ESSURE
Report
- Report Number
- 2951250-2019-09818
- Event Type
- Injury
- Date Received
- October 8, 2019
- Report Date
- November 22, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED. THE OUTCOMES FOR HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE AND NAUSEA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MIGRAINE, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS" PELVIC PAIN, ABDOMINAL PAIN, HORMONAL CHANGES, MIGRAINE, HEADACHES AND NAUSEA". DATE(S) OF INSERTION: (B)(6) 2009 (AS PER PIF DISCREPANCY NOTED). DATE(S) OF REMOVAL: (B)(6) 2019 (AS PER PIF DISCREPANCY NOTED). QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 21-FEB-2023: PIF RECEIVED. REPORTER INFORMATION, REPORTER CAUSALITY COMMENT ADDED. ANNEX F UPDATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED. THE OUTCOMES FOR HEADACHE, MIGRAINE, HORMONE LEVEL ABNORMAL AND NAUSEA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MIGRAINE, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS PELVIC PAIN, ABDOMINAL PAIN, HORMONAL CHANGES, MIGRAINE, HEADACHES AND NAUSEA. DATE(S) OF INSERTION: (B)(6) 2009 (AS PER PIF DISCREPANCY NOTED). DATE(S) OF REMOVAL: (B)(6) 2019 (AS PER PIF DISCREPANCY NOTED). QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 19-APR-2023: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF MENORRHAGIA AND DYSMENORRHEA. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HEADACHE ("HEADACHES"), MIGRAINE ("MIGRAINE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY AND LEFT SALPINGECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED. THE OUTCOMES FOR HEADACHE, MIGRAINE, HORMONE LEVEL ABNORMAL AND NAUSEA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MIGRAINE, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS PELVIC PAIN, ABDOMINAL PAIN, HORMONAL CHANGES, MIGRAINE, HEADACHES AND NAUSEA. DATE(S) OF INSERTION: (B)(6) 2009 VERSULS (AS PER PIF DISCREPANCY NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2019: SPECIMEN SUBMITTED: UTERUS, CERVIX, LEFT TUBE. CLINICAL DATA: HISTORY: TOOK LEFT TUBE ONLY. PROCEDURE: TOTAL VAGINAL HYSTERECTOMY. PRE AND POST-OPERATIVE DIAGNOSIS: DYSMENORRHEA, MENOPAUSE. DIAGNOSIS: UTERUS, CERVIX, LEFT FALLOPIAN TUBE, HYSTERECTOMY WITH LEFT SALPINGECTOMY: ENDOMETRIUM - BENIGN PROLIFERATIVE PHASE. MYOMETRIUM - NO PATHOLOGIC ABNORMALITY. CERVIX - NO PATHOLOGIC ABNORMALITY. LEFT FALLOPIAN TUBE - NO PATHOLOGIC ABNORMALITY. METAL COIL, CONSISTENT WITH ESSURE DEVICE FOUND WITHIN RIGHT UTERINE CORNU/ PROXIMAL FALLOPIAN TUBE. GROSS DESCRIPTION: A METAL COIL IS NOTED IN THE PROXIMAL ASPECT OF THE RIGHT FALLOPIAN TUBE. NO COIL IS FOUND IN THE LEFT CORNU. SECTIONING THROUGH THE MYOMETRIUM REVEALS NO GROSS ABNORMALITIES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 02-NOV-2023: REPORTERS,PATIENT INFORMATION,MEDICAL HISTORY,LAB DATA,NON DRUG TREATMENT ADDDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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 PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN HAD RESOLVED AND THE HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MIGRAINE, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS" PELVIC PAIN, ABDOMINAL PAIN, HORMONAL CHANGES, MIGRAINE, HEADACHES AND NAUSEA". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. THE CASE IS UPGRADED FROM OTHER EVENT TO INCIDENT. PREVIOUSLY REPORTED ¿INJURY¿ WAS UPDATED TO MORE SPECIFIED EVENT¿ CHRONIC PELVIC PAIN, ABDOMINAL PAIN, BLEEDING, MIGRAINE, HEADACHES AND NAUSEA¿. REPORTER¿S INFORMATION, DEMOGRAPHICS, ESSURE INDICATION (AMENDED) AND ESSURE REMOVAL DATE WERE ADDED. NO LOT NUMBER 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 |
|---|---|---|---|---|---|---|---|
| 961197 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |