ESSURE
Report
- Report Number
- 2951250-2019-05578
- Event Type
- Injury
- Date Received
- September 6, 2019
- Date of Event
- September 1, 2012
- Report Date
- April 1, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC/PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 893029) 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 AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("HYPERSENSITIVITY"), ALLERGY TO SYNTHETIC FABRIC ("CLOTHING ALLERGY"), FOOD ALLERGY ("FOOD ALLERGY") AND URTICARIA ("RASHES OR SKIN CONDITIONS TYPE: LARGE HIVES"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN: ABDOMINAL"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS: UNSPECIFIED"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS: UNSPECIFIED"), RASH ("BREAKING OUT\RASHES OR SKIN CONDITION: PAINFUL OVER ENTIRE BODY"), ABDOMINAL DISTENSION ("BLOATING/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SWOLLEN STOMACH"), PELVIC DISCOMFORT ("DISCOMFORT"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE:YEAST INFECTIONS"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE"), BACK PAIN ("BACK PAIN") AND CYSTITIS ("BLADDER INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RASH, URINARY TRACT INFECTION, HYPERSENSITIVITY, MIGRAINE, DYSPAREUNIA, URTICARIA, BACK PAIN AND CYSTITIS HAD RESOLVED AND THE ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, ABDOMINAL DISTENSION, PELVIC DISCOMFORT, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION, FEMALE SEXUAL DYSFUNCTION, NAUSEA, VAGINAL DISCHARGE, FATIGUE, ALLERGY TO SYNTHETIC FABRIC AND FOOD ALLERGY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO SYNTHETIC FABRIC, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FOOD ALLERGY, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC DISCOMFORT, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS UNKNOWN IF THE ESSURE CONFIRMATION TEST WAS DONE. IN PFS DATE OF BIRTH REPORTED AS ON (B)(6) 1980. HENCE PARTIAL DATE TAKEN. DISCREPANCY IN PFS: ESSURE REMOVAL. REMOVAL RECOMMENDED BY TREATING PHYSICIAN? YES. ESSURE REMOVED? UNKNOWN BUT IN SAME PFS DATE(S) OF REMOVAL: ON (B)(6) 2018; SALPING. (BILATERAL}, HYST. (PARTIAL) WAS REPORTED. LOT NUMBER: 893029, MANUFACTURING DATE: 2011-08, EXPIRATION DATE: 2014-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-MAR-2020: 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 ('PAIN: PELVIC/PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) 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 AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED RECURRENT ABORTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HYPERSENSITIVITY ("HYPERSENSITIVITY"), ALLERGY TO SYNTHETIC FABRIC ("CLOTHING ALLERGY"), FOOD ALLERGY ("FOOD ALLERGY") AND URTICARIA ("RASHES OR SKIN CONDITIONS TYPE: LARGE HIVES"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN: ABDOMINAL"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS: UNSPECIFIED"), URINARY TRACT DISORDER ("BLADDER/URINARY PROBLEMS: UNSPECIFIED"), RASH ("BREAKING OUT\RASHES OR SKIN CONDITION: PAINFUL OVER ENTIRE BODY"), ABDOMINAL DISTENSION ("BLOATING/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SWOLLEN STOMACH"), PELVIC DISCOMFORT ("DISCOMFORT"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE:YEAST INFECTIONS"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE"), BACK PAIN ("BACK PAIN") AND CYSTITIS ("BLADDER INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RASH, URINARY TRACT INFECTION, HYPERSENSITIVITY, MIGRAINE, DYSPAREUNIA, URTICARIA, BACK PAIN AND CYSTITIS HAD RESOLVED AND THE ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, ABDOMINAL DISTENSION, PELVIC DISCOMFORT, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION, FEMALE SEXUAL DYSFUNCTION, NAUSEA, VAGINAL DISCHARGE, FATIGUE, ALLERGY TO SYNTHETIC FABRIC AND FOOD ALLERGY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO SYNTHETIC FABRIC, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FOOD ALLERGY, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC DISCOMFORT, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS UNKNOWN IF THE ESSURE CONFIRMATION TEST WAS DONE. IN PFS DATE OF BIRTH REPORTED AS (B)(6) 1980. HENCE PARTIAL DATE TAKEN. DISCREPANCY IN PFS: ESSURE REMOVAL. REMOVAL RECOMMENDED BY TREATING PHYSICIAN? YES. ESSURE REMOVED? UNKNOWN BUT IN SAME PFS DATE(S) OF REMOVAL: (B)(6) 2018; SALPING. (BILATERAL}, HYST. (PARTIAL) WAS REPORTED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED: REPORTER, PATIENT DEMOGRAPHICS, MEDICAL HISTORY WERE ADDED. ESSURE LOT NUMBER ADDED. ON (B)(6) 2012, SHE IMPLANTED ESSURE (PREVIOUSLY REPORTED AS (B)(6) 2012). ADDED EVENTS ABNORMAL BLEEDING (VAGINAL), FOOD ALLERGY, CLOTHING ALLERGY, YEAST INFECTIONS, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), RASHES OR SKIN CONDITIONS TYPE: LARGE HIVES, MIGRAINES / HEADACHES, NAUSEA, VAGINAL DISCHARGE, FATIGUE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAINFUL OVER ENTIRE BODY, HYPERSENSITIVITY, BACK PAIN, BLADDER INFECTION, SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. UPDATED EVENT INFECTION/INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI (PREVIOUSLY REPORTED AS INFECTION). 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 ('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. 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"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), BLADDER DISORDER ("BLADDER / URINARY PROBLEMS: UNSPECIFIED"), URINARY TRACT DISORDER ("BLADDER / URINARY PROBLEMS: UNSPECIFIED"), RASH ("BREAKING OUT"), ABDOMINAL DISTENSION ("BLOATING"), PELVIC DISCOMFORT ("DISCOMFORT") AND INFECTION ("INFECTION: UNKNOWN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, RASH, ABDOMINAL DISTENSION, PELVIC DISCOMFORT AND INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BLADDER DISORDER, DYSMENORRHOEA, INFECTION, MENORRHAGIA, PELVIC DISCOMFORT, PELVIC PAIN, RASH AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IT WAS UNKNOWN IF THE ESSURE CONFIRMATION TEST WAS DONE. IN PFS DATE OF BIRTH REPORTED AS ''(B)(6) 1980''. HENCE PARTIAL DATE TAKEN. DISCREPANCY IN PFS: ESSURE REMOVAL. REMOVAL RECOMMENDED BY TREATING PHYSICIAN? YES. ESSURE REMOVED? UNKNOWN BUT IN SAME PFS DATE(S) OF REMOVAL: (B)(6) 2018; SALPING. (BILATERAL}, HYST. (PARTIAL) WAS REPORTED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2019: PLAINTIFF FACT SHEET RECEIVED. THE CASE IS NOW INCIDENT. PREVIOUSLY REPORTED EVENT ¿INJURY¿ WAS UPDATED TO MORE SPECIFIED EVENTS ¿PELVIC PAIN, PAIN: ABDOMINAL, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING, BLADDER / URINARY PROBLEMS, BREAKING OUT, BLOATING, DISCOMFORT, INFECTION (UNKNOWN)¿. REPORTER, DEMOGRAPHICS; ESSURE INDICATION (AMENDED), ESSURE INSERTION / REMOVAL DATE WERE 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-CONFORMANCE'S 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 |
|---|---|---|---|---|---|---|---|
| 763096 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893029 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R |