ESSURE
Report
- Report Number
- 2951250-2017-00145
- Event Type
- Injury
- Date Received
- January 16, 2017
- Date of Event
- November 1, 2011
- Report Date
- August 20, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), THE SECOND EPISODE OF CARDIAC DISORDER ("BLOOD OR HEART DISORDER/CONDITION TYPE: ABLATION HEART") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508291) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PAIN PELVIC. ON (B)(6) 2002, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), THE FIRST EPISODE OF CARDIAC DISORDER ("HEART DISORDER"), BLOOD DISORDER ("BLOOD DISORDER"), CARDIAC ABLATION ("ABLATION HEART"), TOOTH DISORDER ("DENTAL PROBLEM"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). IN 2005, THE PATIENT UNDERWENT PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), THE FIRST EPISODE OF CARDIAC DISORDER ("HEART DISORDER"), BLOOD DISORDER ("BLOOD DISORDER"), CARDIAC ABLATION ("ABLATION HEART"), TOOTH DISORDER ("DENTAL PROBLEM"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE SECOND EPISODE OF CARDIAC DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFLAMMATION ("INFLAMMATION") AND CYST ("CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)), SURGERY (HYSTERECTOMY TO HAVE ESSURE REMOVED) AND SURGERY (ABLATION HEART). ESSURE (ESS205) WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, INFLAMMATION, CYST, MENORRHAGIA, VAGINAL HAEMORRHAGE, BLOOD DISORDER, CARDIAC ABLATION, TOOTH DISORDER, DYSMENORRHOEA, FATIGUE, ALOPECIA, NAUSEA, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLOOD DISORDER, CARDIAC ABLATION, CYST, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, INFLAMMATION, MENORRHAGIA, NAUSEA, PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF CARDIAC DISORDER AND THE SECOND EPISODE OF CARDIAC DISORDER TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 113.3 KGS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET WAS RECEIVED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), HYSTERECTOMY PARTIAL), BLOOD OR HEART DISORDER/CONDITION TYPE: ABLATION HEART, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), FATIGUE, HAIR LOSS, PAIN, NAUSEA, WEIGHT GAIN / LOSS. LOT NUMBER ADDED. 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 PELVIC PAIN ("PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), THE SECOND EPISODE OF CARDIAC ABLATION ("BLOOD OR HEART DISORDER/CONDITION TYPE: ABLATION HEART") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508291) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PAIN PELVIC. ON (B)(6) 2002, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), CARDIAC DISORDER ("HEART DISORDER"), BLOOD DISORDER ("BLOOD DISORDER"), THE FIRST EPISODE OF CARDIAC ABLATION ("ABLATION HEART"), TOOTH LOSS ("DENTAL PROBLEM-TEETH LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND BACK PAIN ("BACK PAIN"). IN 2005, THE PATIENT UNDERWENT PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), CARDIAC DISORDER ("HEART DISORDER"), BLOOD DISORDER ("BLOOD DISORDER"), THE FIRST EPISODE OF CARDIAC ABLATION ("ABLATION HEART"), TOOTH LOSS ("DENTAL PROBLEM-TEETH LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE SECOND EPISODE OF CARDIAC ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFLAMMATION ("INFLAMMATION"), CYST ("CYSTS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH IBUPROFEN, SURGERY (HYSTERECTOMY (PARTIAL)), SURGERY (HYSTERECTOMY TO HAVE ESSURE REMOVED) AND SURGERY (ABLATION HEART). ESSURE (ESS205) WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, THE LAST EPISODE OF CARDIAC ABLATION, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, CARDIAC DISORDER, BLOOD DISORDER, TOOTH LOSS, DYSMENORRHOEA, FATIGUE, ALOPECIA, NAUSEA, WEIGHT INCREASED, WEIGHT DECREASED, BACK PAIN AND VAGINAL DISCHARGE HAD NOT RESOLVED AND THE INFLAMMATION AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, BLOOD DISORDER, CARDIAC DISORDER, CYST, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, INFLAMMATION, MENORRHAGIA, NAUSEA, PELVIC PAIN, TOOTH LOSS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT INCREASED, THE FIRST EPISODE OF CARDIAC ABLATION AND THE SECOND EPISODE OF CARDIAC ABLATION TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 113.3 KGS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED: REPORTERS DETAILS ADDED. EVENT ADDED AS VAGINAL DISCHARGE, BACK PAIN, DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO. EVENT DENTAL PROBLEM UPDATED TO TOOTH LOSS. EVENT OUTCOME ADDED. 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 A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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 PELVIC PAIN ("PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), CARDIAC ABLATION ("BLOOD OR HEART DISORDER/CONDITION TYPE: ABLATION HEART") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508291) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PAIN PELVIC. ON (B)(6) 2002, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2005, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), BLOOD DISORDER ("BLOOD DISORDER"), TOOTH LOSS ("DENTAL PROBLEM-TEETH LOSS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CARDIAC ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INFLAMMATION ("INFLAMMATION"), CYST ("CYSTS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH IBUPROFEN, SURGERY (HYSTERECTOMY (PARTIAL)), SURGERY (HYSTERECTOMY TO HAVE ESSURE REMOVED) AND SURGERY (ABLATION HEART). ESSURE (ESS205) WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, CARDIAC ABLATION, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, BLOOD DISORDER, TOOTH LOSS, DYSMENORRHOEA, FATIGUE, ALOPECIA, NAUSEA, WEIGHT INCREASED, WEIGHT DECREASED, BACK PAIN AND VAGINAL DISCHARGE HAD NOT RESOLVED AND THE INFLAMMATION AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, BLOOD DISORDER, CARDIAC ABLATION, CYST, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, INFLAMMATION, MENORRHAGIA, NAUSEA, PELVIC PAIN, TOOTH LOSS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 113.3 KGS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. EVENT HEART DISORDER CLUBBED WITH CARDIAC ABLATION. 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY TEST WAS POSITIVE. SERUM HBCG WAS POSITIVE, CONSISTENT WITH 1 ST TRIMESTER PREGNANCY"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), CARDIAC ABLATION ("BLOOD OR HEART DISORDER/CONDITION TYPE: ABLATION HEART") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508291) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PAIN PELVIC, GASTRIC BYPASS, ALCOHOLISM, DEPRESSION, BRONCHOSPASM AND GASTRIC BYPASS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NORCO. CONCURRENT CONDITIONS INCLUDED MALAISE, VOMITING, COUGH (COUGH PRODUCTIVE OF YELLOWISH-WHITE SPUTUM.), OBESITY, GASTROESOPHAGEAL REFLUX DISEASE, VULVOVAGINITIS, ASTHMA, SUPRAVENTRICULAR TACHYCARDIA, DIZZINESS, KNEE OSTEOARTHRITIS, HEMATEMESIS, BLOOD IN STOOL, DERMATITIS, MENOMETRORRHAGIA AND HYPERTENSION. FAMILY HISTORY INCLUDED RHINITIS ALLERGIC. IN (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2005, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), BLOOD DISORDER ("BLOOD DISORDER"), TOOTH LOSS ("DENTAL PROBLEM-TEETH LOSS") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2005, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2006, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA") AND NAUSEA ("NAUSEA"). IN (B)(6) 2011, THE PATIENT UNDERWENT CARDIAC ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ALOPECIA ("HAIR LOSS"), BACK PAIN ("BACK PAIN") AND ABDOMINAL PAIN LOWER ("PAIN TO THE LEFT AND RIGHT SIDE OF LOWER ABDOMEN"). IN 2013, THE PATIENT EXPERIENCED WEIGHT DECREASED ("WEIGHT LOSS"). IN 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFLAMMATION ("INFLAMMATION") AND CYST ("CYSTS"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE (ESS205) IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH IBUPROFEN, SURGERY (UNDERWENT HYSTERECTOMY (PARTIAL)), SURGERY (UNDERWENT PARTIAL HYSTERECTOMY) AND SURGERY (ABLATION HEART). ESSURE (ESS205) TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, CARDIAC ABLATION, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, BLOOD DISORDER, TOOTH LOSS, DYSMENORRHOEA, FATIGUE, ALOPECIA, NAUSEA, WEIGHT INCREASED, WEIGHT DECREASED, BACK PAIN AND VAGINAL DISCHARGE HAD NOT RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, INFLAMMATION, CYST AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, BLOOD DISORDER, CARDIAC ABLATION, CYST, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, INFLAMMATION, MENORRHAGIA, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH LOSS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ON (B)(6) 2005, IT WAS REPORTED THAT HER PARTNER HAS HAD A VASECTOMY. URINE PREGNANCY TEST WAS POSITIVE. SERUM HBCG WAS POSITIVE, CONSISTENT WITH 1 ST TRIMESTER PREGNANCY. EIGHT COILS WERE SEEN PROTRUDING INTO THE UTERINE CAVITY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.9 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2005: POSITIVE CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES ERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: NAUSEA, RASH, ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-SEP-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. REPORTER INFORMATION, PATIENT¿S DEMOGRAPHIC INFORMATION, OTHER RELEVANT HISTORY AND LAB DATA UPDATED. EVENTS: ABDOMINAL PAIN LOWER, PREGNANCY TEST WAS POSITIVE. SERUM HBCG WAS POSITIVE, CONSISTENT WITH 1 ST TRIMESTER PREGNANCY, DEVICE INEFFECTIVE WERE NEWLY ADDED. 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 PELVIC PAIN ('PAIN/PELVIC ARE'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY TEST WAS POSITIVE. SERUM HBCG WAS POSITIVE, CONSISTENT WITH 1 ST TRIMESTER PREGNANCY'), SUPRAVENTRICULAR TACHYCARDIA ('BLOOD OR HEART DISORDER/CONDITION:SUPRAVENTRICULAR TACHYCARDIA') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508291) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED PAIN PELVIC, GASTRIC BYPASS, ALCOHOLISM, DEPRESSION, BRONCHOSPASM AND GASTRIC BYPASS. CURRENT WEIGHT: 146 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NORCO. CONCURRENT CONDITIONS INCLUDED MALAISE, VOMITING, COUGH (COUGH PRODUCTIVE OF YELLOWISH-WHITE SPUTUM.), OBESITY, GASTROESOPHAGEAL REFLUX DISEASE, VULVOVAGINITIS, ASTHMA, SUPRAVENTRICULAR TACHYCARDIA, DIZZINESS, KNEE OSTEOARTHRITIS, HEMATEMESIS, BLOOD IN STOOL, DERMATITIS, MENOMETRORRHAGIA AND HYPERTENSION. FAMILY HISTORY INCLUDED RHINITIS ALLERGIC. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) SINCE 2005. IN (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2005, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND BLOOD DISORDER ("BLOOD DISORDER") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN OR WEIGHT LOSS : WEIGHT LOSS"). IN (B)(6) 2005, THE PATIENT EXPERIENCED TOOTH LOSS ("DENTAL PROBLEM-TEETH LOSS\ LOSS OF ALL TEETH"). IN (B)(6) 2005, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2006, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), CYST ("CYSTS\ TWO GRAPEFRUIT SIZED CYSTS WERE REMOVED AT THE SAME TIME OF THE HYSTERECTOMY"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA / HEAVY BLEEDING DURING MENSTRUAL CYCLE") AND NAUSEA ("NAUSEA"). IN (B)(6) 2011, THE PATIENT EXPERIENCED SUPRAVENTRICULAR TACHYCARDIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2011, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/PAINFUL DURING MENSTRUAL CYCLE/MENSTRUATION PAIN"), BACK PAIN ("BACK PAIN") AND ABDOMINAL PAIN LOWER ("PAIN TO THE LEFT AND RIGHT SIDE OF LOWER ABDOMEN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFLAMMATION ("INFLAMMATION"). THE PATIENT WAS TREATED WITH IBUPROFEN, POVIDONE-IODINE (VAGINAL DOUCHE), PROMETHAZINE AND SURGERY (HEART ABLATION AND UNDERWENT HYSTERECTOMY (PARTIAL)). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, SUPRAVENTRICULAR TACHYCARDIA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, BLOOD DISORDER, TOOTH LOSS, DYSMENORRHOEA, FATIGUE, ALOPECIA, NAUSEA, WEIGHT DECREASED, BACK PAIN AND VAGINAL DISCHARGE HAD NOT RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE, INFLAMMATION, CYST AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE (ESS205) OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, BLOOD DISORDER, CYST, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, INFLAMMATION, MENORRHAGIA, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, SUPRAVENTRICULAR TACHYCARDIA, TOOTH LOSS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ON (B)(6) 2005, IT WAS REPORTED THAT HER PARTNER HAS HAD A VASECTOMY. URINE PREGNANCY TEST WAS POSITIVE. SERUM HBCG WAS POSITIVE, CONSISTENT WITH 1 ST TRIMESTER PREGNANCY. EIGHT COILS WERE SEEN PROTRUDING INTO THE UTERINE CAVITY. DISCREPANCY: DATE OF INSERTION PREVIOUSLY FU REPORTED (B)(6) 2004 & IN CURRENT FU IT IS REPORTED (B)(6) 2006. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.9 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2005: RESULTS: POSITIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES ERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: NAUSEA, RASH, ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-AUG-2019: PFS RECEIVED: PREVIOUSLY REPORTED EVENT "BLOOD OR HEART DISORDER/CONDITION TYPE: ABLATION HEART" PT UPDATED TO "SUPRAVENTRICULAR TACHYCARDIA." 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.
QUALITY-SAFETY EVALUATION OF PTC: SAMPLE 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 MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JAN-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (ESS205) INSERTED AND EXPERIENCED SEVERE ABDOMINAL PAIN AND ABNORMAL BLEEDING (SEEN AS GENITAL HAEMORRHAGE). PLAINTIFF UNDERWENT A HYSTERECTOMY TO HAVE ESSURE REMOVED. ABDOMINAL PAIN AND GENITAL HAEMORRHAGE ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING ESSURE THERAPY, ABDOMINAL PAIN AND GENITAL HAEMORRHAGE MAY OCCUR. CONSIDERING THAT EVENTS STARTED AFTER ESSURE INSERTION AND THE LACK OF ALTERNATIVE EXPLANATIONS, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT AS A SURGICAL INTERVENTION WAS REQUIRED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO RECEIVED ESSURE (ESS205) FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2002, THE PATIENT STARTED ESSURE (ESS205). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUS CRITERION MEDICALLY SIGNIFICANT), INFLAMMATION ("INFLAMMATION") AND CYST ("CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TO HAVE ESSURE REMOVED). ESSURE (ESS205) WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, INFLAMMATION AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, GENITAL HAEMORRHAGE, INFLAMMATION AND CYST TO BE RELATED TO ESSURE (ESS205). COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (ESS205) INSERTED AND EXPERIENCED SEVERE ABDOMINAL PAIN AND ABNORMAL BLEEDING (SEEN AS GENITAL HAEMORRHAGE). PLAINTIFF UNDERWENT A HYSTERECTOMY TO HAVE ESSURE REMOVED. ABDOMINAL PAIN AND GENITAL HAEMORRHAGE ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING ESSURE THERAPY, ABDOMINAL PAIN AND GENITAL HAEMORRHAGE MAY OCCUR. CONSIDERING THAT EVENTS STARTED AFTER ESSURE INSERTION AND THE LACK OF ALTERNATIVE EXPLANATIONS, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT AS A SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT.~ FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37087 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 508291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | NORCO |