ESSURE
Report
- Report Number
- 2951250-2019-04183
- Event Type
- Injury
- Date Received
- July 25, 2019
- Date of Event
- October 1, 2012
- Report Date
- March 18, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MISSING COIL/NO ESSURE DEVICE WAS FOUND / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE :UTERUS') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904752) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENSES IRREGULAR AND FOLLICULAR CYST OF OVARY. ESSURE CONFIRMATION TEST WAS DONE. CONCURRENT CONDITIONS INCLUDED TUBAL LIGATION, GESTATIONAL HYPERTENSION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND ARTHRALGIA ("JOINT ARCHES PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) - RIGHT COIL/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN 2012, PLAINTIFF HAD SURGICAL REMOVAL OF COIL(S) - RIGHT COIL. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY YES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSCOPY - ON AN UNKNOWN DATE: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). LEFT TUBE WAS VISIBLE FOR ESSURE DEVICE, BUT NOT THE RIGHT ONE.. PATHOLOGY TEST - ON (B)(6) 2012: FINAL DIAGNOSIS BILATERAL FALLOPIAN TUBES GROSS DESCRIPTION: BILATERAL FALLOPIAN TUBES. RECEIVED ARE TWO FALLOPIAN TUBES.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL BLEEDING, PELVIC PAIN, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. REPORTER INFORMATION UPDATED. PATIENT DEMOGRAPHIC INFORMATION UPDATED. PRODUCT INFORMATION DETAILS UPDATED. ESSURE START DATE UPDATED. OTHER RELEVANT HISTORY AND LAB DATA UPDATED. LOT NUMBER NEWLY ADDED. EVENT DEVICE DISLOCATION WAS UPDATED TO DEVICE EXPULSION. 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 EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MISSING COIL/NO ESSURE DEVICE WAS FOUND / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE :UTERUS') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904752) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MENSES IRREGULAR AND FOLLICULAR CYST OF OVARY. ESSURE CONFIRMATION TEST WAS DONE. CONCURRENT CONDITIONS INCLUDED TUBAL LIGATION, GESTATIONAL HYPERTENSION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND ARTHRALGIA ("JOINT ARCHES PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) - RIGHT COIL/SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED IN 2012. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN 2012, PLAINTIFF HAD SURGICAL REMOVAL OF COIL(S) - RIGHT COIL. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY YES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSCOPY - ON AN UNKNOWN DATE: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). LEFT TUBE WAS VISIBLE FOR ESSURE DEVICE, BUT NOT THE RIGHT ONE. PATHOLOGY TEST - ON (B)(6) 2012: FINAL DIAGNOSIS BILATERAL FALLOPIAN TUBES GROSS DESCRIPTION: BILATERAL FALLOPIAN TUBES. RECEIVED ARE TWO FALLOPIAN TUBES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-MAR-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 DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MISSING COIL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: ESSURE CONFIRMATION TEST WAS DONE. CONCURRENT CONDITIONS INCLUDED TUBAL LIGATION. IN 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN") AND ARTHRALGIA ("JOINT ARCHES PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) - RIGHT COIL). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN 2012, PLAINTIFF HAD SURGICAL REMOVAL OF COIL(S) - RIGHT COIL. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY YES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUL-2019: PLAINTIFF FACT SHEET RECEIVED. EVENTS PER PFS: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MISSING COIL, HORMONAL CHANGES DESCRIBE: MOOD SWING, ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DEPRESSION, ANXIETY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN AND JOINT ARCHES PAIN. INCIDENT: 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 |
|---|---|---|---|---|---|---|---|
| 621178 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 904752 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | MIRENA| MIRENA |