ESSURE
Report
- Report Number
- 2951250-2020-02394
- Event Type
- Injury
- Date Received
- March 12, 2020
- Report Date
- May 24, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF SALPINGITIS ('LEFT FALLOPIAN TUBE WITH CHRONIC INFLAMMATION') AND PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36516, 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED VAGINITIS AND GENITOURINARY CHLAMYDIA INFECTION. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2013 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/DEPRESSION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEM"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ANXIETY ("MENTAL ANGUISH"), VULVOVAGINAL CANDIDIASIS ("CANDIDA VAGINOSIS") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), AND ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE SALPINGITIS, ABDOMINAL PAIN, DEPRESSION, BLADDER DISORDER, URINARY TRACT DISORDER, HEAVY MENSTRUAL BLEEDING, VAGINAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL CANDIDIASIS AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE AND VAGINAL INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, DEPRESSION, GENITAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN, POST PROCEDURAL COMPLICATION, SALPINGITIS, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON THE LEFT TUBE 5 COILS WERE PROTRUDING OUT OF THE TUBE AND INTO THE ENDOMETRIAL CAVITY AND ON THE RIGHT SIDE 2 COILS WERE PROTRUDING INTO THE ENDOMETRIAL CAVITY. CURRENT WEIGHT 164LBS PATIENT RECEIVED TREATMENT FOR BLADDER/ URINARY PROBLEMS. LOT NUMBER: 880431 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. LOT NUMBER: A36516 MANUFACTURE DATE: 2012-08 EXPIRATION DATE: 2015-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-MAY-2021: MR RECEIVED : EVENT "LEFT FALLOPIAN TUBE WITH CHRONIC INFLAMMATION", REPORTER 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 ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36516, 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED VAGINITIS AND GENITOURINARY CHLAMYDIA INFECTION. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2013 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/DEPRESSION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEM"), MENORRHAGIA ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE GENITAL HAEMORRHAGE, VAGINAL INFECTION, ABDOMINAL PAIN, DEPRESSION, BLADDER DISORDER, URINARY TRACT DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON THE LEFT TUBE 5 COILS WERE PROTRUDING OUT OF THE TUBE AND INTO THE ENDOMETRIAL CAVITY AND ON THE RIGHT SIDE 2 COILS WERE PROTRUDING INTO THE ENDOMETRIAL CAVITY. LOT NUMBER: 880431, MANUFACTURE DATE: 2011-07, EXPIRATION DATE: 2014-07. LOT NUMBER: A36516, MANUFACTURE DATE: 2012-08, EXPIRATION DATE: 2015-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAR-2020: FU(5) AND FU(6) PROCESSED TOGETHER. PFS RECEIVED. EVENT OUTCOME UPDATE FOR: PELVIC PAIN. CONCOMITANT DRUGS 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 ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36516, 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED VAGINITIS AND GENITOURINARY CHLAMYDIA INFECTION. CONCOMITANT PRODUCTS INCLUDED NSAIDS SINCE (B)(6) 2013 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/DEPRESSION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEM"), MENORRHAGIA ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ANXIETY ("MENTAL ANGUISH"), VULVOVAGINAL CANDIDIASIS ("CANDIDA VAGINOSIS") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND VAGINAL INFECTION HAD RESOLVED AND THE ABDOMINAL PAIN, DEPRESSION, BLADDER DISORDER, URINARY TRACT DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE, ANXIETY, VULVOVAGINAL CANDIDIASIS AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON THE LEFT TUBE 5 COILS WERE PROTRUDING OUT OF THE TUBE AND INTO THE ENDOMETRIAL CAVITY AND ON THE RIGHT SIDE 2 COILS WERE PROTRUDING INTO THE ENDOMETRIAL CAVITY. CURRENT WEIGHT 164LBS. LOT NUMBER: 880431, MANUFACTURE DATE: 2011-07, EXPIRATION DATE: 2014-07. LOT NUMBER: A36516, MANUFACTURE DATE: 2012-08, EXPIRATION DATE: 2015-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: FU 7,8 AND 9 PROCESS TOGETHER. PPF RECEIVED EVENTS " CANDIDA VAGINOSIS, POST PROCEDURAL COMPLICATION" WERE ADDED. OUTCOME OF EVENTS "PAIN, BLEEDING AND INFECTION " WERE UPDATED AS RECOVERED. REPORTER INFORMATION WAS ADDED. 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 AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36516, 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED VAGINITIS AND (B)(6) INFECTION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GEN. ABNORM. BLEED"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DEPRESSION ("PSYCH INJURY/DEPRESSION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEM"), MENORRHAGIA ("MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL INFECTION, ABDOMINAL PAIN, DEPRESSION, BLADDER DISORDER, URINARY TRACT DISORDER, MENORRHAGIA, VAGINAL HAEMORRHAGE AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON THE LEFT TUBE 5 COILS WERE PROTRUDING OUT OF THE TUBE AND INTO THE ENDOMETRIAL CAVITY AND ON THE RIGHT SIDE 2 COILS WERE PROTRUDING INTO THE ENDOMETRIAL CAVITY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-FEB-2020: PFS RECEIVED. REPORTERS INFORMATION WERE ADDED. LOT NO. WERE ADDED. EVENT: GENITAL HEMORRHAGE WAS UPDATED AS NON-SERIOUS. NEW EVENTS:PLAINTIFF DID NOT UNDERGO ESSURE CONFIRMATION TEST, HYSTERECTOMY ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION ,MENTAL ANGUISH WERE ADDED. EVENT:PSYCH INJURY WERE UPDATED TO PSYCH INJURY/DEPRESSION. FU3 AND 4 PROCESSED TOGETHER. ON 21-FEB-2020: MR RECEIVED. REPORTERS INFORMATION WERE ADDED. MEDICAL HISTORY WERE ADDED. FU3 AND 4 PROCESSED TOGETHER. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288771 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A36516, 880431 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| NSAIDS| NSAIDS| NSAIDS |