ESSURE
Report
- Report Number
- 2951250-2017-02864
- Event Type
- Injury
- Date Received
- August 10, 2017
- Date of Event
- September 1, 2012
- Report Date
- June 15, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE"), PELVIC INFLAMMATORY DISEASE ("INFLAMMATORY PELVIC DYSFUNCTION"), MENSTRUAL DISORDER ("PERSISTENT MENSTRUATION ISSUES"), PELVIC PAIN ("PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANXIETY, FIBROMYALGIA, HYPOGLYCEMIA, GRAVIDA, MULTIGRAVIDA AND PARITY 2. THE PATIENT DENIES ANY PREVIOUS ABDOMINAL SURGERIES. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL DYSPHORIC DISORDER, LOSS OF ENERGY, WEIGHT GAIN, HAIR LOSS, EAR RINGING AND VAGINAL PAIN. CONCOMITANT PRODUCTS INCLUDED NORMENSAL (NECON). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSORIASIS ("FIBROMYALGIA PSORIASIS") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY.), SURGERY (TOTAL VAGINAL HYSTERECTOMY.), SURGERY (IN (B)(6) 2016, UNDERWENT A HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.), SURGERY (TOTAL VAGINAL HYSTERECTOMY), SURGERY (TOTAL VAGINAL HYSTERECTOMY), SURGERY (TOTAL VAGINAL HYSTERECTOMY) AND SURGERY (TOTAL VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHOEA, ALLERGY TO METALS, PSORIASIS AND FIBROMYALGIA OUTCOME WAS UNKNOWN, THE MENSTRUAL DISORDER HAD NOT RESOLVED AND THE PELVIC PAIN, MENORRHAGIA, DYSPAREUNIA AND VAGINAL HAEMORRHAGE WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FIBROMYALGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PSORIASIS AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS REFUSED ALL FORMS OF CONSERVATIVE THERAPY INCLUDING BIRTH CONTROL AND ABLATION DIAGNOSTIC RESULTS: ON (B)(6) 2016 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN THE RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE. THE REMAINING FALLOPIAN TUBE DISPLAYS A PROTRUDING SPIRAL METALLIC WIRE FROM THE ISTHMIC END. CONFIRMING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHEA, PELVIC PAIN. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE"), PELVIC INFLAMMATORY DISEASE ("INFLAMMATORY PELVIC DYSFUNCTION"), MENSTRUAL DISORDER ("PERSISTENT MENSTRUATION ISSUES"), PELVIC PAIN ("PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANXIETY, FIBROMYALGIA, HYPOGLYCEMIA, VAGINAL DELIVERY, GRAVIDA II AND PARITY 2. THE PATIENT DENIES ANY PREVIOUS ABDOMINAL SURGERIES. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL DYSPHORIC DISORDER, LOSS OF ENERGY, WEIGHT GAIN, HAIR LOSS, EAR RINGING AND VAGINAL PAIN. CONCOMITANT PRODUCTS INCLUDED NORMENSAL (NECON). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, MENSTRUAL DISORDER AND PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE MENSTRUAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS REFUSED ALL FORMS OF CONSERVATIVE THERAPY INCLUDING BIRTH CONTROL AND ABLATION. DIAGNOSTIC RESULTS: ON (B)(6) 2016 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN THE RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE. THE REMAINING FALLOPIAN TUBE DISPLAYS A PROTRUDING SPIRAL METALLIC WIRE FROM THE ISTHMIC END. CONFIRMING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHEA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-MAR-2018: PFS+MR RECEIVED, REPORTER ADDED, PATIENT HISTORICAL AND CONCOMITANT CONDITION ADDED, LOT NUMBER RECEIVED, PRODUCT INFORMATION UPDATED, EVENTS ADDED AS FOLLOWS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DEVICE MONITORING PROCEDURE NOT PERFORMED, PELVIC PAIN, DYSPAREUNIA, DYSMENORRHEA, MENORRHAGIA, VAGINAL HEMORRHAGE. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE"), PELVIC INFLAMMATORY DISEASE ("INFLAMMATORY PELVIC DYSFUNCTION"), MENSTRUAL DISORDER ("PERSISTENT MENSTRUATION ISSUES"), PELVIC PAIN ("PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANXIETY, FIBROMYALGIA, HYPOGLYCEMIA, GRAVIDA, MULTIGRAVIDA AND PARITY 2. THE PATIENT DENIES ANY PREVIOUS ABDOMINAL SURGERIES. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL DYSPHORIC DISORDER, LOSS OF ENERGY, WEIGHT GAIN, HAIR LOSS, EAR RINGING AND VAGINAL PAIN. CONCOMITANT PRODUCTS INCLUDED NORMENSAL (NECON). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ALLERGY TO METALS ("NICKEL ALLERGY"), PSORIASIS ("FIBROMYALGIA PSORIASIS"), FIBROMYALGIA ("FIBROMYALGIA"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY.), SURGERY (TOTAL VAGINAL HYSTERECTOMY.), SURGERY (IN (B)(6) 2016, UNDERWENT A HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.), SURGERY (TOTAL VAGINAL HYSTERECTOMY), SURGERY (TOTAL VAGINAL HYSTERECTOMY), SURGERY (TOTAL VAGINAL HYSTERECTOMY) AND SURGERY (TOTAL VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHOEA, ALLERGY TO METALS, PSORIASIS, FIBROMYALGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN, THE MENSTRUAL DISORDER HAD NOT RESOLVED AND THE PELVIC PAIN, MENORRHAGIA, DYSPAREUNIA AND VAGINAL HAEMORRHAGE WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FIBROMYALGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PSORIASIS AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS REFUSED ALL FORMS OF CONSERVATIVE THERAPY INCLUDING BIRTH CONTROL AND ABLATION. DIAGNOSTIC RESULTS: ON (B)(6) 2016 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN THE RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE. THE REMAINING FALLOPIAN TUBE DISPLAYS A PROTRUDING SPIRAL METALLIC WIRE FROM THE ISTHMIC END. CONFIRMING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHEA, PELVIC PAIN. 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 DEPRESSION, MENTAL ANGUISH WERE 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 EMBEDDED DEVICE ("RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE"), PELVIC INFLAMMATORY DISEASE ("INFLAMMATORY PELVIC DYSFUNCTION"), MENSTRUAL DISORDER ("PERSISTENT MENSTRUATION ISSUES"), PELVIC PAIN ("PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANXIETY, FIBROMYALGIA, HYPOGLYCEMIA, GRAVIDA, MULTIGRAVIDA AND PARITY 2. THE PATIENT DENIES ANY PREVIOUS ABDOMINAL SURGERIES. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL DYSPHORIC DISORDER, LOSS OF ENERGY, WEIGHT GAIN, HAIR LOSS, EAR RINGING AND VAGINAL PAIN. CONCOMITANT PRODUCTS INCLUDED NORMENSAL (NECON). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN JANUARY 2016, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSORIASIS ("FIBROMYALGIA PSORIASIS") AND FIBROMYALGIA ("FIBROMYALGIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY.), SURGERY (IN APR-2016, UNDERWENT A HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHOEA, ALLERGY TO METALS, PSORIASIS AND FIBROMYALGIA OUTCOME WAS UNKNOWN, THE MENSTRUAL DISORDER HAD NOT RESOLVED AND THE PELVIC PAIN, MENORRHAGIA, DYSPAREUNIA AND VAGINAL HAEMORRHAGE WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FIBROMYALGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PSORIASIS AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS REFUSED ALL FORMS OF CONSERVATIVE THERAPY INCLUDING BIRTH CONTROL AND ABLATION DIAGNOSTIC RESULTS: ON (B)(6)2016 PATIENT HAD SURGICAL PATHOLOGY REPORT RESULTED IN THE RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE. THE REMAINING FALLOPIAN TUBE DISPLAYS A PROTRUDING SPIRAL METALLIC WIRE FROM THE ISTHMIC END. CONFIRMING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHEA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLAINTIFF FACT SHEET RECEIVED: EVENTS (AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA PSORIASIS, NICKEL ALLERGY) WAS ADDED AND EVENTS OUTCOME UPDATED. 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 EMBEDDED DEVICE ('RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE'), PELVIC INFLAMMATORY DISEASE ('INFLAMMATORY PELVIC DYSFUNCTION'), PELVIC PAIN ('PAIN'), MENSTRUAL DISORDER ('PERSISTENT MENSTRUATION ISSUES'), MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, FIBROMYALGIA, HYPOGLYCEMIA, GRAVIDA, MULTIGRAVIDA AND PARITY 2. THE PATIENT DENIES ANY PREVIOUS ABDOMINAL SURGERIES. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL DYSPHORIC DISORDER, LOSS OF ENERGY, WEIGHT GAIN, HAIR LOSS, EAR RINGING AND VAGINAL PAIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ALLERGY TO METALS ("NICKEL ALLERGY"), PSORIASIS ("FIBROMYALGIA PSORIASIS"), FIBROMYALGIA ("FIBROMYALGIA"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHOEA, ALLERGY TO METALS, PSORIASIS, FIBROMYALGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE PELVIC PAIN, MENORRHAGIA, DYSPAREUNIA AND VAGINAL HAEMORRHAGE WAS RESOLVING AND THE MENSTRUAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FIBROMYALGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PSORIASIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS REFUSED ALL FORMS OF CONSERVATIVE THERAPY INCLUDING BIRTH CONTROL AND ABLATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2016: SURGICAL PATHOLOGY REPORT RESULTED IN THE RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE. THE REMAINING FALLOPIAN TUBE DISPLAYS A PROTRUDING SPIRAL METALLIC WIRE FROM THE ISTHMIC END. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHEA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAR-2020: PFS RECEIVED. REPORTER'S INFORMATION ADDED. EVENTS: ABDOMINAL PAIN , WEIGHT GAIN WERE ADDED. 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 EMBEDDED DEVICE ('RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE'), PELVIC INFLAMMATORY DISEASE ('INFLAMMATORY PELVIC DYSFUNCTION'), PELVIC PAIN ('PAIN'), MENSTRUAL DISORDER ('PERSISTENT MENSTRUATION ISSUES'), MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, FIBROMYALGIA, HYPOGLYCEMIA, GRAVIDA, MULTIGRAVIDA AND PARITY 2. THE PATIENT DENIES ANY PREVIOUS ABDOMINAL SURGERIES. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL DYSPHORIC DISORDER, LOSS OF ENERGY, WEIGHT GAIN, HAIR LOSS, EAR RINGING AND VAGINAL PAIN. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORETHISTERONE ACETATE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL), NAPROXEN AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ALLERGY TO METALS ("NICKEL ALLERGY"), PSORIASIS ("FIBROMYALGIA PSORIASIS"), FIBROMYALGIA ("FIBROMYALGIA"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS") AND HYPERSENSITIVITY ("ALLERGIC REACTION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2016, UNDERWENT A HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE., TOTAL VAGINAL HYSTERECTOMY AND TOTAL VAGINAL HYSTERECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, PSORIASIS, FIBROMYALGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL HAEMORRHAGE, ALLERGY TO METALS, ABDOMINAL PAIN AND HYPERSENSITIVITY HAD RESOLVED AND THE MENSTRUAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FIBROMYALGIA, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PSORIASIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS REFUSED ALL FORMS OF CONSERVATIVE THERAPY INCLUDING BIRTH CONTROL AND ABLATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2016: SURGICAL PATHOLOGY REPORT RESULTED IN THE RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE. THE REMAINING FALLOPIAN TUBE DISPLAYS A PROTRUDING SPIRAL METALLIC WIRE FROM THE ISTHMIC END. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHEA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-JUN-2020: PFS RECEIVED OUTCOME OF EVENT " ABDOMINAL PAIN" WAS UPDATED AS RECOVERED. CONCOMITANT DRUGS WERE 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 EMBEDDED DEVICE ('RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE'), PELVIC INFLAMMATORY DISEASE ('INFLAMMATORY PELVIC DYSFUNCTION'), PELVIC PAIN ('PAIN'), MENSTRUAL DISORDER ('PERSISTENT MENSTRUATION ISSUES'), MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, FIBROMYALGIA, HYPOGLYCEMIA, GRAVIDA, MULTIGRAVIDA AND PARITY 2. THE PATIENT DENIES ANY PREVIOUS ABDOMINAL SURGERIES. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL DYSPHORIC DISORDER, LOSS OF ENERGY, WEIGHT GAIN, HAIR LOSS, EAR RINGING AND VAGINAL PAIN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ALLERGY TO METALS ("NICKEL ALLERGY"), PSORIASIS ("FIBROMYALGIA PSORIASIS"), FIBROMYALGIA ("FIBROMYALGIA"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS") AND HYPERSENSITIVITY ("ALLERGIC REACTION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2016, UNDERWENT A HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE, TOTAL VAGINAL HYSTERECTOMY AND TOTAL VAGINAL HYSTERECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, PSORIASIS, FIBROMYALGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED, ABDOMINAL PAIN AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL HAEMORRHAGE, ALLERGY TO METALS AND HYPERSENSITIVITY HAD RESOLVED AND THE MENSTRUAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FIBROMYALGIA, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PSORIASIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS REFUSED ALL FORMS OF CONSERVATIVE THERAPY INCLUDING BIRTH CONTROL AND ABLATION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2016: SURGICAL PATHOLOGY REPORT RESULTED IN THE RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE. THE REMAINING FALLOPIAN TUBE DISPLAYS A PROTRUDING SPIRAL METALLIC WIRE FROM THE ISTHMIC END. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHEA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. REPORTER INFORMATION ADDED. EVENT: ALLERGIC REACTION ADDED. EVENT OUTCOME FOR PREVIOUSLY REPORTED EVENT ABNORMAL BLEEDING (VAGINAL) WAS UPDATED TO RECOVERED/RESOLVED. 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 EMBEDDED DEVICE ('RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE'), PELVIC INFLAMMATORY DISEASE ('INFLAMMATORY PELVIC DYSFUNCTION'), PELVIC PAIN ('PAIN'), MENSTRUAL DISORDER ('PERSISTENT MENSTRUATION ISSUES'), MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND DYSPAREUNIA ('DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ANXIETY, FIBROMYALGIA, HYPOGLYCEMIA, GRAVIDA, MULTIGRAVIDA AND PARITY 2. THE PATIENT DENIES ANY PREVIOUS ABDOMINAL SURGERIES. CONCURRENT CONDITIONS INCLUDED PREMENSTRUAL DYSPHORIC DISORDER, LOSS OF ENERGY, WEIGHT GAIN, HAIR LOSS, EAR RINGING AND VAGINAL PAIN. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ALLERGY TO METALS ("NICKEL ALLERGY"), PSORIASIS ("FIBROMYALGIA PSORIASIS"), FIBROMYALGIA ("FIBROMYALGIA"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6)2016, UNDERWENT A HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE., TOTAL VAGINAL HYSTERECTOMY AND TOTAL VAGINAL HYSTERECTOMY.). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, PSORIASIS, FIBROMYALGIA, DEPRESSION, ANXIETY, WEIGHT INCREASED, ABDOMINAL PAIN AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND ALLERGY TO METALS HAD RESOLVED, THE MENSTRUAL DISORDER HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FIBROMYALGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PSORIASIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: HAS REFUSED ALL FORMS OF CONSERVATIVE THERAPY INCLUDING BIRTH CONTROL AND ABLATION DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST. ON (B)(6) 2016: SURGICAL PATHOLOGY REPORT RESULTED IN THE RIGHT FALLOPIAN TUBE STUMP CONTAINS AN EMBEDDED SPIRALED METALLIC WIRE. THE REMAINING FALLOPIAN TUBE DISPLAYS A PROTRUDING SPIRAL METALLIC WIRE FROM THE ISTHMIC END.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: EMBEDDED DEVICE, PELVIC INFLAMMATORY DISEASE, DYSMENORRHEA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: PFS RECEIVED: NEW EVENT ADDED- POST PROCEDURAL COMPLICATION. EVENT OUTCOME OF PELVIC PAIN, NICKEL ALLERGY AND MENORRHAGIA WAS UPDATED AS RECOVERED/RESOLVED. 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 MENSTRUAL DISORDER ("PERSISTENT MENSTRUATION ISSUES") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2016, UNDERWENT A HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE.). AT THE TIME OF THE REPORT, THE MENSTRUAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED MENSTRUAL DISORDER 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 |
|---|---|---|---|---|---|---|---|
| 566193 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ACETAMINOPHEN| NAPROXEN| NECON| NECON| NECON| NECON| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS |