ESSURE
Report
- Report Number
- 2951250-2018-01053
- Event Type
- Injury
- Date Received
- March 15, 2018
- Date of Event
- July 1, 2012
- Report Date
- May 26, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL HFA) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), 12 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA/ ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN") AND VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL HFA) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), 12 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("MENTAL ANGUISH"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), DYSMENORRHOEA ("DYSMENORRHEA"), FATIGUE ("FATIGUE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER, VULVOVAGINAL PAIN, ABDOMINAL PAIN AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-NOV-2018: PFS RECEIVED. CONCOMITANT DRUG ADDED. EVENT WEIGHT GAIN ADDED. INCIDENT: NO 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PERSISTENT PELVIC PAIN/ PELVIC PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL HFA) SINCE JANUARY 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), 12 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA/ ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN/ ABDOMINAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY RELATED TO ESSURE: YES"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER, WEIGHT INCREASED AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLANTIFF STATES THAT SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PLAINTIFF FACT SHEET RECEIVED : EVENTS ADDED- PSYCHOLOGICAL TRAUMA. OUTCOME OF MENORRHAGIA UPDATED TO ¿RECOVERED / RESOLVED¿. NO VALID LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), DYSMENORRHOEA ("DYSMENORRHEA"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER, VULVOVAGINAL PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2018: PFS AND MEDICAL RECORD RECEIVED: EVENT ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DEPRESSION, MENTAL ANGUISH PUFFY UTERUS, HIGH BLOOD PRESSURE, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, WEIGHT GAIN, MEMORY IMPAIRMENT, APAREUNIA, UPPER RIGHT ABDOMINAL PAIN, VAGINAL CANAL PAIN, FULL ABDOMINAL PAIN, SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST ADDED. REPORTERS, CONCURRENT CONDITION ADDED. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL HFA) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), 12 DAYS AFTER INSERTION OF ESSURE. IN JULY 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA/ ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN") AND VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-FEB-2019: PLAINTIFF FACT SHEET WAS RECEIVED. LOT NUMBER WAS ADDED. OUTCOME OF EVENTS- "PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), DYSPAREUNIA, VAGINAL CANAL PAIN" WAS UPDATED TO RECOVERED / RESOLVED FROM UNKNOWN. REPORTER INFORMATION WAS UPDATED. EVENTS ONSET DATE WAS ADDED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PERSISTENT PELVIC PAIN/ PELVIC PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL HFA) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), 12 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA/ ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN/ ABDOMINAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY RELATED TO ESSURE: YES"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER, WEIGHT INCREASED AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF STATES THAT SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA. LOT NUMBER 962114 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAR-2020: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 ('PERSISTENT PELVIC PAIN/ PELVIC PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL HFA) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), 12 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA/ ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN/ ABDOMINAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY RELATED TO ESSURE: YES"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER, WEIGHT INCREASED AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLAINTIFF STATES THAT SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS IS A RETENTION CASE. ALL THE INFORMATION: REPORTER¿S INFORMATION, REFERENCES DETAILS AND SOURCE DOCUMENTS WERE TRANSFERRED FROM DELETION CASE NO. (B)(4) ((B)(4)). NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 ('PERSISTENT PELVIC PAIN/ PELVIC PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL HFA) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 12 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA/ ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN/ ABDOMINAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY RELATED TO ESSURE: YES"), BALANCE DISORDER ("BALANCE ISSUES") AND FALL ("HAD A SPELL OF FREQUENT FALLS"). THE PATIENT WAS TREATED WITH OCCUPATIONAL THERAPY (OT) AND SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER, WEIGHT INCREASED, PSYCHOLOGICAL TRAUMA, BALANCE DISORDER AND FALL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, BALANCE DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FALL, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLANTIFF STATES THAT SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, ABNORMAL VAGINAL BLEEDING. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: BALANCE ISSUES AND HAD A SPELL OF FREQUENT FALLS. LOT NUMBER 962114 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED.EVENT:ABNORMAL VAGINAL BLEEDING WERE UPDATED TO RECOVERED. 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 ('PERSISTENT PELVIC PAIN/ PELVIC PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ASTHMA, PANCREATITIS AND HEPATIC DISEASE. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL HFA) SINCE (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), 12 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA/ ABNORMAL BLEEDING (MENORRHAGIA)/ MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE") AND ABDOMINAL PAIN ("FULL ABDOMINAL PAIN/ ABDOMINAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN OCTOBER 2015, THE PATIENT EXPERIENCED ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"), UTERINE ENLARGEMENT ("PUFFY UTERUS"), HYPERTENSION ("HIGH BLOOD PRESSURE"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT."), ABDOMINAL PAIN UPPER ("UPPER RIGHT ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL CANAL PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY RELATED TO ESSURE: YES"), BALANCE DISORDER ("BALANCE ISSUES") AND FALL ("HAD A SPELL OF FREQUENT FALLS"). THE PATIENT WAS TREATED WITH OCCUPATIONAL THERAPY (OT) AND SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VULVOVAGINAL PAIN AND ABDOMINAL PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, UTERINE ENLARGEMENT, HYPERTENSION, FATIGUE, MEMORY IMPAIRMENT, FEMALE SEXUAL DYSFUNCTION, ABDOMINAL PAIN UPPER, WEIGHT INCREASED, PSYCHOLOGICAL TRAUMA, BALANCE DISORDER AND FALL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ANXIETY, BALANCE DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FALL, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HYPERTENSION, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, UTERINE ENLARGEMENT, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PLANTIFF STATES THAT SHE RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: BALANCE ISSUES AND HAD A SPELL OF FREQUENT FALLS. LOT NUMBER 962114 IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: NEW EVENTS BALANCE ISSUES AND HAD A SPELL OF FREQUENT FALLS WERE ADDED. 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 ("PERSISTENT PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUAL BLEEDING/MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: SUMMONS RECEIVED- REPORTER INFORMATION ADDED, DEVICE CATEGORY CHANGED FROM DEVICE OTHER EVENT TO INCIDENT AND SHE HAD ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. 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 |
|---|---|---|---|---|---|---|---|
| 186938 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 962114-NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | ALBUTEROL HFA| ALBUTEROL HFA| ALBUTEROL HFA| ALBUTEROL HFA| ALBUTEROL HFA| ALBUTEROL HFA| ALBUTEROL HFA| ALBUTEROL HFA| ALBUTEROL HFA |