ESSURE
Report
- Report Number
- 2951250-2018-00855
- Event Type
- Injury
- Date Received
- February 26, 2018
- Report Date
- August 26, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRACTURING OF THE IMPLANT") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DIABETES MELLITUS, HEADACHE AND HYPERLIPIDEMIA. CONCURRENT CONDITIONS INCLUDED ACHE, BACK PAIN, UPPER RESPIRATORY INFECTION, CANDIDIASIS OF MOUTH, WHEEZING, BRONCHITIS, THRUSH AND LEUKOCYTOPENIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/ PELVIC PAIN FEMALE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT IN (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-NOV-2018: REPORTERS ADDED AND PATIENT DEMOGRAPHIC ADDED. HISTORICAL CONDITION AND CONCOMITANT DISEASES WERE ADDED. ON (B)(6) 2011, SHE IMPLANTED ESSURE (PREVIOUSLY REPORTED AS (B)(6) 2011). SUSPECT DRUG INDICATION ADDED, LOT NUMBER WAS PROVIDED. ADDED EVENTS: DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). ON(B)(6) 2017, SHE EXPLANTED ESSURE (PREVIOUSLY REPORTED AS (B)(6) 2017). 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 DEVICE BREAKAGE ("FRACTURING OF THE IMPLANT") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES MELLITUS, HEADACHE AND HYPERLIPIDEMIA. CONCURRENT CONDITIONS INCLUDED ACHE, BACK PAIN, UPPER RESPIRATORY INFECTION, CANDIDIASIS OF MOUTH, WHEEZING, BRONCHITIS, THRUSH AND LEUKOCYTOPENIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/ PELVIC PAIN FEMALE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT IN (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-NOV-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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 DEVICE BREAKAGE ('FRACTURING OF THE IMPLANT') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES MELLITUS, HEADACHE, HYPERLIPIDEMIA AND LUMBAGO. CONCURRENT CONDITIONS INCLUDED HYPERLIPIDEMIA SINCE (B)(6)2011, DIABETES MELLITUS SINCE (B)(6)2011, ACHE, BACK PAIN, UPPER RESPIRATORY INFECTION, CANDIDIASIS OF MOUTH, WHEEZING, BRONCHITIS, THRUSH, LEUKOCYTOPENIA AND HEADACHE. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM 2012 TO 2018. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/ PELVIC PAIN FEMALE / CHRONIC PELVIC PAIN AFTER ESSURE MAINLY IN THE SACROCOCCYGEAL REGION") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ SACROCOCCYGEAL REGION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), TOOTHACHE ("TOOTH PAIN"), OROPHARYNGEAL PAIN ("SORE THROAT"), COCCYDYNIA ("TAILBONE PAIN"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), BRONCHITIS ("BRONCHITIS"), PHARYNGITIS STREPTOCOCCAL ("STREP THROAT"), COUGH ("COUGH") AND SCAR ("SCAR TISSUE"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT IN (B)(6) 2017). ESSURE WAS REMOVED ON(B)(6)2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, TOOTHACHE, OROPHARYNGEAL PAIN, COCCYDYNIA, MIGRAINE, HEADACHE, BRONCHITIS, PHARYNGITIS STREPTOCOCCAL, COUGH AND SCAR OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED BRONCHITIS, COCCYDYNIA, COUGH, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, OROPHARYNGEAL PAIN, PELVIC PAIN, PHARYNGITIS STREPTOCOCCAL, SCAR AND TOOTHACHE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TYPE OF APPLICATION: DISABILITY DATE (OR YEAR) APPLICATION: (B)(6)2012 NATURE OF CLAIMED INJURY/DISABILITY: TAILBONE AREA OUTCOME OF APPLICATION: DENIED BASIS OF YOUR CLAIM: PAIN WAS CLAIM DENIED? YES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2013: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 852005 MANUFACTURE DATE: 2011-04 EXPIRATION DATE: 2014-04 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)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 DEVICE BREAKAGE ('FRACTURING OF THE IMPLANT') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES MELLITUS, HEADACHE, HYPERLIPIDEMIA AND LUMBAGO. CONCURRENT CONDITIONS INCLUDED HYPERLIPIDEMIA SINCE (B)(6) 2011, DIABETES MELLITUS SINCE (B)(6) 2011, ACHE, BACK PAIN, UPPER RESPIRATORY INFECTION, CANDIDIASIS OF MOUTH, WHEEZING, BRONCHITIS, THRUSH, LEUKOCYTOPENIA AND HEADACHE. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM 2012 TO 2018. ON (B)(6) -2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/ PELVIC PAIN FEMALE / CHRONIC PELVIC PAIN AFTER ESSURE MAINLY IN THE SACROCOCCYGEAL REGION") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ SACROCOCCYGEAL REGION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), TOOTHACHE ("TOOTH PAIN"), OROPHARYNGEAL PAIN ("SORE THROAT"), COCCYDYNIA ("TAILBONE PAIN"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), BRONCHITIS ("BRONCHITIS"), PHARYNGITIS STREPTOCOCCAL ("STREP THROAT"), COUGH ("COUGH") AND SCAR ("SCAR TISSUE"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT IN (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6)-2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, TOOTHACHE, OROPHARYNGEAL PAIN, COCCYDYNIA, MIGRAINE, HEADACHE, BRONCHITIS, PHARYNGITIS STREPTOCOCCAL, COUGH AND SCAR OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED BRONCHITIS, COCCYDYNIA, COUGH, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, OROPHARYNGEAL PAIN, PELVIC PAIN, PHARYNGITIS STREPTOCOCCAL, SCAR AND TOOTHACHE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TYPE OF APPLICATION: DISABILITY DATE (OR YEAR) APPLICATION: (B)(6)2012 NATURE OF CLAIMED INJURY/DISABILITY: TAILBONE AREA OUTCOME OF APPLICATION: DENIED BASIS OF YOUR CLAIM: PAIN WAS CLAIM DENIED? YES DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON(B)(6)-2013: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: SOCIAL MEDIA RECEIVED. EVENTS ADDED- TOOTH PAIN, SORE THROAT, TAILBONE PAIN, MIGRAINES, HEADACHES, BRONCHITIS, STREP THROAT, COUGH, SCAR. AKA NAME WAS ADDED. 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 DEVICE BREAKAGE ('FRACTURING OF THE IMPLANT') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DIABETES MELLITUS, HEADACHE, HYPERLIPIDEMIA AND LUMBAGO. CONCURRENT CONDITIONS INCLUDED HYPERLIPIDEMIA SINCE (B)(6) 2011, DIABETES MELLITUS SINCE (B)(6) 2011, ACHE, BACK PAIN, UPPER RESPIRATORY INFECTION, CANDIDIASIS OF MOUTH, WHEEZING, BRONCHITIS, THRUSH, LEUKOCYTOPENIA AND HEADACHE. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM 2012 TO 2018. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/ PELVIC PAIN FEMALE / CHRONIC PELVIC PAIN AFTER ESSURE MAINLY IN THE SACROCOCCYGEAL REGION") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/ SACROCOCCYGEAL REGION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), TOOTHACHE ("TOOTH PAIN"), OROPHARYNGEAL PAIN ("SORE THROAT"), COCCYDYNIA ("TAILBONE PAIN"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), BRONCHITIS ("BRONCHITIS"), PHARYNGITIS STREPTOCOCCAL ("STREP THROAT"), COUGH ("COUGH") AND SCAR ("SCAR TISSUE"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT IN (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, TOOTHACHE, OROPHARYNGEAL PAIN, COCCYDYNIA, MIGRAINE, HEADACHE, BRONCHITIS, PHARYNGITIS STREPTOCOCCAL, COUGH AND SCAR OUTCOME WAS UNKNOWN AND THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED BRONCHITIS, COCCYDYNIA, COUGH, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, OROPHARYNGEAL PAIN, PELVIC PAIN, PHARYNGITIS STREPTOCOCCAL, SCAR AND TOOTHACHE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TYPE OF APPLICATION: DISABILITY. DATE (OR YEAR) APPLICATION: (B)(6) 2012. NATURE OF CLAIMED INJURY/DISABILITY: TAILBONE AREA. OUTCOME OF APPLICATION: DENIED. BASIS OF YOUR CLAIM: PAIN. WAS CLAIM DENIED? YES . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JAN-2020: SOCIAL MEDIA RECEIVED. EVENTS ADDED- TOOTH PAIN, SORE THROAT, TAILBONE PAIN, MIGRAINES, HEADACHES, BRONCHITIS, STREP THROAT, COUGH, SCAR. AKA NAME WAS ADDED. 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 DEVICE BREAKAGE ("FRACTURING OF THE IMPLANT") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT IN (B)(6) 2017). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 139701 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 852005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | IBUPROFEN.| IBUPROFEN.| IBUPROFEN. |