ESSURE
Report
- Report Number
- 2951250-2017-02267
- Event Type
- Injury
- Date Received
- June 21, 2017
- Date of Event
- September 4, 2014
- Report Date
- December 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 857597, 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION AND MOOD ALTERED. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) SINCE 2011 TO AUGUST 2014 FOR BIRTH CONTROL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN") AND MOOD ALTERED ("MOODINESS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS IMPLANTED WITH ESSURE ON (B)(6) 2011 AND (B)(6) 2011. MY LEFT TUBE WOULDN'T ACCEPT THE COIL, SO I HAD TO MAKE AN APPOINTMENT TO GET THAT REDONE (LEFT WAS DONE IN 2ND PROCEDURE). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED - NEW EVENT "HORMONAL CHANGES, ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), BLADDER PROBLEMS OR CHANGE, URINARY PROBLEMS OR CHANGES, MIGRAINES, HEADACHES, NAUSEA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, MOODINESS" WERE ADDED. LOT NUMBER WAS ADDED. EVENT 'HYSTERECTOMY' WAS DELETED AND ADDED AS SURGICAL TREATMENT. PRODUCT EXPLANT DATE WAS UPDATED. HISTORICAL CONDITIONS WAS ADDED. NEW REPORTER WAS ADDED. LAB DATA WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)/LONG LASTING HEAVY BLEEDS(SPOTTED SPORADICALLY DISCHARGE)") AND CHOLECYSTECTOMY ("GALL BLADDER REMOVAL") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 857597/ 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION AND MOOD ALTERED. NORMAL PELVIS WITH NO EVIDENCE OF ADHESIONS, PATHOLOGY REPORT GROSS DESCRIPTION: A - UTERUS, CERVIX, BILATERAL FALLOPIAN TUBE SEGMENTS: A 101 GRAM, UTERUS AND CERVIX, WAS RECEIVED IN CONTINUITY WITH THE LEFT FALLOPIAN TUBE. THE RIGHT FALLOPIAN TUBE WAS LOOSE WITHIN FIXATIVE SOLUTION. THE UTERUS AND CERVIX MEASURE 9.8 X 5.3 X 4.1 CM. UTERINE SEROSA WAS UNREMARKABLE. A 4 X 3 CM, CERVIX, IS COVERED WITH SMOOTH, TAN ECTOCERVICAL EPITHELIUM. A GAPING, CENTRALLY LOCATED OS, MEASURES 1.5 X 1 CM. THE ENDOMETRIAL CANAL MEASURES 4.2 CM, LONG AND REACHES A CORNU TO CORNU WIDTH OF 2.3 CM. BRIGHT RED-TAN ENDOMETRIUM AVERAGES 1 ROM THICK. TRABECULATED MYOMETRIUM MEASURES 1.8 CM THRU THE UTERINE BODY. BILATERAL FALLOPIAN TUBE OSTIA ARE REMARKABLE FOR SPIRALED WIRE INTRALUMINAL FALLOPIAN TUBE CONTRACEPTIVE DEVICES. THE LEFT FALLOPIAN TUBE MEASURES 8 X 0.5 CM. THE RIGHT FALLOPIAN TUBE MEASURES 4.3 X 0.5 CM, AND WAS GROSSLY UNREMARKABLE. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, SMOKER, HYPERPLASIA, DYSPLASIA, METRORRHAGIA AND DYSPAREUNIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM OCTOBER 2011 TO AUGUST 2014 FOR BIRTH CONTROL AS WELL AS CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3) AND IBUPROFEN (MOTRIN). IN 2011, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL PROBLEM- DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL PROBLEM- ANXIETY"). IN (B)(6)2011, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES / SEVERE HEADACHE"). IN (B)(6)2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6)2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA / FELT NAUSEATED LIKE I WAS PREGNANT"), FATIGUE ("FATIGUE/WEAK AND TIRED ALL THE TIME"), BACK PAIN ("BACK PAIN /LOWER BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MOOD SWINGS ("MOOD SWINGS"). IN 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE") AND URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"). IN (B)(6)2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)-SEVERE CRAMPING LIKE LABOR PAIN."). IN 2016, THE PATIENT UNDERWENT CHOLECYSTECTOMY (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), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA) / LONG LASTING HEAVY BLEEDS (SPOTTED SPORADICALLY)"), MOOD ALTERED ("MOOD ALTERED/MOODINESS"), COMPLICATION OF DEVICE INSERTION ("ON THE RIGHT-HAND SIDE I WAS UNABLE TO ADVANCE THE INSERT INTO THE FALLOPIAN TUBE.") AND NIGHT SWEATS ("HORMONAL CHANGES: NIGHT SWEATS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN/ 80 LBS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, BACK PAIN, DEPRESSION, ABDOMINAL PAIN, ANXIETY, MOOD SWINGS, COMPLICATION OF DEVICE INSERTION, CHOLECYSTECTOMY AND NIGHT SWEATS OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, BLADDER DISORDER, CHOLECYSTECTOMY, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, MOOD ALTERED, MOOD SWINGS, NAUSEA, NIGHT SWEATS, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS IMPLANTED WITH ESSURE ON (B)(6)2011 AND (B)(6)2011. MY LEFT TUBE WOULDN'T ACCEPT THE COIL, SO I HAD TO MAKE AN APPOINTMENT TO GET THAT REDONE (LEFT WAS DONE IN 2ND PROCEDURE). HAD 2 ATTEMPTS TO IMPLANT DEVICES. THE LEFT TUBAL OSTIUM HAD 4 TRAILING COILS. THE RIGHT TUBAL OSTIUM HAD 4 TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2012: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBER:857597, MANUFACTURE DATE: MAY-2011, EXPIRATION DATE: MAY-2014 . LOT NUMBER: 863570, MANUFACTURE DATE: MAY-2011, EXPIRATION DATE: MAY-2014. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-NOV-2018: EVENT "HORMONAL CHANGES: NIGHT SWEATS", REPORTER , CONCOMITANT DRUG ADDED FROM PFS. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)/LONG LASTING HEAVY BLEEDS(SPOTTED SPORADICALLY DISCHARGE)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 857597/ 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION AND MOOD ALTERED. NORMAL PELVIS WITH NO EVIDENCE OF ADHESIONS,. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, SMOKER, HYPERPLASIA, DYSPLASIA, METRORRHAGIA AND DYSPAREUNIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FROM (B)(6) 2011 TO (B)(6) 2014 FOR BIRTH CONTROL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE/WEAK AND TIRED ALL THE TIME"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)-SEVERE CRAMPING LIKE LABOR PAIN."). IN 2016, THE PATIENT UNDERWENT CHOLECYSTECTOMY ("GALL BLADDER REMOVAL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), MOOD ALTERED ("MOOD ALTERED/MOODINESS"), DEPRESSION ("PSYCHOLOGICAL PROBLEM- DEPRESSION"), ANXIETY ("PSYCHOLOGICAL PROBLEM- ANXIETY") AND COMPLICATION OF DEVICE INSERTION ("ON THE RIGHT-HAND SIDE I WAS UNABLE TO ADVANCE THE INSERT INTO THE FALLOPIAN TUBE."). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, BACK PAIN, DEPRESSION, ABDOMINAL PAIN, ANXIETY, MOOD SWINGS, COMPLICATION OF DEVICE INSERTION AND CHOLECYSTECTOMY OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, BLADDER DISORDER, CHOLECYSTECTOMY, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, MOOD ALTERED, MOOD SWINGS, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS IMPLANTED WITH ESSURE ON (B)(6) 2011 AND (B)(6) 2011. MY LEFT TUBE WOULDN'T ACCEPT THE COIL, SO I HAD TO MAKE AN APPOINTMENT TO GET THAT REDONE (LEFT WAS DONE IN 2ND PROCEDURE). HAD 2 ATTEMPTS TO IMPLANT DEVICES. THE LEFT TUBAL OSTIUM HAD 4 TRAILING COILS. THE RIGHT TUBAL OSTIUM HAD 4 TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PATHOLOGY REPORTGROSS DESCRIPTION: A - UTERUS, CERVIX, BILATERAL FALLOPIAN TUBE SEGMENTS: A 101 GRAM, UTERUS AND CERVIX, WAS RECEIVED IN CONTINUITY WITH THE LEFT FALLOPIAN TUBE. THE RIGHT FALLOPIAN TUBE WAS LOOSE WITHIN FIXATIVE SOLUTION. THE UTERUS AND CERVIX MEASURE 9.8 X 5.3 X 4.1 CM. UTERINE SEROSA WAS UNREMARKABLE. A 4 X 3 CM, CERVIX, IS COVERED WITH SMOOTH, TAN ECTOCERVICAL EPITHELIUM. A GAPING, CENTRALLY LOCATED OS, MEASURES 1.5 X 1 CM. THE ENDOMETRIAL CANAL MEASURES 4.2 CM, LONG AND REACHES A CORNU TO CORNU WIDTH OF 2.3 CM. BRIGHT RED-TAN ENDOMETRIUM AVERAGES 1 ROM THICK. TRABECULATED MYOMETRIUM MEASURES 1.8 CM THRU THE UTERINE BODY. BILATERAL FALLOPIAN TUBE OSTIA ARE REMARKABLE FOR SPIRALED WIRE INTRALUMINAL FALLOPIAN TUBE CONTRACEPTIVE DEVICES. THE LEFT FALLOPIAN TUBE MEASURES 8 X 0.5 CM. THE RIGHT FALLOPIAN TUBE MEASURES 4.3 X 0.5 CM, AND WAS GROSSLY UNREMARKABLE. LOT NUMBER:857597 MANUFACTURE DATE: MAY-2011 EXPIRATION DATE: MAY-2014 . LOT NUMBER: 863570 MANUFACTURE DATE: MAY-2011 EXPIRATION DATE: MAY-2014. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL PROBLEM UPDATE. 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 GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)/LONG LASTING HEAVY BLEEDS(SPOTTED SPORADICALLY DISCHARGE)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 857597, 863570) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "ON THE RIGHT-HAND SIDE I WAS UNABLE TO ADVANCE THE INSERT INTO THE FALLOPIAN TUBE." THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION AND MOOD ALTERED. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND SMOKER. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FROM (B)(6) 2011 TO (B)(6) 2014 FOR BIRTH CONTROL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE/WEAK AND TIRED ALL THE TIME"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)-SEVERE CRAMPING LIKE LABOR PAIN."). IN 2016, THE PATIENT UNDERWENT CHOLECYSTECTOMY ("GALL BLADDER REMOVAL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGE"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), MOOD ALTERED ("MOOD ALTERED/MOODINESS"), DEPRESSION ("PSYCHOLOGICAL PROBLEM- DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL PROBLEM- ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, BACK PAIN, DEPRESSION, ABDOMINAL PAIN, ANXIETY, MOOD SWINGS AND CHOLECYSTECTOMY OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, BLADDER DISORDER, CHOLECYSTECTOMY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, MOOD ALTERED, MOOD SWINGS, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS IMPLANTED WITH ESSURE ON (B)(6) 2011 AND (B)(6) 2011. MY LEFT TUBE WOULDN'T ACCEPT THE COIL, SO I HAD TO MAKE AN APPOINTMENT TO GET THAT REDONE (LEFT WAS DONE IN 2ND PROCEDURE). HAD 2 ATTEMPTS TO IMPLANT DEVICES. THE LEFT TUBAL OSTIUM HAD 4 TRAILING COILS. THE RIGHT TUBAL OSTIUM HAD 4 TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUN-2018: PFS+MR RECEIVED: NEW EVENTS: ABDOMINAL PAIN, BACK PAIN, ANXIETY, DEPRESSION, MOOD SWINGS, LONG LASTING HEAVY BLEEDS (SPOTTED SPORADICALLY)DISCHARGE CLUBBED WITH GENITAL HEMORRHAGE,ON THE RIGHT-HAND SIDE I WAS UNABLE TO ADVANCE THE INSERT INTO THE FALLOPIAN TUBE WERE ADDED AND PREVIOUSLY REPORTED EVENT VAGINAL HAEMORRHAGE, MENORRHAGIA OUTCOME UPDATED. REPORTER, CONCOMITANT DISEASE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF HYSTERECTOMY ("HYSTERECTOMY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 2 YEARS 10 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT UNDERWENT HYSTERECTOMY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE HYSTERECTOMY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HYSTERECTOMY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS IMPLANTED WITH ESSURE ON (B)(6) 2011. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 437519 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 857597/ 863570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3 |