ESSURE
Report
- Report Number
- 2951250-2017-04718
- Event Type
- Injury
- Date Received
- October 16, 2017
- Date of Event
- April 1, 2012
- Report Date
- December 26, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") IN A 20-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED DESVENLAFAXINE SUCCINATE (PRISTIQ) SINCE 2005 FOR ANXIETY AND DEPRESSION, ARIPIPRAZOLE (ABILIFY) SINCE 2005 FOR BIPOLAR DISORDER, IBUPROFEN (MOTRIN) FOR DYSMENORRHEA AND IBUPROFEN FOR 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), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSES/ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"), DEPRESSION ("PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), ANXIETY ("PSYCHIATRIC PROBLEMS CONDITION:ANXIETY"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND DYSPAREUNIA ("PAIN DURING SEX"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013, UNDERWENT A PARTIAL HYSTERECTOMY) AND SURGERY (ON (B)(6) 2013, UNDERWENT A PARTIAL HYSTERECTOMY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, DEPRESSION, ANXIETY, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, NAUSEA, VAGINAL DISCHARGE, ABDOMINAL PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA, MENORRHAGIA, FATIGUE AND WEIGHT FLUCTUATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE COMPLAINED ABOUT THESE SYMPTOMS TO HER HEALTHCARE PROVIDERS. MORE SPECIFICALLY, DESPITE TREATMENT, HER SYMPTOMS DID NOT IMPROVE AND, AS A RESULT, IN (B)(6) 2013, SHE MET WITH DOCTOR TO DISCUSS VARIOUS TREATMENT OPTIONS, INCLUDING THE POSSIBILITY OF HAVING A HYSTERECTOMY. THEREAFTER, ON (B)(6) 2013, SHE UNDERWENT A PARTIAL HYSTERECTOMY, DURING WHICH UTERUS WAS REMOVED. THE PAINFUL AND INVASIVE PROCEDURE WAS PERFORMED BY DOCTOR. SHE WAS CURRENTLY INVESTIGATING REMOVAL OPTIONS, AS HER SURGERY DID NOT INCLUDE THE REMOVAL OF THE ESSURE MICRO-INSERTS. CONSEQUENTLY, SHE CONTINUES TO SUFFER FROM THE SYMPTOMS OUTLINED ABOVE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 48.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED: EVENTS ADDED FROM PFS- DEPRESSION, ANXIETY, ABNORMAL BLEEDING (VAGINAL), PAIN, WEIGHT GAIN, NAUSEA, VAGINAL DISCHARGE, ABDOMEN PAIN, PAIN DURING SEX. & DYSMENORRHEA (CRAMPING), ABNORMAL BLEEDING (MENORRHAGIA), CLUBBED TO PREVIOUS EVENTS. EVENTS ONSET DATE, LOT NUMBER, HISTORICAL CONDITION WERE ADDED. & REPORTER INFORMATION WERE 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") IN A 20-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED DESVENLAFAXINE SUCCINATE (PRISTIQ) SINCE 2005 FOR ANXIETY AND DEPRESSION, ARIPIPRAZOLE (ABILIFY) SINCE 2005 FOR BIPOLAR DISORDER, IBUPROFEN (MOTRIN) FOR DYSMENORRHEA AND IBUPROFEN FOR 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), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSES/ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"), DEPRESSION ("PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), ANXIETY ("PSYCHIATRIC PROBLEMS CONDITION:ANXIETY"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND DYSPAREUNIA ("PAIN DURING SEX"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013, UNDERWENT A PARTIAL HYSTERECTOMY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, DEPRESSION, ANXIETY, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, NAUSEA, VAGINAL DISCHARGE, ABDOMINAL PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA, MENORRHAGIA, FATIGUE AND WEIGHT FLUCTUATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE COMPLAINED ABOUT THESE SYMPTOMS TO HER HEALTHCARE PROVIDERS. MORE SPECIFICALLY, DESPITE TREATMENT, HER SYMPTOMS DID NOT IMPROVE AND, AS A RESULT, IN (B)(6) 2013, SHE MET WITH DOCTOR TO DISCUSS VARIOUS TREATMENT OPTIONS, INCLUDING THE POSSIBILITY OF HAVING A HYSTERECTOMY. THEREAFTER, ON (B)(6) 2013, SHE UNDERWENT A PARTIAL HYSTERECTOMY, DURING WHICH UTERUS WAS REMOVED. THE PAINFUL AND INVASIVE PROCEDURE WAS PERFORMED BY DOCTOR. SHE WAS CURRENTLY INVESTIGATING REMOVAL OPTIONS, AS HER SURGERY DID NOT INCLUDE THE REMOVAL OF THE ESSURE MICRO-INSERTS. CONSEQUENTLY, SHE CONTINUES TO SUFFER FROM THE SYMPTOMS OUTLINED ABOVE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 48.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. 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 PRODUCT TECHNICAL COMPLAINT. 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 ("PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") IN A 20-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED DESVENLAFAXINE SUCCINATE (PRISTIQ) SINCE 2005 FOR ANXIETY AND DEPRESSION, ARIPIPRAZOLE (ABILIFY) SINCE 2005 FOR BIPOLAR DISORDER, IBUPROFEN (MOTRIN) FOR DYSMENORRHEA AND IBUPROFEN FOR 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), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSES/ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"), DEPRESSION ("PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION"), ANXIETY ("PSYCHIATRIC PROBLEMS CONDITION:ANXIETY"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND DYSPAREUNIA ("PAIN DURING SEX"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013, UNDERWENT A PARTIAL HYSTERECTOMY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, MENORRHAGIA, FATIGUE, WEIGHT FLUCTUATION, DEPRESSION, ANXIETY, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, NAUSEA, VAGINAL DISCHARGE, ABDOMINAL PAIN AND DYSPAREUNIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE COMPLAINED ABOUT THESE SYMPTOMS TO HER HEALTHCARE PROVIDERS. MORE SPECIFICALLY, DESPITE TREATMENT, HER SYMPTOMS DID NOT IMPROVE AND, AS A RESULT, IN (B)(6) 2013, SHE MET WITH DOCTOR TO DISCUSS VARIOUS TREATMENT OPTIONS, INCLUDING THE POSSIBILITY OF HAVING A HYSTERECTOMY. THEREAFTER, ON (B)(6) 2013, SHE UNDERWENT A PARTIAL HYSTERECTOMY, DURING WHICH UTERUS WAS REMOVED. THE PAINFUL AND INVASIVE PROCEDURE WAS PERFORMED BY DOCTOR. SHE WAS CURRENTLY INVESTIGATING REMOVAL OPTIONS, AS HER SURGERY DID NOT INCLUDE THE REMOVAL OF THE ESSURE MICRO-INSERTS. CONSEQUENTLY, SHE CONTINUES TO SUFFER FROM THE SYMPTOMS OUTLINED ABOVE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 48.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-DEC-2018: PLAINTIFF FACT SHEET RECEIVED. OUTCOMES OF EVENT UPDATED TO NOT RECOVERED / NOT RESOLVED. 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 ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") 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 ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("ABNORMALLY SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING/PROLONGED MENSES/ABNORMAL MENSES"), FATIGUE ("FATIGUE") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013, UNDERWENT A PARTIAL HYSTERECTOMY). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA, MENORRHAGIA, FATIGUE AND WEIGHT FLUCTUATION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, FATIGUE, MENORRHAGIA AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE COMPLAINED ABOUT THESE SYMPTOMS TO HER HEALTHCARE PROVIDERS. MORE SPECIFICALLY, DESPITE TREATMENT, HER SYMPTOMS DID NOT IMPROVE AND, AS A RESULT, IN (B)(6) 2013, SHE MET WITH DOCTOR TO DISCUSS VARIOUS TREATMENT OPTIONS, INCLUDING THE POSSIBILITY OF HAVING A HYSTERECTOMY. THEREAFTER, ON (B)(6) 2013, SHE UNDERWENT A PARTIAL HYSTERECTOMY, DURING WHICH UTERUS WAS REMOVED. THE PAINFUL AND INVASIVE PROCEDURE WAS PERFORMED BY DOCTOR. SHE WAS CURRENTLY INVESTIGATING REMOVAL OPTIONS, AS HER SURGERY DID NOT INCLUDE THE REMOVAL OF THE ESSURE MICRO-INSERTS. CONSEQUENTLY, SHE CONTINUES TO SUFFER FROM THE SYMPTOMS OUTLINED ABOVE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM. ON (B)(6) 2012: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. 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 |
|---|---|---|---|---|---|---|---|
| 730589 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Other| R | ABILIFY| ABILIFY| ABILIFY| IBUPROFEN| IBUPROFEN| IBUPROFEN| MOTRIN| MOTRIN| MOTRIN| PRISTIQ| PRISTIQ| PRISTIQ |