ESSURE
Report
- Report Number
- 2951250-2017-03672
- Event Type
- Injury
- Date Received
- September 15, 2017
- Date of Event
- August 1, 2015
- Report Date
- April 1, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)"), EMBEDDED DEVICE ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), DEVICE EXPULSION ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE"), ABORTION SPONTANEOUS ("ABORTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936-INVALID) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA. NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT HEMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PER ORAL FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. *ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. PAP: RECENTLY, RESULTS PENDING , HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT. CURRENT WEIGHT 135 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA, PARITY 4, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6) 2015, LOW BACK PAIN SINCE (B)(6) 2016 AND MOVEMENTS REDUCED SINCE (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL FOR PAIN AS WELL AS ANESTHETICS, DOXYCYCLINE, IRON FROM (B)(6) 2015 TO (B)(6) 2016, KETOROLAC TROMETHAMINE (TORADOL), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), ORAL CONTRACEPTIVE NOS, OXYCODONE FROM (B)(6) 2016, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2016 AND PARACETAMOL (TYLENOL 8 HOUR). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), 16 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT WAS TREATED WITH AND SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS AND GENITAL HAEMORRHAGE HAD RESOLVED, THE EMBEDDED DEVICE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2016. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER, BEGINNING AT WEEK 1. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- MENINGITIS, HYSTERECTOMY TO REMOVE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JAN-2019: PFS RECEIVED : NEW EVENT ABDOMINAL PAIN WERE ADDED. CONCOMITANT AND HISTORICAL DRUG WERE ADDED. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)"), EMBEDDED DEVICE ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), DEVICE EXPULSION ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE"), ABORTION SPONTANEOUS ("ABORTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936-INVALID) 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". MEDICAL CONDITIONS: NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT HEMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PER ORAL FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA, PARITY 4, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6) 2015, LOW BACK PAIN SINCE (B)(6) 2016 AND MOVEMENTS REDUCED SINCE (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL ES) FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA), DOXYCYCLINE, KETOROLAC TROMETHAMINE (TORADOL) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2016, 8 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT INCREASED ("WEIGHT GAIN") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON (B)(6) -2015 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2016. THE PATIENT HAD ESSURE BEGINNING AT WEEK 1 OF THE PREGNANCY WITH A POTENTIAL FETAL EXPOSURE OF 39 WEEKS DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE EMBEDDED DEVICE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION . ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. PAP: RECENTLY, RESULTS PENDING , HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)"), EMBEDDED DEVICE ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), DEVICE EXPULSION ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE"), ABORTION SPONTANEOUS ("ABORTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936) 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". MEDICAL CONDITIONS: NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT HEMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PER ORAL FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA, PARITY 4, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6) 2015, LOW BACK PAIN SINCE (B)(6) 2016 AND MOVEMENTS REDUCED SINCE (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL ES) FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA), DOXYCYCLINE, KETOROLAC TROMETHAMINE (TORADOL) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2016, 8 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT INCREASED ("WEIGHT GAIN") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON (B)(6) 2015 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2016. THE PATIENT HAD ESSURE IN PLACE BEGINNING AT WEEK 1 OF THE PREGNANCY WITH A POTENTIAL FETAL EXPOSURE OF 39 WEEKS DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN) AND SURGERY (UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE EMBEDDED DEVICE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT. HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. PAP: RECENTLY, RESULTS PENDING, HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-MAY-2018: PFS INFORMATION RECEIVED. PLAINTIFF ALSO COMPLAINED OF WEIGHT GAIN, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) AND DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. SHE UNDERWENT TO SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY) AND BILATERAL SALPINGECTOMY ON (B)(6) 2016. IT WAS REPORTED THAT SHORTLY AFTER REMOVAL HER PAIN DECREASED. 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 ("SEVERE CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)"), EMBEDDED DEVICE ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), DEVICE EXPULSION ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE"), ABORTION SPONTANEOUS ("ABORTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936-INVALID) 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". MEDICAL CONDITIONS: NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT HEMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PER ORAL FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA, PARITY 4, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6) 2015, LOW BACK PAIN SINCE (B)(6) 2016 AND MOVEMENTS REDUCED SINCE (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL ES) FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA), DOXYCYCLINE, KETOROLAC TROMETHAMINE (TORADOL) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2016, 8 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT INCREASED ("WEIGHT GAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON (B)(6) 2015 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2016. THE PATIENT HAD ESSURE IN PLACE BEGINNING AT WEEK 1 OF THE PREGNANCY WITH A POTENTIAL FETAL EXPOSURE OF 39 WEEKS DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE EMBEDDED DEVICE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. PAP: RECENTLY, RESULTS PENDING , HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED: NEW EVENTS: PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND MENTAL ANGUISH WERE ADDED INCIDENT NO VALID 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)"), EMBEDDED DEVICE ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), DEVICE EXPULSION ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE"), ABORTION SPONTANEOUS ("ABORTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936) 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". MEDICAL CONDITIONS: NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT HEMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PER ORAL FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA, PARITY 4, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6) 2015, LOW BACK PAIN SINCE (B)(6) 2016 AND MOVEMENTS REDUCED SINCE (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL ES) FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA), DOXYCYCLINE, KETOROLAC TROMETHAMINE (TORADOL) AND ORAL CONTRACEPTIVE NOS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2016, 8 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT INCREASED ("WEIGHT GAIN") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON (B)(6) 2015 AND ESTIMATED DATE OF DELIVERY WAS ON (B)(6) 2016. THE PATIENT HAD ESSURE IN PLACE BEGINNING AT WEEK 1 OF THE PREGNANCY WITH A POTENTIAL FETAL EXPOSURE OF 39 WEEKS DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE EMBEDDED DEVICE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT. HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. PAP: RECENTLY, RESULTS PENDING , HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: THE CORRECT DATE FROM FOLLOW-UP RECEIVED ON (B)(6) 2018 SHOULD BE (B)(6) 2018. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)"), EMBEDDED DEVICE ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), DEVICE EXPULSION ("THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE"), ABORTION SPONTANEOUS ("ABORTION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". MEDICAL CONDITIONS: NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT EMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PO FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. CONCURRENT CONDITIONS INCLUDED GRAVIDA, PARITY 4, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, UNWANTED PREGNANCY SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6) 2015, LOW BACK PAIN SINCE (B)(6) 2016 AND MOVEMENTS REDUCED SINCE (B)(6) 2016. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL ES) FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA), CONTRACEPTIVES NOS, DOXYCYCLINE AND KETOROLAC TROMETHAMINE (TORADOL). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON (B)(6) 2015 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2016. THE PATIENT HAD ESSURE BEGINNING AT WEEK 1 OF THE PREGNANCY WITH A POTENTIAL FETAL EXPOSURE OF 22 WEEKS DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH IBUPROFEN (MOTRIN), SURGERY (UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY (UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE EMBEDDED DEVICE, DEVICE EXPULSION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PAP: RECENTLY, RESULTS PENDING , HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT. HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-FEB-2018: PFS AND MR RECEIVED. PATIENT¿S DETAILS, CONCOMITANT DISEASE CONCOMITANT DRUGS, LAB DATA, UNSTRUCTURED RELEVANT TESTS WERE ADDED. ABORTION AND ABNORMAL BLEEDING (GENERAL) WERE ADDED AS EVENTS. START DATE OF ESSURE WAS UPDATED. EVENT EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE WAS ADDED FROM MEDICAL RECORD. 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 CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)'), EMBEDDED DEVICE ('THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY'), DEVICE EXPULSION ('THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY') AND ABORTION SPONTANEOUS ('ABORTION') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936-INV) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA. NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT HEMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PER ORAL FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT. HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. PAP: RECENTLY, RESULTS PENDING , HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT CURRENT WEIGHT 135 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED LOW BACK PAIN SINCE (B)(6) 2016, MOVEMENTS REDUCED SINCE (B)(6) 2016, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6) 2015, MULTIGRAVIDA AND PARITY 4. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL FOR PAIN AS WELL AS ANESTHETICS, DOXYCYCLINE, IRON FROM (B)(6) 2015 TO (B)(6) 2016, KETOROLAC TROMETHAMINE (TORADOL), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), ORAL CONTRACEPTIVE NOS, OXYCODONE FROM (B)(6) 2016 TO (B)(6) 2016, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2016 TO (B)(6) 2016 AND PARACETAMOL (TYLENOL 8 HOUR). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), 16 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND HYPERSENSITIVITY ("ALLERGIC REACTION") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT WAS TREATED WITH AND SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE AND HYPERSENSITIVITY HAD RESOLVED, THE EMBEDDED DEVICE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2016. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER, BEGINNING AT WEEK 1. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSPAREUNIA, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- MENINGITIS, HYSTERECTOMY TO REMOVE ESSURE DEVICE. RIGHT: TWO COILS VISUALIZED WITHIN OSTIUM OPENING. LEFT: TWO COILS WERE SEEN THROUGH THE LEFT OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: IMPRESSION: 1. ADEQUATE OCCLUSION OF BOTH FALLOPIAN TUBES WITH ESSURE DEVICES. 2. NO ENDOMETRIAL POLYP; ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. INVESTIGATION - ON (B)(6) 2015: ESSURE CONFIRMATION TEST CONDUCTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE, PELVIC PAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2021: MR RECEIVED. REPORTER INFORMATION, LAB DATA WERE ADDED. AUTO NARRATIVE SUPPLEMENT AND RCC WERE UPDATED. REAL FU WAS RECEIVED AND THERE WAS NO SIGNIFICANT CHANGE IN THE MEDICAL CONTEXT OF CASE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)'), EMBEDDED DEVICE ('THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY'), DEVICE EXPULSION ('THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANT WITH ESSURE'), ABORTION SPONTANEOUS ('ABORTION') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936-INV) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA. NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT HEMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PER ORAL FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT. HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. PAP: RECENTLY, RESULTS PENDING , HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT CURRENT WEIGHT 135 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED LOW BACK PAIN SINCE (B)(6) 2016, MOVEMENTS REDUCED SINCE (B)(6) 2016, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6)2015, MULTIGRAVIDA AND PARITY 4. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL FOR PAIN AS WELL AS ANESTHETICS, DOXYCYCLINE, IRON FROM (B)(6) 2015 TO (B)(6) 2016, KETOROLAC TROMETHAMINE (TORADOL), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), ORAL CONTRACEPTIVE NOS, OXYCODONE FROM (B)(6) 2016 TO (B)(6) 2016, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2016 TO (B)(6) 2016 AND PARACETAMOL (TYLENOL 8 HOUR). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), 16 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND HYPERSENSITIVITY ("ALLERGIC REACTION") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT WAS TREATED WITH AND SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE AND HYPERSENSITIVITY HAD RESOLVED, THE EMBEDDED DEVICE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2016. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER, BEGINNING AT WEEK 1. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- MENINGITIS, HYSTERECTOMY TO REMOVE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. INVESTIGATION - ON (B)(6) 2015: ESSURE CONFIRMATION TEST CONDUCTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PLAINTIFF FACT SHEET WAS RECEIVED. NEW EVENT ALLERGIC REACTION WAS ADDED WITH OUTCOME RECOVERED/RESOLVED. LAB DATA WAS ADDED. NEW REPORTER WAS ADDED. INCIDENT: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE CHRONIC PELVIC PAIN / PAIN /PELVIC PAIN (SEVERE)'), EMBEDDED DEVICE ('THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY'), DEVICE EXPULSION ('THE ESSURE COILS WERE DEEPLY EMBEDDED WITHIN THE TUBE EXTENDING INTO THE UTERINE CAVITY') AND ABORTION SPONTANEOUS ('ABORTION') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 195936-INV) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED ANEMIA. NO PAST SURGICAL HISTORY ON FILE. ALLERGIES: REVIEW OF PATIENT'S ALLERGIES INDICATES NO KNOWN ALLERGIES. PATIENT HEMODYNAMICALLY STABLE WITH NO RESPIRATORY DISTRESS. NO INDICATIONS/COMPLAINTS OF NAUSEA. TOLERATING PER ORAL FLUIDS. ABLE TO AMBULATE WITH STEADY GAIT AND VOID. NO VAGINAL BLEEDING NOTED. IV DISCONTINUED WITH CATHETER INTACT AND NO ACTIVE BLEEDING AT SITE. PATIENT DENIES PAIN. ON (B)(6) 2015, ASSESSMENT: METAL IMPLANTS: NOT APPLICABLE. INTEGUMENTARY. SKIN CHARACTER: WARM; DRY. SKIN COLOR: NORMAL FOR RACE. SKIN TURGOR: ELASTIC. SKIN APPEARANCE: INTACT. HSG SCHEDULED FOR 3 MONTHS TO ENSURE TUBAL LIGATION. PAP: RECENTLY, RESULTS PENDING , HLO ABNL PAP IN 1999 NOT REQUIRING TREATMENT CURRENT WEIGHT 135 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED LOW BACK PAIN SINCE (B)(6) 2016, MOVEMENTS REDUCED SINCE (B)(6) 2016, HSV INFECTION SINCE (B)(6) 2015, THYROID DISORDER SINCE (B)(6) 2015, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION SINCE (B)(6) 2015, PAPANICOLAOU SMEAR ABNORMAL SINCE (B)(6) 2015, CONTRACEPTION SINCE (B)(6) 2015, VAGINAL HAEMORRHAGE SINCE (B)(6) 2015, ABDOMINAL PAIN SINCE (B)(6) 2015, FEVER (> 101.0) SINCE (B)(6) 2015, MULTIGRAVIDA AND PARITY 4. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL FOR PAIN AS WELL AS ANESTHETICS, DOXYCYCLINE, IRON FROM (B)(6) 2015 TO (B)(6) 2016, KETOROLAC TROMETHAMINE (TORADOL), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), ORAL CONTRACEPTIVE NOS, OXYCODONE FROM (B)(6) 2016 TO (B)(6) 2016, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2016 TO (B)(6) 2016 AND PARACETAMOL (TYLENOL 8 HOUR). ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), 16 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND HYPERSENSITIVITY ("ALLERGIC REACTION") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT WITH ESSURE"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 AND THEN ON (B)(6) 2016. THE PATIENT WAS TREATED WITH AND SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND UNDERWENT LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABORTION SPONTANEOUS, GENITAL HAEMORRHAGE AND HYPERSENSITIVITY HAD RESOLVED, THE EMBEDDED DEVICE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2016. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER, BEGINNING AT WEEK 1. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABORTION SPONTANEOUS, ANXIETY, DEPRESSION, DYSPAREUNIA, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENORRHAGIA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 134 LBS. LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- MENINGITIS, HYSTERECTOMY TO REMOVE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. INVESTIGATION - ON (B)(6) 2015: ESSURE CONFIRMATION TEST CONDUCTED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:EMBEDDED DEVICE AND PARTIAL EXPULSION OF DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAY-2020: QUALITY SAFETY EVALUATION OF PTC. EVENTS OF PREGNANCY WITH CONTRACEPTIVE DEVICE AND GENITAL HAEMORRHAGE DOWNGRADED TO NON-SERIOUS. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 650931 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 195936-INV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| O| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ANESTHESIA| ANESTHESIA| ANESTHESIA| ANESTHESIA| ANESTHESIA| ANESTHETICS| ANESTHETICS| ANESTHETICS| ANESTHETICS| CONTRACEPTIVES NOS| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IRON| IRON| IRON| IRON| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| OXYCODONE| OXYCODONE| OXYCODONE| OXYCODONE| PARACETAMOL| PARACETAMOL| PARACETAMOL| PARACETAMOL| TORADOL| TORADOL| TORADOL| TORADOL| TORADOL| TORADOL| TORADOL| TORADOL| TORADOL| TYLENOL 8 HOUR| TYLENOL 8 HOUR| TYLENOL 8 HOUR| TYLENOL 8 HOUR| TYLENOL ES| TYLENOL ES| TYLENOL ES| TYLENOL ES| TYLENOL ES |