ESSURE
Report
- Report Number
- 2951250-2017-07872
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- January 1, 2009
- Report Date
- October 28, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN/ PAIN/NOTHING HELPED MY E-BELLY,PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627289) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION AND PLASTIC SURGERY. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND INSOMNIA. CONCOMITANT PRODUCTS INCLUDED ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN (MOTRIN), VICODIN (NORCO) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND BACK PAIN ("BACK PAIN"). IN 2010, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") AND ALOPECIA ("HAIR LOSS"). IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING/ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH IRON AND SURGERY (HYSTERECTOMY, BILATERAL SALPHINGECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, HEADACHE, DYSMENORRHOEA AND FATIGUE OUTCOME WAS UNKNOWN AND THE MIGRAINE, ALOPECIA AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 50.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2009 : HYSTEROSALPINGOGRAM : THE RIGHT ESSURE DEVICE IS SEEN SUCH THAT THE PROXIMAL END OF THE OUTER COIL ABUTS THE CORNUA OF THE UTERUS.CONTRAST FILLS THE UTERUS BUT NEVER EXTEND BEYOND THE CORNUA OF THE UTERUS.CONTRAST DOES NOT EXTEND INTO THE RIGHT FALLOPIAN TUBE. THE LEFT ESSURE DEVICE IS SEEN AND THERE IS SOME SEPARATION OF THE INNER AND OUTER COIL SUCH THAT THE PLATINUM BOND OF THE OUTER COIL IS SEEN WITHIN THE LEFT CORNUAL ASPECT OF THE UTERUS.THE REMAINDER OF THE OUTER COIL EXTENDS INTO THE PROXIMAL LEFT FALLOPIAN TUBE AS DOES THE INNER COIL .CONTRAST DOES NOT PASS THE CORNUAL SEGMENT OF THE UTERUS .THE LEFT FALLOPIAN TUBE NEVER FILLS. UTERUS DEMONSTRATES NO EVIDENCE OF FILLING DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-SEP-2018: PFS RECEIVED- NEW EVENT ABNORMAL BLEEDING (MENORRHAGIA), URINARY TRACT INFECTIONS, MIGRAINES, HEADACHES, DYSMENORRHEA (CRAMPING), FATIGUE, HAIR LOSS, BACK PAIN WERE ADDED. OUTCOME OF PELVIC PAIN UPDATED TO RECOVERED / RESOLVED. LOT NUMBER, HEIGHT, WEIGHT, CONCOMITANT AND HISTORICAL CONDITION, TREATMENT AND CONCOMITANT MEDICATION, LAB DATA WERE ADDED. 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.
THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN/ PAIN/NOTHING HELPED MY E-BELLY,PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627289) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION AND PLASTIC SURGERY. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND INSOMNIA. CONCOMITANT PRODUCTS INCLUDED ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN (MOTRIN), VICODIN (NORCO) AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) , THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND BACK PAIN ("BACK PAIN"). IN (B)(6), THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") AND ALOPECIA ("HAIR LOSS"). IN (B)(6), THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING/ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH IRON AND SURGERY (HYSTERECTOMY, BILATERAL SALPHINGECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, HEADACHE, DYSMENORRHOEA AND FATIGUE OUTCOME WAS UNKNOWN AND THE MIGRAINE, ALOPECIA AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 50.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2009 : HYSTEROSALPINGOGRAM : THE RIGHT ESSURE DEVICE IS SEEN SUCH THAT THE PROXIMAL END OF THE OUTER COIL ABUTS THE CORNUA OF THE UTERUS.CONTRAST FILLS THE UTERUS BUT NEVER EXTEND BEYOND THE CORNUA OF THE UTERUS.CONTRAST DOES NOT EXTEND INTO THE RIGHT FALLOPIAN TUBE. THE LEFT ESSURE DEVICE IS SEEN AND THERE IS SOME SEPARATION OF THE INNER AND OUTER COIL SUCH THAT THE PLATINUM BOND OF THE OUTER COIL IS SEEN WITHIN THE LEFT CORNUAL ASPECT OF THE UTERUS.THE REMAINDER OF THE OUTER COIL EXTENDS INTO THE PROXIMAL LEFT FALLOPIAN TUBE AS DOES THE INNER COIL .CONTRAST DOES NOT PASS THE CORNUAL SEGMENT OF THE