ESSURE
Report
- Report Number
- 2951250-2017-06830
- Event Type
- Injury
- Date Received
- November 17, 2017
- Date of Event
- July 1, 2011
- Report Date
- November 30, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE, ABNORMAL BLEEDING") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT HAS NO HISTORY OF ALLERGIES OR ASTHMA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HYPERTENSION, HYPERLIPIDAEMIA, ANXIETY, IRREGULAR MENSTRUAL CYCLE, NOCTURIA, URINARY FREQUENCY, VITAMIN D DEFICIENCY, ANXIETY, DYSFUNCTIONAL UTERINE BLEEDING, POST COITAL BLEEDING, URINARY URGENCY, INCREASED URINARY FREQUENCY, STRESS INCONTINENCE AND PERINEAL PAIN. CONCOMITANT PRODUCTS INCLUDED SERTRALINE (ZOLOFT) AND VENLAFAXINE FOR ANXIETY, HYDROCHLOROTHIAZIDE AND VALSARTAN SINCE 2013 FOR HYPERTENSION AS WELL AS ACETYLSALICYLIC ACID (ASPIRIN) SINCE 2002, INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS), RANITIDINE AND SERTRALINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). 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)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY/BILATERAL SLPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. ON (B)(6) 2016, THE PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, WEIGHT INCREASED, VAGINAL DISCHARGE AND FATIGUE HAD RESOLVED AND THE ABDOMINAL DISTENSION, HEADACHE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 177 LBS. INSERTION DATE: THE COIL WAS VISUALIZED IN THE TUBAL OSTIA APPROXIMATELY 3 COILS WERE SEEN PROTRUDING FROM THE TUBAL OSTIA. THE ESSURE DEVICE TO BE PRESENT IN THE PATIENT'S LEFT CORNUA WITH APPROX. 2 COILS PROTRUDING FROM THE PATIENT'S OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: DYSMENORRHEA, ABDOMINAL PAIN, ALLERGY TO METALS, FATIGUE, ABDOMINAL DISTENSION, PELVIC PAIN , DYSPAREUNIA AND WEIGHT GAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAY-2018: THIS CASE IS MEDICALLY CONFIRMED. REPORTER INFORMATION WAS ADDED. THIS CASE CONCERNS 33 YEAR OLD PATIENT. HER DEMOGRAPHIC WAS ADDED. HER CONCURRENT CONDITIONS WERE ADDED. LAB DATA WAS AMENDED. ASSURE INDICATION WAS AMENDED. ASSURE LOT NUMBER WAS ADDED. HER CONCOMITANT MEDICATIONS WERE ADDED. FOLLOWING EVENTS: ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA), HEADACHES, MIGRAINES, WEIGHT GAIN, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), VAGINAL DISCHARGE AND FATIGUE WERE ADDED. SHE HAD RECOVERED FORM ABNORMAL BLEEDING, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, VAGINAL DISCHARGE, MIGRAINES, WEIGHT GAIN AND PELVIC PAIN. 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 ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE, ABNORMAL BLEEDING") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT HAS NO HISTORY OF ALLERGIES OR ASTHMA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HYPERTENSION, HYPERLIPIDAEMIA, ANXIETY, IRREGULAR MENSTRUAL CYCLE, NOCTURIA, URINARY FREQUENCY, VITAMIN D DEFICIENCY, ANXIETY, DYSFUNCTIONAL UTERINE BLEEDING, POST COITAL BLEEDING, URINARY URGENCY, INCREASED URINARY FREQUENCY, STRESS INCONTINENCE AND PERINEAL PAIN. CONCOMITANT PRODUCTS INCLUDED SERTRALINE (ZOLOFT) AND VENLAFAXINE FOR ANXIETY, HYDROCHLOROTHIAZIDE AND VALSARTAN SINCE 2013 FOR HYPERTENSION AS WELL AS ACETYLSALICYLIC ACID (ASPIRIN) SINCE 2002, INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS), RANITIDINE AND SERTRALINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). 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)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY/BILATERAL SLPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. ON (B)(6) 2016, THE PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, WEIGHT INCREASED, VAGINAL DISCHARGE AND FATIGUE HAD RESOLVED AND THE ABDOMINAL DISTENSION, HEADACHE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 177 LBS. INSERTION DATE: THE COIL WAS VISUALIZED IN THE TUBAL OSTIA APPROXIMATELY 3 COILS WERE SEEN PROTRUDING FROM THE TUBAL OSTIA. THE ESSURE DEVICE TO BE PRESENT IN THE PATIENT'S LEFT CORNUA WITH APPROX. 2 COILS PROTRUDING FROM THE PATIENT'S OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: DYSMENORRHEA, ABDOMINAL PAIN, ALLERGY TO METALS, FATIGUE, ABDOMINAL DISTENSION, PELVIC PAIN , DYSPAREUNIA AND WEIGHT GAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINTS. 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 ('CHRONIC PELVIC PAIN') AND GENITAL HAEMORRHAGE ('EXCESSIVE, ABNORMAL BLEEDING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT HAS NO HISTORY OF ALLERGIES OR ASTHMA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HYPERTENSION, HYPERLIPIDAEMIA, ANXIETY, IRREGULAR MENSTRUAL CYCLE, NOCTURIA, URINARY FREQUENCY, VITAMIN D DEFICIENCY, ANXIETY, DYSFUNCTIONAL UTERINE BLEEDING, POST COITAL BLEEDING, URINARY URGENCY, INCREASED URINARY FREQUENCY, STRESS INCONTINENCE, PERINEAL PAIN AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED SERTRALINE HYDROCHLORIDE (ZOLOFT) AND VENLAFAXINE FOR ANXIETY, HYDROCHLOROTHIAZIDE AND VALSARTAN SINCE 2013 FOR HYPERTENSION AS WELL AS ACETYLSALICYLIC ACID (ASPIRIN) SINCE 2002, INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS), RANITIDINE AND SERTRALINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). 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)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. ON (B)(6) 2016, THE PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, WEIGHT INCREASED, VAGINAL DISCHARGE AND FATIGUE HAD RESOLVED AND THE ABDOMINAL DISTENSION, HEADACHE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 177 LBS. INSERTION DATE: THE COIL WAS VISUALIZED IN THE TUBAL OSTIA APPROXIMATELY 3 COILS WERE SEEN PROTRUDING FROM THE TUBAL OSTIA. THE ESSURE DEVICE TO BE PRESENT IN THE PATIENT'S LEFT CORNUA WITH APPROX. 2 COILS PROTRUDING FROM THE PATIENT'S OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: DYSMENORRHEA, ABDOMINAL PAIN, ALLERGY TO METALS, FATIGUE, ABDOMINAL DISTENSION, PELVIC PAIN , DYSPAREUNIA AND WEIGHT GAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-APR-2021: MEDICAL RECORD RECEIVED. REPORTERS INFORMATION AND MEDICAL HISTORY WERE ADDED. THERE WAS NO SIGNIFICANT CHANGE IN THE MEDICAL CONTEXT OF CASE. 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 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 PELVIC PAIN ('CHRONIC PELVIC PAIN') AND GENITAL HAEMORRHAGE ('EXCESSIVE, ABNORMAL BLEEDING') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATIENT HAS NO HISTORY OF ALLERGIES OR ASTHMA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HYPERTENSION, HYPERLIPIDAEMIA, ANXIETY, IRREGULAR MENSTRUAL CYCLE, NOCTURIA, URINARY FREQUENCY, VITAMIN D DEFICIENCY, ANXIETY, DYSFUNCTIONAL UTERINE BLEEDING, POST COITAL BLEEDING, URINARY URGENCY, INCREASED URINARY FREQUENCY, STRESS INCONTINENCE, PERINEAL PAIN AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED SERTRALINE HYDROCHLORIDE (ZOLOFT) AND VENLAFAXINE FOR ANXIETY, HYDROCHLOROTHIAZIDE AND VALSARTAN SINCE 2013 FOR HYPERTENSION AS WELL AS ACETYLSALICYLIC ACID (ASPIRIN) SINCE 2002, INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS), RANITIDINE AND SERTRALINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. ON (B)(6) 2016, THE PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, WEIGHT INCREASED, VAGINAL DISCHARGE AND FATIGUE HAD RESOLVED AND THE ABDOMINAL DISTENSION, HEADACHE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 177 LBS. INSERTION DATE: THE COIL WAS VISUALIZED IN THE TUBAL OSTIA APPROXIMATELY 3 COILS WERE SEEN PROTRUDING FROM THE TUBAL OSTIA. THE ESSURE DEVICE TO BE PRESENT IN THE PATIENT'S LEFT CORNUA WITH APPROX. 2 COILS PROTRUDING FROM THE PATIENT'S OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: DYSMENORRHEA, ABDOMINAL PAIN, ALLERGY TO METALS, FATIGUE, ABDOMINAL DISTENSION, PELVIC PAIN , DYSPAREUNIA AND WEIGHT GAIN." QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-NOV-2021: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 PELVIC PAIN ("CHRONIC PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE, ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA") AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, DYSPAREUNIA, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: FULL OCCLUSION OF BOTH TUBES. COMPANY CAUSALITY COMMENT. 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 |
|---|---|---|---|---|---|---|---|
| 819492 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 844600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Required Intervention| O | ASPIRIN| ASPIRIN| ASPIRIN [ACETYLSALICYLIC ACID]| ASPIRIN [ACETYLSALICYLIC ACID]| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| IUD NOS| IUD NOS| IUD NOS| IUD NOS| RANITIDINE| RANITIDINE| RANITIDINE| RANITIDINE| SERTRALINE| SERTRALINE| SERTRALINE| SERTRALINE| VALSARTAN| VALSARTAN| VALSARTAN| VALSARTAN| VENLAFAXINE| VENLAFAXINE| VENLAFAXINE| VENLAFAXINE| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT |