ESSURE
Report
- Report Number
- 2951250-2017-05853
- Event Type
- Injury
- Date Received
- October 31, 2017
- Report Date
- April 9, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING GENERAL") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12281215) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ENDOMETRIOSIS, PENICILLIN ALLERGY AND NONSMOKER. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, 18 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON (B)(6) 2007, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA") AND DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND ABDOMINAL PAIN ("LEFT SIDE ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCIPIC ASSISTED VAGINAL HYSTERECTOMY AND TUBAL LIGATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2007. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, NAUSEA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HORMONE LEVEL ABNORMAL, VAGINAL DISCHARGE, WEIGHT INCREASED, WEIGHT DECREASED, ABDOMINAL PAIN AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.2 KG/SQM. HYSTEROSALPINGOGRAM - ON 13-FEB-2006: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING GENERAL") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12281215) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ENDOMETRIOSIS, PENICILLIN ALLERGY AND NONSMOKER. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6)2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6)2005, 18 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). IN JANUARY 2006, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MENOPAUSE ("HORMONAL CHANGES DESCRIBE: MENOPAUSAL"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6)2007, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA") AND ADHESION ("ADHESIONS DISEASE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), NAUSEA ("NAUSEA"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND ABDOMINAL PAIN ("LEFT SIDE ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCIPIC ASSISTED VAGINAL HYSTERECTOMY AND TUBAL LIGATION , TOTAL HYSTERECTOMY (UTERUS AND). ESSURE (ESS205) WAS REMOVED ON (B)(6)2007. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, NAUSEA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HORMONE LEVEL ABNORMAL, VAGINAL DISCHARGE, WEIGHT INCREASED, WEIGHT DECREASED, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENOPAUSE, DEPRESSION, ANXIETY AND ADHESION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADHESION, ALOPECIA, ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENOPAUSE, MENORRHAGIA, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2006: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PFS RECEIVED. EVENTS HORMONAL CHANGES DESCRIBE: MENOPAUSAL, DEPRESSION, MENTAL ANGUISH AND ADHESIONS DISEASE 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 ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING GENERAL") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12281215) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ENDOMETRIOSIS, PENICILLIN ALLERGY AND NONSMOKER. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) -2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, 18 DAYS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"). ON (B)(6) 2007, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA") AND DYSPAREUNIA ("DYSPAREUNIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), ALOPECIA ("HAIR LOSS"), NAUSEA ("NAUSEA"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("WEIGHT LOSS") AND ABDOMINAL PAIN ("LEFT SIDE ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCIPIC ASSISTED VAGINAL HYSTERECTOMY AND TUBAL LIGATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2007. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, NAUSEA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HORMONE LEVEL ABNORMAL, VAGINAL DISCHARGE, WEIGHT INCREASED, WEIGHT DECREASED, ABDOMINAL PAIN AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-FEB-2018: PFS AND MEDICAL RECORD RECEIVED: EVENT GENITAL BLEEDING,APAREUNIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA,FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, NAUSEA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HORMONE LEVEL ABNORMAL, VAGINAL DISCHARGE, WEIGHT GAIN, WEIGHT LOSS,ABDOMINAL PAIN,VAGINAL BLEEDING ADDED.CONCURRENT CONDITION,MEDICAL HISTORY,CONCOMITANT MEDICATION ADDED.REPORTERS ADDED.LAB DATA 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 ('SEVERE PELVIC PAIN') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12281215) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS:(B)(6) 2007,SURGICAL PATHOLOGY REPORT ,UTERUS WITH CERVIX, VAGINAL HYSTERECTOMY: MILD CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. ENDOMETRIUM OF PROLIFERATIVE PHASE. MYOMETRIUM WITHOUT MORPHOLOGIC ABNORMALITY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ENDOMETRIOSIS, PENICILLIN ALLERGY AND NONSMOKER. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), 18 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2006, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MENOPAUSAL SYMPTOMS ("HORMONAL CHANGES DESCRIBE: MENOPAUSAL"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2007, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA") AND ADHESION ("ADHESIONS DISEASE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING GENERAL"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), NAUSEA ("NAUSEA"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN ("LEFT SIDE ABDOMEN PAIN") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCIPIC ASSISTED VAGINAL HYSTERECTOMY AND TUBAL LIGATION , TOTAL HYSTERECTOMY (UTERUS AND). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2007. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENORRHAGIA HAD RESOLVED AND THE GENITAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, NAUSEA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HORMONE LEVEL ABNORMAL, VAGINAL DISCHARGE, WEIGHT INCREASED, WEIGHT DECREASED, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENOPAUSAL SYMPTOMS, DEPRESSION, ANXIETY, ADHESION AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADHESION, ALOPECIA, ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENOPAUSAL SYMPTOMS, MENORRHAGIA, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PAIN AND ABNORMAL BLEEDING. TH WERE NOTED TO HAVE ABOUT FOUR COIL OUT OF THE TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION.OCCLUDED FALLOPIAN TUBES. NORMAL MORPHOLOGY OF THE UTERUS. THE UTERUS IS SIGNIFICANTLY RETROFLEXED.. IMAGING PROCEDURE - ON (B)(6) 2006: RESULT NOT PROVIDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-MAR-2021: MR RECEIVED. REPORTER'S INFORMATION ADDED.FU RECEIVED.NO NEW SIGNIFICANT CHANGE MADE IN MEDICAL CONTEXT OF CASE. 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 PELVIC PAIN ('SEVERE PELVIC PAIN') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12281215) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: (B)(6) 2007,SURGICAL PATHOLOGY REPORT ,UTERUS WITH CERVIX, VAGINAL HYSTERECTOMY: MILD CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. ENDOMETRIUM OF PROLIFERATIVE PHASE. MYOMETRIUM WITHOUT MORPHOLOGIC ABNORMALITY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ENDOMETRIOSIS, PENICILLIN ALLERGY AND NONSMOKER. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), 18 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2006, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MENOPAUSAL SYMPTOMS ("HORMONAL CHANGES DESCRIBE: MENOPAUSAL"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2007, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA") AND ADHESION ("ADHESIONS DISEASE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING GENERAL"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), NAUSEA ("NAUSEA"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN ("LEFT SIDE ABDOMEN PAIN") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCIPIC ASSISTED VAGINAL HYSTERECTOMY AND TUBAL LIGATION , TOTAL HYSTERECTOMY (UTERUS AND). ESSURE (ESS205) WAS REMOVED ON 1-MAR-2007. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENORRHAGIA HAD RESOLVED AND THE GENITAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, NAUSEA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HORMONE LEVEL ABNORMAL, VAGINAL DISCHARGE, WEIGHT INCREASED, WEIGHT DECREASED, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENOPAUSAL SYMPTOMS, DEPRESSION, ANXIETY, ADHESION AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADHESION, ALOPECIA, ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENOPAUSAL SYMPTOMS, MENORRHAGIA, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PAIN AND ABNORMAL BLEEDING. TH WERE NOTED TO HAVE ABOUT FOUR COIL OUT OF THE TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.2 KG/SQM. HYSTEROSALPINGOGRAM - ON 13-FEB-2006: TOTAL BILATERAL OCCLUSION.OCCLUDED FALLOPIAN TUBES. NORMAL MORPHOLOGY OF THE UTERUS. THE UTERUS IS SIGNIFICANTLY RETROFLEXED.. IMAGING PROCEDURE - ON 13-FEB-2006: RESULT NOT PROVIDED. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-APR-2021: 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 PELVIC PAIN ('SEVERE PELVIC PAIN') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12281215) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: (B)(6) 2007,SURGICAL PATHOLOGY REPORT ,UTERUS WITH CERVIX, VAGINAL HYSTERECTOMY: MILD CHRONIC CERVICITIS WITH SQUAMOUS METAPLASIA. ENDOMETRIUM OF PROLIFERATIVE PHASE. MYOMETRIUM WITHOUT MORPHOLOGIC ABNORMALITY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, ENDOMETRIOSIS, PENICILLIN ALLERGY AND NONSMOKER. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PARACETAMOL (TYLENOL REGULAR). ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2005, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), 18 DAYS AFTER INSERTION OF ESSURE (ESS205). IN (B)(6) 2006, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MENOPAUSAL SYMPTOMS ("HORMONAL CHANGES DESCRIBE: MENOPAUSAL"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2007, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA") AND ADHESION ("ADHESIONS DISEASE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING GENERAL"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), NAUSEA ("NAUSEA"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), ABDOMINAL PAIN ("LEFT SIDE ABDOMEN PAIN") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY AND TUBAL LIGATION , TOTAL HYSTERECTOMY (UTERUS AND). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2007. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENORRHAGIA HAD RESOLVED AND THE GENITAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA, NAUSEA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HORMONE LEVEL ABNORMAL, VAGINAL DISCHARGE, WEIGHT INCREASED, WEIGHT DECREASED, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENOPAUSAL SYMPTOMS, DEPRESSION, ANXIETY, ADHESION AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADHESION, ALOPECIA, ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENOPAUSAL SYMPTOMS, MENORRHAGIA, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION. OCCLUDED FALLOPIAN TUBES. NORMAL MORPHOLOGY OF THE UTERUS. THE UTERUS IS SIGNIFICANTLY RETROFLEXED.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PFS RECEIVED-NEW EVENT POST REMOVAL COMPLICATION WERE ADDED. OUTCOME OF PELVIC PAIN , MENORRHAGIA UPDATED TO RECOVERED / RESOLVED. 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 PELVIC PAIN ("SEVERE PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2006: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. COMPANY CAUSALITY COMMENT: INCIDENT~ NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770316 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12281215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| TYLENOL REGULAR| TYLENOL REGULAR| TYLENOL REGULAR| TYLENOL REGULAR| TYLENOL REGULAR| TYLENOL REGULAR |