS, HEADACHE, BREAST PAIN, PELVIC PAIN, INFLAMMATION, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, MOOD SWINGS, POLLAKIURIA, VAGINAL DISCHARGE, PAIN IN EXTREMITY AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, ABDOMINAL DISTENSION, RASH, ALOPECIA, MIGRAINE, DEPRESSION, FATIGUE AND ANAEMIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANAEMIA, BACK PAIN, BREAST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, INFLAMMATION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PAIN IN EXTREMITY, PELVIC PAIN, POLLAKIURIA, PRURITUS, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT MEDICAL ATTENTION FOR HER SYMPTOMS FROM HEALTHCARE PROVIDER.PATIENT STILL SUFFERS FROM THE ABOVE MENTIONED SYMPTOMS AND IS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 139 LBS. PLAINTIFF RECEIVED TREATMENT FOR PAIN DATE(S) OF INSERTION: (B)(6) 2011 (DISCREPANCY NOTED) CURRENT WEIGHT 178 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.2 KG/SQM. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: INFLAMMATION NOS 802745, 802746-NOT VALID LOT NUMBER:802745 MANUFACTURE DATE:2010/11 EXPIRATION DATE: 2013/11 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED EVENTS "HORMONAL CHANGES DESCRIBE: MOOD SWINGS, ABNORMAL BLEEDING (VAGINAL), BLADDER OR URINARY PROBLEMS OR CHANGES: FREQUENT URINATION, VAGINAL DISCHARGE, LEGS PAIN, RASHES ON HER FACE AND ARMS, VAGINAL PAIN" WERE ADDED. MEDICAL HISTORY AND REPORTER INFORMATION 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745, 802746) 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 "PLAINTIFF DENIES UNDERGOING AN ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL DISTENSION ("ABNORMAL BLOATING"), RASH ("RASHES"), MIGRAINE ("MIGRAINES"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN") AND PRURITUS ("RASHES OR SKIN CONDITIONS: ITCHING"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND PELVIC PAIN ("PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), BACK PAIN ("SEVERE BACK PAIN"), HEADACHE ("HEADACHES;"), BREAST PAIN ("BREAST PAIN") AND ANAEMIA ("ANEMIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY PLUS ENDOMETRIAL ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, ABDOMINAL DISTENSION, RASH, ALOPECIA, MIGRAINE, DEPRESSION, FATIGUE AND ANAEMIA HAD NOT RESOLVED AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, PRURITUS, HEADACHE, BREAST PAIN AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANAEMIA, BACK PAIN, BREAST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PRURITUS, RASH, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: *PATIENT SOUGHT MEDICAL ATTENTION FOR HER SYMPTOMS FROM HEALTHCARE PROVIDER. PATIENT STILL SUFFERS FROM THE ABOVE MENTIONED SYMPTOMS AND IS CURRENTLY INVESTIGATING HER OPTIONS FOR REMOVAL OF THE ESSURE DEVICES. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.2 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED: NEW EVENTS: VAGINAL HAEMORRHAGE, MENORRHAGIA, PRURITUS, HEADACHE, WEIGHT INCREASED, BREAST PAIN, ANAEMIA, DEVICE MONITORING PROCEDURE NOT PERFORMED WERE ADDED. REPORTER, PATIENT DEMOGRAPHIC INFORMATION, CONCOMITANT DISEASE UPDATED. PRODUCT LOT NUMBER ADDED. CASE IS NOW INCIDENT. 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 |
|---|---|---|---|---|---|---|---|
| 382210 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802745, 802746(NOT VALID) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R |