ESSURE
Report
- Report Number
- 2951250-2016-02437
- Event Type
- Injury
- Date Received
- November 1, 2016
- Date of Event
- December 18, 2009
- Report Date
- August 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE: LEFT AND RIGHT) / EFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE'), UTERINE PERFORATION ('LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA/PERFORATION: UTERUS'), DEVICE DISLOCATION ('COIL CONNECTING TO MY COLON'), DEVICE EXPULSION ('MIGRATION OF DEVICE: LOCATION: UTERUS') AND KIDNEY INFECTION ('INFECTION: KIDNEY / NEPHROPATHY / KIDNEY DISEASE') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 627753) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HIGH CHOLESTEROL FROM 2003 TO 2005, GRAVIDA II, PARITY 2 (BIRTH DATES: ON (B)(6) 2006, ON (B)(6) 2008. INDUCED WITH 2ND CHILD DUE TO SHORT CORD.), LEFT INGUINAL HERNIA, HERNIORRHAPHY, SUPRAVENTRICULAR TACHYCARDIA, GENITAL HERPES, HYPOAESTHESIA, PARESTHESIA, CARPAL TUNNEL SYNDROME, SPASTIC COLON, ENDOMETRIOSIS, ULCER NOS, HEMORRHOIDS, GROIN PAIN, SALPINGITIS, UTERINE INFLAMMATION, PELVIC INFLAMMATORY DISEASE, LIPOMA, LIGHTHEADEDNESS, DIZZINESS, URINARY TRACT INFECTION, ADNEXA UTERI CYST, CONDYLOMA ACUMINATUM AND GRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFLUCAN FROM 2006 TO 2007, ERRIN FROM ON (B)(6) 2007, CEFPROZIL FROM 2005 TO 2006, PRAVACHOL FROM 2003 TO 2005, DUET DHA, PREMISES, MIRENA AND ERRIN. CONCURRENT CONDITIONS INCLUDED NEPHROPATHY SINCE 2013, CARPAL TUNNEL SYNDROME SINCE 2007, BLOOD PRESSURE HIGH SINCE 2003, ENDOMETRIOSIS SINCE 2000, DYSPAREUNIA SINCE 2000, PELVIC PAIN SINCE 2000, CRAMP IN LOWER ABDOMEN SINCE 2000, CYST SINCE 2000, HEMORRHOIDS SINCE 2000, HERNIA SINCE 1999, OVERWEIGHT, MENSTRUAL CRAMP, ALCOHOL USE AND SMOKER. FAMILY HISTORY INCLUDED OVARIAN CANCER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, AMOXICILLIN FROM 2011 TO 2012, ATORVASTATIN, AZITHROMYCIN, BUTALBITAL SINCE 2011, CEFALEXIN (CEPHALEXIN) SINCE 2005, CEFUROXIME, CIPROFLOXACIN SINCE 2005, DICLOFENAC SINCE 2007, DOXYCYCLINE SINCE 2005, ERYTHROMYCIN SINCE 2006, FAMOTIDINE, HYDROCODONE SINCE 2005, IBUPROFEN SINCE 2010, INFLUENZA VACCINE INACT SAG 3V (FLUVIRIN), LEVOFLOXACIN, LISINOPRIL SINCE 2016, METOPROLOL, METRONIDAZOLE, MUPIROCIN SINCE 2011, NITROFURANTOIN SINCE 2005, OPIUM DERIVATIVES AND EXPECTORANTS, OXYCODONE, PHENAZOPYRIDINE SINCE 2005, PROCATEROL HYDROCHLORIDE (PRO-AIR) AND PROMETHAZINE SINCE 2005. IN 2009, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL CRAMPING"), 1 MONTH 3 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2009, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6)2010, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, PELVIC PAIN AND ABDOMINAL PAIN LOWER. ON (B)(6) 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSGEUSIA ("METAL TASTE IN MOUTH") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HAIR GROWTH ABNORMAL ("HAIR GROWTH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6)2017, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION/UTI AND MOVED TO MY UPPER KIDNEY"), FEELING ABNORMAL ("BRAIN FOG/ENERGY"), SKIN DISCOLOURATION ("SKIN COLOR") AND ASTHENIA ("BRAIN FOG / ENERGY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: (B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL ON (B)(6) 2010.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, DEVICE EXPULSION, KIDNEY INFECTION, ABDOMINAL DISTENSION, PROCEDURAL PAIN, HAIR GROWTH ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, NAUSEA, DYSGEUSIA, BLADDER DISORDER, URINARY TRACT DISORDER, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, ABDOMINAL PAIN LOWER, FEELING ABNORMAL AND ASTHENIA OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED AND SKIN DISCOLOURATION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, DEVICE EXPULSION, DYSGEUSIA, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, HAIR GROWTH ABNORMAL, KIDNEY INFECTION, MENORRHAGIA, NAUSEA, PROCEDURAL PAIN, SKIN DISCOLOURATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PER PFS: IT WAS REPORTED THAT SHE DID YOU UNDERGO AN ESSURE CONFIRMATION TEST BUT SHE UNDERWENT ESSURE CONFIRMATION TEST: ON (B)(6) 2009 (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. ON (B)(6) 2009, CT (COMPUTERISED TOMOGRAM) PELVIS REVEALED UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, LEFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE. CURRENT WEIGHT 190 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 163 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS CASE: (B)(4) WAS FOUND TO BE DUPLICATE TO CASE: (B)(4), ALL INFORMATION WAS TRANSFERRED FROM DELETION CASE TO RETENTION CASE INCLUDING EVENTS, REPORTER, SOURCE DOCUMENTS, REFERENCE NUMBERS. NEW EVENT: COIL CONNECTING TO MY COLON WAS ADDED FROM DELETION CASE TO THIS CASE. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. INCIDENT: 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE: LEFT AND RIGHT) / EFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE'), UTERINE PERFORATION ('LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA/PERFORATION: UTERUS'), DEVICE DISLOCATION ('COIL CONNECTING TO MY COLON'), DEVICE EXPULSION ('MIGRATION OF DEVICE: LOCATION: UTERUS') AND KIDNEY INFECTION ('INFECTION: KIDNEY/NEPHROPATHY/KIDNEY DISEASE') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627753) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HIGH CHOLESTEROL FROM 2003 TO 2005, GRAVIDA II, PARITY 2 (BIRTH DATES: (B)(6) 2006, (B)(6) 2008. INDUCED WITH 2ND CHILD DUE TO SHORT CORD), LEFT INGUINAL HERNIA, HERNIORRHAPHY, SUPRAVENTRICULAR TACHYCARDIA, GENITAL HERPES, HYPOAESTHESIA, PARESTHESIA, CARPAL TUNNEL SYNDROME, SPASTIC COLON, ENDOMETRIOSIS, ULCER NOS, HEMORRHOIDS, GROIN PAIN, SALPINGITIS, UTERINE INFLAMMATION, PELVIC INFLAMMATORY DISEASE, LIPOMA, LIGHTHEADEDNESS, DIZZINESS, URINARY TRACT INFECTION, ADNEXA UTERI CYST, CONDYLOMA ACUMINATUM AND GRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFLUCAN FROM 2006 TO 2007, ERRIN FROM (B)(6) 2007, CEFPROZIL FROM 2005 TO 2006, PRAVACHOL FROM 2003 TO 2005, DUET DHA, PREMISES, MIRENA AND ERRIN. CONCURRENT CONDITIONS INCLUDED NEPHROPATHY SINCE 2013, CARPAL TUNNEL SYNDROME SINCE 2007, BLOOD PRESSURE HIGH SINCE 2003, ENDOMETRIOSIS SINCE 2000, DYSPAREUNIA SINCE 2000, PELVIC PAIN SINCE 2000, CRAMP IN LOWER ABDOMEN SINCE 2000, CYST SINCE 2000, HEMORRHOIDS SINCE 2000, HERNIA SINCE 1999, OVERWEIGHT, MENSTRUAL CRAMP, ALCOHOL USE AND SMOKER. FAMILY HISTORY INCLUDED OVARIAN CANCER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, AMOXICILLIN FROM 2011 TO 2012, ATORVASTATIN, AZITHROMYCIN, BUTALBITAL SINCE 2011, CEFALEXIN (CEPHALEXIN) SINCE 2005, CEFUROXIME, CIPROFLOXACIN SINCE 2005, DICLOFENAC SINCE 2007, DOXYCYCLINE SINCE 2005, ERYTHROMYCIN SINCE 2006, FAMOTIDINE, HYDROCODONE SINCE 2005, IBUPROFEN SINCE 2010, INFLUENZA VACCINE INACT SAG 3V (FLUVIRIN), LEVOFLOXACIN, LISINOPRIL SINCE 2016, METOPROLOL, METRONIDAZOLE, MUPIROCIN SINCE 2011, NITROFURANTOIN SINCE 2005, OPIUM DERIVATIVES AND EXPECTORANTS, OXYCODONE, PHENAZOPYRIDINE SINCE 2005, PROCATEROL HYDROCHLORIDE (PRO-AIR) AND PROMETHAZINE SINCE 2005. IN 2009, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA CRAMPING") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL CRAMPING"), 1 MONTH 3 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2009, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2010, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, PELVIC PAIN AND ABDOMINAL PAIN LOWER. IN (B)(6) 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSGEUSIA ("METAL TASTE IN MOUTH") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HAIR GROWTH ABNORMAL ("HAIR GROWTH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING VAGINAL, MENORRHAGIA"). ON (B)(6) 2017, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION/UTI AND MOVED TO MY UPPER KIDNEY"), FEELING ABNORMAL ("BRAIN FOG/ENERGY"), SKIN DISCOLOURATION ("SKIN COLOR") AND ASTHENIA ("BRAIN FOG/ENERGY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL 02-FEB-2010. ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, DEVICE EXPULSION, KIDNEY INFECTION, ABDOMINAL DISTENSION, PROCEDURAL PAIN, HAIR GROWTH ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, NAUSEA, DYSGEUSIA, BLADDER DISORDER, URINARY TRACT DISORDER, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, ABDOMINAL PAIN LOWER, FEELING ABNORMAL AND ASTHENIA OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED AND SKIN DISCOLOURATION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, DEVICE EXPULSION, DYSGEUSIA, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, HAIR GROWTH ABNORMAL, KIDNEY INFECTION, MENORRHAGIA, NAUSEA, PROCEDURAL PAIN, SKIN DISCOLOURATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: PER PFS: IT WAS REPORTED THAT SHE DID YOU UNDERGO AN ESSURE CONFIRMATION TEST BUT SHE UNDERWENT ESSURE CONFIRMATION TEST: (B)(6) 2009 (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. ON (B)(6) 2009, CT (COMPUTERISED TOMOGRAM) PELVIS REVEALED UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, LEFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE. CURRENT WEIGHT 190 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 163 LBS . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS CASE (B)(4) WAS FOUND TO BE DUPLICATE TO CASE (B)(4), ALL INFORMATION WAS TRANSFERRED FROM DELETION CASE TO RETENTION CASE INCLUDING EVENTS, REPORTER, SOURCE DOCUMENTS, REFERENCE NUMBERS. NEW EVENT: COIL CONNECTING TO MY COLON WAS ADDED FROM DELETION CASE TO THIS CASE. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. INCIDENT 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PEFORATION (FALLOPIAN TUBE: LEFT AND RIGHT) / EFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE'), UTERINE PERFORATION ('LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA/PERFORATION: UTERUS'), DEVICE DISLOCATION ('COIL CONNECTING TO MY COLON'), DEVICE EXPULSION ('MIGRATION OF DEVICE: LOCATION: UTERUS') AND KIDNEY INFECTION ('INFECTION: KIDNEY/NEPHROPATHY/KIDNEY DISEASE') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627753) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HIGH CHOLESTEROL FROM 2003 TO 2005, GRAVIDA II, PARITY 2 (BIRTH DATES: (B)(6) 2006, (B)(6) 2008. INDUCED WITH 2ND CHILD DUE TO SHORT CORD.), LEFT INGUINAL HERNIA, HERNIORRHAPHY, SUPRAVENTRICULAR TACHYCARDIA, GENITAL HERPES, HYPOAESTHESIA, PARESTHESIA, CARPAL TUNNEL SYNDROME, SPASTIC COLON, ENDOMETRIOSIS, ULCER NOS, HEMORRHOIDS, GROIN PAIN, SALPINGITIS, UTERINE INFLAMMATION, PELVIC INFLAMMATORY DISEASE, LIPOMA, LIGHTHEADEDNESS, DIZZINESS, URINARY TRACT INFECTION, ADNEXA UTERI CYST, CONDYLOMA ACUMINATUM AND GRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFLUCAN FROM 2006 TO 2007, ERRIN FROM FEBRUARY 2007 TO JUNE 2007, CEFPROZIL FROM 2005 TO 2006, PRAVACHOL FROM 2003 TO 2005, DUET DHA, PREMISES, MIRENA AND ERRIN. CONCURRENT CONDITIONS INCLUDED NEPHROPATHY SINCE 2013, CARPAL TUNNEL SYNDROME SINCE 2007, BLOOD PRESSURE HIGH SINCE 2003, ENDOMETRIOSIS SINCE 2000, DYSPAREUNIA SINCE 2000, PELVIC PAIN SINCE 2000, CRAMP IN LOWER ABDOMEN SINCE 2000, CYST SINCE 2000, HEMORRHOIDS SINCE 2000, HERNIA SINCE 1999, OVERWEIGHT, MENSTRUAL CRAMP, ALCOHOL USE AND SMOKER. FAMILY HISTORY INCLUDED OVARIAN CANCER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, AMOXICILLIN FROM 2011 TO 2012, ATORVASTATIN, AZITHROMYCIN, BUTALBITAL SINCE 2011, CEFALEXIN (CEPHALEXIN) SINCE 2005, CEFUROXIME, CIPROFLOXACIN SINCE 2005, DICLOFENAC SINCE 2007, DOXYCYCLINE SINCE 2005, ERYTHROMYCIN SINCE 2006, FAMOTIDINE, HYDROCODONE SINCE 2005, IBUPROFEN SINCE 2010, INFLUENZA VACCINE INACT SAG 3V (FLUVIRIN), LEVOFLOXACIN, LISINOPRIL SINCE 2016, METOPROLOL, METRONIDAZOLE, MUPIROCIN SINCE 2011, NITROFURANTOIN SINCE 2005, OPIUM DERIVATIVES AND EXPECTORANTS, OXYCODONE, PHENAZOPYRIDINE SINCE 2005, PROCATEROL HYDROCHLORIDE (PRO-AIR) AND PROMETHAZINE SINCE 2005. IN 2009, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL CRAMPING"), 1 MONTH 3 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2009, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON 2-FEB-2010, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, PELVIC PAIN AND ABDOMINAL PAIN LOWER. IN (B)(6) 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSGEUSIA ("METAL TASTE IN MOUTH") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HAIR GROWTH ABNORMAL ("HAIR GROWTH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2017, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION/UTI AND MOVED TO MY UPPER KIDNEY"), FEELING ABNORMAL ("BRAIN FOG/ENERGY"), SKIN DISCOLOURATION ("SKIN COLOR") AND ASTHENIA ("BRAIN FOG/ENERGY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY-(B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL (B)(6) 2010.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, DEVICE EXPULSION, KIDNEY INFECTION, ABDOMINAL DISTENSION, PROCEDURAL PAIN, HAIR GROWTH ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, NAUSEA, DYSGEUSIA, BLADDER DISORDER, URINARY TRACT DISORDER, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, ABDOMINAL PAIN LOWER, FEELING ABNORMAL AND ASTHENIA OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED AND SKIN DISCOLOURATION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, DEVICE EXPULSION, DYSGEUSIA, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, HAIR GROWTH ABNORMAL, KIDNEY INFECTION, MENORRHAGIA, NAUSEA, PROCEDURAL PAIN, SKIN DISCOLOURATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: IT WAS REPORTED THAT SHE DID YOU UNDERGO AN ESSURE CONFIRMATION TEST BUT SHE UNDERWENT ESSURE CONFIRMATION TEST: (B)(6) 2009 (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. ON (B)(6) 2009, CT (COMPUTERISED TOMOGRAM) PELVIS REVEALED UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, LEFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE. CURRENT WEIGHT 190 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 163 LBS. LOT NUMBER: 627753 MANUFACTURING DATE: 2008/08 EXPIRATION DATE: 2010/08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PEFORATION (FALLOPIAN TUBE: LEFT AND RIGHT) / EFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE"), THE FIRST EPISODE OF UTERINE PERFORATION ("LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA/PERFORATION: UTERUS"), THE SECOND EPISODE OF UTERINE PERFORATION ("PERFORATION: UTERUS"), DEVICE EXPULSION ("MIGRATION OF DEVICE: LOCATION: UTERUS") AND KIDNEY INFECTION ("INFECTION: KIDNEY/NEPHROPATHY") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627753) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 (BIRTH DATES: (B)(6) 2006, (B)(6)2008. INDUCED WITH 2ND CHILD DUE TO SHORT CORD.) AND HIGH CHOLESTEROL FROM 2003 TO 2005. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFLUCAN FROM 2006 TO 2007, ERRIN FROM FEBRUARY 2007 TO JUNE 2007, CEFPROZIL FROM 2005 TO 2006, PRAVACHOL FROM 2003 TO 2005, DUET DHA AND PREMISES. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, NEPHROPATHY SINCE 2013, ENDOMETRIOSIS SINCE 2000, DYSPAREUNIA SINCE 2000, PELVIC PAIN SINCE 2000, CRAMP IN LOWER ABDOMEN SINCE 2000, CYST SINCE 2000, HEMORRHOIDS SINCE 2000, HERNIA SINCE 1999, CARPAL TUNNEL SYNDROME SINCE 2007, BLOOD PRESSURE HIGH SINCE 2003 AND MENSTRUAL CRAMP. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN FROM 2011 TO 2012, BUTALBITAL SINCE 2011, CEFALEXIN (CEPHALEXIN) SINCE 2005, CIPROFLOXACIN SINCE 2005, DICLOFENAC SINCE 2007, DOXYCYCLINE SINCE 2005, ERYTHROMYCIN SINCE 2006, HYDROCODONE SINCE 2005, IBUPROFEN SINCE 2010, LISINOPRIL SINCE 2016, METOPROLOL, MUPIROCIN SINCE 2011, NITROFURANTOIN SINCE 2005, PHENAZOPYRIDINE SINCE 2005 AND PROMETHAZINE SINCE 2005. IN 2009, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 1 MONTH 3 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL CRAMPING"). ON 18-DEC-2009, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON 2-FEB-2010, THE PATIENT EXPERIENCED THE FIRST EPISODE OF UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, PELVIC PAIN AND ABDOMINAL PAIN LOWER. IN NOVEMBER 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSGEUSIA ("METAL TASTE IN MOUTH") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON 14-SEP-2012, THE PATIENT EXPERIENCED HAIR GROWTH ABNORMAL ("HAIR GROWTH"). ON 6-FEB-2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON 2-OCT-2013, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEPHROPATHY ("INFECTION: KIDNEY/NEPHROPATHY"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON 24-FEB-2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON 11-APR-2017, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND THE SECOND EPISODE OF UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), THE FIRST EPISODE OF FEELING ABNORMAL ("BRAIN FOG/ENERGY"), SKIN DISCOLOURATION ("SKIN COLOR"), ASTHENIA ("BRAIN FOG/ENERGY") AND THE SECOND EPISODE OF FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY(B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL (B)(6) 2010.), SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL (B)(6) 2010.), SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL (B)(6) 2010.) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY(B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL (B)(6)2010.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, THE LAST EPISODE OF UTERINE PERFORATION, DEVICE EXPULSION, KIDNEY INFECTION, ABDOMINAL DISTENSION, PROCEDURAL PAIN, HAIR GROWTH ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, NEPHROPATHY, NAUSEA, DYSGEUSIA, BLADDER DISORDER, URINARY TRACT DISORDER, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, ABDOMINAL PAIN LOWER AND ASTHENIA OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED, SKIN DISCOLOURATION AND THE LAST EPISODE OF FEELING ABNORMAL HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, BLADDER DISORDER, CYSTITIS, DEVICE EXPULSION, DYSGEUSIA, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, HAIR GROWTH ABNORMAL, KIDNEY INFECTION, MENORRHAGIA, NAUSEA, NEPHROPATHY, PROCEDURAL PAIN, SKIN DISCOLOURATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF FEELING ABNORMAL, THE FIRST EPISODE OF UTERINE PERFORATION, THE SECOND EPISODE OF FEELING ABNORMAL AND THE SECOND EPISODE OF UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: IT WAS REPORTED THAT SHE DID YOU UNDERGO AN ESSURE CONFIRMATION TEST BUT SHE UNDERWENT ESSURE CONFIRMATION TEST: (B)(6) 2009 (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. ON (B)(6) 2009, CT (COMPUTERISED TOMOGRAM) PELVIS REVEALED UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, LEFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE. CURRENT WEIGHT 190 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 163 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PFS RECEIVED. REPORTER AND PATIENTS DEMOGRAPHICS WERE UPDATED. HER HISTORICAL CONDITION, CONCURRENT CONDITION WAS ADDED. LAB DATA WAS ADDED. ESSURE LOT NUMBER WAS ADDED. ESSURE REMOVAL DATE WAS UPDATED. CONCOMITANT MEDICATIONS WERE ADDED. EVENTS: MIGRATION OF DEVICE: LOCATION: UTERUS; PERFORATION: UTERUS, PERFORATION (FALLOPIAN TUBE: LEFT), PERFORATION (FALLOPIAN TUBE: RIGHT), PAIN: BELLY BUTTON (LEFT AND RIGHT) (CLUBBED PREVIOUSLY REPORTED EVENT), HAIR GROWTH, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), BLADDER INFECTION, URINARY TRACT INFECTION, INFECTION: KIDNEY/NEPHROPATHY, NAUSEA, BLADDER PROBLEMS, URINARY PROBLEMS, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), FATIGUE, WEIGHT GAIN, LOWER ABDOMINAL CRAMPING, BRAIN FOG/ENERGY AND SKIN COLOR. SHE HAD RECOVERED FOR THE EVENTS: ABDOMINAL PAIN, WEIGHT GAIN, BRAIN FOG/ENERGY AND SKIN COLOR. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE: LEFT AND RIGHT) / EFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE"), THE FIRST EPISODE OF UTERINE PERFORATION ("LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA/PERFORATION: UTERUS"), THE SECOND EPISODE OF UTERINE PERFORATION ("PERFORATION: UTERUS"), DEVICE EXPULSION ("MIGRATION OF DEVICE: LOCATION: UTERUS") AND KIDNEY INFECTION ("INFECTION: KIDNEY/NEPHROPATHY") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627753) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 (BIRTH DATES: (B)(6) 2006, (B)(6)2008. INDUCED WITH 2ND CHILD DUE TO SHORT CORD.), HIGH CHOLESTEROL FROM 2003 TO 2005, LEFT INGUINAL HERNIA, HERNIORRHAPHY, SUPRAVENTRICULAR TACHYCARDIA, GENITAL HERPES, HYPOAESTHESIA, PARESTHESIA, CARPAL TUNNEL SYNDROME, SPASTIC COLON, ENDOMETRIOSIS, ULCER, HEMORRHOIDS, GROIN PAIN, SALPINGITIS, UTERINE INFLAMMATION, PELVIC INFLAMMATORY DISEASE, LIPOMA, LIGHTHEADEDNESS, DIZZINESS, URINARY TRACT INFECTION, ADNEXA UTERI CYST, CONDYLOMA ACUMINATUM AND VAGINAL DELIVERY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFLUCAN FROM 2006 TO 2007, ERRIN FROM (B)(6) 2007, CEFPROZIL FROM 2005 TO 2006, PRAVACHOL FROM 2003 TO 2005, DUET DHA AND PREMISES. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, NEPHROPATHY SINCE 2013, ENDOMETRIOSIS SINCE 2000, DYSPAREUNIA SINCE 2000, PELVIC PAIN SINCE 2000, CRAMP IN LOWER ABDOMEN SINCE 2000, CYST SINCE 2000, HEMORRHOIDS SINCE 2000, HERNIA SINCE 1999, CARPAL TUNNEL SYNDROME SINCE 2007, BLOOD PRESSURE HIGH SINCE 2003, MENSTRUAL CRAMP, ALCOHOL USE AND SMOKER. FAMILY HISTORY INCLUDED OVARIAN CANCER. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN FROM 2011 TO 2012, BUTALBITAL SINCE 2011, CEFALEXIN (CEPHALEXIN) SINCE 2005, CIPROFLOXACIN SINCE 2005, DICLOFENAC SINCE 2007, DOXYCYCLINE SINCE 2005, ERYTHROMYCIN SINCE 2006, HYDROCODONE SINCE 2005, IBUPROFEN SINCE 2010, LISINOPRIL SINCE 2016, METOPROLOL, MUPIROCIN SINCE 2011, NITROFURANTOIN SINCE 2005, PHENAZOPYRIDINE SINCE 2005 AND PROMETHAZINE SINCE 2005. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2009, 1 MONTH 3 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL CRAMPING"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2010, THE PATIENT EXPERIENCED THE FIRST EPISODE OF UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, PELVIC PAIN AND ABDOMINAL PAIN LOWER. IN (B)(6) 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSGEUSIA ("METAL TASTE IN MOUTH") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HAIR GROWTH ABNORMAL ("HAIR GROWTH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEPHROPATHY ("INFECTION: KIDNEY/NEPHROPATHY"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2017, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND THE SECOND EPISODE OF UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), THE FIRST EPISODE OF FEELING ABNORMAL ("BRAIN FOG/ENERGY"), SKIN DISCOLOURATION ("SKIN COLOR"), ASTHENIA ("BRAIN FOG/ENERGY"), THE SECOND EPISODE OF FEELING ABNORMAL ("BRAIN FOG") AND LETHARGY ("ENERGY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY-(B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL (B)(6) 2010.). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, THE LAST EPISODE OF UTERINE PERFORATION, DEVICE EXPULSION, KIDNEY INFECTION, ABDOMINAL DISTENSION, PROCEDURAL PAIN, HAIR GROWTH ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, NEPHROPATHY, NAUSEA, DYSGEUSIA, BLADDER DISORDER, URINARY TRACT DISORDER, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, ABDOMINAL PAIN LOWER, ASTHENIA AND LETHARGY OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED, SKIN DISCOLOURATION AND THE LAST EPISODE OF FEELING ABNORMAL HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, BLADDER DISORDER, CYSTITIS, DEVICE EXPULSION, DYSGEUSIA, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, HAIR GROWTH ABNORMAL, KIDNEY INFECTION, LETHARGY, MENORRHAGIA, NAUSEA, NEPHROPATHY, PROCEDURAL PAIN, SKIN DISCOLOURATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF FEELING ABNORMAL, THE FIRST EPISODE OF UTERINE PERFORATION, THE SECOND EPISODE OF FEELING ABNORMAL AND THE SECOND EPISODE OF UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: IT WAS REPORTED THAT SHE DID YOU UNDERGO AN ESSURE CONFIRMATION TEST BUT SHE UNDERWENT ESSURE CONFIRMATION TEST: (B)(6) 2009 (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. ON (B)(6) 2009, CT (COMPUTERISED TOMOGRAM) PELVIS REVEALED UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, LEFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE. CURRENT WEIGHT 190 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 163 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: NEW REPORTER WERE ADDED. CASE WAS MEDICALLY CONFIRMED. HISTORICAL AND CONCOMITANT CONDITIONS WERE ADDED. ON (B)(6) 2018: EVENT "ENERGY" SPLIT AND RE CODED AS LETHARGY. INCIDENT. AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PEFORATION (FALLOPIAN TUBE: LEFT AND RIGHT) / EFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE"), THE FIRST EPISODE OF UTERINE PERFORATION ("LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA/PERFORATION: UTERUS"), THE SECOND EPISODE OF UTERINE PERFORATION ("PERFORATION: UTERUS"), DEVICE EXPULSION ("MIGRATION OF DEVICE: LOCATION: UTERUS") AND KIDNEY INFECTION ("INFECTION: KIDNEY/NEPHROPATHY") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627753) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 2 (BIRTH DATES: (B)(6) 2006, (B)(6) 2008. INDUCED WITH 2ND CHILD DUE TO SHORT CORD.), HIGH CHOLESTEROL FROM 2003 TO 2005, LEFT INGUINAL HERNIA, HERNIORRHAPHY, SUPRAVENTRICULAR TACHYCARDIA, GENITAL HERPES, HYPOAESTHESIA, PARESTHESIA, CARPAL TUNNEL SYNDROME, SPASTIC COLON, ENDOMETRIOSIS, ULCER NOS, HEMORRHOIDS, GROIN PAIN, SALPINGITIS, UTERINE INFLAMMATION, PELVIC INFLAMMATORY DISEASE, LIPOMA, LIGHTHEADEDNESS, DIZZINESS, URINARY TRACT INFECTION, ADNEXA UTERI CYST, CONDYLOMA ACUMINATUM AND GRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFLUCAN FROM 2006 TO 2007, ERRIN FROM FEBRUARY 2007 TO JUNE 2007, CEFPROZIL FROM 2005 TO 2006, PRAVACHOL FROM 2003 TO 2005, DUET DHA AND PREMISES. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, NEPHROPATHY SINCE 2013, ENDOMETRIOSIS SINCE 2000, DYSPAREUNIA SINCE 2000, PELVIC PAIN SINCE 2000, CRAMP IN LOWER ABDOMEN SINCE 2000, CYST SINCE 2000, HEMORRHOIDS SINCE 2000, HERNIA SINCE 1999, CARPAL TUNNEL SYNDROME SINCE 2007, BLOOD PRESSURE HIGH SINCE 2003, MENSTRUAL CRAMP, ALCOHOL USE AND SMOKER. FAMILY HISTORY INCLUDED OVARIAN CANCER. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, AMOXICILLIN FROM 2011 TO 2012, ATORVASTATIN, AZITHROMYCIN, BUTALBITAL SINCE 2011, CEFALEXIN (CEPHALEXIN) SINCE 2005, CEFUROXIME, CIPROFLOXACIN SINCE 2005, DICLOFENAC SINCE 2007, DOXYCYCLINE SINCE 2005, ERYTHROMYCIN SINCE 2006, FAMOTIDINE, HYDROCODONE SINCE 2005, IBUPROFEN SINCE 2010, INFLUENZA VACCINE INACTIVATED (FLUVIRIN), LEVOFLOXACIN, LISINOPRIL SINCE 2016, METOPROLOL, METRONIDAZOLE, MUPIROCIN SINCE 2011, NITROFURANTOIN SINCE 2005, OPIUM DERIVATIVES AND EXPECTORANTS, OXYCODONE, PHENAZOPYRIDINE SINCE 2005, PROCATEROL HYDROCHLORIDE (PRO-AIR), PROMETHAZINE SINCE 2005 AND SACCHAROMYCES BOULARDII (FLORASTOR). IN 2009, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 1 MONTH 3 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL CRAMPING"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2010, THE PATIENT EXPERIENCED THE FIRST EPISODE OF UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN, PELVIC PAIN AND ABDOMINAL PAIN LOWER. IN NOVEMBER 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSGEUSIA ("METAL TASTE IN MOUTH") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2012, THE PATIENT EXPERIENCED HAIR GROWTH ABNORMAL ("HAIR GROWTH"). ON (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEPHROPATHY ("INFECTION: KIDNEY/NEPHROPATHY"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2017, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND THE SECOND EPISODE OF UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), FEELING ABNORMAL ("BRAIN FOG/ENERGY"), SKIN DISCOLOURATION ("SKIN COLOR") AND ASTHENIA ("BRAIN FOG/ENERGY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY-(B)(6) 2017, LAPAROSCOPIC REMOVAL OF COIL (B)(6) 2010. ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, THE LAST EPISODE OF UTERINE PERFORATION, DEVICE EXPULSION, KIDNEY INFECTION, ABDOMINAL DISTENSION, PROCEDURAL PAIN, HAIR GROWTH ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, NEPHROPATHY, NAUSEA, DYSGEUSIA, BLADDER DISORDER, URINARY TRACT DISORDER, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, ABDOMINAL PAIN LOWER, FEELING ABNORMAL AND ASTHENIA OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED AND SKIN DISCOLOURATION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ASTHENIA, BLADDER DISORDER, CYSTITIS, DEVICE EXPULSION, DYSGEUSIA, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, HAIR GROWTH ABNORMAL, KIDNEY INFECTION, MENORRHAGIA, NAUSEA, NEPHROPATHY, PROCEDURAL PAIN, SKIN DISCOLOURATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF UTERINE PERFORATION AND THE SECOND EPISODE OF UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: IT WAS REPORTED THAT SHE DID YOU UNDERGO AN ESSURE CONFIRMATION TEST BUT SHE UNDERWENT ESSURE CONFIRMATION TEST: (B)(6) 2009 (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.8 KG/SQM. ON 18-DEC-2009, CT (COMPUTERISED TOMOGRAM) PELVIS REVEALED UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED), MIGRATION OF ESSURE DEVICE, LEFT SIDED DEVICE APPEARS TO LIE WITHIN THE PERITONEAL CAVITY OUTSIDE OF THE FALLOPIAN TUBE. CURRENT WEIGHT 190 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 163 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT. AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
QUALITY-SAFETY EVALUATION OF PTC RECEIVED ON 17-NOV-2016: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT. THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). SAMPLE IS NOT AVAILABLE. 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, 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. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, 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. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT IS UNDER LITIGATION. IT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THREE MONTHS LATER, SHE UNDERWENT A SURGERY TO REMOVE THE LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA. UTERINE PERFORATION IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH, THE EXACT DATE OF PERFORATION IS UNKNOWN, GIVEN THE NATURE OF THIS EVENT AND SUGGESTIVE TEMPORAL RELATIONSHIP, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS INCIDENT DUE TO SURGICAL DEVICE REMOVAL. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER / ATTORNEY IN THE UNITED STATES, ON BEHALF OF A PLAINTIFF/PLAINTIFF'S FAMILY IN UNITED STATES ON 13-OCT-2016 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2009. IN THE DAYS FOLLOWING IMPLANT, THE CONSUMER BEGAN SUFFERING FROM SEVERE ABDOMINAL PAIN AND BLOATING. IN (B)(6) 2009, SHE UNDERWENT A CT (COMPUTERIZED TOMOGRAPHY) SCAN OF HER PELVIS TO DETERMINE THE CAUSE OF HER PELVIC PAIN. AT THAT TIME, IT WAS DISCOVERED THAT THE ESSURE DEVICE ON THE LEFT HAD MIGRATED. ON (B)(6) 2010, SHE UNDERWENT SURGERY TO REMOVE THE LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA. FOLLOWING THE SURGERY, SHE SUFFERED A LONG AND PAINFUL POST-OPERATIVE RECOVERY. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT IS UNDER LITIGATION. IT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THREE MONTHS LATER, SHE UNDERWENT A SURGERY TO REMOVE THE LEFT COIL THAT HAD MIGRATED OUT OF HER FALLOPIAN TUBE AND PUNCTURED HER LEFT UTERINE CORNUA. UTERINE PERFORATION IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH, THE EXACT DATE OF PERFORATION IS UNKNOWN, GIVEN THE NATURE OF THIS EVENT AND SUGGESTIVE TEMPORAL RELATIONSHIP, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS INCIDENT DUE TO SURGICAL DEVICE REMOVAL. A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 721837 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 627753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R |