ESSURE
Report
- Report Number
- 2951250-2016-01082
- Event Type
- Injury
- Date Received
- July 14, 2016
- Date of Event
- January 1, 2016
- Report Date
- April 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: MW5062378) ON 15-JUN-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 23-MAR-2020. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN/SEVERE PAIN'), ABDOMINAL PAIN LOWER ('LOWER ABDOMEN HURT ALL THE TIME / I WAS HAVING SHOOTING PAINS IN MY ABDOMEN AND RUNNING DOWN MY LEGS'), BACK PAIN ('MY LOWER BACK HURT ALL THE TIME / SHOOTING PAINS IN MY BACK AND RUNNING DOWN MY LEGS'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('I KNEW I WAS PREGNANT') AND ABORTION SPONTANEOUS ('STARTED BLEEDING HEAVILY AND EVENTUALLY PASSED A BIGGER CLOT WHICH I KNEW WAS MY BABY') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MISCARRIAGE AND PREGNANCY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("CRAMPING AFTER THE PROCEDURE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH HAEMORRHAGE IN PREGNANCY AND ABDOMINAL PAIN LOWER. IN 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MENSTRUATION DELAYED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("PERIODS STARTED BEING EXTREMELY HEAVY WITH CLOTS/I WOULD BLEED SO HEAVY/HEAVY MENSTRUAL BLEEDING"), DIZZINESS ("I WOULD GET EXTREMELY DIZZY"), MIGRAINE ("STARTED HAVING HORRIBLE MIGRANES EVERY DAY/SEVERE MIGRAINES") AND PELVIC DISCOMFORT ("DISCOMFORT"), WAS FOUND TO HAVE WEIGHT INCREASED ("OVER THE YEARS I GAINED 60 PONDS") AND UNDERWENT LOOP ELECTROSURGICAL EXCISION PROCEDURE ("LEEP"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY AND REMOVAL OF ESSURE COILS ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, MENORRHAGIA, DIZZINESS, PELVIC DISCOMFORT AND LOOP ELECTROSURGICAL EXCISION PROCEDURE OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN LOWER, BACK PAIN, PROCEDURAL PAIN AND MIGRAINE HAD RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. 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 PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, BACK PAIN, DIZZINESS, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL PAIN AND WEIGHT INCREASED WITH ESSURE. THE REPORTER CONSIDERED LOOP ELECTROSURGICAL EXCISION PROCEDURE, MENORRHAGIA, MIGRAINE, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: ESSURE COILS WERE PROPERLY PLACED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. EVENT ADDED- LEEP. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FDA (REFERENCE NUMBER: MW5062378) ON 15-JUN-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 19-APR-2017. THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN/SEVERE PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN HURT ALL THE TIME / I WAS HAVING SHOOTING PAINS IN MY ABDOMEN AND RUNNING DOWN MY LEGS"), BACK PAIN ("MY LOWER BACK HURT ALL THE TIME / SHOOTING PAINS IN MY BACK AND RUNNING DOWN MY LEGS"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("I KNEW I WAS PREGNANT") AND ABORTION SPONTANEOUS ("STARTED BLEEDING HEAVILY AND EVENTUALLY PASSED A BIGGER CLOT WHICH I KNEW WAS MY BABY") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MISCARRIAGE AND PREGNANCY. CONCOMITANT PRODUCTS INCLUDED CITALOPRAM HYDROBROMIDE (CELEXA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("CRAMPING AFTER THE PROCEDURE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH HAEMORRHAGE IN PREGNANCY AND ABDOMINAL PAIN LOWER. IN 2016, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MENSTRUATION DELAYED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("PERIODS STARTED BEING EXTREMELY HEAVY WITH CLOTS/I WOULD BLEED SO HEAVY/HEAVY MENSTRUAL BLEEDING"), DIZZINESS ("I WOULD GET EXTREMELY DIZZY"), MIGRAINE ("STARTED HAVING HORRIBLE MIGRAINES EVERY DAY/SEVERE MIGRAINES"), WEIGHT INCREASED ("OVER THE YEARS I GAINED 60 PONDS") AND PELVIC DISCOMFORT ("DISCOMFORT"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY AND REMOVAL OF ESSURE COILS ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, ABORTION SPONTANEOUS, MENORRHAGIA, DIZZINESS AND PELVIC DISCOMFORT OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN LOWER, BACK PAIN, PROCEDURAL PAIN AND MIGRAINE HAD RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED MENORRHAGIA, MIGRAINE, PELVIC DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, ABORTION SPONTANEOUS, BACK PAIN, DIZZINESS, PREGNANCY WITH CONTRACEPTIVE DEVICE, PROCEDURAL PAIN AND WEIGHT INCREASED WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE COILS WERE PROPERLY PLACED QUALITY-SAFETY EVALUATION OF PTC: LOT NUMBER: 872990; MANUFACTURING DATE: JUN-2011; EXPIRATION DATE: JUN-2014. IN THIS CASE NO PRODUCT WAS RETURNED. 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, IT IS POSSIBLE THE ESSURE DEVICE COULD HAVE BEEN DEFECTIVE PRIOR TO REMOVAL FROM THE PACKAGE. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS OR 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. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MED DRA LLT: DEVICE INEFFECTIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-APR-2017: DATA TRANSFERRED FROM CASE (B)(4), SINCE IT WAS A DUPLICATE OF THIS CASE. ALL THE REPORTERS, EVENTS, LAB DATA, PATIENT'S DEMOGRAPHIC DETAILS, SOURCE DOCUMENTS WERE TRANSFERRED FROM THE DUPLICATE CASE. "ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE INITIAL' INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY" COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HER LOWER BACK AND LOWER ABDOMEN HURT ALL THE TIME. AFTER MORE THAN 4 YEARS, HER PERIODS WERE 2 WEEKS LATE AND ONE DAY SHE HAD BLEEDING HEAVILY AND EVENTUALLY PASSED A BIGGER CLOT, WHICH SHE KNEW WAS HER BABY. UPON RECEIPT OF FURTHER INFORMATION, SHE ALSO REPORTED CHRONIC PELVIC PAIN/SEVERE PAIN. SHE UNDERWENT A BILATERAL SALPINGECTOMY AND ESSURE WAS REMOVED 4.5 YEARS AFTER INSERTION. CONSIDERING THAT ESSURE USE MAY CAUSE PAIN (PELVIC, LOWER ABDOMINAL AND BACK PAIN) AND THAT THERE IS NO ALTERNATIVE EXPLANATION, THESE EVENTS ARE ASSESSED AS RELATED TO ESSURE. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SINCE THE PREGNANCY OCCURRED MORE THAN 4 YEARS AFTER INSERTION AND IT IS UNKNOWN IF ESSURE INSERTS WERE CORRECTLY PLACED, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. ALTHOUGH THE GESTATIONAL AGE WAS NOT PROVIDED, SINCE IN MOST OF THE CASES, THE MISCARRIAGE IS DUE TO CHROMOSOME ABNORMALITIES OR GROSS MORPHOLOGICAL MALFORMATIONS, THIS MISCARRIAGE IS ASSESSED AS NOT RELATED TO ESSURE INSERTS. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
FOLLOW-UP FROM 11-AUG-2016: DESPITE FOLLOW-UP ATTEMPTS, NO RESPONSE WAS RECEIVED TO DATE. NO FURTHER INFORMATION IS EXPECTED.
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY (CASE# MW5062378) IN UNITED STATES ON 15-JUN-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2012, LOT NUMBER 872990. THE CONSUMER HAD CRAMPING AFTER THE PROCEDURE LIKE HER DOCTOR HAD SAID SHE WOULD. THAT WENT AWAY SHORTLY, BUT THEN HER PERIODS STARTED BEING EXTREMELY HEAVY WITH CLOTS. SHE WOULD BLEED SO HEAVY SOMETIMES THAT SHE WOULD GET EXTREMELY DIZZY AND HAVE TO SIT DOWN. SHE STARTED HAVING HORRIBLE MIGRAINES EVERY DAY. HER LOWER BACK AND LOWER ABDOMEN HURT ALL THE TIME. SHE NEVER THOUGHT IT WAS THE ESSURE BECAUSE WHEN SHE ASKED ANY DOCTORS, THEY ALL SAID THAT IT WAS IMPOSSIBLE THAT IT WOULD BE THE ESSURE CAUSING THAT. SO SHE DECIDED TO JUST TRY AND LIVE WITH IT. OVER THE YEARS SHE GAINED 60 POUNDS (SHE HAD ALWAYS BEEN VERY TINY, EVEN WHEN SHE WAS PREGNANT). SHE MISSED A LOT OF WORK AND IT WAS HARD KEEPING JOBS AND STILL TAKING CARE OF HER FAMILY. SHE WENT TO THE ER (EMERGENCY ROOM) SEVERAL TIMES FOR MIGRAINES AND PAIN AND THEY JUST GAVE HER PAIN MEDICATIONS AND SENT HER HOME. ABOUT A MONTH AGO (IMPLYING (B)(6) 2016), SHE WAS 2 WEEKS LATE FOR HER PERIOD (SHE WAS NEVER LATE). SHE HAD ALL THE PREGNANCY SYMPTOMS AND SHE KNEW SHE WAS PREGNANT. ONE DAY SHE STARTED HAVING SEVERE CRAMPING JUST LIKE WHEN SHE HAD MISCARRIED BEFORE. SHE STARTED BLEEDING HEAVILY AND EVENTUALLY PASSED A BIGGER CLOT, WHICH SHE KNEW WAS HER BABY. SHE WAS STILL WAS IN SO MUCH PAIN - SHE COULD NOT WORK OR TAKE CARE OF HER FAMILY. SHE WAS HAVING SHOOTING PAINS IN HER ABDOMEN AND BACK AND RUNNING DOWN HER LEGS. HER DOCTOR WAS ABLE TO GET HER INTO SURGERY AND HAD HER TUBES REMOVED WITH THE COILS ON (B)(6) 2016. AT TIME OF REPORT, IT WAS A WEEK SINCE SURGERY AND SHE HAD NO MIGRAINES, WAS PAIN FREE, HAD MORE ENERGY AND WAS FEELING LIKE HERSELF AGAIN. SHE EVEN HAD LOST WEIGHT. LIFE THREATENING, DISABILITY/PERMANENT DAMAGE AND REQUIRED INTERVENTION WERE MENTIONED AS SERIOUSNESS CRITERIA. CONCOMITANT MEDICATION INCLUDED CELEXA (CITALOPRAM HYDROBROMIDE). FOLLOW-UP RECEIVED ON 05-JUL-2016: QUALITY-SAFETY EVALUATION: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT. (B)(4). LOT NUMBER: 872990; MANUFACTURING DATE: JUN-2011; EXPIRATION DATE: JUN-2014. IN THIS CASE NO PRODUCT WAS RETURNED. 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, IT IS POSSIBLE THE ESSURE DEVICE COULD HAVE BEEN DEFECTIVE PRIOR TO REMOVAL FROM THE PACKAGE. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS OR 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. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MED DRA LLT: DEVICE INEFFECTIVE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HER LOWER BACK AND LOWER ABDOMEN HURT ALL THE TIME. AFTER 6 YEARS, HER PERIODS WERE 2 WEEKS LATE AND ONE DAY SHE HAD BLEEDING HEAVILY AND EVENTUALLY PASSED A BIGGER CLOT, WHICH SHE KNEW WAS HER BABY. BACK PAIN, LOWER ABDOMEN PAIN, PREGNANCY WITH ESSURE ARE LISTED EVENTS WHILE SPONTANEOUS ABORTION IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE USE MAY CAUSE PAIN (LOWER AND BACK PAIN) AND THAT THERE IS NO ALTERNATIVE EXPLANATION, THESE EVENTS ARE ASSESSED AS RELATED TO ESSURE. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SINCE THE PREGNANCY OCCURRED 6 YEARS AFTER INSERTION AND IT IS UNKNOWN IF ESSURE INSERTS WERE CORRECTLY PLACED, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. ALTHOUGH THE GESTATIONAL AGE WAS NOT PROVIDED, SINCE IN MOST OF THE CASES, THE MISCARRIAGE IS DUE TO CHROMOSOME ABNORMALITIES OR GROSS MORPHOLOGICAL MALFORMATIONS, THIS MISCARRIAGE IS ASSESSED AS NOT RELATED TO ESSURE INSERTS. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS AND LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448645 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 872990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other| R | CELEXA (CITALOPRAM HYDROBROMIDE)| OTHER THERAPEUTIC PRODUCTS |