ESSURE
Report
- Report Number
- 2951250-2019-07865
- Event Type
- Injury
- Date Received
- September 23, 2019
- Report Date
- November 5, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) 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 ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), MENORRHAGIA ("BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE,"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY FULL,SALPINGECTOMY BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, MENORRHAGIA, FATIGUE, MIGRAINE, HEADACHE, WEIGHT INCREASED AND NAUSEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR APAREUNIA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC/ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING). 3 TRAILING COIL(S) WERE NOTED ON THE RIGHT SIDE AND 4 TRAILING COIL(S) WERE NOTED ON THE LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE COILS IN GOOD POSITION WITH COMPLETE. OCCLUSION OF BOTH OVIDUCTS. IUD IN THE RIGHT PELVIS, OUTSIDE THE UTERINE LUMEN, PRESUMABLY IN THE PERITONEAL CAVITY.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-NOV-2020: QUALITY-SAFETY EVALUATION OF PTC. (PRODUCT TECHNICAL COMPLAINT). 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 ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) 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 ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), MENORRHAGIA ("BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE,"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY FULL,SALPINGECTOMY BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, MENORRHAGIA, FATIGUE, MIGRAINE, HEADACHE, WEIGHT INCREASED AND NAUSEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR APAREUNIA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC/ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING). 3 TRAILING COIL(S) WERE NOTED ON THE RIGHT SIDE AND 4 TRAILING COIL(S) WERE NOTED ON THE LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE COILS IN GOOD POSITION WITH COMPLETE OCCLUSION OF BOTH OVIDUCTS. IUD IN THE RIGHT PELVIS, OUTSIDE THE UTERINE LUMEN, PRESUMABLY IN THE PERITONEAL CAVITY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: MR RECEIVED : REPORTER, LOT NUMBER ADDED, RCC UPDATED. 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 ('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 ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), MENORRHAGIA ("BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE,"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY FULL,SALPINGECTOMY BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, MENORRHAGIA, FATIGUE, MIGRAINE, HEADACHE, WEIGHT INCREASED AND NAUSEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR APAREUNIA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC/ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. PREVIOUSLY REPORTED EVENT "INJURY" IS REPLACED BY "PELVIC PAIN" EVENTS-" APAREUNIA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, MIGRAINES, HEADACHES, WEIGHT GAIN AND NAUSEA", LAB DATA 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-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 900752 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882183 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |