ESSURE
Report
- Report Number
- 2951250-2017-02857
- Event Type
- Injury
- Date Received
- August 14, 2017
- Date of Event
- October 1, 2013
- Report Date
- March 6, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN.") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 840014) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CAESAREAN SECTION AND GESTATIONAL DIABETES. CONCURRENT CONDITIONS INCLUDED ANEMIC, MENSES IRREGULAR AND PAIN. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID (VITAMIN C), FERROUS SULFATE, IBUPROFEN AND MACROGOL 3350 (MIRALAX). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), NAUSEA ("NAUSEA"), VOMITING ("VOMITING") AND ANAEMIA ("ANEMIC"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY DA VINCI ROBOTIC ASSIST). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, NAUSEA, VOMITING AND ANAEMIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE, VOMITING AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS EVEN SUBSEQUENTLY FORCED TO UNDERGO ONE OR MORE SURGERIES TO REMOVE ONEOR MORE OF THE ESSURE COILS. OCT-2016 WERE PERFORMED HYSTERECTOMY . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION, (B)(6) 2014, HYSTEROSALPINGOGRAM IMPRESSION: NO ABNORMAL SPILLAGE OF CONTRAST INTO THE PERITONEUM SUGGESTING SUCCESSFUL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA. DYSMENORRHEA . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2018: PFS RECEIVED. NEW EVENT ANEMIC WAS ADDED, THE EVENT WAS SEVERE AFTER ESSURE PLACEMENT. 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 ("PELVIC PAIN/PAIN.") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 840014) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIC. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN OCTOBER 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). IN DECEMBER 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), NAUSEA ("NAUSEA") AND VOMITING ("VOMITING"). THE PATIENT WAS TREATED WITH SURGERY (SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS/ HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, NAUSEA AND VOMITING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE, VOMITING AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS EVEN SUBSEQUENTLY FORCED TO UNDERGO ONE OR MORE SURGERIES TO REMOVE ONEOR MORE OF THE ESSURE COILS. OCT-2016 WERE PERFORMED HYSTERECTOMY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 20-JAN-2014: TOTAL BILATERAL OCCLUSION, MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET, NEW REPORTER INFORMATION, PATIENT DEMOGRAPHIC INFORMATION, LAB DATA, ESSURE INDICATION PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES, LOT NUMBER 840014,NEW EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) ,NAUSEA AND VOMITING 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 PELVIC PAIN ('PELVIC PAIN/PAIN.') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 840014,B40014) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAESAREAN SECTION AND GESTATIONAL DIABETES. (B)(6) 2014, HYSTEROSALPINGOGRAM IMPRESSION: NO ABNORMAL SPILLAGE OF CONTRAST INTO THE PERITONEUM SUGGESTING SUCCESSFUL. CONCURRENT CONDITIONS INCLUDED ANEMIC, MENSES IRREGULAR AND PAIN. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID, FERROUS SULFATE, IBUPROFEN, MACROGOL 3350 (MIRALAX) AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN OCTOBER 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ANAEMIA ("BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), NAUSEA ("NAUSEA") AND VOMITING ("VOMITING"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY DA VINCI ROBOTIC ASSIST). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, NAUSEA, VOMITING AND ANAEMIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE, VOMITING AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS EVEN SUBSEQUENTLY FORCED TO UNDERGO ONE OR MORE SURGERIES TO REMOVE ONEOR MORE OF THE ESSURE COILS. OCT-2016 WERE PERFORMED HYSTERECTOMY. TRAILING COILS: RIGHT: 03. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: RESULTS: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON AN UNKNOWN DATE: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA. DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-FEB-2020: MEDICAL RECORDS RECEIVED: LOT NUMBER, REPORTERS, LAB DATA WERE ADDED. LEGACY DEVICE REPORT NUM: 2951250-2017-02857: MEDWATCH 3500A MFR NUMBER. 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 PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (UNDERGO ONE OR MORE SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, PELVIC PAIN AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF WAS EVEN SUBSEQUENTLY FORCED TO UNDERGO ONE OR MORE SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS. 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 |
|---|---|---|---|---|---|---|---|
| 571857 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 840014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | ASCORBIC ACID| DEPO PROVERA| FERROUS SULFATE| FERROUS SULFATE| IBUPROFEN| IBUPROFEN| MIRALAX| MIRALAX| MIRENA INTRAUTERINE DEVICE| MIRENA INTRAUTERINE DEVICE| MIRENA INTRAUTERINE DEVICE| VITAMIN C |