ESSURE
Report
- Report Number
- 2951250-2019-06759
- Event Type
- Injury
- Date Received
- September 17, 2019
- Date of Event
- September 9, 2015
- Report Date
- April 8, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT FALLOPIAN TUBE'), SALPINGITIS ('CHRONIC AND ACUTE SALPINGITIS WITH GRANULOMATOUS'), MENORRHAGIA ('MENORRHAGIA') AND VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS IN 2013, ANEMIA, VAGINITIS, BLOATING, WEIGHT GAIN, ENDOMETRITIS AND MENOMETRORRHAGIA. CONCURRENT CONDITIONS INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2015 TO (B)(6) 2015 FOR BIRTH CONTROL AS WELL AS PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED FEELING ABNORMAL ("DOES NOT FEEL GREAT"), INSOMNIA ("INSOMNIA") AND FATIGUE ("EXHAUSTED"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY / MORE ANXIETY/PSYCH INJURY RELATED TO ESSURE/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY & MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING: GEN. ABNORM. BLEED"), PELVIC PAIN ("PAIN: PELVIC/PAIN PELVIC AREA/ PHYSICAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC SURGICAL REMOVAL, HYST (FULL), SALPING (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, SALPINGITIS, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION AND MIGRAINE OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE FEELING ABNORMAL, INSOMNIA, ANXIETY AND FATIGUE HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANXIETY, FATIGUE, FEELING ABNORMAL AND INSOMNIA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEPRESSION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SALPINGITIS AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN: PELVIC/ABDOMINAL. DUPLICATE CASE INSERTION DATE : (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2015: BILATERAL OCCLUSION. 1. THERE IS A ROUNDED CENTRAL LUCENCY IN THE UTERINE CAVITY, MOST LIKELY REPRESENTS A FIBROID. 2. BILATERALLY ESSURE DEVICES ARE IN THE EXPECTED LOCATION. NO CONTRAST FILLING OF THE FALLOPIAN TUBE IS SEEN.; ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. FALLOPIAN TUBES WERE BLOCKED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORDS: SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: ALL THE INFORMATION FROM THE DUPLICATE CASE HAS BEEN TRANSFERRED FROM THE DELETION CASE (B)(4). NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT FALLOPIAN TUBE'), SALPINGITIS ('CHRONIC AND ACUTE SALPINGITIS WITH GRANULOMATOUS'), MENORRHAGIA ('MENORRHAGIA') AND VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS IN 2013, ANEMIA, VAGINITIS, BLOATING, WEIGHT GAIN, ENDOMETRITIS, MENOMETRORRHAGIA, INSOMNIA, PELVIC PAIN FEMALE, ABDOMINAL PAIN, MENSES IRREGULAR AND PELVIC DISCOMFORT. CONCURRENT CONDITIONS INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2015 TO (B)(6) 2015 FOR BIRTH CONTROL AS WELL AS PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED FEELING ABNORMAL ("DOES NOT FEEL GREAT"), INSOMNIA ("INSOMNIA") AND FATIGUE ("EXHAUSTED"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY / MORE ANXIETY/PSYCH INJURY RELATED TO ESSURE/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY & MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING: GEN. ABNORM. BLEED"), PELVIC PAIN ("PAIN: PELVIC/PAIN PELVIC AREA/ PHYSICAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC SURGICAL REMOVAL, HYST (FULL), SALPING (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, SALPINGITIS, DEPRESSION AND MIGRAINE OUTCOME WAS UNKNOWN, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, GENITAL HAEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE FEELING ABNORMAL, INSOMNIA, ANXIETY AND FATIGUE HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANXIETY, FATIGUE, FEELING ABNORMAL AND INSOMNIA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEPRESSION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SALPINGITIS AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN: PELVIC/ABDOMINAL. DUPLICATE CASE INSERTION DATE : (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2015: BILATERAL OCCLUSION. 1. THERE IS A ROUNDED CENTRAL LUCENCY IN THE UTERINE CAVITY, MOST LIKELY REPRESENTS A FIBROID. 2. BILATERALLY ESSURE DEVICES ARE IN THE EXPECTED LOCATION. NO CONTRAST FILLING OF THE FALLOPIAN TUBE IS SEEN.; ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. FALLOPIAN TUBES WERE BLOCKED.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORDS: SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAR-2021: MEDICAL RECORD RECEIVED: MEDICAL HISTORY, PATIENT DEMOGRAPHIC, REPORTER INFORMATION ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT FALLOPIAN TUBE'), SALPINGITIS ('CHRONIC AND ACUTE SALPINGITIS WITH GRANULOMATOUS'), MENORRHAGIA ('MENORRHAGIA') AND VAGINAL HEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS IN 2013, ANEMIA, VAGINITIS, BLOATING, WEIGHT GAIN, ENDOMETRITIS AND MENOMETRORRHAGIA. CONCURRENT CONDITIONS INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2015 TO (B)(6) 2015 FOR BIRTH CONTROL AS WELL AS PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. IN 2015, THE PATIENT EXPERIENCED FEELING ABNORMAL ("DOES NOT FEEL GREAT"), INSOMNIA ("INSOMNIA") AND FATIGUE ("EXHAUSTED"). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN JULY 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY / MORE ANXIETY/PSYCH INJURY RELATED TO ESSURE/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY & MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HEMORRHAGE ("BLEEDING: GEN. ABNORM. BLEED"), PELVIC PAIN ("PAIN: PELVIC/PAIN PELVIC AREA/ PHYSICAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC SURGICAL REMOVAL, HYST (FULL), SALPING (BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, SALPINGITIS, DEPRESSION AND MIGRAINE OUTCOME WAS UNKNOWN, THE MENORRHAGIA, VAGINAL HEMORRHAGE, GENITAL HEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE FEELING ABNORMAL, INSOMNIA, ANXIETY AND FATIGUE HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANXIETY, FATIGUE, FEELING ABNORMAL AND INSOMNIA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEPRESSION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SALPINGITIS AND VAGINAL HEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN: PELVIC/ABDOMINAL. DUPLICATE CASE INSERTION DATE: (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2015: BILATERAL OCCLUSION. 1. THERE IS A ROUNDED CENTRAL LUCENCY IN THE UTERINE CAVITY, MOST LIKELY REPRESENTS A FIBROID. 2. BILATERALLY ESSURE DEVICES ARE IN THE EXPECTED LOCATION. NO CONTRAST FILLING OF THE FALLOPIAN TUBE IS SEEN; ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. FALLOPIAN TUBES WERE BLOCKED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORDS: SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT FALLOPIAN TUBE'), SALPINGITIS ('CHRONIC AND ACUTE SALPINGITIS WITH GRANULOMATOUS'), MENORRHAGIA ('MENORRHAGIA') AND VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS IN 2013, ANEMIA, VAGINITIS, BLOATING, WEIGHT GAIN, ENDOMETRITIS AND MENOMETRORRHAGIA. CONCURRENT CONDITIONS INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2015 TO (B)(6) 2015 FOR BIRTH CONTROL AS WELL AS PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2015. IN 2015, THE PATIENT EXPERIENCED FEELING ABNORMAL ("DOES NOT FEEL GREAT"), INSOMNIA ("INSOMNIA") AND FATIGUE ("EXHAUSTED"). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY / MORE ANXIETY/PSYCH INJURY RELATED TO ESSURE/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY & MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("BLEEDING: GEN. ABNORMAL. BLEED"), PELVIC PAIN ("PAIN: PELVIC/PAIN PELVIC AREA/ PHYSICAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC SURGICAL REMOVAL, HYST (FULL), SALPING (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, SALPINGITIS, DEPRESSION AND MIGRAINE OUTCOME WAS UNKNOWN, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, GENITAL HAEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE FEELING ABNORMAL, INSOMNIA, ANXIETY AND FATIGUE HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANXIETY, FATIGUE, FEELING ABNORMAL AND INSOMNIA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEPRESSION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SALPINGITIS AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN: PELVIC/ABDOMINAL. DUPLICATE CASE INSERTION DATE : (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2015: BILATERAL OCCLUSION. 1. THERE IS A ROUNDED CENTRAL LUCENCY IN THE UTERINE CAVITY, MOST LIKELY REPRESENTS A FIBROID. 2. BILATERALLY ESSURE DEVICES ARE IN THE EXPECTED LOCATION. NO CONTRAST FILLING OF THE FALLOPIAN TUBE IS SEEN.; ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. FALLOPIAN TUBES WERE BLOCKED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORDS: SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED: EVENT OUTCOME OF MENORRHAGIA AND VAGINAL HAEMORRHAGE WERE UPDATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT FALLOPIAN TUBE'), SALPINGITIS ('CHRONIC AND ACUTE SALPINGITIS WITH GRANULOMATOUS'), MENORRHAGIA ('MENORRHAGIA'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA') AND GENITAL HAEMORRHAGE ('BLEEDING: GEN. ABNORM. BLEED') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS IN 2013, ANEMIA, VAGINITIS, BLOATING, WEIGHT GAIN, ENDOMETRITIS AND MENOMETRORRHAGIA. CONCURRENT CONDITIONS INCLUDED INTRAMURAL LEIOMYOMA OF UTERUS. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM ON (B)(6) 2015 FOR BIRTH CONTROL AS WELL AS PARACETAMOL (ACETAMINOPHEN) SINCE ON (B)(6) 2015. IN 2015, THE PATIENT EXPERIENCED FEELING ABNORMAL ("DOES NOT FEEL GREAT"), INSOMNIA ("INSOMNIA") AND FATIGUE ("EXHAUSTED"). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY / MORE ANXIETY/PSYCH INJURY RELATED TO ESSURE/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY & MENTAL ANGUISH") AND DEPRESSION ("DEPRESSION"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PAIN: PELVIC/PAIN PELVIC AREA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC SURGICAL REMOVAL, HYST (FULL), SALPING (BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, SALPINGITIS, MENORRHAGIA, VAGINAL HAEMORRHAGE, DEPRESSION AND MIGRAINE OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE FEELING ABNORMAL, INSOMNIA, ANXIETY AND FATIGUE HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANXIETY, FATIGUE, FEELING ABNORMAL AND INSOMNIA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEPRESSION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SALPINGITIS AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN: PELVIC/ABDOMINAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE: ON (B)(6) 2015: BILATERAL OCCLUSION. 1. THERE IS A ROUNDED CENTRAL LUCENCY IN THE UTERINE CAVITY, MOST LIKELY REPRESENTS A FIBROID. 2. BILATERALLY ESSURE DEVICES ARE IN THE EXPECTED LOCATION. NO CONTRAST FILLING OF THE FALLOPIAN TUBE IS SEEN: ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. FALLOPIAN TUBES WERE BLOCKED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA MEDICAL RECORDS: SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-OCT-2019: PFS AND MR RECEIVED - NEW EVENTS MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT FALLOPIAN TUBE, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DEPRESSION, MIGRAINES/HEADACHES AND CHRONIC AND ACUTE SALPINGITIS WITH GRANULOMATOUS WERE ADDED. PATIENT HEIGHT, NEW REPORTER, MEDICAL HISTORY AND LAB DATA WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC') AND GENITAL HAEMORRHAGE ('BLEEDING: GEN. ABNORM. BLEED') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2015, THE PATIENT EXPERIENCED FEELING ABNORMAL ("DOES NOT FEEL GREAT"), INSOMNIA ("INSOMNIA"), ANXIETY ("ANXIETY / MORE ANXIETY/PSYCH INJURY RELATED TO ESSURE") AND FATIGUE ("EXHAUSTED"). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYST (FULL), SALPING (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE FEELING ABNORMAL, INSOMNIA, ANXIETY AND FATIGUE HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ANXIETY, FATIGUE, FEELING ABNORMAL AND INSOMNIA WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PAIN: PELVIC/ABDOMINAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2015: BILATERAL OCCLUSION.. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENT(S) IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PFS RECEIVED- CASE BECOMES INCIDENT. NEW EVENTS PAIN: PELVIC/ABDOMINAL, BLEEDING: GEN. ABNORM. BLEED WERE ADDED. PRODUCT INFORMATION INDICATION, DATE OF ESSURE INSERTION AND REMOVAL WERE ADDED. LAB DATA WERE ADDED. CONSUMER ADDRESS WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 870886 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| NORETHINDRONE ACETATE| NORETHINDRONE ACETATE| NORETHINDRONE ACETATE| NORETHINDRONE ACETATE| NORETHINDRONE ACETATE |