ESSURE

Report

Report Number: 2951250-2014-00284
Event Type: Injury
Date Received: July 17, 2014
Report Date: October 11, 2024
Manufacturer: BAYER PHARMA AG
Product Code: HHS
UDI-DI: 10888853003051
PMA / PMN Number: P020014
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 1

PTC INVESTIGATION RESULT WAS RECEIVED ON JULY 9, 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC GLOBAL NUMBER (B)(4). 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 CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE 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 AT THIS TIME. MEDICAL ASSESSMENT: THE MEDICAL EVENT REPORTED IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. ADDITIONALLY, THE CASE REPORTED DIFFICULT TO USE DUE TO ANATOMY AND A DEPLOYMENT ISSUE WITH PLACEMENT LOCATION BUT THESE EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT, THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS CASE REPORT DERIVED FROM MEDICAL LITERATURE, ARTICLE ENTITLED "ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT", REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN. THE EVENT WAS CONSIDERED AS RELATED TO ESSURE BY THE REPORTER. THE EVENT IS SERIOUS DUE MEDICAL IMPORTANCE, LISTED IN THE ESSURE REFERENCE SAFETY INFORMATION AND REGARDED AS INCIDENT, SINCE DEVICE REMOVAL BY HYSTEROSCOPY WAS PERFORMED. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE, THE PATIENT EXPERIENCED PAIN ONE WEEK AFTER PLACEMENT, INCREASED WITH TIME AND DID NOT DISAPPEAR USING STANDARD ANALGESIC DRUGS. THEN, AS THE EVENT PERSISTED, THE DEVICE WAS REMOVED BY HYSTEROSCOPY. THE SYMPTOMS DISAPPEARED AFTER ESSURE REMOVAL. CONSIDERING THIS POSITIVE TEMPORAL RELATIONSHIP AND DECHALLENGE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. ADDITIONALLY NON-SERIOUS EVENTS DEVICE DIFFICULT TO INSERT DUE TO TUBAL OBSTRUCTION AND 10 COILS IN RIGHT TUBAL AND 12 COILS IN LEFT TUBAL WERE REPORTED. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE. THERE IS NO REASON TO SUSPECT A QUALITY DEFECT OF THE PRODUCT. REPORT SOURCE LITERATURE DESCRIPTION: JOURNAL: J OBSTET GYNAECOL; AUTHOR: CASTELO-BRANCO C; ARJONA BERRAL JE. RODRIGUEZ JIMENEZ B. VELASCO SANCHEZ E,ET AL; TITLE: ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT; VOLUME: XX YEAR: 2014 PAGES: 1-2.

Additional Manufacturer Narrative · 1

DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS

Description of Event or Problem · 1

THIS CASE REPORT FROM (B)(6) WAS DERIVED FROM MEDICAL LITERATURE ON JUNE 17, 2014, ARTICLE ENTITLED "ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT". IT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN-TUBE MICRO-INSERTS) IMPLANTED FOR HYSTEROSCOPIC STERILISATION AND EXPERIENCED MODERATE CHRONIC PELVIC PAIN STARTING ONE WEEK AFTER INSERTION. THE DEVICE WAS DIFFICULT TO INSERT. NUMBER OF DEVICES WAS 10 COILS IN RIGHT TUBAL AND 12 COILS IN LEFT TUBAL. CASE REPORT: (B)(6) FEMALE PATIENT (CASE 4 FROM TABLE 1) HAD ESSURE MICRO-INSERT IMPLANTED FOR HYSTEROSCOPIC STERILIZATION. THE SURGEON DESCRIBED THE PROCEDURE AS HIGH LEVEL OF DIFFICULTY DUE TO TUBAL OBSTRUCTION. THE SURGEON REPORTED SATISFACTORY DEVICE PLACEMENT. THERE WERE 10 COILS IN RIGHT TUBAL AND 12 COILS IN LEFT TUBAL. PATIENT EXPERIENCED PAIN ONE WEEK AFTER PLACEMENT, IT WAS ASSESSED AS MODERATE VIA PAIN ASSESSMENT TOLERANCE. HSG (HYSTEROSALPINGOGRAM) WAS DONE AS A CONTROL TEST. CHRONIC PELVIC PAIN THAT STARTED ONE WEEK AFTER PLACEMENT INCREASED WITH TIME AND DID NOT DISAPPEAR USING STANDARD ANALGESIC DRUGS REQUIRING MICRO-INSERT REMOVAL. THE DEVICE WAS REMOVED BY HYSTEROSCOPY, TIME BETWEEN MICRO-INSERT PLACEMENT AND REMOVAL WAS 12 MONTHS. THE SYMPTOMS DISAPPEARED AFTER ESSURE REMOVAL. AUTHOR'S COMMENTS: THE PRESENT, VERY LARGE SAMPLE DEMONSTRATES THAT CHRONIC PELVIC PAIN IS A VERY RARE COMPLICATION WITH THE ESSURE SYSTEM. INDEED SIX OF THE SEVEN WOMEN REPORTED THAT THE ONSET OF SYMPTOMS STARTED IMMEDIATELY AFTER THE PROCEDURE AND DID NOT IMPROVE WITH THE INTAKE OF STANDARD ANALGESICS. IN THREE OF THESE PATIENTS, THE SURGEON DESCRIBED THE DEVICE PLACEMENT AS DIFFICULT, REQUIRING A HYSTEROSALPINGOGRAPHY AS A CONTROL TEST, SHOWING DEVICE OCCLUSION AS WELL AS DEVICE DISPOSAL. THIS FACT IS NOTEWORTHY, SINCE PELVIC PAIN MAY BE RELATED TO MALPOSITIONING OF A MICROINSERT. THREE OF THE SEVEN CASES DESCRIBED THE PAIN DURING THE PROCEDURE AS HIGH, WITH THIS PERCENTAGE BEING GREATER THAN THAT M OBSERVED IN THE WHOLE COHORT. SERIES IS THE LARGEST TO DATE EVALUATING THE FEASIBILITY, SAFETY AND EFFECTIVENESS OF ESSURE HYSTEROSCOPIC STERILISATION, WITH THE INCIDENCE OF CHRONIC PP OBSERVED BEING EXTREMELY LOW. AUTHOR IDENTIFIED ALL WOMEN UNDERGOING THE PROCEDURE DURING THE STUDY PERIOD. THE CAUSES THAT MIGHT EXPLAIN CHRONIC PP IN WOMEN WITH ESSURE REMAIN UNKNOWN AND, CONSEQUENTLY, FURTHER STUDIES ARE WARRANTED. PUBLICATION ABSTRACT: THE AIM OF THIS STUDY WAS TO ASSESS THE INCIDENCE OF CHRONIC PELVIC PAIN IN WOMEN AFTER PLACEMENT OF ESSURE MICROINSERTS. THIS WAS A CASE SERIES STUDY AT THE HYSTEROSCOPY UNIT IN A TEACHING HOSPITAL. AUTHOR INCLUDED 4,274 PATIENTS UNDERGOING PERMANENT STERILISATION WITH ESSURE MICROINSERTS FROM (B)(6) 2005 TO (B)(6) 2011. ESSURE DEVICES WERE REMOVED IN ALL PATIENTS REPORTING PELVIC PAIN AFTER INSERTION. ALL DATA WERE COLLECTED FROM THE HYSTEROSCOPY UNIT DATABASE WITH LATER REVIEW OF MEDICAL RECORDS IN CASES OF CHRONIC PELVIC PAIN AND A TELEPHONE SURVEY AFTER MICROINSERT REMOVAL. MAIN OUTCOME MEASURES WERE: GRADE OF PROCEDURE DIFFICULTY PERCEIVED BY THE SURGEON; TOLERANCE DESCRIBED BY THE PATIENT AFTER PLACEMENT; THE NEED FOR ANALGESICS DURING OR IMMEDIATELY AFTER THE PROCEDURE; SIDE-EFFECTS; AVERAGE TIME BETWEEN DEVICE PLACEMENT AND THE ONSET OF SYMPTOMS; TIME BETWEEN DEVICE PLACEMENT AND REMOVAL; TECHNIQUE FOR DEVICE REMOVAL AND ANY SYMPTOMS THEREAFTER. A TOTAL OF SEVEN WOMEN (0.16%) PRESENTED WITH CHRONIC PELVIC PAIN REQUIRING MICROINSERT REMOVAL, WITH FOUR CLASSIFYING THE PAIN PERCEIVED DURING THE PROCEDURE AS MEDIUM-HIGH. SIX PATIENTS DID NOT REQUIRE ANALGESICS AFTER THE PROCEDURE AND A VASOVAGAL SYNDROME REQUIRING ENDOVENOUS ANALGESIA AND MONITORING OCCURRED IN ONLY ONE CASE. SIX WOMEN REPORTED PAIN IMMEDIATELY AFTER THE PROCEDURE, WITH A MEAN TIME BETWEEN PLACEMENT AND REMOVAL OF 29.4 MONTHS. IN ALL CASES, THE SYMPTOMS DISAPPEARED AFTER ESSURE REMOVAL. AUTHOR CONCLUDED THAT THE DEVELOPMENT OF CHRONIC PELVIC PAIN IS VERY UNCOMMON AFTER PLACEMENT OF ESSURE MICROINSERTS. REMOVAL OF THESE DEVICES USUALLY IMPROVES THE PAIN. OTHER CASES FROM THIS ARTICLE: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
420333	ESSURE	TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE	HHS	BAYER PHARMA AG	ESS305		10888853003051
420356	ESSURE	TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE	HHS	BAYER PHARMA AG	ESS305		10888853003051

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR	Female	Other\| R