ESSURE
Report
- Report Number
- 2951250-2017-01632
- Event Type
- Injury
- Date Received
- April 25, 2017
- Date of Event
- September 9, 2016
- Report Date
- November 26, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE EXPULSION ("ONE OF THE ESSURE COILS HAD MIGRATED INTO HER UTERUS / LEFT COIL MIGRATED INTO THE UTERUS") AND GENITAL HAEMORRHAGE ("ABNORMAL/HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C18717) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED REMOVAL OF KIDNEY STONE. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE (DEPO PROVERA), NAPROXEN, OXYCODONE AND PANADEINE CO (TYLENOL #3). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 6 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED/ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("SEVERE PELVIC PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE LOWER PAIN/ SEVERE ABDOMINAL CRAMPING"), BACK PAIN ("SEVERE BACK PAIN"), WEIGHT DECREASED ("WEIGHT LOSS"), DERMATITIS ("DERMATITIS WHICH WORSENED AFTER ESSURE PLACEMENT AND LIGHTENED AFTER REMOVAL") AND UTERINE PAIN ("UTERINE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (PROCEDURE TO EFFECTUATE ESSURE REMOVAL INCLUDING HYSTERECTOMY BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER, PELVIC PAIN, DYSPAREUNIA, WEIGHT INCREASED, WEIGHT DECREASED, FATIGUE, MIGRAINE, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA AND UTERINE PAIN OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN, BACK PAIN, ANXIETY AND DEPRESSION WAS RESOLVING AND THE DERMATITIS AND HEADACHE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEPRESSION, DERMATITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, UTERINE PAIN, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2016: ESSURE OCCLUSION CONFIRMED NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2016: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. X-RAY - ON (B)(6) 2016: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. (B)(6) 2016, (B)(6) 2016 : MRI OF PELVIS : HYSTEROSALPINGOGRAM : NO FILLING OF THE RIGHT TUBE. EACH WERE NOTED ON THE LEFT ALTHOUGHT THERE IS FILLING OF THE LEFT TUBE WITHOUT DEFINITE INTRAPERITONEAL SPILLAGE. (2)RIGHT ESSURE PARTIALLY EXTRA LUMINAL, CONCERNING FOR RUPTURE INTO THE PERITONEAL CAVITY. CONCERNING FOR PERFORATION. LEFT ESSURE DEVICE IS COILED AND DISLODGED WITHIN THE LEFT. ESSURE HAD MIGRATED MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: EVENTS- "ABNORMAL BLEEDING (VAGINAL), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), ANXIETY, DEPRESSION, DERMATITIS WHICH WORSENED AFTER ESSURE PLACEMENT AND LIGHTENED AFTER REMOVAL, HEADACHES, DYSMENORRHEA (CRAMPING), PERFORATION (UTERUS), UTERINE PAIN", REPORTER, LOT NUMBER ADDEDFROM PFS. INCIDENT AT THE TIME OF REPORTING, 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE EXPULSION ("ONE OF THE ESSURE COILS HAD MIGRATED INTO HER UTERUS / LEFT COIL MIGRATED INTO THE UTERUS") AND GENITAL HAEMORRHAGE ("ABNORMAL/HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C18717) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED REMOVAL OF KIDNEY STONE AND DEPRESSION IN 2015. CONCURRENT CONDITIONS INCLUDED MULTIPAROUS SINCE (B)(6) 2015. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE (DEPO PROVERA), NAPROXEN, OXYCODONE AND PANADEINE CO (TYLENOL #3). ON (B)(6) -2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 6 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED/ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("SEVERE PELVIC PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PAIN ("UTERINE PAIN"), DERMATITIS ("DERMATITIS WHICH WORSENED AFTER ESSURE PLACEMENT AND LIGHTENED AFTER REMOVAL"), WEIGHT DECREASED ("WEIGHT LOSS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE LOWER PAIN/ SEVERE ABDOMINAL CRAMPING") AND BACK PAIN ("SEVERE BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (PROCEDURE TO EFFECTUATE ESSURE REMOVAL INCLUDING HYSTERECTOMY BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, GENITAL HAEMORRHAGE, UTERINE PAIN, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, PELVIC PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN, THE DERMATITIS AND HEADACHE HAD NOT RESOLVED AND THE ANXIETY, DEPRESSION, ABDOMINAL PAIN AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEPRESSION, DERMATITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, UTERINE PAIN, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2016: ESSURE OCCLUSION CONFIRMED NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2016: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. X-RAY - ON (B)(6) 2016: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. (B)(6) 2016, (B)(6) 2016 : MRI OF PELVIS : HYSTEROSALPINGOGRAM : NO FILLING OF THE RIGHT TUBE. EACH WERE NOTED ON THE LEFT ALTHOUGHT THERE IS FILLING OF THE LEFT TUBE WITHOUT DEFINITE INTRAPERITONEAL SPILLAGE. (2)RIGHT ESSURE PARTIALLY EXTRA LUMINAL, CONCERNING FOR RUPTURE INTO THE PERITONEAL CAVITY. CONCERNING FOR PERFORATION. LEFT ESSURE DEVICE IS COILED AND DISLODGED WITHIN THE LEFT. ESSURE HAD MIGRATED ON (B)(6) 2016 HYSTEROSALPINGOGRAM (PER MR) IMPRESSION: PATENT LEFT TUBE. ON (B)(6) 2016, PELVIC ULTRASOUND OR CT FOR FURTHER EVALUATION RECOMMENDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUL-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, 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 UTERINE PERFORATION ('PERFORATION (UTERUS)'), DEVICE EXPULSION ('ONE OF THE ESSURE COILS HAD MIGRATED INTO HER UTERUS / LEFT COIL MIGRATED INTO THE UTERUS') AND EMBEDDED DEVICE ('EMBEDDING OF THE LEFT ESSURE COIL INTO THE UTERINE MYOMETRIUM / DEVICE WAS COILED AND DISLODGED WITHIN THE LEFT UTERINE.') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C18717) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED REMOVAL OF KIDNEY STONE AND DEPRESSION IN 2015. CONCURRENT CONDITIONS INCLUDED MULTIPAROUS SINCE (B)(6) 2015. CONCOMITANT PRODUCTS INCLUDED CODEINE PHOSPHATE;PARACETAMOL (PANADEINE CO), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NAPROXEN AND OXYCODONE. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED/ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), 6 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL/HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") AND PELVIC PAIN ("SEVERE PELVIC PAIN"). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN AUGUST 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN OCTOBER 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN NOVEMBER 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PAIN ("UTERINE PAIN"), DERMATITIS ("DERMATITIS WHICH WORSENED AFTER ESSURE PLACEMENT AND LIGHTENED AFTER REMOVAL"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE LOWER PAIN/ SEVERE ABDOMINAL CRAMPING") AND BACK PAIN ("SEVERE BACK PAIN") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND PROCEDURE TO EFFECTUATE ESSURE REMOVAL INCLUDING HYSTERECTOMY BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, UTERINE PAIN, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, PELVIC PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN, THE DERMATITIS AND HEADACHE HAD NOT RESOLVED AND THE ANXIETY, DEPRESSION, ABDOMINAL PAIN AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEPRESSION, DERMATITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, UTERINE PAIN, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2016: RESULTS: ESSURE OCCLUSION CONFIRMED. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2016: RESULTS: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS.. X-RAY - ON (B)(6) 2016: RESULTS: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS.. DIAGNOSTIC RESULTS: (B)(6) 2016 : MRI OF PELVIS : HYSTEROSALPINGOGRAM : NO FILLING OF THE RIGHT TUBE. EACH WERE NOTED ON THE LEFT ALTHOUGHT THERE IS FILLING OF THE LEFT TUBE WITHOUT DEFINITE INTRAPERITONEAL SPILLAGE. (2)RIGHT ESSURE PARTIALLY EXTRA LUMINAL, CONCERNING FOR RUPTURE INTO THE PERITONEAL CAVITY. CONCERNING FOR PERFORATION. LEFT ESSURE DEVICE IS COILED AND DISLODGED WITHIN THE LEFT. ESSURE HAD MIGRATED. ON 06MAY2016 HYSTEROSALPINGOGRAM (PER MR) IMPRESSION: PATENT LEFT TUBE. ON 09SEP2016, PELVIC ULTRASOUND OR CT FOR FURTHER EVALUATION RECOMMENDED. BATCH NO C18717 PRODUCTION DATE 2014-02-05 EXPIRATION DATE 2017-02-28 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-NOV-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 UTERINE PERFORATION ('PERFORATION (UTERUS)'), DEVICE EXPULSION ('ONE OF THE ESSURE COILS HAD MIGRATED INTO HER UTERUS / LEFT COIL MIGRATED INTO THE UTERUS') AND EMBEDDED DEVICE ('EMBEDDING OF THE LEFT ESSURE COIL INTO THE UTERINE MYOMETRIUM / DEVICE WAS COILED AND DISLODGED WITHIN THE LEFT UTERINE.') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C18717) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED REMOVAL OF KIDNEY STONE AND DEPRESSION IN 2015. CONCURRENT CONDITIONS INCLUDED MULTIPAROUS SINCE (B)(6) 2015. CONCOMITANT PRODUCTS INCLUDED CODEINE PHOSPHATE; PARACETAMOL (PANADEINE CO), IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), NAPROXEN AND OXYCODONE. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED/ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), 6 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL/HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") AND PELVIC PAIN ("SEVERE PELVIC PAIN"). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PAIN ("UTERINE PAIN"), DERMATITIS ("DERMATITIS WHICH WORSENED AFTER ESSURE PLACEMENT AND LIGHTENED AFTER REMOVAL"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE LOWER PAIN/ SEVERE ABDOMINAL CRAMPING") AND BACK PAIN ("SEVERE BACK PAIN") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND PROCEDURE TO EFFECTUATE ESSURE REMOVAL INCLUDING HYSTERECTOMY BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE EXPULSION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, UTERINE PAIN, FATIGUE, WEIGHT INCREASED, WEIGHT DECREASED, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, PELVIC PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN, THE DERMATITIS AND HEADACHE HAD NOT RESOLVED AND THE ANXIETY, DEPRESSION, ABDOMINAL PAIN, AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEPRESSION, DERMATITIS, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, UTERINE PAIN, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2016: RESULTS: ESSURE OCCLUSION CONFIRMED. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2016: RESULTS: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. X-RAY - ON (B)(6) 2016: RESULTS: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. DIAGNOSTIC RESULTS: (B)(6) 2016, (B)(6) 2016: MRI OF PELVIS: HYSTEROSALPINGOGRAM: NO FILLING OF THE RIGHT TUBE. EACH WERE NOTED ON THE LEFT ALTHOUGHT THERE IS FILLING OF THE LEFT TUBE WITHOUT DEFINITE INTRAPERITONEAL SPILLAGE. (2) RIGHT ESSURE PARTIALLY EXTRA LUMINAL, CONCERNING FOR RUPTURE INTO THE PERITONEAL CAVITY. CONCERNING FOR PERFORATION. LEFT ESSURE DEVICE IS COILED AND DISLODGED WITHIN THE LEFT. ESSURE HAD MIGRATED. ON (B)(6) 2016 HYSTEROSALPINGOGRAM (PER MR). IMPRESSION: PATENT LEFT TUBE. ON (B)(6) 2016, PELVIC ULTRASOUND OR CT FOR FURTHER EVALUATION RECOMMENDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-NOV-2020: MR RECEIVED: ADDED EVENT EMBEDDING OF THE LEFT ESSURE COIL INTO THE UTERINE MYOMETRIUM. GENITAL HEMORRHAGE DOWNGRADED. INCIDENT 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 DEVICE EXPULSION ("ONE OF THE ESSURE COILS HAD MIGRATED INTO HER UTERUS") AND GENITAL HAEMORRHAGE ("ABNORMAL/HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 10 MONTHS 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), MENORRHAGIA ("PROLONGED/ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE LOWER PAIN/ SEVERE ABDOMINAL CRAMPING"), PELVIC PAIN ("SEVERE PELVIC PAIN"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (PROCEDURE TO EFFECTUATE ESSURE REMOVAL INCLUDING HYSTERECTOMY BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, MENORRHAGIA, ABDOMINAL PAIN LOWER, PELVIC PAIN, BACK PAIN, DYSPAREUNIA, WEIGHT INCREASED, WEIGHT DECREASED, FATIGUE AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2016: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. X-RAY - ON (B)(6) 2016: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAY-2017: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2015 AND 10 MONTHS 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT REPORTED ADVERSE EVENTS INCLUDING ONE OF THE ESSURE COILS HAD MIGRATED INTO HER UTERUS AND ABNORMAL/HEAVY BLEEDING (REGARDED AS GENITAL HEMORRHAGE). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY AND ESSURE REMOVAL ON (B)(6) 2016). DURING ESSURE MICRO-INSERT THERAPY, THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF THE FALLOPIAN TUBES. THIS MOVEMENT COULD BE A DEVICE EXPULSION INTO THE UTERUS/OUT OF THE BODY, DEVICE DISLOCATION INTO THE FALLOPIAN TUBE OR CAN OCCUR AS A RESULT OF A PERFORATION DURING INSERTION. IN THIS CASE, THE EXACT DATE AND MECHANISM OF THE EVENT IS NOT KNOWN. GENITAL HEMORRHAGE IS HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS PARTICULAR CASE, ALTERNATIVE EXPLANATION WAS NOT AVAILABLE FOR THE EVENT. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("ONE OF THE ESSURE COILS HAD MIGRATED INTO HER UTERUS") AND GENITAL HAEMORRHAGE ("ABNORMAL/HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 10 MONTHS 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), MENORRHAGIA ("PROLONGED/ABNORMAL MENSES"), ABDOMINAL PAIN LOWER ("SEVERE LOWER PAIN/ SEVERE ABDOMINAL CRAMPING"), PELVIC PAIN ("SEVERE PELVIC PAIN"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS"), FATIGUE ("FATIGUE") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (PROCEDURE TO EFFECTUATE ESSURE REMOVAL INCLUDING HYSTERECTOMY BILATERAL SALPINGECTOMY ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, MENORRHAGIA, ABDOMINAL PAIN LOWER, PELVIC PAIN, BACK PAIN, DYSPAREUNIA, WEIGHT INCREASED, WEIGHT DECREASED, FATIGUE AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2016: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. X-RAY - ON (B)(6) 2016: ONE OF THE ESSURE COILS MIGRATED INTO HER UTERUS. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2015 AND 10 MONTHS 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT REPORTED ADVERSE EVENTS INCLUDING ONE OF THE ESSURE COILS HAD MIGRATED INTO HER UTERUS AND ABNORMAL/HEAVY BLEEDING (REGARDED AS GENITAL HEMORRHAGE). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY AND ESSURE REMOVAL ON (B)(6) 2016). DURING ESSURE MICRO-INSERT THERAPY, THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF THE FALLOPIAN TUBES. THIS MOVEMENT COULD BE A DEVICE EXPULSION INTO THE UTERUS/OUT OF THE BODY, DEVICE DISLOCATION INTO THE FALLOPIAN TUBE OR CAN OCCUR AS A RESULT OF A PERFORATION DURING INSERTION. IN THIS CASE, THE EXACT DATE AND MECHANISM OF THE EVENT IS NOT KNOWN. GENITAL HEMORRHAGE IS HIGHLY PREVALENT IN WOMEN, AND MAY HAVE MULTIPLE CAUSES. IN THIS PARTICULAR CASE, ALTERNATIVE EXPLANATION WAS NOT AVAILABLE FOR THE EVENT. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299624 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C18717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| OXYCODONE| OXYCODONE| OXYCODONE| OXYCODONE| PANADEINE CO| PANADEINE CO| TYLENOL #3| TYLENOL #3 |