UTERUS .THE LEFT FALLOPIAN TUBE NEVER FILLS. UTERUS DEMONSTRATES NO EVIDENCE OF FILLING DEFECT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-OCT-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 PELVIC PAIN ('CHRONIC PELVIC PAIN/ PAIN/NOTHING HELPED MY E-BELLY,PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627289) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION AND PLASTIC SURGERY. *(B)(6) 2009 : HYSTEROSALPINGOGRAM : THE RIGHT ESSURE DEVICE IS SEEN SUCH THAT THE PROXIMAL END OF THE OUTER COIL ABUTS THE CORNUA OF THE UTERUS. CONTRAST FILLS THE UTERUS BUT NEVER EXTEND BEYOND THE CORNUA OF THE UTERUS. CONTRAST DOES NOT EXTEND INTO THE RIGHT FALLOPIAN TUBE. THE LEFT ESSURE DEVICE IS SEEN AND THERE IS SOME SEPARATION OF THE INNER AND OUTER COIL SUCH THAT THE PLATINUM BOND OF THE OUTER COIL IS SEEN WITHIN THE LEFT CORNUAL ASPECT OF THE UTERUS. THE REMAINDER OF THE OUTER COIL EXTENDS INTO THE PROXIMAL LEFT FALLOPIAN TUBE AS DOES THE INNER COIL .CONTRAST DOES NOT PASS THE CORNUAL SEGMENT OF THE UTERUS .THE LEFT FALLOPIAN TUBE NEVER FILLS. UTERUS DEMONSTRATES NO EVIDENCE OF FILLING DEFECT. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND INSOMNIA. CONCOMITANT PRODUCTS INCLUDED ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), ORAL CONTRACEPTIVE NOS FROM 2003 TO 2008 AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND BACK PAIN ("BACK PAIN"). IN 2010, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") AND ALOPECIA ("HAIR LOSS/MY HAIR HAS BEEN THINNING"). IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING/ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES/HEAD HURTS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MALAISE ("FEELING SICK"), PAIN ("MY BODY ACHES"), PAIN IN EXTREMITY ("BOTTOM OF MY FEET HURT WHEN I WALK"), INFECTION ("INFECTED ") AND ANXIETY ("ANXIOUS"). THE PATIENT WAS TREATED WITH IRON AND SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, HEADACHE, DYSMENORRHOEA, FATIGUE, MALAISE, PAIN, PAIN IN EXTREMITY, INFECTION AND ANXIETY OUTCOME WAS UNKNOWN AND THE MIGRAINE, ALOPECIA AND BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BACK PAIN, DYSMENORRHOEA, FATIGUE, HEADACHE, INFECTION, MALAISE, MENORRHAGIA, MIGRAINE, PAIN, PAIN IN EXTREMITY, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 50.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS AND SOCIAL MEDIA RECEIVED. NEW EVENTS ADDED: SICK, MY BODY ACHES, BOTTOM OF MY FEET HURT WHEN I WALK, INFECTED, ANXIOUS. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH 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 ('CHRONIC PELVIC PAIN/ PAIN/NOTHING HELPED MY E-BELLY,PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627289) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION AND PLASTIC SURGERY. *(B)(6) 2009 : HYSTEROSALPINGOGRAM : THE RIGHT ESSURE DEVICE IS SEEN SUCH THAT THE PROXIMAL END OF THE OUTER COIL ABUTS THE CORNUA OF THE UTERUS.CONTRAST FILLS THE UTERUS BUT NEVER EXTEND BEYOND THE CORNUA OF THE UTERUS.CONTRAST DOES NOT EXTEND INTO THE RIGHT FALLOPIAN TUBE. THE LEFT ESSURE DEVICE IS SEEN AND THERE IS SOME SEPARATION OF THE INNER AND OUTER COIL SUCH THAT THE PLATINUM BOND OF THE OUTER COIL IS SEEN WITHIN THE LEFT CORNUAL ASPECT OF THE UTERUS.THE REMAINDER OF THE OUTER COIL EXTENDS INTO THE PROXIMAL LEFT FALLOPIAN TUBE AS DOES THE INNER COIL .CONTRAST DOES NOT PASS THE CORNUAL SEGMENT OF THE UTERUS .THE LEFT FALLOPIAN TUBE NEVER FILLS. UTERUS DEMONSTRATES NO EVIDENCE OF FILLING DEFECT. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND INSOMNIA. CONCOMITANT PRODUCTS INCLUDED ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), ORAL CONTRACEPTIVE NOS FROM 2003 TO 2008 AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND BACK PAIN ("BACK PAIN"). IN 2010, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") AND ALOPECIA ("HAIR LOSS/MY HAIR HAS BEEN THINNING"). IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING/ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES/HEAD HURTS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MALAISE ("FEELING SICK"), PAIN ("MY BODY ACHES"), PAIN IN EXTREMITY ("BOTTOM OF MY FEET HURT WHEN I WALK"), INFECTION ("INFECTED "), ANXIETY ("ANXIOUS"), ABDOMINAL DISTENSION ("I WAS ALWAYS BLOATED. "), GASTROINTESTINAL DISORDER ("GI ISSUES") AND INFLAMMATION ("CHRONIC INFLAMMATION"). THE PATIENT WAS TREATED WITH IRON AND SURGERY (HYSTERECTOMY, BILATERAL SALPHINGECTOMY ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GASTROINTESTINAL DISORDER HAD RESOLVED, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, HEADACHE, DYSMENORRHOEA, FATIGUE, MALAISE, PAIN, PAIN IN EXTREMITY, INFECTION, ANXIETY AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN, THE MIGRAINE, ALOPECIA AND BACK PAIN WAS RESOLVING AND THE INFLAMMATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ANXIETY, BACK PAIN, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, INFECTION, INFLAMMATION, MALAISE, MENORRHAGIA, MIGRAINE, PAIN, PAIN IN EXTREMITY, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 50.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: BLOATING, INFLAMMATION, GI ISSUES QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED. NEW EVENTS: BLOATING, INFLAMMATION, GI ISSUES WERE ADDED. NEW REPORTER ADDED. 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 ('CHRONIC PELVIC PAIN/ PAIN/NOTHING HELPED MY E-BELLY,PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627289) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION, PLASTIC SURGERY, NABOTHIAN CYST, ENDOCERVICITIS, DYSFUNCTIONAL UTERINE BLEEDING, D & C AND DYSPAREUNIA. *(B)(6) 2009 : HYSTEROSALPINGOGRAM : THE RIGHT ESSURE DEVICE IS SEEN SUCH THAT THE PROXIMAL END OF THE OUTER COIL ABUTS THE CORNUA OF THE UTERUS.CONTRAST FILLS THE UTERUS BUT NEVER EXTEND BEYOND THE CORNUA OF THE UTERUS.CONTRAST DOES NOT EXTEND INTO THE RIGHT FALLOPIAN TUBE. THE LEFT ESSURE DEVICE IS SEEN AND THERE IS SOME SEPARATION OF THE INNER AND OUTER COIL SUCH THAT THE PLATINUM BOND OF THE OUTER COIL IS SEEN WITHIN THE LEFT CORNUAL ASPECT OF THE UTERUS. THE REMAINDER OF THE OUTER COIL EXTENDS INTO THE PROXIMAL LEFT FALLOPIAN TUBE AS DOES THE INNER COIL .CONTRAST DOES NOT PASS THE CORNUAL SEGMENT OF THE UTERUS .THE LEFT FALLOPIAN TUBE NEVER FILLS. UTERUS DEMONSTRATES NO EVIDENCE OF FILLING DEFECT. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND INSOMNIA. CONCOMITANT PRODUCTS INCLUDED ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), ORAL CONTRACEPTIVE NOS FROM 2003 TO 2008 AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND BACK PAIN ("BACK PAIN"). IN 2010, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") AND ALOPECIA ("HAIR LOSS/MY HAIR HAS BEEN THINNING"). IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING/ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES/HEAD HURTS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MALAISE ("FEELING SICK"), PAIN ("MY BODY ACHES"), PAIN IN EXTREMITY ("BOTTOM OF MY FEET HURT WHEN I WALK"), INFECTION ("INFECTED "), ANXIETY ("ANXIOUS"), ABDOMINAL DISTENSION ("I WAS ALWAYS BLOATED. "), GASTROINTESTINAL DISORDER ("GI ISSUES"), INFLAMMATION ("CHRONIC INFLAMMATION"), AMNESIA ("MEMORY LOSS") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH IRON AND SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GASTROINTESTINAL DISORDER, AMNESIA AND FEELING ABNORMAL HAD RESOLVED, THE VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, URINARY TRACT INFECTION, HEADACHE, DYSMENORRHOEA, FATIGUE, MALAISE, PAIN, PAIN IN EXTREMITY, INFECTION, ANXIETY AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN, THE MIGRAINE, ALOPECIA AND BACK PAIN WAS RESOLVING AND THE INFLAMMATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, AMNESIA, ANXIETY, BACK PAIN, DYSMENORRHOEA, FATIGUE, FEELING ABNORMAL, GASTROINTESTINAL DISORDER, HEADACHE, HEAVY MENSTRUAL BLEEDING, INFECTION, INFLAMMATION, MALAISE, MIGRAINE, PAIN, PAIN IN EXTREMITY, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 50.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBER:627289. MANUFACTURE DATE:2008-05. EXPIRATION DATE: 2010-05. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-OCT-2021: 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 PELVIC PAIN ('CHRONIC PELVIC PAIN/ PAIN/NOTHING HELPED MY E-BELLY,PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627289) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION, PLASTIC SURGERY, NABOTHIAN CYST, ENDOCERVICITIS, DYSFUNCTIONAL UTERINE BLEEDING, D & C AND DYSPAREUNIA. *(B)(6) 2009 : HYSTEROSALPINGOGRAM : THE RIGHT ESSURE DEVICE IS SEEN SUCH THAT THE PROXIMAL END OF THE OUTER COIL ABUTS THE CORNUA OF THE UTERUS. CONTRAST FILLS THE UTERUS BUT NEVER EXTEND BEYOND THE CORNUA OF THE UTERUS. CONTRAST DOES NOT EXTEND INTO THE RIGHT FALLOPIAN TUBE. THE LEFT ESSURE DEVICE IS SEEN AND THERE IS SOME SEPARATION OF THE INNER AND OUTER COIL SUCH THAT THE PLATINUM BOND OF THE OUTER COIL IS SEEN WITHIN THE LEFT CORNUAL ASPECT OF THE UTERUS. THE REMAINDER OF THE OUTER COIL EXTENDS INTO THE PROXIMAL LEFT FALLOPIAN TUBE AS DOES THE INNER COIL .CONTRAST DOES NOT PASS THE CORNUAL SEGMENT OF THE UTERUS .THE LEFT FALLOPIAN TUBE NEVER FILLS. UTERUS DEMONSTRATES NO EVIDENCE OF FILLING DEFECT. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND INSOMNIA. CONCOMITANT PRODUCTS INCLUDED ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), ORAL CONTRACEPTIVE NOS FROM 2003 TO 2008 AND ZOLPIDEM TARTRATE (AMBIEN). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND BACK PAIN ("BACK PAIN"). IN 2010, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") AND ALOPECIA ("HAIR LOSS/MY HAIR HAS BEEN THINNING"). IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SPOTTING/ABNORMAL BLEEDING (VAGINAL)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES/HEAD HURTS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MALAISE ("FEELING SICK"), PAIN ("MY BODY ACHES"), PAIN IN EXTREMITY ("BOTTOM OF MY FEET HURT WHEN I WALK"), INFECTION ("INFECTED "), ANXIETY ("ANXIOUS"), ABDOMINAL DISTENSION ("I WAS ALWAYS BLOATED. "), GASTROINTESTINAL DISORDER ("GI ISSUES"), INFLAMMATION ("CHRONIC INFLAMMATION"), AMNESIA ("MEMORY LOSS") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH IRON AND SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GASTROINTESTINAL DISORDER, AMNESIA AND FEELING ABNORMAL HAD RESOLVED, THE VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, URINARY TRACT INFECTION, HEADACHE, DYSMENORRHOEA, FATIGUE, MALAISE, PAIN, PAIN IN EXTREMITY, INFECTION, ANXIETY AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN, THE MIGRAINE, ALOPECIA AND BACK PAIN WAS RESOLVING AND THE INFLAMMATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, AMNESIA, ANXIETY, BACK PAIN, DYSMENORRHOEA, FATIGUE, FEELING ABNORMAL, GASTROINTESTINAL DISORDER, HEADACHE, HEAVY MENSTRUAL BLEEDING, INFECTION, INFLAMMATION, MALAISE, MIGRAINE, PAIN, PAIN IN EXTREMITY, PELVIC PAIN, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 50.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: BLOATING, INFLAMMATION, GI ISSUES, MEMORY LOSS, BRAIN FOG. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-OCT-2021: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION, EVENTS: MEMORY LOSS, BRAIN FOG 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 PELVIC PAIN ("CHRONIC PELVIC PAIN/ PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("SPOTTING"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE ON (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED 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 |
|---|---|---|---|---|---|---|---|
| 835311 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 627289 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | AMBIEN| AMBIEN| AMBIEN| AMBIEN| AMBIEN| AMBIEN| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| MOTRIN| MOTRIN| NORCO| NORCO| NORCO| NORCO| NORCO| NORCO| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS |