ESSURE
Report
- Report Number
- 2951250-2019-02404
- Event Type
- Injury
- Date Received
- June 3, 2019
- Report Date
- August 13, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('ACUTE PELVIC INFLAMMATORY DISEASE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12237554) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED EPIGASTRIC PAIN, DYSPEPSIA AND GASTROESOPHAGEAL REFLUX DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BUPROPION, NSAIDS, LORAZEPAM AND CIMETIDINE. CONCURRENT CONDITIONS INCLUDED OBESITY, CRAMP IN LOWER ABDOMEN, CHRONIC PAIN, DEPRESSION, DYSFUNCTIONAL UTERINE BLEEDING, MUSCULOSKELETAL PAIN, MENOMETRORRHAGIA, VOMITING, SPONDYLOLISTHESIS, COCCYDYNIA, CANNABIS ABUSE, CANNABIS DEPENDENCE, DIARRHEA, LEG PAIN, MENOPAUSAL DISORDER, IRRITABLE COLON AND PAIN. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), CIMETIDINE, LORAZEPAM, NAPROXEN, OMEPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2003, THE PATIENT EXPERIENCED BACK PAIN ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: SEVERE BACK PAIN"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), IRRITABLE BOWEL SYNDROME ("IBS (IRRITABLE BOWEL SYNDROME}"), PREMENSTRUAL SYNDROME ("HORMONAL CHANGES DESCRIBE: PMS CONSTANTLY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY AND BACK SURGERY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, MENORRHAGIA AND IRRITABLE BOWEL SYNDROME OUTCOME WAS UNKNOWN AND THE BACK PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, FATIGUE, PREMENSTRUAL SYNDROME AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PREMENSTRUAL SYNDROME, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THERE WERE NOTED TO BE FIVE COILS VISIBLE FROM THE OPENING OF THE TUBE. (B)(6) 2004: SECOND ESSURE PLACED AS RIGHT ESSURE EXPELLED AND SECOND ESSURE PLACED. DATE(S) OF INSERTION: (B)(6) 2003, (B)(6) 2003 (RIGHT SIDE) (AS PER SECOND AMENDED PFS) (B)(6) 2003, (B)(6) 2004 (AS PER THIRD AMENDED PFS). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2003: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : SEVERE BACK PAIN, NAUSEA, PELVIC INFLAMMATORY DISEASES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JUN-2020: PFS RECEIVED: EVENT WAS UPDATED TO IRRITABLE BOWEL SYNDROME FROM GASTROINTESTINAL PROBLEM. INSERTION DATE WAS ADDED ON RCC FIELD. A TECHNICAL INVESTIGATION WAS 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 INFLAMMATORY DISEASE ('ACUTE PELVIC INFLAMMATORY DISEASE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12237554) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED EPIGASTRIC PAIN, DYSPEPSIA AND GASTROESOPHAGEAL REFLUX DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BUPROPION, NSAIDS, LORAZEPAM AND CIMETIDINE. CONCURRENT CONDITIONS INCLUDED OBESITY, CRAMP IN LOWER ABDOMEN, CHRONIC PAIN, DEPRESSION, DYSFUNCTIONAL UTERINE BLEEDING, MUSCULOSKELETAL PAIN, MENOMETRORRHAGIA, VOMITING, SPONDYLOLISTHESIS, COCCYDYNIA, CANNABIS ABUSE, CANNABIS DEPENDENCE, DIARRHEA, LEG PAIN, MENOPAUSAL DISORDER, IRRITABLE COLON AND PAIN. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), CIMETIDINE, LORAZEPAM, NAPROXEN, OMEPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). IN 2003, THE PATIENT EXPERIENCED BACK PAIN ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: SEVERE BACK PAIN"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), IRRITABLE BOWEL SYNDROME ("IBS (IRRITABLE BOWEL SYNDROME}"), PREMENSTRUAL SYNDROME ("HORMONAL CHANGES DESCRIBE: PMS CONSTANTLY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY AND BACK SURGERY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, MENORRHAGIA AND IRRITABLE BOWEL SYNDROME OUTCOME WAS UNKNOWN AND THE BACK PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, FATIGUE, PREMENSTRUAL SYNDROME AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PREMENSTRUAL SYNDROME, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THERE WERE NOTED TO BE FIVE COILS VISIBLE FROM THE OPENING OF THE TUBE. (B)(6) 2004: SECOND ESSURE PLACED AS RIGHT ESSURE EXPELLED AND SECOND ESSURE PLACED. DATE(S) OF INSERTION: (B)(6) 2003, (B)(6) 2003 (RIGHT SIDE) (AS PER SECOND AMENDED PFS). (B)(6) 2003, (B)(6) 2004 (AS PER THIRD AMENDED PFS). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2003: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : SEVERE BACK PAIN, NAUSEA, PELVIC INFLAMMATORY DISEASES. LOT NUMBER: 12237554 MANUFACTURING DATE: 2003-06 EXPIRATION DATE: 2005-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUL-2020: QUALITY SAFETY EVALUATION OF PTC. 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 INFLAMMATORY DISEASE ('ACUTE PELVIC INFLAMMATORY DISEASE'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') AND BACK PAIN ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: SEVERE BACK PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12237554) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED EPIGASTRIC PAIN, DYSPEPSIA AND GASTROESOPHAGEAL REFLUX DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BUPROPION, NSAIDS, LORAZEPAM AND CIMETIDINE. CONCURRENT CONDITIONS INCLUDED OBESITY, CRAMP IN LOWER ABDOMEN, CHRONIC PAIN, DEPRESSION, DYSFUNCTIONAL UTERINE BLEEDING, MUSCULOSKELETAL PAIN, MENOMETRORRHAGIA, VOMITING, SPONDYLOLISTHESIS, COCCYDYNIA, CANNABIS ABUSE, CANNABIS DEPENDENCE, DIARRHEA, LEG PAIN, MENOPAUSAL DISORDER, IRRITABLE COLON AND PAIN. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), CIMETIDINE, LORAZEPAM, NAPROXEN, OMEPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). IN 2003, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), PREMENSTRUAL SYNDROME ("HORMONAL CHANGES DESCRIBE: PMS CONSTANTLY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY AND BACK SURGERY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, MENORRHAGIA AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, BACK PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, FATIGUE, PREMENSTRUAL SYNDROME AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PREMENSTRUAL SYNDROME, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THERE WERE NOTED TO BE FIVE COILS VISIBLE FROM THE OPENING OF THE TUBE. (B)(6) 2004: SECOND ESSURE PLACED AS RIGHT ESSURE EXPELLED AND SECOND ESSURE PLACED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. HYSTEROSALPINGOGRAM - ON 03-NOV-2003: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : SEVERE BACK PAIN, NAUSEA, PELVIC INFLAMMATORY DISEASES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 INFLAMMATORY DISEASE ('ACUTE PELVIC INFLAMMATORY DISEASE'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') AND BACK PAIN ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: SEVERE BACK PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12237554) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED EPIGASTRIC PAIN, DYSPEPSIA AND GASTROESOPHAGEAL REFLUX DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BUPROPION, NSAIDS, LORAZEPAM AND CIMETIDINE. CONCURRENT CONDITIONS INCLUDED OBESITY, CRAMP IN LOWER ABDOMEN, CHRONIC PAIN, DEPRESSION, DYSFUNCTIONAL UTERINE BLEEDING, MUSCULOSKELETAL PAIN, MENOMETRORRHAGIA, VOMITING, SPONDYLOLISTHESIS, COCCYDYNIA, CANNABIS ABUSE, CANNABIS DEPENDENCE, DIARRHEA, LEG PAIN, MENOPAUSAL DISORDER, IRRITABLE COLON AND PAIN. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), CIMETIDINE, LORAZEPAM, NAPROXEN, OMEPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). IN 2003, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), PREMENSTRUAL SYNDROME ("HORMONAL CHANGES DESCRIBE: PMS CONSTANTLY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY AND BACK SURGERY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, MENORRHAGIA AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, BACK PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, FATIGUE, PREMENSTRUAL SYNDROME AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PREMENSTRUAL SYNDROME, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THERE WERE NOTED TO BE FIVE COILS VISIBLE FROM THE OPENING OF THE TUBE. 21JUN2004: SECOND ESSURE PLACED AS RIGHT ESSURE EXPELLED AND SECOND ESSURE PLACED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. HYSTEROSALPINGOGRAM - ON 03-NOV-2003: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : SEVERE BACK PAIN, NAUSEA, PELVIC INFLAMMATORY DISEASES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JUN-2019: QUALITY SAFETY EVALUATION OF PTC. 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 INFLAMMATORY DISEASE ('ACUTE PELVIC INFLAMMATORY DISEASE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12237554) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED EPIGASTRIC PAIN, DYSPEPSIA AND GASTROESOPHAGEAL REFLUX DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BUPROPION, NSAIDS, LORAZEPAM AND CIMETIDINE. CONCURRENT CONDITIONS INCLUDED OBESITY, CRAMP IN LOWER ABDOMEN, CHRONIC PAIN, DEPRESSION, DYSFUNCTIONAL UTERINE BLEEDING, MUSCULOSKELETAL PAIN, MENOMETRORRHAGIA, VOMITING, SPONDYLOLISTHESIS, COCCYDYNIA, CANNABIS ABUSE, CANNABIS DEPENDENCE, DIARRHEA, LEG PAIN, MENOPAUSAL DISORDER, IRRITABLE COLON AND PAIN. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), CIMETIDINE, LORAZEPAM, NAPROXEN, OMEPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2003, THE PATIENT EXPERIENCED BACK PAIN ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: SEVERE BACK PAIN"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), IRRITABLE BOWEL SYNDROME ("IBS (IRRITABLE BOWEL SYNDROME}"), PREMENSTRUAL SYNDROME ("HORMONAL CHANGES DESCRIBE: PMS CONSTANTLY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), CERVICAL CYST ("NABOTHIAN CYSTS") AND CERVICITIS ("ACUTE AND CHRONIC CERVICITIS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY AND BACK SURGERY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, MENORRHAGIA, IRRITABLE BOWEL SYNDROME, CERVICAL CYST AND CERVICITIS OUTCOME WAS UNKNOWN AND THE BACK PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, FATIGUE, PREMENSTRUAL SYNDROME AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, CERVICAL CYST, CERVICITIS, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PREMENSTRUAL SYNDROME, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THERE WERE NOTED TO BE FIVE COILS VISIBLE FROM THE OPENING OF THE TUBE. (B)(6) 2004: SECOND ESSURE PLACED AS RIGHT ESSURE EXPELLED AND SECOND ESSURE PLACED. DATE(S) OF INSERTION: (B)(6) 2003, (B)(6) 2003 (RIGHT SIDE) (AS PER SECOND AMENDED PFS) (B)(6) 2003, (B)(6) 2004 (AS PER THIRD AMENDED PFS) RIGHT SIDE EXPELLED AFTER (B)(6) 2003 , REIMPLANTED ON (B)(6) 2004 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2003: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : SEVERE BACK PAIN, NAUSEA, PELVIC INFLAMMATORY DISEASES. LOT NUMBER: 12237554 MANUFACTURING DATE: 2003-06 EXPIRATION DATE: 2005-03 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUL-2020: PLAINTIFF FACT SHEET RECEIVED. REPORTER ADDED. EVENT ACUTE AND CHRONIC CERVICITIS AND NABOTHIAN CYSTS WERE ADDED. RCC ADDED 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 INFLAMMATORY DISEASE ('ACUTE PELVIC INFLAMMATORY DISEASE'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') AND BACK PAIN ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: SEVERE BACK PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12237554) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED EPIGASTRIC PAIN, DYSPEPSIA AND GASTROESOPHAGEAL REFLUX DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BUPROPION, NSAIDS, LORAZEPAM AND CIMETIDINE. CONCURRENT CONDITIONS INCLUDED OBESITY, CRAMP IN LOWER ABDOMEN, CHRONIC PAIN, DEPRESSION, DYSFUNCTIONAL UTERINE BLEEDING, MUSCULOSKELETAL PAIN, MENOMETRORRHAGIA, VOMITING, SPONDYLOLISTHESIS, COCCYDYNIA, CANNABIS ABUSE, CANNABIS DEPENDENCE, DIARRHEA, LEG PAIN, MENOPAUSAL DISORDER, IRRITABLE COLON AND PAIN. CONCOMITANT PRODUCTS INCLUDED CELECOXIB (CELEXA), CIMETIDINE, LORAZEPAM, NAPROXEN, OMEPRAZOLE AND PARACETAMOL (ACETAMINOPHEN). IN 2003, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), PREMENSTRUAL SYNDROME ("HORMONAL CHANGES DESCRIBE: PMS CONSTANTLY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND BACK SURGERY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, MENORRHAGIA AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, BACK PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, FATIGUE, PREMENSTRUAL SYNDROME AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BACK PAIN, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PREMENSTRUAL SYNDROME, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: THERE WERE NOTED TO BE FIVE COILS VISIBLE FROM THE OPENING OF THE TUBE. ON (B)(6) 2004: SECOND ESSURE PLACED AS RIGHT ESSURE EXPELLED AND SECOND ESSURE PLACED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2003: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : SEVERE BACK PAIN, NAUSEA, PELVIC INFLAMMATORY DISEASES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAY-2019: PFS RECEIVED. LAB DATA ADDED. LOT NUMBER ADDED CONCOMITANT MEDICATION AND CONDITION ADDED AND HISTORICAL DRUG ADDED. HER DEMOGRAPHIC WAS ADDED .EVENTS: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS, ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION, HORMONAL CHANGES DESCRIBE: PMS CONSTANTLY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION, PAIN, VAGINAL DISCHARGE, OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: SEVERE BACK PAIN, LOWER ABDOMINAL PAIN,PELVIC INFLAMMATORY DISEASES WERE ADDED. ON 30-MAY-2019: ¿ CORRECTION DUE TO DISCREPANCY BETWEEN CODING ACTION ITEM AND MATCH POINT CODER QUERY ¿. CODING CORRECTION EVENT HORMONAL CHANGES DESCRIBE: PMS CONSTANTLY UPDATED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456339 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12237554 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CIMETIDINE| CIMETIDINE| CIMETIDINE| CIMETIDINE| CIMETIDINE| CIMETIDINE| LORAZEPAM| LORAZEPAM| LORAZEPAM| LORAZEPAM| LORAZEPAM| LORAZEPAM| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| NAPROXEN| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE |