ESSURE
Report
- Report Number
- 2951250-2017-03535
- Event Type
- Injury
- Date Received
- September 11, 2017
- Date of Event
- May 29, 2013
- Report Date
- May 7, 2020
- 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
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN/ PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), UTERINE POLYP ("CANCEROUS POLYPS") AND TOOTH DISORDER ("DENTAL PROBLEMS") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 825629, 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 IN 2007, POST-TRAUMATIC STRESS DISORDER IN 2008 AND DISSOCIAL PERSONALITY DISORDER IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILLS FROM 2008 TO (B)(6) 2013 AND DEPO-PROVERA IN 2008. CONCURRENT CONDITIONS INCLUDED ENDOCERVICAL CURETTAGE, CHEST PAIN, GENERALIZED ANXIETY DISORDER, INFECTION, TOOTH DISORDER (WORSENED POST ESSURE PLACEMENT), NICKEL SENSITIVITY (SHE WAS BORN WITH THIS ALLERGY) AND CERVICAL INTRAEPITHELIAL NEOPLASIA III. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"), DYSPAREUNIA ("PAINFUL INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"). IN AUGUST 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN/ GAINED 50 LBS."). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINE HEADACHES"), HEADACHE ("HEADACHES"), EYE DISORDER ("VISION/EYE PROBLEMS") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE POLYP (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("ALLERGIC REACTIONS ASSOCIATED WITH NICKEL ALLERGY/ NICKEL ALLERGY"), ABDOMINAL PAIN LOWER ("PAIN IN LOWER ABDOMINAL AREA"), ORAL PAIN ("PAIN IN MOUTH"), ARTHRALGIA ("PAIN IN JOINTS / PAIN IN ANKLE"), PAIN IN EXTREMITY ("PAIN IN HANDS") AND VISION BLURRED ("BLURRY VISION"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017 TO (B)(6) 2017. THE PATIENT WAS TREATED WITH OXYCODONE, SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (WISDOM TEETH EXTRACTION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, ORAL PAIN, ARTHRALGIA AND PAIN IN EXTREMITY WAS RESOLVING, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED AND THE UTERINE POLYP, TOOTH DISORDER, WEIGHT INCREASED, ALLERGY TO METALS, NERVOUS SYSTEM DISORDER, VAGINAL HAEMORRHAGE, HEADACHE, EYE DISORDER, VISUAL IMPAIRMENT AND VISION BLURRED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NERVOUS SYSTEM DISORDER, ORAL PAIN, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, UTERINE POLYP, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF PLAINTIFF¿S UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES. PELVIC PAIN SECONDARY TO ESSURE DEVICE. THE COIL WAS RELEASED AND PLACEMENT WAS CONFIRMED WITH 3 COILS INTO THE ENDOMETRIAL CAVITY. AS PER DISCHARGE SUMMARY: SURGERY PERFORMED WITHOUT DIFFICULTY OR COMPLICATION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: FALLOPIAN TUBES ARE FULLY OCCLUDED; IN JANUARY 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED (B)(6) 2017, SURGICAL PATHOLOGY REPORT SHOWED UTERUS, CERVIX, TUBES ESSURE X2: CHRONIC ENDOCERVICITIS. PROLIFERATIVE ENDOMETRIUM. UNREMARKABLE SEGMENTS OF FALLOPIAN TUBES. GROSS DESCRIPTION: ONE ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.0 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED RED. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. THE OTHER ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.1 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED BLACK. THERE IS A 1.4 X 1.0 X 0.9 CM, HEMORRHAGIC AREA NEAR DISTAL FIMBRIA. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: CONFIRMING ABDOMINAL PAIN, PELVIC PAIN, ALLERGY TO NICKEL, DENTAL CARIES. LOT NUMBER:822365 MANUFACTURE DATE: 2011/01 EXPIRATION DATE: 2014/01 . LOT NUMBER:825629 MANUFACTURE DATE: 2011/02 EXPIRATION DATE: 2014/02. 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 ("CHRONIC PELVIC PAIN/ PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), UTERINE POLYP ("CANCEROUS POLYPS") AND TOOTH DISORDER ("DENTAL PROBLEMS") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 825629, 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 IN 2007, POST-TRAUMATIC STRESS DISORDER IN 2008 AND DISSOCIAL PERSONALITY DISORDER IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILLS FROM 2008 TO (B)(6) 2013 AND DEPO-PROVERA IN 2008. CONCURRENT CONDITIONS INCLUDED ENDOCERVICAL CURETTAGE, CHEST PAIN, GENERALIZED ANXIETY DISORDER, INFECTION, TOOTH DISORDER (WORSENED POST ESSURE PLACEMENT), NICKEL SENSITIVITY (SHE WAS BORN WITH THIS ALLERGY) AND CERVICAL INTRAEPITHELIAL NEOPLASIA III. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"), DYSPAREUNIA ("PAINFUL INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN/ GAINED 50 LBS."). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINE HEADACHES"), HEADACHE ("HEADACHES"), EYE DISORDER ("VISION/EYE PROBLEMS") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE POLYP (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("ALLERGIC REACTIONS ASSOCIATED WITH NICKEL ALLERGY/ NICKEL ALLERGY"), ABDOMINAL PAIN LOWER ("PAIN IN LOWER ABDOMINAL AREA"), ORAL PAIN ("PAIN IN MOUTH"), ARTHRALGIA ("PAIN IN JOINTS / PAIN IN ANKLE"), PAIN IN EXTREMITY ("PAIN IN HANDS") AND VISION BLURRED ("BLURRY VISION"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017 TO (B)(6) 2017. THE PATIENT WAS TREATED WITH OXYCODONE, SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (LOOP ELECTROSURGICAL EXCISION PROCEDURE) AND SURGERY (WISDOM TEETH EXTRACTION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, ORAL PAIN, ARTHRALGIA AND PAIN IN EXTREMITY WAS RESOLVING, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED AND THE UTERINE POLYP, TOOTH DISORDER, WEIGHT INCREASED, ALLERGY TO METALS, NERVOUS SYSTEM DISORDER, VAGINAL HAEMORRHAGE, HEADACHE, EYE DISORDER, VISUAL IMPAIRMENT AND VISION BLURRED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NERVOUS SYSTEM DISORDER, ORAL PAIN, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, UTERINE POLYP, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF PLAINTIFF¿S UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES. PELVIC PAIN SECONDARY TO ESSURE DEVICE. THE COIL WAS RELEASED AND PLACEMENT WAS CONFIRMED WITH 3 COILS INTO THE ENDOMETRIAL CAVITY. AS PER DISCHARGE SUMMARY: SURGERY PERFORMED WITHOUT DIFFICULTY OR COMPLICATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: FALLOPIAN TUBES ARE FULLY OCCLUDED; IN (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED (B)(6) 2017, SURGICAL PATHOLOGY REPORT SHOWED UTERUS, CERVIX, TUBES ESSURE X2: CHRONIC ENDOCERVICITIS. PROLIFERATIVE ENDOMETRIUM. UNREMARKABLE SEGMENTS OF FALLOPIAN TUBES. GROSS DESCRIPTION: ONE ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.0 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED RED. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. THE OTHER ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.1 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED BLACK. THERE IS A 1.4 X 1.0 X 0.9 CM, HEMORRHAGIC AREA NEAR DISTAL FIMBRIA. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDES: CONFIRMING ABDOMINAL PAIN, PELVIC PAIN, ALLERGY TO NICKEL, DENTAL CARIES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-OCT-2018: PFS RECEIVED. OUTCOME ADDED FOR EVENTS: PAIN IN LOWER ABDOMINAL AREA, PAIN IN MOUTH, PAIN IN JOINTS / PAIN IN ANKLE AND PAIN IN HANDS. EVENT ONSET DATE ADDED: WEIGHT GAIN/ GAINED 50 LBS. 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 ("CHRONIC PELVIC PAIN/ PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), UTERINE POLYP ("CANCEROUS POLYPS") AND TOOTH DISORDER ("DENTAL PROBLEMS") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 825629, 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 IN 2007, POST-TRAUMATIC STRESS DISORDER IN 2008 AND PERSONALITY DISORDER IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILLS FROM 2008 TO (B)(6) 2013 AND DEPO-PROVERA IN 2008. CONCURRENT CONDITIONS INCLUDED ENDOCERVICAL CURETTAGE, CHEST PAIN, GENERALIZED ANXIETY DISORDER, INFECTION, TOOTH DISORDER (WORSENED POST ESSURE PLACEMENT), NICKEL SENSITIVITY (SHE WAS BORN WITH THIS ALLERGY) AND CERVICAL INTRAEPITHELIAL NEOPLASIA III. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"), DYSPAREUNIA ("PAINFUL INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINE HEADACHES"), HEADACHE ("HEADACHES"), EYE DISORDER ("VISION/EYE PROBLEMS") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE POLYP (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), WEIGHT INCREASED ("WEIGHT GAIN/ GAINED 50 LBS."), ALLERGY TO METALS ("ALLERGIC REACTIONS ASSOCIATED WITH NICKEL ALLERGY/ NICKEL ALLERGY"), ABDOMINAL PAIN LOWER ("PAIN IN LOWER ABDOMINAL AREA"), ORAL PAIN ("PAIN IN MOUTH"), ARTHRALGIA ("PAIN IN JOINTS / PAIN IN ANKLE"), PAIN IN EXTREMITY ("PAIN IN HANDS") AND VISION BLURRED ("BLURRY VISION"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017 TO (B)(6) 2017. THE PATIENT WAS TREATED WITH OXYCODONE, SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (LOOP ELECTROSURGICAL EXCISION PROCEDURE) AND SURGERY (WISDOM TEETH EXTRACTION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED AND THE UTERINE POLYP, TOOTH DISORDER, WEIGHT INCREASED, ALLERGY TO METALS, NERVOUS SYSTEM DISORDER, VAGINAL HAEMORRHAGE, HEADACHE, EYE DISORDER, ABDOMINAL PAIN LOWER, ORAL PAIN, ARTHRALGIA, PAIN IN EXTREMITY, VISUAL IMPAIRMENT AND VISION BLURRED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NERVOUS SYSTEM DISORDER, ORAL PAIN, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, UTERINE POLYP, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF PLAINTIFF¿S UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES. PELVIC PAIN SECONDARY TO ESSURE DEVICE. THE COIL WAS RELEASED AND PLACEMENT WAS CONFIRMED WITH 3 COILS INTO THE ENDOMETRIAL CAVITY. AS PER DISCHARGE SUMMARY: SURGERY PERFORMED WITHOUT DIFFICULTY OR COMPLICATION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: FALLOPIAN TUBES ARE FULLY OCCLUDED; IN (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. (B)(6) 2017, SURGICAL PATHOLOGY REPORT SHOWED UTERUS, CERVIX, TUBES ESSURE X2: CHRONIC ENDOCERVICITIS. PROLIFERATIVE ENDOMETRIUM. UNREMARKABLE SEGMENTS OF FALLOPIAN TUBES. GROSS DESCRIPTION: ONE ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.0 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED RED. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. THE OTHER ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.1 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED BLACK. THERE IS A 1.4 X 1.0 X 0.9 CM, HEMORRHAGIC AREA NEAR DISTAL FIMBRIA. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDES: CONFIRMING ABDOMINAL PAIN, PELVIC PAIN, ALLERGY TO NICKEL, DENTAL CARIES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-FEB-2018: MEDICAL RECORDS AND PLAINTIFF FACT SHEET WAS RECEIVED. EVENTS ADDED PER PFS: NEUROLOGICAL CONDITIONS OR PROBLEMS, CANCEROUS POLYPS, DENTAL PROBLEMS, ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA), HEADACHES, VISION/EYE PROBLEMS, PAIN IN LOWER ABDOMINAL AREA, PAIN IN MOUTH, PAIN IN JOINTS/ PAIN IN ANKLES AND PAIN IN HANDS, BLURRY VISION. REPORTERS WERE ADDED. PATIENT DEMOGRAPHICS ADDED. HISTORICAL AND CONCOMITANT CONDITIONS AND DRUGS ADDED. LOT NUMBER ADDED. PATIENT WAS HOSPITALIZED FOR PELVIC PAIN. 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 ('CHRONIC PELVIC PAIN/ PAIN'), ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN'), UTERINE POLYP ('CANCEROUS POLYPS') AND TOOTH DISORDER ('DENTAL PROBLEMS') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 825629, 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POST-TRAUMATIC STRESS DISORDER IN 2008, DISSOCIAL PERSONALITY DISORDER IN 2008, PARITY 1 IN 2007 AND GRAVIDA I. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILLS FROM 2008 TO (B)(6) 2013 AND DEPO-PROVERA IN 2008. CONCURRENT CONDITIONS INCLUDED ENDOCERVICAL CURETTAGE, CHEST PAIN, GENERALIZED ANXIETY DISORDER, INFECTION, TOOTH DISORDER (WORSENED POST ESSURE PLACEMENT), NICKEL SENSITIVITY (SHE WAS BORN WITH THIS ALLERGY) AND CERVICAL INTRAEPITHELIAL NEOPLASIA III. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"), DYSPAREUNIA ("PAINFUL INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ GAINED 50 LBS."). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINE HEADACHES"), HEADACHE ("HEADACHES"), EYE DISORDER ("VISION/EYE PROBLEMS") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE POLYP (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("ALLERGIC REACTIONS ASSOCIATED WITH NICKEL ALLERGY/ NICKEL ALLERGY"), ABDOMINAL PAIN LOWER ("PAIN IN LOWER ABDOMINAL AREA"), ORAL PAIN ("PAIN IN MOUTH"), ARTHRALGIA ("PAIN IN JOINTS / PAIN IN ANKLE"), PAIN IN EXTREMITY ("PAIN IN HANDS"), VISION BLURRED ("BLURRY VISION") AND ABDOMINAL DISTENSION ("CONSTANT BLOT"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017 TO (B)(6) 2017. THE PATIENT WAS TREATED WITH OXYCODONE AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, LOOP ELECTROSURGICAL EXCISION PROCEDURE AND WISDOM TEETH EXTRACTION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, ORAL PAIN, ARTHRALGIA AND PAIN IN EXTREMITY WAS RESOLVING, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED AND THE UTERINE POLYP, TOOTH DISORDER, WEIGHT INCREASED, ALLERGY TO METALS, NERVOUS SYSTEM DISORDER, VAGINAL HAEMORRHAGE, HEADACHE, EYE DISORDER, VISUAL IMPAIRMENT, VISION BLURRED AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NERVOUS SYSTEM DISORDER, ORAL PAIN, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, UTERINE POLYP, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF PLAINTIFF¿S UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES. PELVIC PAIN SECONDARY TO ESSURE DEVICE. THE COIL WAS RELEASED AND PLACEMENT WAS CONFIRMED WITH 3 COILS INTO THE ENDOMETRIAL CAVITY. AS PER DISCHARGE SUMMARY: SURGERY PERFORMED WITHOUT DIFFICULTY OR COMPLICATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: FALLOPIAN TUBES ARE FULLY OCCLUDED; IN (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. (B)(6) 2017, SURGICAL PATHOLOGY REPORT SHOWED UTERUS, CERVIX, TUBES ESSURE X2: CHRONIC ENDOCERVICITIS. PROLIFERATIVE ENDOMETRIUM. UNREMARKABLE SEGMENTS OF FALLOPIAN TUBES. GROSS DESCRIPTION: ONE ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.0 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED RED. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. THE OTHER ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.1 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED BLACK. THERE IS A 1.4 X 1.0 X 0.9 CM, HEMORRHAGIC AREA NEAR DISTAL FIMBRIA. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDES: CONFIRMING ABDOMINAL PAIN, PELVIC PAIN, ALLERGY TO NICKEL, DENTAL CARIES. LOT NUMBER:822365 MANUFACTURE DATE: 2011/01 EXPIRATION DATE: 2014/01 LOT NUMBER:825629 MANUFACTURE DATE: 2011/02 EXPIRATION DATE: 2014/02 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED: EVENT WAS ADDED- CONSTANT BLOT AND REPORTER INFORMATION ADDED 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 ('CHRONIC PELVIC PAIN/ PAIN'), ABDOMINAL PAIN ('SEVERE ABDOMINAL PAIN'), UTERINE POLYP ('CANCEROUS POLYPS') AND TOOTH DISORDER ('DENTAL PROBLEMS') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 825629, 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POST-TRAUMATIC STRESS DISORDER IN 2008, DISSOCIAL PERSONALITY DISORDER IN 2008, PARITY 1 IN 2007 AND GRAVIDA I. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: BIRTH CONTROL PILLS FROM 2008 TO (B)(6) 2013 AND DEPO-PROVERA IN 2008. CONCURRENT CONDITIONS INCLUDED ENDOCERVICAL CURETTAGE, CHEST PAIN, GENERALIZED ANXIETY DISORDER, INFECTION, TOOTH DISORDER (WORSENED POST ESSURE PLACEMENT), NICKEL SENSITIVITY (SHE WAS BORN WITH THIS ALLERGY) AND CERVICAL INTRAEPITHELIAL NEOPLASIA III. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"), DYSPAREUNIA ("PAINFUL INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ GAINED 50 LBS."). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/ DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINE HEADACHES"), HEADACHE ("HEADACHES"), EYE DISORDER ("VISION/EYE PROBLEMS") AND VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED UTERINE POLYP (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND NERVOUS SYSTEM DISORDER ("NEUROLOGICAL CONDITIONS OR PROBLEMS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), ALLERGY TO METALS ("ALLERGIC REACTIONS ASSOCIATED WITH NICKEL ALLERGY/ NICKEL ALLERGY"), ABDOMINAL PAIN LOWER ("PAIN IN LOWER ABDOMINAL AREA"), ORAL PAIN ("PAIN IN MOUTH"), ARTHRALGIA ("PAIN IN JOINTS / PAIN IN ANKLE"), PAIN IN EXTREMITY ("PAIN IN HANDS"), VISION BLURRED ("BLURRY VISION") AND ABDOMINAL DISTENSION ("CONSTANT BLOT"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017 TO (B)(6) 2017. THE PATIENT WAS TREATED WITH OXYCODONE AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, LOOP ELECTROSURGICAL EXCISION PROCEDURE AND WISDOM TEETH EXTRACTION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, ORAL PAIN, ARTHRALGIA AND PAIN IN EXTREMITY WAS RESOLVING, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED AND THE UTERINE POLYP, TOOTH DISORDER, WEIGHT INCREASED, ALLERGY TO METALS, NERVOUS SYSTEM DISORDER, VAGINAL HAEMORRHAGE, HEADACHE, EYE DISORDER, VISUAL IMPAIRMENT, VISION BLURRED AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NERVOUS SYSTEM DISORDER, ORAL PAIN, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, UTERINE POLYP, VAGINAL HAEMORRHAGE, VISION BLURRED, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF PLAINTIFF¿S UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES. PELVIC PAIN SECONDARY TO ESSURE DEVICE. THE COIL WAS RELEASED AND PLACEMENT WAS CONFIRMED WITH 3 COILS INTO THE ENDOMETRIAL CAVITY. AS PER DISCHARGE SUMMARY: SURGERY PERFORMED WITHOUT DIFFICULTY OR COMPLICATION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) . HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: FALLOPIAN TUBES ARE FULLY OCCLUDED; IN (B)(6) 2014: RESULTS: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. (B)(6) 2017, SURGICAL PATHOLOGY REPORT SHOWED UTERUS, CERVIX, TUBES ESSURE X2: CHRONIC ENDOCERVICITIS. PROLIFERATIVE ENDOMETRIUM. UNREMARKABLE SEGMENTS OF FALLOPIAN TUBES. GROSS DESCRIPTION: ONE ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.0 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED RED. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. THE OTHER ATTACHED FIMBRIATED FALLOPIAN TUBE MEASURES 6.1 CM IN LENGTH AND UP TO 0.8 CM IN DIAMETER. THE PROXIMAL PORTION IS INKED BLACK. THERE IS A 1.4 X 1.0 X 0.9 CM, HEMORRHAGIC AREA NEAR DISTAL FIMBRIA. THERE IS A METALLIC OBJECT IDENTIFIED AT PROXIMAL PORTION WHEN CUT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDES: CONFIRMING ABDOMINAL PAIN, PELVIC PAIN, ALLERGY TO NICKEL, DENTAL CARIES. LOT NUMBER:822365 MANUFACTURE DATE: 2011/01 EXPIRATION DATE: 2014/01 LOT NUMBER:825629 MANUFACTURE DATE: 2011/02 EXPIRATION DATE: 2014/02 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT) 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 ("CHRONIC PELVIC PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), MENORRHAGIA ("PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES"), ALOPECIA ("HAIR LOSS"), WEIGHT INCREASED ("WEIGHT GAIN") AND ALLERGY TO METALS ("ALLERGIC REACTIONS ASSOCIATED WITH NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A PELVIC SURGERY TO TRY AND ALLEVIATE THE SYMPTOMS) AND SURGERY (TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, WEIGHT INCREASED AND ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF PLAINTIFF¿S UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-NOV-2017: SUMMONS RECEIVED: NEW REPORTER, PRODUCT STOP DATE UPDATE AND EVENTS CHRONIC PELVIC PAIN, WEIGHT GAIN, AND ALLERGIC REACTIONS ASSOCIATED WITH NICKEL ALLERGY WERE ADDED. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), MENORRHAGIA ("PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. REMOVING OF THE ESSURE COILS ALSO REQUIRED REMOVAL OF PLAINTIFF'S UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2014: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED 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 |
|---|---|---|---|---|---|---|---|
| 636710 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 825629, 822365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Hospitalization| O| R |