ESSURE
Report
- Report Number
- 2951250-2017-10526
- Event Type
- Injury
- Date Received
- December 11, 2017
- Date of Event
- June 1, 2013
- Report Date
- December 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), RESPIRATORY ARREST ("STOPPED BREATHING DURING ESSURE REMOVAL SURGERY") AND COMPLICATION OF DEVICE REMOVAL ("STOPPED BREATHING DURING ESSURE REMOVAL SURGERY") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST WAS NOT CONDUCTED". CONCOMITANT PRODUCTS INCLUDED SERTRALINE (ZOLOFT) FROM 2004 TO 2017. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN FEBRUARY 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES/ DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN MARCH 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"). IN JUNE 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), WEIGHT INCREASED ("WEIGHT GAIN") AND NAUSEA ("NAUSEA"). ON (B)(6) 2017, 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED RESPIRATORY ARREST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), COMPLICATION OF DEVICE REMOVAL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND SLEEP APNOEA SYNDROME ("SLEEP APNEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH IBUPROFEN, SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) WITH ESSURE REMOVAL), ALTERNATIVE THERAPY (CPAP MACHINE FROM NOV-2017 TO PRESENT), ALTERNATIVE THERAPY (WALKING AND EXERCISE), ALTERNATIVE THERAPY (WALKING AND EXERCISE) AND ALTERNATIVE THERAPY (CPAP MACHINE FROM NOV-2017 TO PRESENT). ESSURE WAS REMOVED ON (B)(6) 2017. ON (B)(6) 2017, THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. IN APRIL 2017, THE PELVIC PAIN, DYSPAREUNIA AND ABDOMINAL PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE RESPIRATORY ARREST, COMPLICATION OF DEVICE REMOVAL, SLEEP APNOEA SYNDROME, DYSMENORRHOEA, ABDOMINAL DISTENSION, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, VAGINAL DISCHARGE, WEIGHT INCREASED AND NAUSEA OUTCOME WAS UNKNOWN AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, COMPLICATION OF DEVICE REMOVAL, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RESPIRATORY ARREST, SLEEP APNOEA SYNDROME, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN THE PLAINTIFF FACT SHEET (PFS) FROM (B)(6) 2018 THAT ESSURE WAS INSERTED ON (B)(6) 2013 (DISCREPANCY BETWEEN INI REPORT AND FOLLOW-UP). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET (PFS) ¿PLAINTIFF¿S DEMOGRAPHIC DATA; ONSET DATE OF EVENTS DYSMENORRHOEA AND DYSPAREUNIA FEB-2013), PAIN, BLOATING AND HAIR LOSS (JUN-2013); NEW ADVERSE EVENTS (ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA, BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES / HEADACHES, VAGINAL DISCHARGE, NAUSEA, WEIGHT GAIN, STOPPED BREATHING DURING ESSURE REMOVAL SURGERY, SLEEP APNEA AND ESSURE CONFIRMATION TEST WAS NOT CONDUCTED); TREATMENT DRUG (IBUPROFEN); AND ESSURE METHOD OF REMOVAL (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED)). 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN"), RESPIRATORY ARREST ("STOPPED BREATHING DURING ESSURE REMOVAL SURGERY") AND COMPLICATION OF DEVICE REMOVAL ("STOPPED BREATHING DURING ESSURE REMOVAL SURGERY") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST WAS NOT CONDUCTED". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED SERTRALINE HYDROCHLORIDE (ZOLOFT) FROM 2004 TO 2017. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES/ DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("PAINFUL INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6)2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND HEADACHE ("HEADACHES"). IN (B)(6)2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6)2017, THE PATIENT EXPERIENCED RESPIRATORY ARREST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), COMPLICATION OF DEVICE REMOVAL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND SLEEP APNOEA SYNDROME ("SLEEP APNEA"), 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH IBUPROFEN, CPAP MACHINE FROM (B)(6)2017 TO PRESENT, SURGERY (TOTAL HYSTERECTOMY (UTERUS AND CERVIX REMOVED) WITH ESSURE REMOVAL) AND WALKING AND EXERCISE. ESSURE WAS REMOVED ON (B)(6)2017. ON (B)(6)2017, THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED. IN (B)(6)2017, THE PELVIC PAIN, DYSPAREUNIA AND ABDOMINAL PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE RESPIRATORY ARREST, COMPLICATION OF DEVICE REMOVAL, SLEEP APNOEA SYNDROME, DYSMENORRHOEA, ABDOMINAL DISTENSION, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, VAGINAL DISCHARGE, WEIGHT INCREASED, NAUSEA AND HEADACHE OUTCOME WAS UNKNOWN AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, COMPLICATION OF DEVICE REMOVAL, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RESPIRATORY ARREST, SLEEP APNOEA SYNDROME, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN THE PLAINTIFF FACT SHEET (PFS) FROM (B)(6)18 THAT ESSURE WAS INSERTED ON (B)(6)2013 (DISCREPANCY BETWEEN INI REPORT AND FOLLOW-UP). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.9 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-NOV-2018: PFS RECEIVED : EVENT ADDED: HEADACHES. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (PATIENT UNDERWENT A PROCEDURE TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL DISTENSION, ALOPECIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE 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 |
|---|---|---|---|---|---|---|---|
| 885041 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | ZOLOFT| ZOLOFT| ZOLOFT |