ESSURE
Report
- Report Number
- 2951250-2020-02890
- Event Type
- Injury
- Date Received
- April 2, 2020
- Report Date
- July 7, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('SEVERE (CHRONIC) PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED FOR STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN SYMPTOMS ALMOST IMMEDIATELY AFTER THE IMPLANTATION"), 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE PAIN IN THE BAK"), ARTHRALGIA ("SEVERE PAIN IN HIPS"), HEADACHE ("SEVERE PAIN IN HEAD"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("PROBLEMS CONCENTRATING"), MENSTRUAL DISORDER ("CHANGES IN MENSTRUAL CYCLE"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY HEAVY BLEEDING"), FEELING ABNORMAL ("BRAIN FOG") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE, FALLOPIAN TUBES REMOVED, POSSIBLY UTERUS AND OVARIES REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PROCEDURAL PAIN, BACK PAIN, ARTHRALGIA, HEADACHE, FATIGUE, AMNESIA, DISTURBANCE IN ATTENTION, MENSTRUAL DISORDER, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, FEELING ABNORMAL AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, FEELING ABNORMAL, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. LOT NUMBER: 810886 MANUFACTURING DATE: 2010-12 EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUL-2021: NEW EVENTS: BRAIN FOG, HAIR LOSS 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 ABDOMINAL PAIN ('SEVERE (CHRONIC) PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED FOR STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN SYMPTOMS ALMOST IMMEDIATELY AFTER THE IMPLANTATION"), 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE PAIN IN THE BAK"), ARTHRALGIA ("SEVERE PAIN IN HIPS"), HEADACHE ("SEVERE PAIN IN HEAD"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("PROBLEMS CONCENTRATING"), MENSTRUAL DISORDER ("CHANGES IN MENSTRUAL CYCLE"), HEAVY MENSTRUAL BLEEDING ("ABNORMALLY HEAVY BLEEDING"), FEELING ABNORMAL ("BRAIN FOG") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE, FALLOPIAN TUBES REMOVED, POSSIBLY UTERUS AND OVARIES REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PROCEDURAL PAIN, BACK PAIN, ARTHRALGIA, HEADACHE, FATIGUE, AMNESIA, DISTURBANCE IN ATTENTION, MENSTRUAL DISORDER, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, FEELING ABNORMAL AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, FEELING ABNORMAL, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, MENSTRUAL DISORDER AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LAWYER REPORTED ESSURE LOT # 810886 MANUFACTURING RELEASE DATE WAS 5-JAN-2011. LOT NUMBER: 810886 MANUFACTURING DATE: 2010-12 EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: DUE TO INTERNAL REVIEW IT WAS DETECTED THAT PREVIOUS FOLLOW UP WAS RECEIVED ON 1-JUL-2021 (AND NOT ON 5-JUL-2021). ADDITION: LAWYER REPORTED ESSURE LOT # 810886 MANUFACTURING RELEASE DATE WAS 5-JAN-2011. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN MATERIAL WAS REMOVED FROM MY BODY') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL FO ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. LOT NUMBER: 810886 MANUFACTURING DATE: 2010-12 EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-APR-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 ABDOMINAL PAIN ('SEVERE (CHRONIC) PAIN IN THE ABDOMEN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAIN SYMPTOMS ALMOST IMMEDIATELY AFTER THE IMPLANTATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE PAIN IN THE BAK"), ARTHRALGIA ("SEVERE PAIN IN HIPS"), HEADACHE ("SEVERE PAIN IN HEAD"), FATIGUE ("EXTREME AND CHRONIC FATIGUE"), AMNESIA ("MEMORY LOSS"), DISTURBANCE IN ATTENTION ("PROBLEMS CONCENTRATING"), MENSTRUAL DISORDER ("CHANGES IN MENSTRUAL CYCLE") AND MENORRHAGIA ("ABNORMALLY HEAVY BLEEDING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL FO ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, PROCEDURAL PAIN, BACK PAIN, ARTHRALGIA, HEADACHE, FATIGUE, AMNESIA, DISTURBANCE IN ATTENTION, MENSTRUAL DISORDER, MENORRHAGIA AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ARTHRALGIA, BACK PAIN, DISTURBANCE IN ATTENTION, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENSTRUAL DISORDER AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. LOT NUMBER: 810886, MANUFACTURING DATE: 2010-12, EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JAN-2021: SUMMONS WAS RECEIVED. A NEW REPORTER (LAWYER) WAS ADDED. IT WAS REPORTED THAT PLAINTIFF EXPERIENCED PAIN SYMPTOMS ALMOST IMMEDIATELY AFTER THE IMPLANTATION. THE SYMPTOMS INCLUDED SEVERE (CHRONIC) PAIN IN THE ABDOMEN, BACK, HIPS AND/OR HEAD. IN ADDITION, AFTER IMPLANTATION, SHE FACED WITH EXTREME AND CHRONIC FATIGUE, MEMORY LOSS, AND PROBLEMS CONCENTRATING. CHANGES IN MENSTRUAL CYCLE ALSO OCCURRED. THOSE CHANGES WERE OFTEN ACCOMPANIED BY ABNORMALLY HEAVY BLEEDING AND HORMONAL PROBLEMS. 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('FOREIGN MATERIAL WAS REMOVED FROM MY BODY') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810886) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL FO ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381427 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810886 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |