Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ('TWO POST-IMPLANT PREGNANCIES (SECOND PREGNANCY WITH ESSURE AND MIRENA IN PLACE)') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431/ 871978) INSERTED FOR FEMALE STERILISATION. CO-SUSPECT PRODUCTS INCLUDED MIRENA INTRAUTERINE DELIVERY SYSTEM. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY WITH CONTRACEPTIVE DEVICE IN 2013 AND PARITY 3. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT HAD MIRENA 52 MG INSERTED (INTRA-UTERINE), RELEASING PRODUCT AT 20 MCG/24HR CONTINUOUSLY. IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2016, THE PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6)2016. POTENTIAL FETAL EXPOSURE TO MIRENA OCCURRED DURING THE FIRST AND SECOND TRIMESTERS. EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE VAGINAL DELIVERY OCCURRED ON (B)(6)2016. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE AND MIRENA. THE REPORTER COMMENTED: SHE SUFFERED PHYSICAL PAIN AND EMOTIONAL ANGUISH BECAUSE OF THE ESSURE DEVICE. CASE (B)(4) CASE HAS BEEN CREATED FOR OTHER FIRST PREGNANCY IN 2013 WITH ESSURE IN PLACE AND CASE (B)(4) FOR PREGNANCY WITH MIRENA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN - ON (B)(6) 2015: SINGLE LIVE INTRAUTERINE PREGNANCY MEASURES APPROXIMATELY 16 WEEKS 5 DAYS. LOT NUMBER: 871978 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06. LOT NUMBER: 880431 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAY-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. THIS CASE REPORT REFERS TO A (B)(6) FEMALE PLAINTIFF WHO HAD MIRENA (LEVONORGESTREL) INSERTED AND ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND GOT PREGNANT TWICE. THIS CASE REFERS TO THE SECOND PREGNANCY. PREGNANCY IS SERIOUS AND LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR MIRENA. UNINTENDED PREGNANCIES MAY OCCUR DURING THE USE OF ANY CONTRACEPTIVE METHOD. RISK OF UNINTENDED PREGNANCIES DURING IUS USE MAY BE INCREASED IN CASE OF ABNORMAL UTERINE ANATOMY OR INCORRECT LOCALIZATION OF THE IUS. IN THIS PARTICULAR CASE, THE IUS WAS REPORTED TO BE IN SITU DURING DIAGNOSIS OF PREGNANCY. IN THIS CASE, A CONTRACEPTIVE FAILURE CANNOT BE EXCLUDED. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.