ESSURE
Report
- Report Number
- 2951250-2019-09632
- Event Type
- Injury
- Date Received
- October 7, 2019
- Report Date
- May 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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 "SHE DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, UTI, GALLBLADDER OPERATION AND INFLAMMATION. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE (B)(6) 2011, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NITROFURANTOIN (MACRODANTIN) AND SILDENAFIL CITRATE (INTEGRA) SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) / UNBEARABLE BLEEDING"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), TOOTH DISORDER ("DENTAL PROBLEMS"), CERVICITIS ("MILD CHRONIC CERVICITIS"), OVERWEIGHT ("OVERWEIGHT") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL) AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, MENORRHAGIA, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, TOOTH DISORDER AND CERVICITIS OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, FATIGUE, ALOPECIA, WEIGHT INCREASED, OVERWEIGHT AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, CERVICITIS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, OVERWEIGHT, PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE (B)(6) 2011 AND (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2016: INTERPRETATION NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY. PREGNANCY TEST URINE - ON (B)(6) 2011: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-SEP-2019: PFS AND MR RECEIVED. LOT NUMBER ADDED. CHRONIC ENDOMETRITIS EVENT ADDED FROM MR. NEW EVENTS: HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL), DENTAL PROBLEMS, MILD CHRONIC CERVICITIS, OVERWEIGHT, BLOATING WERE ADDED. OUTCOME OF THE EVENTS OVERWEIGHT AND BLOATING WERE ADDED. NEW REPORTERS ADDED, PLAINTIFF'S INFORMATION UPDATED. CONCOMITANT CONDITIONS AND DRUGS WERE ADDED. 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 ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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 "SHE DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, UTI, GALLBLADDER OPERATION AND INFLAMMATION. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE (B)(6) 2011, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NITROFURANTOIN (MACRODANTIN) AND SILDENAFIL CITRATE (INTEGRA) SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) / UNBEARABLE BLEEDING"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), TOOTH DISORDER ("DENTAL PROBLEMS"), CERVICITIS ("MILD CHRONIC CERVICITIS"), OVERWEIGHT ("OVERWEIGHT"), ABDOMINAL DISTENSION ("BLOATING") AND MIGRAINE ("MIGRAINE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL) AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, MENORRHAGIA, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, TOOTH DISORDER, CERVICITIS AND MIGRAINE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, FATIGUE, ALOPECIA, WEIGHT INCREASED, OVERWEIGHT AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, CERVICITIS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, OVERWEIGHT, PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE-(B)(6) 2011 AND (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2016: INTERPRETATION NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY.. PREGNANCY TEST URINE - ON (B)(6) 2011: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: PELVIC PAIN. LOT NUMBER: 841528 MANUFACTURING DATE: 2011/03 EXPIRATION DATE: 2014/03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED: EVENT MIGRAINE AND REPORTER INFORMATION WAS ADDED. 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 ENDOMETRITIS ('CHRONIC ENDOMETRITIS') AND PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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 "SHE DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, UTI, GALLBLADDER OPERATION AND INFLAMMATION. CONCOMITANT PRODUCTS INCLUDED DOCUSATE SODIUM (COLACE) SINCE (B)(6) 2011, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NITROFURANTOIN (MACRODANTIN) AND SILDENAFIL CITRATE (INTEGRA) SINCE (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) / UNBEARABLE BLEEDING"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), TOOTH DISORDER ("DENTAL PROBLEMS"), CERVICITIS ("MILD CHRONIC CERVICITIS"), OVERWEIGHT ("OVERWEIGHT") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL) AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, MENORRHAGIA, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, TOOTH DISORDER AND CERVICITIS OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, FATIGUE, ALOPECIA, WEIGHT INCREASED, OVERWEIGHT AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, CERVICITIS, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, OVERWEIGHT, PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE-(B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. GYNAECOLOGICAL EXAMINATION - ON (B)(6) 2016: INTERPRETATION NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY.. PREGNANCY TEST URINE - ON (B)(6) 2011: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: PELVIC PAIN. LOT NUMBER: 841528 MANUFACTURING DATE: 2011/03 EXPIRATION DATE: 2014/03 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-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 ('PELVIC PAIN') IN AN ADULT 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 MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO CONFIRMATION TEST". 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), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("OTHER INJURIES/SYMPTOMS: FATIGUE") AND ALOPECIA ("OTHER INJURIES/SYMPTOMS: HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("OTHER INJURIES/SYMPTOMS: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, FATIGUE, ALOPECIA AND WEIGHT INCREASED HAD RESOLVED AND THE MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE (B)(6) 2011 AND (B)(6) 2011. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET WAS RECEIVED. PREVIOUSLY REPORTED EVENT INJURY WAS REPLACED WITH NEW EVENTS: DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, FATIGUE, HAIR LOSS, WEIGHT GAIN, SHE DID NOT UNDERGO CONFIRMATION TEST. REPORTER INFORMATION, DATE OF BIRTH, ESSURE REMOVAL DATE WERE ADDED. ESSURE INSERTION DATE WERE UPDATED. DEVICE CATEGORY CHANGED FROM DEVICE OTHER EVENT TO INCIDENT. INCIDENT: 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 |
|---|---|---|---|---|---|---|---|
| 954840 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | COLACE| COLACE| COLACE| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| INTEGRA [SILDENAFIL CITRATE]| INTEGRA [SILDENAFIL CITRATE]| INTEGRA [SILDENAFIL CITRATE]| MACRODANTIN| MACRODANTIN| MACRODANTIN |