ESSURE
Report
- Report Number
- 2951250-2020-05061
- Event Type
- Injury
- Date Received
- April 22, 2020
- Report Date
- July 24, 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 MEDICAL DEVICE REMOVAL ('ESSURE REMOVED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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) AND EXPERIENCED FEMALE ORGASMIC DISORDER ("SPONTANEOUS FEMALE ORGASM"), FIBROMYALGIA ("FIBROMYALGIA"), PERSISTENT GENITAL AROUSAL DISORDER ("PGAD"), IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL DISEASE") AND ABDOMINAL DISCOMFORT ("FEEL LIKE THERE IS BABY KICKING(FLUTTERS)/FEELS LIKE THERE IS PHANTOM BABY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, FEMALE ORGASMIC DISORDER, FIBROMYALGIA, PERSISTENT GENITAL AROUSAL DISORDER, IRRITABLE BOWEL SYNDROME AND ABDOMINAL DISCOMFORT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, FEMALE ORGASMIC DISORDER, FIBROMYALGIA, IRRITABLE BOWEL SYNDROME, MEDICAL DEVICE REMOVAL AND PERSISTENT GENITAL AROUSAL DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2018-DISCREPANCY NOTED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2018: THERE WAS NO CONTRAST SEEN TO EXTEND INTO EITHER THE RIGHT OR LEFT FALLOPIAN TUBE. THERE WAS NO SPILLAGE SEEN INTO THE PERITONEAL CAVITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- MEDICAL DEVICE REMOVAL. LOT NUMBER: 822365, MANUFACTURING DATE:2011-01, EXPIRATION DATE:2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUL-2020: QUALITY-SAFETY EVALUATION OF PTC. 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 ('ESSURE REMOVED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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) AND EXPERIENCED FEMALE ORGASMIC DISORDER ("SPONTANEOUS FEMALE ORGASM"), FIBROMYALGIA ("FIBROMYALGIA"), PERSISTENT GENITAL AROUSAL DISORDER ("PGAD"), IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL DISEASE") AND ABDOMINAL DISCOMFORT ("FEEL LIKE THERE IS BABY KICKING(FLUTTERS)/FEELS LIKE THERE IS PHANTOM BABY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, FEMALE ORGASMIC DISORDER, FIBROMYALGIA, PERSISTENT GENITAL AROUSAL DISORDER, IRRITABLE BOWEL SYNDROME AND ABDOMINAL DISCOMFORT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, FEMALE ORGASMIC DISORDER, FIBROMYALGIA, IRRITABLE BOWEL SYNDROME, MEDICAL DEVICE REMOVAL AND PERSISTENT GENITAL AROUSAL DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2018-DISCREPANCY NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2018: THERE WAS NO CONTRAST SEEN TO EXTEND INTO EITHER THE RIGHT OR LEFT FALLOPIAN TUBE. THERE WAS NO SPILLAGE SEEN INTO THE PERITONEAL CAVITY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- MEDICAL DEVICE REMOVAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-JUN-2020: MR RECEIVED: LOT NUMBER, LAB DATA WERE 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 MEDICAL DEVICE REMOVAL ('ESSURE REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED FEMALE ORGASMIC DISORDER ("SPONTANEOUS FEMALE ORGASM"), FIBROMYALGIA ("FIBROMYALGIA") AND PERSISTENT GENITAL AROUSAL DISORDER ("PGAD"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, FEMALE ORGASMIC DISORDER, FIBROMYALGIA AND PERSISTENT GENITAL AROUSAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FEMALE ORGASMIC DISORDER, FIBROMYALGIA, MEDICAL DEVICE REMOVAL AND PERSISTENT GENITAL AROUSAL DISORDER TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: INFORMATION RECEIVED VIA SOCIAL MEDIA: ADDED THE NEW EVENTS SPONTANEOUS FEMALE ORGASM, FIBROMYALGIA AND PGAD''. REPORTER INFORMATION 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED FEMALE ORGASMIC DISORDER ("SPONTANEOUS FEMALE ORGASM"), FIBROMYALGIA ("FIBROMYALGIA"), PERSISTENT GENITAL AROUSAL DISORDER ("PGAD"), IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL DISEASE") AND ABDOMINAL DISCOMFORT ("FEEL LIKE THERE IS BABY KICKING(FLUTTERS)/FEELS LIKE THERE IS PHANTOM BABY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, FEMALE ORGASMIC DISORDER, FIBROMYALGIA, PERSISTENT GENITAL AROUSAL DISORDER, IRRITABLE BOWEL SYNDROME AND ABDOMINAL DISCOMFORT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, FEMALE ORGASMIC DISORDER, FIBROMYALGIA, IRRITABLE BOWEL SYNDROME, MEDICAL DEVICE REMOVAL AND PERSISTENT GENITAL AROUSAL DISORDER TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAY-2020: FU 2 AND 3 WERE PROCESSED TOGETHER. REPORTER INFORMATION WERE UPDATED. NEW EVENT IBS AND ABNORMAL FEELING LOWER ABDOMEN WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, 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 (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA- MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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 |
|---|---|---|---|---|---|---|---|
| 451604 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822365 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |