ESSURE
Report
- Report Number
- 2951250-2017-05237
- Event Type
- Injury
- Date Received
- October 20, 2017
- Date of Event
- December 1, 2011
- Report Date
- June 12, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("LEFT SIDE WAS PUNCTURED BY THE COIL/PATIENT DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES/FAILURE TO OCCLUDE") AND PELVIC PAIN ("ABNORMALLY SEVERE PELVIC PAIN / PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA ( PAINFUL SEXUAL INTERCOURSE)") AND HYPOAESTHESIA ("NUMBNESS IN LEFT LEG/FOOT"). IN 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2015, THE PATIENT EXPERIENCED DERMAL CYST ("RASHES OR SKIN CONDITION TYPE: CYST-LIKE BUMPS ON THIGHS AND GENTIAL REGION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN IN HER ABDOMEN"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHNAGES"), TOOTH DISORDER ("DENTAL PROBLEMS"), MOOD SWINGS ("HORMONAL CHANGES-MOOD SWINGS"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUX"), ADNEXA UTERI PAIN ("OVARIAN PAIN"), BACK PAIN ("LOWER BACK PAIN"), PAIN IN EXTREMITY ("UPPER LEG PAIN") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY AND SURGERY. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DERMAL CYST, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HYPOAESTHESIA, MOOD SWINGS, MENSTRUATION IRREGULAR, WEIGHT FLUCTUATION, ADNEXA UTERI PAIN, BACK PAIN, PAIN IN EXTREMITY AND FATIGUE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, BACK PAIN, BLADDER DISORDER, DERMAL CYST, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HYPOAESTHESIA, MENORRHAGIA, MENSTRUATION IRREGULAR, MOOD SWINGS, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2012, PLAINTIFF UNDERWEXIT A LAPAROSCOPIC TUBAL LIGATION BY OCCLUSION WAS PERFORMED. DESPITE HAVING REMOVAL SURGERY, SHE CONTINUED TO EXPERIENCE PAIN IN HER ABDOMEN. DISCREPANT INFORMATION WAS RECEIVED :IN SUMMONS -REMOVAL SURGERY HAS BEEN DONE. AS PER PFS -ESSURE NOT REMOVED AND CURRENTLY NOT PLANNING FOR ESSURE REMOVAL . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES; ON (B)(6) 2012: DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES. 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 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 FALLOPIAN TUBE PERFORATION ("LEFT SIDE WAS PUNCTURED BY THE COIL/PATIENT DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES/FAILURE TO OCCLUDE") AND PELVIC PAIN ("ABNORMALLY SEVERE PELVIC PAIN / PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA ( PAINFUL SEXUAL INTERCOURSE)") AND HYPOAESTHESIA ("NUMBNESS IN LEFT LEG/FOOT"). IN (B)(6), THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6), THE PATIENT EXPERIENCED SKIN DISORDER ("RASHES OR SKIN CONDITION TYPE: CYST-LIKE BUMPS ON THIGHS AND GENTIAL REGION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN IN HER ABDOMEN"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), TOOTH DISORDER ("DENTAL PROBLEMS"), MOOD SWINGS ("HORMONAL CHANGES-MOOD SWINGS"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS"), WEIGHT FLUCTUATION ("WEIGHT FLUX"), ADNEXA UTERI PAIN ("OVARIAN PAIN"), BACK PAIN ("LOWER BACK PAIN"), MYALGIA ("UPPER LEG PAIN") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY AND SURGERY. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, SKIN DISORDER, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HYPOAESTHESIA, MOOD SWINGS, MENSTRUATION IRREGULAR, WEIGHT FLUCTUATION, ADNEXA UTERI PAIN, BACK PAIN, MYALGIA AND FATIGUE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXA UTERI PAIN, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HYPOAESTHESIA, MENORRHAGIA, MENSTRUATION IRREGULAR, MOOD SWINGS, MYALGIA, NAUSEA, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2012, PLAINTIFF UNDERWENT A LAPAROSCOPIC TUBAL LIGATION BY OCCLUSION WAS PERFORMED. DESPITE HAVING REMOVAL SURGERY, SHE CONTINUED TO EXPERIENCE PAIN IN HER ABDOMEN. DISCREPANT INFORMATION WAS RECEIVED :IN SUMMONS -REMOVAL SURGERY HAS BEEN DONE. AS PER PFS -ESSURE NOT REMOVED AND CURRENTLY NOT PLANNING FOR ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES; ON (B)(6) 2012: DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUN-2018: PFS RECEIVED- NEW EVENTS: ABNORMAL BLEEDING VAGINAL, ABNORMAL BLEEDING MENORRHAGIA, RASHES OR SKIN CONDITIONS TYPE: CYST ON THIGHS AND GENITAL REGION, BLADDER OR URINARY PROBLEMS OR CHANGES, NAUSEA, DENTAL PROBLEMS, DYSMENORRHEA ( CRAMPING), DYSPAREUNIA, FATIGUE, NUMBNESS IN LEFT LEG/FOOT, MOOD SWINGS, IRREGULAR PERIODS, WEIGH FLUX,PATIENT DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES EVENT UPDATED TO LEFT SIDE WAS PUNCTURED BY THE COIL WERE ADDED. LOT NUMBER WAS ADDED. DATE OF BIRTH WAS ADDED. PRODUCT 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 FALLOPIAN TUBE PERFORATION ('LEFT SIDE WAS PUNCTURED BY THE COIL/PATIENT DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES/FAILURE TO OCCLUDE FALLOPIAN TUBE(S)/FAILED ESSURE') AND PELVIC PAIN ('ABNORMALLY SEVERE PELVIC PAIN / PAIN') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CHRONIC KIDNEY DISEASE IN 2009. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BABY ASPIRIN FROM 2009 TO 2011 AND SIMUASTATIN FROM 2009 TO 2011. CONCURRENT CONDITIONS INCLUDED IGA NEPHROPATHY SINCE 2009. CONCOMITANT PRODUCTS INCLUDED FISH OIL SINCE 2009, LISINOPRIL SINCE 2009 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES-MOOD SWINGS"), 1 MONTH 14 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), NAUSEA ("NAUSEA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL / ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA ( PAINFUL SEXUAL INTERCOURSE)"), HYPOAESTHESIA ("NUMBNESS IN LEFT LEG/FOOT/ NUMBNESS"), MENSTRUATION IRREGULAR ("IRREGULAR PERIODS / INCONSISTENT PERIODS"), FATIGUE ("FATIGUE") AND ABDOMINAL PAIN LOWER ("PAIN CRAMPS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DERMAL CYST ("RASHES OR SKIN CONDITION TYPE: CYST-LIKE BUMPS ON THIGHS AND GENTIAL REGION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN IN HER ABDOMEN"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHNAGES"), WEIGHT FLUCTUATION ("WEIGHT FLUX"), ADNEXA UTERI PAIN ("OVARIAN PAIN"), BACK PAIN ("LOWER BACK PAIN") AND PAIN IN EXTREMITY ("UPPER LEG PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TUBAL LIGATION). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DERMAL CYST, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HYPOAESTHESIA, MOOD SWINGS, MENSTRUATION IRREGULAR, WEIGHT FLUCTUATION, ADNEXA UTERI PAIN, BACK PAIN, PAIN IN EXTREMITY, FATIGUE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI PAIN, BACK PAIN, BLADDER DISORDER, DERMAL CYST, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HYPOAESTHESIA, MENORRHAGIA, MENSTRUATION IRREGULAR, MOOD SWINGS, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2012, PLAINTIFF UNDERWEXIT A LAPAROSCOPIC TUBAL LIGATION BY OCCLUSION WAS PERFORMED. DESPITE HAVING REMOVAL SURGERY, SHE CONTINUED TO EXPERIENCE PAIN IN HER ABDOMEN. DISCREPANT INFORMATION WAS RECEIVED :IN SUMMONS -REMOVAL SURGERY HAS BEEN DONE. AS PER PFS -ESSURE NOT REMOVED AND CURRENTLY NOT PLANNING FOR ESSURE REMOVAL. OTHER INJURIES OR COMPLICATIONS: PLEASE DESCRIBE: FAILED ESSURE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES; ON (B)(6) 2012: RESULTS: DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUN-2019: PFS RECEIVED: EVENT ABDOMINAL PAIN LOWER WAS ADDED. EVENT ONSET DATE WERE UPDATED. REPORTERS WERE ADDED. HISTORICAL AND CONCOMITANT DRUGS WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("ABNORMALLY SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PATIENT DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES" IN 2012. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN IN HER ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2012, PLAINTIFF UNDERWENT A LAPAROSCOPIC TUBAL LIGATION BY OCCLUSION WAS PERFORMED. DESPITE HAVING REMOVAL SURGERY, SHE CONTINUED TO EXPERIENCE PAIN IN HER ABDOMEN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES; ON (B)(6) 2012: DID NOT HAVE FULL OCCLUSION OF HER FALLOPIAN TUBES. 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 |
|---|---|---|---|---|---|---|---|
| 744679 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| FISH OIL| LISINOPRIL |