ESSURE
Report
- Report Number
- 2951250-2017-02045
- Event Type
- Injury
- Date Received
- June 8, 2017
- Date of Event
- June 12, 2012
- Report Date
- July 30, 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 FALLOPIAN TUBE PERFORATION ("ON HER FALLOPIAN TUBES, ON THE LEFT SIDE PERFORATION OF THE ESSURE DEVICE THROUGH THE TUBE MESOSALPINX, ON THE RIGHT SIDE THERE ALSO WAS A PERFORATION OF THE COILS FROM THE ESSURE BUT DID NOT GO IN TO THE MESOSALPINX ON THAT SIDE"), UTERINE PERFORATION ("PERFORATION (UTERUS)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627074) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE OF FALLOPIAN TUBE OCCLUSION WITH HER ESSURE PROCEDURE (PATENT FALLOPIAN TUBES BILATERALLY)" ON (B)(6) 2012. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: VITAMIN B12 FROM 2007 TO 2008, VITAMIN B1 FROM 2007 TO 2008 AND ANTI DEPRESSANT IN 2005. CONCURRENT CONDITIONS INCLUDED MENOPAUSAL SYMPTOMS SINCE (B)(6) 2012, HOT FLASHES SINCE (B)(6) 2012, WEIGHT GAIN SINCE (B)(6) 2012, NIGHT SWEATS SINCE (B)(6) 2012, MORBID OBESITY, MENSTRUAL DISORDER SINCE (B)(6) 2012, HEADACHE SINCE (B)(6) 2013, BUNIONECTOMY SINCE (B)(6) 2013, ADENOMYOSIS SINCE (B)(6) 2013, DYSFUNCTIONAL UTERINE BLEEDING SINCE (B)(6) 2013 AND CERVICAL POLYP SINCE (B)(6) 2013. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (MINI-PILL) SINCE 2007 FOR BIRTH CONTROL AS WELL AS MULTIVITAMIN SINCE 2007. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAIN, SEVERE MENSTRUAL PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY (FULL) AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE HAEMORRHAGE, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2012, (B)(6) 2012. DOCTOR COULD NOT VISUALIZE THE OPENING OF THE FALLOPIAN TUBES DUE TO MENSTRUAL DEBRIS, SO THE PROCEDURE WAS STOPPED AFTER 3 MINUTES AND PERFORMED ON (B)(6) 2012 AND DATE RECEIVED ON (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FAILURE OF FALLOPIAN TUBE OCCLUSION (PATENT) THEN FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: UTERINE HAEMORRHAGE (CONFIRMING VAGINAL HAEMORRHAGE). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- PERFORATION (UTERUS). HISTORICAL DRUG ADDED. ESSURE IMPLANT DATE WAS UPDATED TO (B)(6) 2012 (PREVIOUSLY REPORTED AS (B)(6) 2012). 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 FALLOPIAN TUBE PERFORATION ("ON HER FALLOPIAN TUBES, ON THE LEFT SIDE PERFORATION OF THE ESSURE DEVICE THROUGH THE TUBE MESOSALPINX, ON THE RIGHT SIDE THERE ALSO WAS A PERFORATION OF THE COILS FROM THE ESSURE BUT DID NOT GO IN TO THE MESOSALPINX ON THAT SIDE."), ABDOMINAL PAIN LOWER ("PAIN, LOWER ABDOMINAL PAIN") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627074) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE OF FALLOPIAN TUBE OCCLUSION WITH HER ESSURE PROCEDURE (PATENT FALLOPIAN TUBES BILATERALLY)" ON (B)(6) 2012. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENOPAUSAL SYMPTOMS SINCE (B)(6) 2012, HOT FLASHES SINCE (B)(6) 2012, WEIGHT GAIN SINCE (B)(6) 2012, NIGHT SWEATS SINCE (B)(6) 2012, MORBID OBESITY, MENSTRUAL DISORDER SINCE (B)(6) 2012, PELVIC PAIN SINCE (B)(6) 2013, HEADACHE SINCE (B)(6) 2013, FOOT SURGERY SINCE (B)(6) 2013, ADENOMYOSIS SINCE (B)(6) 2013, DYSFUNCTIONAL UTERINE BLEEDING SINCE (B)(6) 2013, PELVIC PAIN SINCE (B)(6) 2013 AND CERVICAL POLYP SINCE (B)(6) 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 1 MONTH 7 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("PAIN, SEVERE MENSTRUAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE HAEMORRHAGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2012, (B)(6) 2012. DOCTOR COULD NOT VISUALIZE THE OPENING OF THE FALLOPIAN TUBES DUE TO MENSTRUAL DEBRIS, SO THE PROCEDURE WAS STOPPED AFTER 3 MINUTES AND PERFORMED ON (B)(6) 2012 AND DATE RECEIVED ON (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FAILURE OF FALLOPIAN TUBE OCCLUSION (PATENT). CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: UTERINE HAEMORRHAGE (CONFIRMING VAGINAL HAEMORRHAGE) MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS AND MR RECEIVED: NEW REPORTERS, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT INDICATION UPDATED, LOT NO, CONCOMITANT DISEASE, NEW EVENTS FALLOPIAN TUBE PERFORATION, VAGINAL HAEMORRHAGE AND UTERINE HAEMORRHAGE ADDED. OUTCOME FOR THE EVENTS ABDOMINAL PAIN LOWER, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA, DYSMENORRHOEA, DEVICE INEFFECTIVE ADDED AS RECOVERED / RESOLVED. 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 FALLOPIAN TUBE PERFORATION ("ON HER FALLOPIAN TUBES, ON THE LEFT SIDE PERFORATION OF THE ESSURE DEVICE THROUGH THE TUBE MESOSALPINX, ON THE RIGHT SIDE THERE ALSO WAS A PERFORATION OF THE COILS FROM THE ESSURE BUT DID NOT GO IN TO THE MESOSALPINX ON THAT SIDE"), UTERINE PERFORATION ("PERFORATION (UTERUS)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 627074) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "FAILURE OF FALLOPIAN TUBE OCCLUSION WITH HER ESSURE PROCEDURE (PATENT FALLOPIAN TUBES BILATERALLY)" ON 16-JUN-2012. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: VITAMIN B12 FROM 2007 TO 2008, VITAMIN B1 FROM 2007 TO 2008 AND ANTI DEPRESSANT IN 2005. CONCURRENT CONDITIONS INCLUDED MENOPAUSAL SYMPTOMS SINCE (B)(6) 2012, HOT FLASHES SINCE (B)(6) 2012, WEIGHT GAIN SINCE (B)(6) 2012, NIGHT SWEATS SINCE (B)(6) 2012, MORBID OBESITY, MENSTRUAL DISORDER SINCE (B)(6) 2012, HEADACHE SINCE (B)(6) 2013, BUNIONECTOMY SINCE (B)(6) 2013, ADENOMYOSIS SINCE (B)(6) 2013, DYSFUNCTIONAL UTERINE BLEEDING SINCE (B)(6) 2013 AND CERVICAL POLYP SINCE (B)(6) 2013. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (MINI-PILL) SINCE 2007 FOR BIRTH CONTROL AS WELL AS MULTIVITAMIN SINCE 2007. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAIN, SEVERE MENSTRUAL PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN OCTOBER 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER AND UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UAND SURGERY TERINE PERFORATION AND UTERINE HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, UTERINE HAEMORRHAGE, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2012. DOCTOR COULD NOT VISUALIZE THE OPENING OF THE FALLOPIAN TUBES DUE TO MENSTRUAL DEBRIS, SO THE PROCEDURE WAS STOPPED AFTER 3 MINUTES AND PERFORMED ON (B)(6) 2012 AND DATE RECEIVED ON 14FEB2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 12-JUN-2012: FAILURE OF FALLOPIAN TUBE OCCLUSION (PATENT) THEN FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: UTERINE HAEMORRHAGE (CONFIRMING VAGINAL HAEMORRHAGE) QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-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 ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL 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 INEFFECTIVE "FAILURE OF FALLOPIAN TUBE OCCLUSION WITH HER ESSURE PROCEDURE (PATENT FALLOPIAN TUBES BILATERALLY)". 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), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN") AND DYSPAREUNIA ("PAIN DURING INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, MENORRHAGIA, DYSMENORRHOEA AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA AND MENORRHAGIA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FAILURE OF FALLOPIAN TUBE OCCLUSION (PATIENT). COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 406173 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 627074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other| R | MINI-PILL| MINI-PILL| MULTIVITAMIN| MULTIVITAMIN |