ESSURE
Report
- Report Number
- 2951250-2016-01452
- Event Type
- Injury
- Date Received
- August 25, 2016
- Report Date
- September 27, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC PELVIC PAIN / INCREASINGLY SEVERE PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B60753) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FIRST PREGNANCY". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS ("MISCARRIED"), GASTRITIS BACTERIAL ("BACTERIA IN HER STOMACH LINING") WITH ABDOMINAL PAIN UPPER, MENSTRUATION IRREGULAR ("PERIODS HAVE BEEN IRREGULAR"), HEAVY MENSTRUAL BLEEDING ("SOMETIMES SHE BLEEDS FOR 3 WEEKS STRAIGHT / HEAVY MENSTRUAL BLEEDING"), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), ALOPECIA ("EXCESSIVE HAIR LOSS"), FATIGUE ("CHRONIC FATIGUE") AND DISCOMFORT ("INCREASINGLY DISCOMFORT") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("FIRST PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2016, HYSTERECTOMY WAS DONE TO REMOVE ESSURE, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, GASTRITIS BACTERIAL, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, BACK PAIN, ABDOMINAL DISTENSION, ALOPECIA, FATIGUE AND DISCOMFORT OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABORTION SPONTANEOUS, ALOPECIA, BACK PAIN, DISCOMFORT, FATIGUE, GASTRITIS BACTERIAL, HEAVY MENSTRUAL BLEEDING, MENSTRUATION IRREGULAR, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS INSERTED ON (B)(6) 2014, WITH LOT NUMBER B60753, EXPIRATION DATE (B)(6) 2016. ESSURE WAS NOT INSERTED AT POST-PARTUM STATE. THE PROCEDURE WAS DONE BY ANOTHER PROVIDER BUT IT WAS SAID THAT PROCEDURE WAS FINE. ESSURE WAS REMOVED ON (B)(6) 2016. SHE IS PREVENTED FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE SHE ENJOYED PRE-OPERATIVELY, AND SHE HAS OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2014: RESULTS: FINE RESULTS/ TUBES WERE OCCLUDED. X-RAY OF PELVIS AND HIP - IN (B)(6) 2014: RESULTS: LOCATION/ TEST RESULT SATISFACTORY. DIAGNOSTIC RESULTS: ON (B)(6) 2014 ESSURE WAS INSERTED. SHORTLY AFTER UNDERGOING THE ESSURE PROCEDURE, AN HSG TEST WAS PERFORMED AND SHE WAS ADVISED THAT HER COILS WERE PROPERLY PLACED. HOWEVER, HER POST-PROCEDURE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE PAIN AND DISCOMFORT, INCLUDING HEAVY MENSTRUAL BLEEDING, CHRONIC PELVIC PAIN, CHRONIC BACK PAIN, ABDOMINAL BLOATING, EXCESSIVE HAIR LOSS, AND CHRONIC FATIGUE. SHE NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. SHE NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. CONSUMER WAS TOLD THAT HER CONFIRMATION TEST IN (B)(6) 2014 WAS FINE. SINCE INSERTION SHE HAD BEEN PREGNANT 4 TIMES AND MISCARRIED HER PREGNANCIES. QUALITY-SAFETY EVALUATION OF PTC: BATCH: B60753, EXP. DATE: 31-AUG-2016, AND MFR DATE: 15-AUG-2013. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS OR LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS AND LACK OF EFFICACY ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-SEP-2021: MR RECEIVED. REPORTERS AND MEDICAL HISTORY WERE 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.
QUALITY-SAFETY EVALUATION OF PTC: BATCH(B)(4), EXP. DATE 31-AUG-2016, MFR DATE 15-AUG-2013. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS OR LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS AND LACK OF EFFICACY ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JAN-2017: UPDATED QUALITY-SAFETY EVALUATION OF PTC WITH BATCH NUMBER. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE HAD BEEN PREGNANT 4 TIMES AND MISCARRIED. THIS CASE REFERS TO THE FIRST PREGNANCY. SHE ALSO HAD BACTERIA IN HER STOMACH LINING. ACCORDING TO ADDITIONAL INFORMATION RECEIVED VIA LEGAL CLAIM, THE PLAINTIFF ALSO HAD CHRONIC PAIN AND HYSTERECTOMY WAS DONE TO REMOVE ESSURE TWO YEARS AFTER PLACEMENT. PREGNANCY WITH ESSURE AND PELVIC PAIN ARE LISTED IN THE ESSURE'S REFERENCE SAFETY INFORMATION WHILE THE OTHER EVENTS ARE UNLISTED. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE. IN THE PRESENT CASE, CONSUMER INSERTED ESSURE IN 2014 AND CONFIRMATION TEST WAS PERFORMED IN (B)(6) 2014 AND CONCLUDE THAT INSERTION WAS FINE. GIVEN EVENT'S NATURE DEVICE FAILURE AND THE CAUSALITY CANNOT BE EXCLUDED. MISCARRIAGE, IT IS THE MOST COMMON COMPLICATION OF EARLY PREGNANCY. IN THIS CASE, THE GESTATIONAL AGE WAS NOT PROVIDED. HOWEVER, CONSIDERING THAT A MECHANICAL INTERFERENCE OF ESSURE MICRO-INSERTS IN EARLY DEVELOPING PREGNANCY IS UNLIKELY, THIS EVENT WAS CONSIDERED UNRELATED TO THE INSERT. REGARDING THE EVENT BACTERIA IN HER STOMACH LINING, SEEN AS BACTERIAL GASTRITIS; GIVEN ITS' PATHOPHYSIOLOGY AND ESSURE'S LOCAL ACTION IN FALLOPIAN TUBES; CAUSALITY BETWEEN THIS EVENT AND ESSURE IS CONSIDERED AS VERY UNLIKELY. BESIDES, ABDOMINAL AND PELVIC PAIN MAY OCCUR DURING ESSURE USE. CONSIDERING ITS NATURE AND THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THIS EVENT AND ESSURE USE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE INTERVENTION WAS REQUIRED (SURGICAL REMOVAL OF ESSURE). ACCORDING TO PRODUCT TECHNICAL ANALYSIS THERE IS NO REASON TO SUSPECT ABOUT A QUALITY DEFECT OF THE PRODUCT. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
UPDATED QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT (PTC) RECEIVED ON 10-NOV-2016: THIS ADVERSE EVENT REPORT IS RELATED TO A PTC AND THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4) NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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 OF DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND THE REPORTED LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. A LACK OF EFFICACY AND THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED. A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE HAD BEEN PREGNANT 4 TIMES AND MISCARRIED. THIS CASE REFERS TO THE FIRST PREGNANCY. SHE ALSO HAD BACTERIA IN HER STOMACH LINING. ACCORDING TO ADDITIONAL INFORMATION RECEIVED VIA LEGAL CLAIM, THE PLAINTIFF ALSO HAD CHRONIC PAIN AND HYSTERECTOMY WAS DONE TO REMOVE ESSURE TWO YEARS AFTER PLACEMENT. PREGNANCY WITH ESSURE AND PELVIC PAIN ARE LISTED IN THE ESSURE'S REFERENCE SAFETY INFORMATION WHILE THE OTHER EVENTS ARE UNLISTED. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE. IN THE PRESENT CASE, CONSUMER INSERTED ESSURE IN 2014 AND CONFIRMATION TEST WAS PERFORMED IN (B)(6) 2014 AND CONCLUDE THAT INSERTION WAS FINE. GIVEN EVENT'S NATURE DEVICE FAILURE AND THE CAUSALITY CANNOT BE EXCLUDED. MISCARRIAGE, IT IS THE MOST COMMON COMPLICATION OF EARLY PREGNANCY. IN THIS CASE, THE GESTATIONAL AGE WAS NOT PROVIDED. HOWEVER, CONSIDERING THAT A MECHANICAL INTERFERENCE OF ESSURE MICRO-INSERTS IN EARLY DEVELOPING PREGNANCY IS UNLIKELY, THIS EVENT WAS CONSIDERED UNRELATED TO THE INSERT. REGARDING THE EVENT BACTERIA IN HER STOMACH LINING, SEEN AS BACTERIAL GASTRITIS; GIVEN ITS' PATHOPHYSIOLOGY AND ESSURE'S LOCAL ACTION IN FALLOPIAN TUBES; CAUSALITY BETWEEN THIS EVENT AND ESSURE IS CONSIDERED AS VERY UNLIKELY. BESIDES, ABDOMINAL AND PELVIC PAIN MAY OCCUR DURING ESSURE USE. CONSIDERING ITS NATURE AND THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THIS EVENT AND ESSURE USE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE INTERVENTION WAS REQUIRED (SURGICAL REMOVAL OF ESSURE). ACCORDING TO PRODUCT TECHNICAL ANALYSIS THERE IS NO REASON TO SUSPECT ABOUT A QUALITY DEFECT OF THE PRODUCT. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
(B)(4).
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM AN ADULT FEMALE CONSUMER IN UNITED STATES ON 15-MAR-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN 2014. IN (B)(6) 2014, SHE HAD HER CONFIRMATION TEST PERFORMED AND IT WAS FINE. SINCE INSERTION SHE HAS EXPERIENCED PELVIC PAIN, SHE COULD NOT PICK HER CHILDREN UP WITHOUT A STABBING PAIN IN HER STOMACH, HER PERIODS HAVE BEEN IRREGULAR, SOMETIMES SHE BLEEDS FOR 3 WEEKS STRAIGHT, AND SHE HAD BEEN PREGNANT 4 TIMES AND MISCARRIED HER PREGNANCIES. SHE ALSO STATED SHE HAD BACTERIA IN HER STOMACH LINING AND WAS TREATED FOR IT. NOTE THIS CASE REFERS FOR THE FIRST PREGNANCY AND THE OTHERS EVENTS; SECOND, THIRD AND FOURTH PREGNANCIES WERE REPORTED UNDER REFERENCES 2016-052084, 2016-052098 AND 2016-052103 RESPECTIVELY. FOLLOW-UP RECEIVED ON 18-APR-2016: THE PTC INVESTIGATION RESULT WAS PROVIDED. (B)(4). QUALITY-SAFETY EVALUATION OF PTC: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. LEGAL CLAIM RECEIVED ON 04-AUG-2016 ON (B)(6) 2014 ESSURE WAS INSERTED. SHORTLY AFTER UNDERGOING THE ESSURE PROCEDURE, AN HSG TEST WAS PERFORMED AND SHE WAS ADVISED THAT HER COILS WERE PROPERLY PLACED. HOWEVER, HER POST-PROCEDURE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE PAIN AND DISCOMFORT, INCLUDING HEAVY MENSTRUAL BLEEDING, CHRONIC PELVIC PAIN, CHRONIC BACK PAIN, ABDOMINAL BLOATING, EXCESSIVE HAIR LOSS, AND CHRONIC FATIGUE. SHE NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. ON (B)(6) 2016, HYSTERECTOMY WAS DONE TO REMOVE ESSURE. SHE IS PREVENTED FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE SHE ENJOYED PRE-OPERATIVELY, AND SHE HAS OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES. FOLLOW-UP RECEIVED ON 16-AUG-2016 ESSURE WAS INSERTED ON (B)(6) 2014, WITH LOT NUMBER B60753, EXPIRATION DATE AUG-2016. ESSURE WAS NOT INSERTED AT POST-PARTUM STATE. THE PROCEDURE WAS DONE BY ANOTHER PROVIDER BUT IT WAS SAID THAT PROCEDURE WAS FINE. HSG WAS DONE AND BOTH FALLOPIAN TUBES WERE OCCLUDED. PELVIC X-RAY WAS PERFORMED 3 MONTHS AFTER PLACEMENT AND SHOWED LOCATION/ TEST RESULT SATISFACTORY. NO FURTHER INFORMATION WAS PROVIDED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO AN ADULT FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE HAD BEEN PREGNANT 4 TIMES AND MISCARRIED. THIS CASE REFERS TO THE FIRST PREGNANCY. SHE ALSO HAD BACTERIA IN HER STOMACH LINING. ACCORDING TO ADDITIONAL INFORMATION RECEIVED VIA LEGAL CLAIM, THE PLAINTIFF ALSO HAD CHRONIC PAIN AND HYSTERECTOMY WAS DONE TO REMOVE ESSURE TWO YEARS AFTER PLACEMENT. PREGNANCY WITH ESSURE AND PELVIC PAIN ARE LISTED IN THE ESSURE'S REFERENCE SAFETY INFORMATION WHILE THE OTHER EVENTS ARE UNLISTED. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE. IN THE PRESENT CASE, CONSUMER INSERTED ESSURE IN 2014 AND CONFIRMATION TEST WAS PERFORMED IN (B)(6) 2014 AND CONCLUDE THAT INSERTION WAS FINE. GIVEN EVENT'S NATURE DEVICE FAILURE AND THE CAUSALITY CANNOT BE EXCLUDED. MISCARRIAGE, IT IS THE MOST COMMON COMPLICATION OF EARLY PREGNANCY. IN THIS CASE, THE GESTATIONAL AGE WAS NOT PROVIDED. HOWEVER, CONSIDERING THAT A MECHANICAL INTERFERENCE OF ESSURE MICRO-INSERTS IN EARLY DEVELOPING PREGNANCY IS UNLIKELY, THIS EVENT WAS CONSIDERED UNRELATED TO THE INSERT. REGARDING THE EVENT BACTERIA IN HER STOMACH LINING, SEEN AS BACTERIAL GASTRITIS; GIVEN ITS' PATHOPHYSIOLOGY AND ESSURE'S LOCAL ACTION IN FALLOPIAN TUBES; CAUSALITY BETWEEN THIS EVENT AND ESSURE IS CONSIDERED AS VERY UNLIKELY. BESIDES, ABDOMINAL AND PELVIC PAIN MAY OCCUR DURING ESSURE USE. CONSIDERING ITS NATURE AND THE ABSENCE OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THIS EVENT AND ESSURE USE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE INTERVENTION WAS REQUIRED (SURGICAL REMOVAL OF ESSURE). ACCORDING TO FIRST PRODUCT TECHNICAL ANALYSIS THERE IS NO REASON TO SUSPECT ABOUT A QUALITY DEFECT OF THE PRODUCT. UPDATE IN THIS ANALYSIS IS EXPECTED AFTER RECEIVING LAST FOLLOW-UP INFORMATION WITH ESSURE LOT NUMBER. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 556855 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B60753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |