ESSURE
Report
- Report Number
- 2951250-2020-06414
- Event Type
- Injury
- Date Received
- May 1, 2020
- Report Date
- April 9, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06516) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), NEPHROLITHIASIS ("I HAVE HAD A 6MM KIDNEY STONE IN MY LEFT SIDE SINCE RIGHT BEFORE MY REMOVAL"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), HYPERSENSITIVITY ("ALLERGY"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("TROUBLE GETTING MY WEIGHT DOWN/POUNDS ARENT COMING OUT/"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY + BI - S). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL INFECTION HAD RESOLVED AND THE WEIGHT INCREASED, PSYCHOLOGICAL TRAUMA, CYSTITIS AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, NEPHROLITHIASIS, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: I DON'T SEE THE DOC ABOUT MY E-HELL UNIT UNTIL MAY2. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: WEIGHT GAIN, MEDICAL DEVICE REMOVAL. BATCH NO C06516, PRODUCTION DATE 2013-12-24, EXPIRATION DATE 2016-12-31. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUN-2020: 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 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') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06516) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), NEPHROLITHIASIS ("I HAVE HAD A 6MM KIDNEY STONE IN MY LEFT SIDE SINCE RIGHT BEFORE MY REMOVAL"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), HYPERSENSITIVITY ("ALLERGY"), MENTAL DISORDER ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("TROUBLE GETTING MY WEIGHT DOWN/POUNDS ARENT COMING OUT/"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY + BI - S). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL INFECTION HAD RESOLVED AND THE WEIGHT INCREASED, MENTAL DISORDER, CYSTITIS AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENTAL DISORDER, NEPHROLITHIASIS, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: I DON'T SEE THE DOC ABOUT MY E-HELL UNIT UNTIL MAY2. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: WEIGHT GAIN, MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAY-2020: PIF RECEIVED. EVENT MEDICAL DEVICE REMOVAL UPDATED TO PAIN. NEW EVENT ADDED: PELVIC PAIN, GENITAL BLEEDING, ALLERGY, PSYCH INJURY, FATIGUE, BLADDER PROBLEM, URINARY PROBLEM, BLADDER INFECTIONS, UTI, VAGINAL INFECTIONS AND VAGINAL DISCHARGE. LOT NO. 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 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') AND PELVIC INFLAMMATORY DISEASE ('PID') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C06516) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INTRAUTERINE DEVICE REMOVAL, MIGRAINE, WEAKNESS GENERALISED, LOW BACK PAIN, AMENORRHEA, CERVICAL DYSPLASIA, LOOP ELECTROSURGICAL EXCISION PROCEDURE, STRESS, VAGINAL DISCHARGE, RINGING IN EARS, EARACHE, PERIPHERAL SWELLING, HEARTBURN, STOMACH PAIN, NAUSEA, MENSES IRREGULAR, DRYNESS VAGINAL, TINGLING FEET/HANDS, ANXIETY, MENORRHAGIA, PAINFUL INTERCOURSE, OLIGOMENORRHEA, CRAMP IN LOWER ABDOMEN, FATIGUE, LOW MOOD, DYSMENORRHEA, UTERINE BLEEDING, DEPRESSION, MEMORY DISTURBANCE, NICKEL SENSITIVITY, PARATUBAL CYST, MULTIGRAVIDA AND PARITY 3. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IMITREX, TYLENOL, IBUPROFEN, DOXY, MOTRIN, ROCEPHIN AND DEPO PROVERA. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), HYPERSENSITIVITY ("ALLERGY"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), NEPHROLITHIASIS ("I HAVE HAD A 6MM KIDNEY STONE IN MY LEFT SIDE SINCE RIGHT BEFORE MY REMOVAL"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION") AND URINARY TRACT INFECTION ("UTI") AND WAS FOUND TO HAVE WEIGHT INCREASED ("TROUBLE GETTING MY WEIGHT DOWN/POUNDS ARENT COMING OUT/"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY + BI - S). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, VAGINAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER AND URINARY TRACT INFECTION HAD RESOLVED AND THE PELVIC INFLAMMATORY DISEASE, VAGINAL DISCHARGE, WEIGHT INCREASED, PSYCHOLOGICAL TRAUMA AND CYSTITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, NEPHROLITHIASIS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: I DON'T SEE THE DOC ABOUT MY E-HELL UNIT UNTIL MAY2 LEFT : TWO COILS WERE OBSERVED IN THE ENDOMETRIAL CAVITY FOLLOWING THE PLACEMENT RIGHT: THREE COILS WERE NOTED IN THE ENDOMETRIAL CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: NORMAL UTERINE SHAPE AND SIZE WITH ESSURE COILS IN PLACE IN THE UTERINE CORNUA BILATERALLY. NO CONTRAST SEEN BEYOND THE DISTAL COILS. SUCCESSFUL ESSURE TL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: WEIGHT GAIN, MEDICAL DEVICE REMOVAL BATCH NO: C06516, PRODUCTION DATE: 2013-12-24 EXPIRATION DATE 2016-12-31. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-APR-2021: MR RECEIVED: EVENT PID ADDED AND MADE MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED DUE TO SURGERY. REPORTER, MEDICAL HISTORY, HISTORICAL DRUG, LAB TEST AND RCC ADDED. 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 MEDICAL DEVICE REMOVAL ('I HAD EVERYTHING REMOVED EXCEPT OVARIES') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), WAS FOUND TO HAVE WEIGHT INCREASED ("TROUBLE GETTING MY WEIGHT DOWN / POUNDS AREN'T COMING OUT") AND EXPERIENCED NEPHROLITHIASIS ("I HAVE HAD A 6MM KIDNEY STONE IN MY LEFT SIDE SINCE RIGHT BEFORE MY REMOVAL"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL, NEPHROLITHIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: I DON'T SEE THE DOC ABOUT MY E-HELL UNIT UNTIL (B)(6). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: WEIGHT GAIN, MEDICAL DEVICE REMOVAL. 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 I HAD EVERYTHING REMOVED EXCEPT OVARIES ADDED AND CASE UPGRADED. ON 23-MAR-2020: SOCIAL MEDIA RECEIVED: NEW REPORTER WAS ADDED, EVENT KIDNEY STONE WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481296 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C06516 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |