ESSURE
Report
- Report Number
- 2951250-2017-05329
- Event Type
- Injury
- Date Received
- October 24, 2017
- Date of Event
- December 1, 2011
- Report Date
- September 3, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, HEADACHE AND ARTHRITIS. CONCURRENT CONDITIONS INCLUDED OBESITY. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 3 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE ARE 4 COILS IN THE UTERINE CAVITY AFTER REMOVAL OF THE RIGHT INSERTION DEVICE. THERE ARE ALSO 4 COILS IN THE UTERINE CAVITY AFTER THE REMOVAL OF LEFT INSERTION DEVICE. DISCREPANT INFORMATION WAS RECEIVED -THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.9 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY, DEPRESSION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-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 PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, HEADACHE AND ARTHRITIS. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) AND SERTRALINE HYDROCHLORIDE (ZOLOFT). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") AND BACK PAIN ("LOWER BACK PAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("HEADACHES/MIGRAINES") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). ON (B)(6) 2015, THE PATIENT EXPERIENCED CERVICITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: CHRONIC CERVICITIS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH BLOOD TRANFUSION AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, WEIGHT INCREASED AND BACK PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY, ANAEMIA, ABDOMINAL DISTENSION, CERVICITIS, MIGRAINE, HEADACHE AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANAEMIA, ANXIETY, BACK PAIN, CERVICITIS, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE ARE 4 COILS IN THE UTERINE CAVITY AFTER REMOVAL OF THE RIGHT INSERTION DEVICE. THERE ARE ALSO 4 COILS IN THE UTERINE CAVITY AFTER THE REMOVAL OF LEFT INSERTION DEVICE. DISCREPANT INFORMATION WAS RECEIVED -THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; IN (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY, DEPRESSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-DEC-2018: PFS RECEIVED. LAB DATA ADDED. EVENT HORMONAL CHANGES DESCRIBE: MOOD SWINGS WERE ADDED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, HEADACHE AND ARTHRITIS. CONCURRENT CONDITIONS INCLUDED OBESITY. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 3 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE ARE 4 COILS IN THE UTERINE CAVITY AFTER REMOVAL OF THE RIGHT INSERTION DEVICE. THERE ARE ALSO 4 COILS IN THE UTERINE CAVITY AFTER THE REMOVAL OF LEFT INSERTION DEVICE. DISCREPANT INFORMATION WAS RECEIVED -THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.9 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY, DEPRESSION . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUN-2018: PFS+MR RECEIVED, REPORTER ADDED LOT NUMBER ADDED,HISTORICAL CONDITION ADDED . EVENT ADDED AS :- ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL,), FATIGUE,PAIN, PSYCHOLOGICAL OR PSYCHIATRICPROBLEMS CONDITION: DEPRESSION, MENTAL ANGUISH,WEIGHT GAIN, EVENT OUTCOME FOR EVENT PELVIC PAIN UPDATED FROM UNKNOWN TO RECOVERING/RESOLVING. 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 PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, HEADACHE AND ARTHRITIS. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED BUPROPION (WELLBUTRIN) AND SERTRALINE (ZOLOFT). IN (B)(6)2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2015, 3 YEARS 3 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANAEMIA ("ANEMIA"), ABDOMINAL DISTENSION ("BLOATING"), CERVICITIS ("CHRONIC CERVICITIS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, WEIGHT INCREASED AND BACK PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, FATIGUE, DEPRESSION, ANXIETY, ANAEMIA, ABDOMINAL DISTENSION, CERVICITIS, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANAEMIA, ANXIETY, BACK PAIN, CERVICITIS, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE ARE 4 COILS IN THE UTERINE CAVITY AFTER REMOVAL OF THE RIGHT INSERTION DEVICE. THERE ARE ALSO 4 COILS IN THE UTERINE CAVITY AFTER THE REMOVAL OF LEFT INSERTION DEVICE. DISCREPANT INFORMATION WAS RECEIVED -THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.9 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6)2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY, DEPRESSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2018: PFS RECEIVED:EVENT ANEMIA, BLOATING, CHRONIC CERVICITIS, MIGRAINES, HEADACHES, LOWER BACK PAIN ADDED. EVENTS OUTCOME 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, HEADACHE AND ARTHRITIS. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) AND SERTRALINE HYDROCHLORIDE (ZOLOFT). IN DECEMBER 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") AND BACK PAIN ("LOWER BACK PAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("HEADACHES/MIGRAINES") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). ON (B)(6) 2015, THE PATIENT EXPERIENCED CERVICITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: CHRONIC CERVICITIS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH BLOOD TRANFUSION AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND BACK PAIN HAD RESOLVED, THE FATIGUE, DEPRESSION, ANXIETY, ANAEMIA, ABDOMINAL DISTENSION, CERVICITIS, MIGRAINE, HEADACHE AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANAEMIA, ANXIETY, BACK PAIN, CERVICITIS, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE ARE 4 COILS IN THE UTERINE CAVITY AFTER REMOVAL OF THE RIGHT INSERTION DEVICE. THERE ARE ALSO 4 COILS IN THE UTERINE CAVITY AFTER THE REMOVAL OF LEFT INSERTION DEVICE. DISCREPANT INFORMATION WAS RECEIVED -THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. SHE RECEIVED TREATMENT FOR PAIN AND ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; IN MARCH 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY, DEPRESSION . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. OUTCOME OF EVENTS "PELVIC PAIN, GENITAL BLEEDING, LOWER BACK PAIN WAS CHANGED TO RECOVERED/RESOLVED".SERIOUSNESS CRITERIA (MEDICALLY SIGNIFICANT) OF EVENT GENITAL HEMORRHAGE WAS REMOVED. 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 A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, HEADACHE AND ARTHRITIS. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) AND SERTRALINE HYDROCHLORIDE (ZOLOFT). ON (B)(6)-2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)- 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") AND BACK PAIN ("LOWER BACK PAIN"). ON (B)(6)--2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6)-2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ANXIETY ("MENTAL ANGUISH"). ON(B)(6)-2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("HEADACHES/MIGRAINES") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). ON (B)(6)--2014, THE PATIENT EXPERIENCED ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"). ON (B)(6)--2015, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). ON (B)(6)--2015, THE PATIENT EXPERIENCED CERVICITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: CHRONIC CERVICITIS"). ON(B)(6)--2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH BLOOD TRANFUSION AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6)--2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND BACK PAIN HAD RESOLVED, THE FATIGUE, DEPRESSION, ANXIETY, ANAEMIA, ABDOMINAL DISTENSION, CERVICITIS, MIGRAINE, HEADACHE AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANAEMIA, ANXIETY, BACK PAIN, CERVICITIS, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE ARE 4 COILS IN THE UTERINE CAVITY AFTER REMOVAL OF THE RIGHT INSERTION DEVICE. THERE ARE ALSO 4 COILS IN THE UTERINE CAVITY AFTER THE REMOVAL OF LEFT INSERTION DEVICE. DISCREPANT INFORMATION WAS RECEIVED -THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. SHE RECEIVED TREATMENT FOR PAIN AND ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)--2012: TOTAL BILATERAL OCCLUSION; IN (B)(6)- 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY, DEPRESSION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)--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 PELVIC PAIN ('PELVIC PAIN') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, HEADACHE AND ARTHRITIS. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) AND SERTRALINE HYDROCHLORIDE (ZOLOFT). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") AND BACK PAIN ("LOWER BACK PAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("MENSTRUAL HEMORRHAGING / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"), HEADACHE ("HEADACHES/MIGRAINES") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). ON (B)(6) 2015, THE PATIENT EXPERIENCED CERVICITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: CHRONIC CERVICITIS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE AND BACK PAIN HAD RESOLVED, THE FATIGUE, DEPRESSION, ANXIETY, ANAEMIA, ABDOMINAL DISTENSION, CERVICITIS, MIGRAINE, HEADACHE AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ANAEMIA, ANXIETY, BACK PAIN, CERVICITIS, DEPRESSION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THERE ARE 4 COILS IN THE UTERINE CAVITY AFTER REMOVAL OF THE RIGHT INSERTION DEVICE. THERE ARE ALSO 4 COILS IN THE UTERINE CAVITY AFTER THE REMOVAL OF LEFT INSERTION DEVICE. DISCREPANT INFORMATION WAS RECEIVED -THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. SHE RECEIVED TREATMENT FOR PAIN AND ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; IN (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: ANXIETY, DEPRESSION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. OUTCOME OF EVENTS "PELVIC PAIN, GENITAL BLEEDING, LOWER BACK PAIN WAS CHANGED TO RECOVERED/RESOLVED".SERIOUSNESS CRITERIA (MEDICALLY SIGNIFICANT) OF EVENT GENITAL HEMORRHAGE WAS REMOVED. 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.
HOLD KV 6/16/23
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 CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA ("MENSTRUAL HEMORRHAGING"). THE PATIENT WAS TREATED WITH SURGERY (A PARTIAL HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. 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 |
|---|---|---|---|---|---|---|---|
| 751661 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R | WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT |