ESSURE
Report
- Report Number
- 2951250-2019-03877
- Event Type
- Injury
- Date Received
- July 16, 2019
- Date of Event
- February 8, 2013
- Report Date
- July 18, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- 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'), MASTITIS ('INFECTION (OTHER) DESCRIBE:BREAST'), KIDNEY INFECTION ('INFECTION (OTHER) DESCRIBE:KIDNEY') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONE') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932164) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: NUVARING FROM 2007 TO 2008. CONCOMITANT PRODUCTS INCLUDED DOXYCYCLINE SINCE (B)(6) 2018 FOR ACNE, ARIPIPRAZOLE (ABILIFY) SINCE (B)(6) 2013, BUPROPION SINCE (B)(6) 2013, CLONAZEPAM SINCE (B)(6) 2013, QUETIAPINE FUMARATE (SEROQUEL) SINCE (B)(6) 2013 AND SERTRALINE SINCE (B)(6) 2013 FOR DEPRESSION, OXYCODONE FOR PELVIC PAIN FEMALE, HYDROCODONE FROM (B)(6) 2013 TO (B)(6) 2018 FOR PELVIC PAIN FEMALE, LOW BACK PAIN, CRAMP IN LOWER ABDOMEN, THROAT PAIN AND MIGRAINE AS WELL AS ETHINYLESTRADIOL;LEVONORGESTREL (SEASONIQUE) FROM (B)(6); (B)(6) 2018 TO (B)(6) 2018 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO(B)(6) 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MASTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 7 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"). ON (B)(6) 2013, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("LOWER BACK PAIN TO PELVIC REGION"), OROPHARYNGEAL PAIN ("THROAT PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING") AND MIGRAINE ("MIGRAINES/ HEADACHE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("BLADDER OR URINARY PROBLEMS OR CHANGES-URINARY TRACT INFECTION (UTI)"). IN OCTOBER 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SURGERY (FULL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND MIGRAINE WAS RESOLVING, THE MASTITIS, KIDNEY INFECTION, NEPHROLITHIASIS, CYSTITIS, OROPHARYNGEAL PAIN, ABDOMINAL PAIN LOWER, URINARY TRACT INFECTION, WEIGHT INCREASED, FATIGUE, DEPRESSION, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, KIDNEY INFECTION, MASTITIS, MENORRHAGIA, MIGRAINE, NEPHROLITHIASIS, OROPHARYNGEAL PAIN, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 185LBS. ON UNKNOWN DATE TONSILLECTOMY SURGERY WAS PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: COULD NOT CONFIRM TOTAL BILATERAL OCCLUSION; ON (B)(6) 2013: COULD NOT CONFIRM TOTAL BILATERAL OCCLUSION; ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLIANT 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-CONFORMANCE'S 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'), MASTITIS ('INFECTION (OTHER) DESCRIBE:BREAST'), KIDNEY INFECTION ('INFECTION (OTHER) DESCRIBE:KIDNEY') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONE') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932164) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: NUVARING FROM 2007 TO 2008. CONCOMITANT PRODUCTS INCLUDED DOXYCYCLINE SINCE (B)(6) 2018 FOR ACNE, ARIPIPRAZOLE (ABILIFY) SINCE (B)(6) 2013, BUPROPION SINCE (B)(6) 2013, CLONAZEPAM SINCE (B)(6) 2013, QUETIAPINE FUMARATE (SEROQUEL) SINCE (B)(6) 2013 AND SERTRALINE SINCE (B)(6) 2013 FOR DEPRESSION, OXYCODONE FOR PELVIC PAIN FEMALE, HYDROCODONE FROM (B)(6) 2013 TO (B)(6) 2018 FOR PELVIC PAIN FEMALE, LOW BACK PAIN, CRAMP IN LOWER ABDOMEN, THROAT PAIN AND MIGRAINE AS WELL AS ETHINYLESTRADIOL; LEVONORGESTREL (SEASONIQUE) FROM (B)(6) 2018 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2012 TO (B)(6) 2013. ON (B)(6)-2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)-2012, THE PATIENT EXPERIENCED MASTITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 7 DAYS AFTER INSERTION OF ESSURE. ON (B)(6)-2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"). ON (B)(6)-2013, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6)-2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("LOWER BACK PAIN TO PELVIC REGION"), OROPHARYNGEAL PAIN ("THROAT PAIN"), ABDOMINAL PAIN LOWER ("CRAMPING") AND MIGRAINE ("MIGRAINES/ HEADACHE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("BLADDER OR URINARY PROBLEMS OR CHANGES-URINARY TRACT INFECTION (UTI)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SURGERY (FULL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)-2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN AND MIGRAINE WAS RESOLVING, THE MASTITIS, KIDNEY INFECTION, NEPHROLITHIASIS, CYSTITIS, OROPHARYNGEAL PAIN, ABDOMINAL PAIN LOWER, URINARY TRACT INFECTION, WEIGHT INCREASED, FATIGUE, DEPRESSION, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, KIDNEY INFECTION, MASTITIS, MENORRHAGIA, MIGRAINE, NEPHROLITHIASIS, OROPHARYNGEAL PAIN, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6) LBS. ON UNKNOWN DATE TONSILLECTOMY SURGERY WAS PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)-2012: COULD NOT CONFIRM TOTAL BILATERAL OCCLUSION; ON (B)(6)-2013: COULD NOT CONFIRM TOTAL BILATERAL OCCLUSION; ON (B)(6)-2013: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)-2019: PLAINTIFF FACT SHEET WAS RECEIVED. LOT NUMBER WERE ADDED. EVENTS ADDED FROM PFS-BREAST INFECTION, KIDNEY INFECTION, BLADDER INFECTION, KIDNEY STONE, PAIN, LOWER BACK PAIN, THROAT PAIN, CRAMPING, MIGRAINES, URINARY TRACT INFECTION, WEIGHT GAIN, ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), FATIGUE, DEPRESSION, DYSMENORRHEA (CRAMPING), HEADACHES, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). REPORTER INFORMATION, MEDICAL HISTORY, CONCOMITANT DRUG, EVENTS ONSET DATE, EVENTS OUTCOME, LAB DATA, ESSURE REMOVAL DATE WERE ADDED. EVENT-INJURY WAS DELETED DEVICE CATEGORY CHANGED FROM DEVICE OTHER EVENT TO INCIDENT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586020 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 932164 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | ABILIFY| ABILIFY| BUPROPION| BUPROPION| CLONAZEPAM| CLONAZEPAM| DEPO-PROVERA| DEPO-PROVERA| DOXYCYCLINE| DOXYCYCLINE| HYDROCODONE| HYDROCODONE| OXYCODONE| OXYCODONE| SEASONIQUE| SEASONIQUE| SEROQUEL| SEROQUEL| SERTRALINE| SERTRALINE| ABILIFY| BUPROPION| CLONAZEPAM| DEPO-PROVERA| DOXYCYCLINE| HYDROCODONE| OXYCODONE| SEASONIQUE| SEROQUEL| SERTRALINE |