ESSURE
Report
- Report Number
- 2951250-2017-07333
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- May 17, 2017
- Report Date
- August 13, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626598) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 5 ((B)(6) 1998, (B)(6) 2001, (B)(6) 2003, (B)(6) 2004, (B)(6) 2008), CESAREAN SECTION, ECTOPIC PREGNANCY (ECTOPIC PREGNANCY WITH LAPAROTOMY) IN 2000, UTERINE BLEEDING AND ENDOMETRIAL BIOPSY. CONCURRENT CONDITIONS INCLUDED BIPOLAR DISORDER, TYPE 2 DIABETES MELLITUS AND PELVIC ADHESIONS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2008 TO (B)(6) 2009 FOR CONTRACEPTION AND GENITAL BLEEDING AS WELL AS DOXEPIN, GABAPENTIN AND OLANZAPINE (ZYPREXA). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, 24 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA,"), MENORRHAGIA ("PROLONGED MENSES / ABNORMAL BLEEDING (MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2009, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). ON (B)(6) 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ABDOMINAL PAIN LOWER AND BACK PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LEFT SALPINGECTOMY, EXTENSIVE LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, UTERINE HAEMORRHAGE, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, FATIGUE, HEADACHE, DEPRESSION, ANXIETY AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE AUTOIMMUNE DISORDER, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, DYSPAREUNIA, MIGRAINE, ALOPECIA, VAGINAL DISCHARGE AND NAUSEA HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, UTERINE HAEMORRHAGE, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING EARLY IN 2009, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DEVICE ACTIVATED AND 3 COILS REMAINED FOLLOWING PLACEMENT. THE DEVICE WAS ACTIVATED AND 2 COILS REMAINED FOLLOWING PLACEMENT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2009: FULL OCCLUSION OF BOTH FALLOPIAN TUBES ON (B)(6) 2008, PLAINTIFF HAD AN HYSTEROSALPINGOGRAM TEST PERFORMED. ON (B)(6) 2017 PATIENT HAD SURGICAL PATHOLOGY REPORT UTERUS WITH LEFT TUBE, HYSTERECTOMY WITH LEFT SALPINGECTOMY: CERVIX: NO HISTOPATHOLOGIC ABNORMALITIES. ENDOMETRIUM: BENIGN ENDOMETRIAL POLYP. PROLIFERATIVE PHASE ENDOMETRIUM. MYOMETRIUM: LEIOMYOMA. ESSURE COIL IN SITU IN RIGHT CORNU. LEFT FALLOPIAN TUBE: ESSURE COIL IN SITU. ESSURE COILS IN THE LUMEN OF THE RIGHT CORNU AND ISTHMUS OF THE LEFT FALLOPIAN TUBE. CONFIRMING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: VAGINAL HEMORRHAGE, UTERINE HEMORRHAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-AUG-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 UTERINE PERFORATION ("PERFORATION (UTERUS)"), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626598) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 5 (B)(6) 1998, (B)(6) 2001, (B)(6) 2003, (B)(6) 2004, (B)(6) 2004), CESAREAN SECTION, ECTOPIC PREGNANCY (ECTOPIC PREGNANCY WITH LAPAROTOMY) IN 2000, UTERINE BLEEDING AND ENDOMETRIAL BIOPSY. CONCURRENT CONDITIONS INCLUDED BIPOLAR DISORDER, TYPE 2 DIABETES MELLITUS AND PELVIC ADHESIONS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2008 TO (B)(6) 2009 FOR CONTRACEPTION AND GENITAL BLEEDING AS WELL AS DOXEPIN, GABAPENTIN AND OLANZAPINE (ZYPREXA). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, 24 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA,"), MENORRHAGIA ("PROLONGED MENSES / ABNORMAL BLEEDING (MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2009, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). ON (B)(6) 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). ON (B)(6) 2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ABDOMINAL PAIN LOWER AND BACK PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LEFT SALPINGECTOMY, EXTENSIVE LYSIS OF ADHESIONS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, UTERINE HAEMORRHAGE, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, FATIGUE, HEADACHE, DEPRESSION, ANXIETY AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE AUTOIMMUNE DISORDER, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, DYSPAREUNIA, MIGRAINE, ALOPECIA, VAGINAL DISCHARGE AND NAUSEA HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, UTERINE HAEMORRHAGE, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING EARLY IN 2009, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DEVICE ACTIVATED AND 3 COILS REMAINED FOLLOWING PLACEMENT. THE DEVICE WAS ACTIVATED AND 2 COILS REMAINED FOLLOWING PLACEMENT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2009: FULL OCCLUSION OF BOTH FALLOPIAN TUBES ON (B)(6) 2008, PLAINTIFF HAD AN HYSTEROSALPINGOGRAM TEST PERFORMED. ON (B)(6) 2017 PATIENT HAD SURGICAL PATHOLOGY REPORT UTERUS WITH LEFT TUBE, HYSTERECTOMY WITH LEFT SALPINGECTOMY: CERVIX: NO HISTOPATHOLOGIC ABNORMALITIES. ENDOMETRIUM: BENIGN ENDOMETRIAL POLYP. PROLIFERATIVE PHASE ENDOMETRIUM. MYOMETRIUM: LEIOMYOMA. ESSURE COIL IN SITU IN RIGHT CORNU. LEFT FALLOPIAN TUBE: ESSURE COIL IN SITU. ESSURE COILS IN THE LUMEN OF THE RIGHT CORNU AND ISTHMUS OF THE LEFT FALLOPIAN TUBE. CONFIRMING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: VAGINAL HEMORRHAGE, UTERINE HEMORRHAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING. 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 UTERINE PERFORATION ("PERFORATION (UTERUS)"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626598) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 5 (15NOV1998, 27JAN2001, 21JAN2003, 19SEP2004, 04OCT2008), CESAREAN SECTION, ECTOPIC PREGNANCY (ECTOPIC PREGNANCY WITH LAPAROTOMY) IN 2000, UTERINE BLEEDING AND ENDOMETRIAL BIOPSY. CONCURRENT CONDITIONS INCLUDED BIPOLAR DISORDER, TYPE 2 DIABETES MELLITUS AND PELVIC ADHESIONS. CONCOMITANT PRODUCTS INCLUDED DOXEPIN, GABAPENTIN, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND OLANZAPINE (ZYPREXA). ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON 1-NOV-2008, 24 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA,"), MENORRHAGIA ("PROLONGED MENSES / ABNORMAL BLEEDING (MENORRHAGIA),"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON 1-JAN-2009, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON 1-FEB-2009, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). ON 1-SEP-2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"), HEADACHE ("HEADACHES") AND NAUSEA ("NAUSEA"). ON 17-MAY-2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LEFT SALPINGECTOMY, EXTENSIVE LYSIS OF ADHESIONS) AND SURGERY (HYSTEROSCOPY; DILATION AND CURETTAGE OF UTERUS.). ESSURE WAS REMOVED ON 17-MAY-2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, FATIGUE, HEADACHE, DEPRESSION, ANXIETY AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER, AUTOIMMUNE DISORDER, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE, ALOPECIA, VAGINAL DISCHARGE AND NAUSEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, AUTOIMMUNE DISORDER, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, UTERINE HAEMORRHAGE, UTERINE LEIOMYOMA, UTERINE PERFORATION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING EARLY IN 2009, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DEVICE ACTIVATED AND 3 COILS REMAINED FOLLOWING PLACEMENT. THE DEVICE WAS ACTIVATED AND 2 COILS REMAINED FOLLOWING PLACEMENT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 9-JAN-2009: FULL OCCLUSION OF BOTH FALLOPIAN TUBES ON10-NOV-2008, PLAINTIFF HAD AN HYSTEROSALPINGOGRAM TEST PERFORMED. ON 17-MAY-2017 PATIENT HAD SURGICAL PATHOLOGY REPORT UTERUS WITH LEFT TUBE, HYSTERECTOMY WITH LEFT SALPINGECTOMY: - CERVIX: NO HISTOPATHOLOGIC ABNORMALITIES. - ENDOMETRIUM: BENIGN ENDOMETRIAL POLYP. PROLIFERATIVE PHASE ENDOMETRIUM. - MYOMETRIUM: LEIOMYOMA. ESSURE COIL IN SITU IN RIGHT CORNU. - LEFT FALLOPIAN TUBE: ESSURE COIL IN SITU. ESSURE COILS IN THE LUMEN OF THE RIGHT CORNU AND ISTHMUS OF THE LEFT FALLOPIAN TUBE. CONFIRMING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: VAGINAL HEMORRHAGE, UTERINE HEMORRHAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-MAR-2018: PFS+MR RECEIVED, :- REPORTER ADDED, CONCOMITANT AND HISTORICAL CONDITION ADDED, PRODUCT INFORMATION ADDED, LOT NUMBER ADDED, EVENTS ADDED AS FOLLOWS:- VAGINAL HAEMORRHAGE, FATIGUE, HEADACHE, NAUSEA, PELVIC PAIN, UTERINE PERFORATION, DEPRESSION, ANXIETY, UTERINE LEIOMYOMA, UTERINE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 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") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LEFT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, AUTOIMMUNE DISORDER, DYSMENORRHOEA, MENSTRUAL DISORDER, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE, ALOPECIA AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, AUTOIMMUNE DISORDER, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BEGINNING EARLY IN 2009, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. DIAGNOSTIC RESULTS: ON (B)(6) 2008, PLAINTIFF HAD AN HYSTEROSALPINGOGRAM TEST PERFORMED. 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 |
|---|---|---|---|---|---|---|---|
| 835465 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 626598 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DOXEPIN| DOXEPIN| DOXEPIN| GABAPENTIN| GABAPENTIN| GABAPENTIN| ZYPREXA| ZYPREXA| ZYPREXA |