ESSURE
Report
- Report Number
- 2951250-2019-08255
- Event Type
- Injury
- Date Received
- September 24, 2019
- Report Date
- October 30, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN PELVIC, CHRONIC'), KIDNEY INFECTION ('INFECTION (OTHER) DESCRIBE: KIDNEY INFECTION') AND CYSTITIS NONINFECTIVE ('INFLAMED BLADDER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 959713-NOT VALID,952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORMED". THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CIPROFLOXACIN HYDROCHLORIDE (CEEPRO), IBUPROFEN AND TRAMADOL. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL BLEEDING)"). IN (B)(6)2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINE"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6)2015, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: FIBROIDS / TUMOR / TERATOMA / CANCER TYPE: ON UTERUS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CYSTITIS NONINFECTIVE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("PAIN ABDOMINAL"), BACK PAIN ("PAIN BACK"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("BLEEDING MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING(MENORRHAGIA)"), ALLERGY TO METALS ("ALLERGY NICKEL"), CYSTITIS ("BLADDER INFECT"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VISUAL IMPAIRMENT ("VISION PROBS"), HEADACHE ("HEADACHES"), TOOTH DISORDER ("DENTAL PROBS."), OVARIAN CYST ("RECURRENT OVARIAN CYSTS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), RASH ("RASHES OR SKIN CONDITION TYPE: RASH ON SKIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY"), FEELING ABNORMAL ("BRAIN FOG"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN") AND IMMUNE SYSTEM DISORDER ("IMMUNE SYSTEM") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BLADDER SURGERY AND HYSTERECTOMY (FULL) AND SALPINGO-OOPHORECTOMY (BILATERAL), TUBAL LIGATION). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CYSTITIS NONINFECTIVE, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, ALLERGY TO METALS, CYSTITIS, FATIGUE, MIGRAINE, VISUAL IMPAIRMENT, HEADACHE, TOOTH DISORDER, OVARIAN CYST, VAGINAL HAEMORRHAGE, URINARY TRACT DISORDER, MOOD SWINGS, UTERINE LEIOMYOMA, VAGINAL DISCHARGE AND VISION BLURRED OUTCOME WAS UNKNOWN, THE KIDNEY INFECTION AND BLADDER DISORDER HAD NOT RESOLVED AND THE WEIGHT INCREASED, ALOPECIA, DEPRESSION, RASH, FEELING ABNORMAL AND IMMUNE SYSTEM DISORDER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, CYSTITIS NONINFECTIVE, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, HEADACHE, IMMUNE SYSTEM DISORDER, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, OVARIAN CYST, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN-PAIN CHRONIC, PELVIC/ABDOMINAL, BACK, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DYSMENORRHEA (CRAMPING), APAREUNIA. CURRENT WEIGHT 150 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. LOT NUMBER: 952109 MANUFACTURING DATE: 2012/02 EXPIRATION DATE: 2015/02. LOT NUMBER:959713 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2019: QUALITY SAFETY EVALUATION OF PTC. 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 ('PAIN PELVIC, CHRONIC'), KIDNEY INFECTION ('INFECTION (OTHER) DESCRIBE: KIDNEY INFECTION') AND CYSTITIS NONINFECTIVE ('INFLAMED BLADDER') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 959713,952109) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORMED". THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CIPROFLOXACIN HYDROCHLORIDE (CEEPRO), IBUPROFEN AND TRAMADOL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL BLEEDING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), MIGRAINE ("MIGRAINE"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEMS") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: FIBROIDS / TUMOR / TERATOMA / CANCER TYPE: ON UTERUS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CYSTITIS NONINFECTIVE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("PAIN ABDOMINAL"), BACK PAIN ("PAIN BACK"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("BLEEDING MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING(MENORRHAGIA)"), ALLERGY TO METALS ("ALLERGY NICKEL"), CYSTITIS ("BLADDER INFECT"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VISUAL IMPAIRMENT ("VISION PROBS"), HEADACHE ("HEADACHES"), TOOTH DISORDER ("DENTAL PROBS."), OVARIAN CYST ("RECURRENT OVARIAN CYSTS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), RASH ("RASHES OR SKIN CONDITION TYPE: RASH ON SKIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRY"), FEELING ABNORMAL ("BRAIN FOG"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN") AND IMMUNE SYSTEM DISORDER ("IMMUNE SYSTEM") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BLADDER SURGERY AND HYSTERECTOMY (FULL) AND SALPINGO-OOPHORECTOMY (BILATERAL), TUBAL LIGATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, CYSTITIS NONINFECTIVE, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, ALLERGY TO METALS, CYSTITIS, FATIGUE, MIGRAINE, VISUAL IMPAIRMENT, HEADACHE, TOOTH DISORDER, OVARIAN CYST, VAGINAL HAEMORRHAGE, URINARY TRACT DISORDER, MOOD SWINGS, UTERINE LEIOMYOMA, VAGINAL DISCHARGE AND VISION BLURRED OUTCOME WAS UNKNOWN, THE KIDNEY INFECTION AND BLADDER DISORDER HAD NOT RESOLVED AND THE WEIGHT INCREASED, ALOPECIA, DEPRESSION, RASH, FEELING ABNORMAL AND IMMUNE SYSTEM DISORDER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, CYSTITIS NONINFECTIVE, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, HEADACHE, IMMUNE SYSTEM DISORDER, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, MOOD SWINGS, OVARIAN CYST, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN-PAIN CHRONIC, PELVIC/ABDOMINAL, BACK, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DYSMENORRHEA (CRAMPING), APAREUNIA. CURRENT WEIGHT 150 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. NEW EVENTS- " ABNORMAL BLEEDING(VAGINAL BLEEDING), HORMONAL CHANGES DESCRIBE: MOOD SWINGS, UTI, BRAIN FOG, DEPRESSION, RASHES OR SKIN CONDITION TYPE: RASH ON SKIN, REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: FIBROIDS/TUMOR / TERATOMA / CANCER TYPE: ON UTERUS, VAGINAL DISCHARGE, LOWER ABDOMEN PAIN, IMMUNE SYSTEM DISORDER,INFLAMED BLADDER, URINARY PROBLEMS AND BLADDER PROBLEM", OUTCOME OF THE WEIGHT GAIN, HAIR LOSS WERE UPDATED RECOVERED. 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 ('PAIN PELVIC, CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORMED". 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), ABDOMINAL PAIN ("PAIN ABDOMINAL"), BACK PAIN ("PAIN BACK"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("BLEEDING MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ALLERGY TO METALS ("ALLERGY NICKEL"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY RELATED TO ESSURE"), CYSTITIS ("BLADDER INFECT"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE"), ALOPECIA ("HAIR LOSS"), VISUAL IMPAIRMENT ("VISION PROBS"), HEADACHE ("HEADACHES"), TOOTH DISORDER ("DENTAL PROBS.") AND OVARIAN CYST ("RECURRENT OVARIAN CYSTS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND NEOPLASM ("TUMORS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGO-OOPHORECTOMY (BILATERAL), TUBAL LIGATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, ALLERGY TO METALS, PSYCHOLOGICAL TRAUMA, CYSTITIS, FATIGUE, MIGRAINE, WEIGHT INCREASED, ALOPECIA, NEOPLASM, VISUAL IMPAIRMENT, HEADACHE, TOOTH DISORDER AND OVARIAN CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, NEOPLASM, OVARIAN CYST, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, TOOTH DISORDER, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN-PAIN CHRONIC, PELVIC/ABDOMINAL, BACK, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DYSMENORRHEA (CRAMPING), APAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-SEP-2019: PFS RECEIVED: CASE BECOME INCIDENT, PREVIOUSLY REPORTED EVENT INJURY TO HERSELF WAS DELETED, NEWLY ADDED EVENT IS-PAIN CHRONIC, PELVIC/ABDOMINAL, BACK, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DYSMENORRHEA (CRAMPING), APAREUNIA, BLEEDING MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),ALLERGY NICKEL,PSYCH INJURY,BLADDER/URINARY PROBLEMS BLADDER INFECT,OTHER INJURIES/SYMPTOMS FATIGUE ,MIGRAINE, WEIGHT GAIN, OTHER, HAIR LOSS, TUMORS, VISION PROBS, HEADACHES, DENTAL PROBS, OVARIAN CYSTS & ESSURE CONFIRMATION TEST NOT PERFORMED. PRODUCT INDICATION WAS UPDATED AND DATE OF ESSURE REMOVAL WAS ADDED, REPORTER WAS ADDED, CONSUMER ADDRESS AND BIRTH DATE WAS ADDED. NO 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 905267 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 959713-NOT VALID,952109 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | CEEPRO| CEEPRO| IBUPROFEN| IBUPROFEN| TRAMADOL| TRAMADOL |