ESSURE
Report
- Report Number
- 2951250-2017-07863
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- August 20, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED STOMACH PAIN, ANEMIA AND PELVIC ADHESIONS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) FROM JULY 2014 TO JUNE 2015 FOR BIRTH CONTROL. ON (B)(6) 2012, 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 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), DECREASED APPETITE ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: LOSS OF APPETITE"), ABDOMINAL PAIN ("ABDOMEN PAIN"), BACK PAIN ("LOWER BACK PAIN, IRRADIATING TO LEGS") AND NEURALGIA ("NERVE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE EXPULSION, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DECREASED APPETITE AND BACK PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL DISTENSION, DYSMENORRHOEA, ABDOMINAL PAIN AND NEURALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DECREASED APPETITE, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, NEURALGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY MIRENA USE -THE ESSURE WAS NO LONGER IN PLACE,FAILED MEDICAL MANAGEMENT UP TO MIRENA INTRAUTERINE DEVICE PLACEMENT DIAGNOSTIC RESULTS: (B)(6) 2013: HYSTEROSALPINGOGRAM: TOTAL BILATERAL OCCLUSION, EVERYTHING LOOKS GOOD. IMPRESSION: SATISFACTORY POSITION OF ESSURE IMPLANTS BOTH SIDES. COMPLETE OCCLUSION OF BOTH FALLOPIAN TUBES. NORMAL ENDOMETRIAL SPACE (AS PER MR). SURGICAL PATHOLOGY: FINAL PATHOLOGIC DIAGNOSIS: A UTERUS (161 GRAMS) AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: - MILD CHRONIC CERVICITIS WITH PROMINENT NABOTHIAN CYSTS AND SQUAMOUS METAPLASIA. - SECRETORY ENDOMETRIUM. - INTRAMURAL ADENOMYOMAS, UP TO 2.8 CM IN GREATEST DIMENSION, BENIGN. - BENIGN FALLOPIAN TUBES. - SMALL METALLIC SURGICAL COILS (2), GROSS ONLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS:MENORRHAGIA, DYSMENORRHEA,LOSS OF APETITE, DEVICE DISLOCATION . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS VAGINAL BLEEDING, MENORRHAGIA, DYSMENORRHEA, LOSS OF APPETITE, PELVIC PAIN, BACK PAIN, NERVE PAIN, DEVICE EXPULSION WERE ADDED. LOT NUMBER & LAB DATA UPDATED. CONCOMITANT & HISTORICAL DRUGS , CONDITIONS WERE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT"), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 955814) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED STOMACH PAIN, ANEMIA AND PELVIC ADHESIONS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) FROM (B)(6) 2014 TO (B)(6) 2015 FOR BIRTH CONTROL. ON (B)(6) 2012, 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 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING"), ABDOMINAL DISTENSION ("BLOATING"), DECREASED APPETITE ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: LOSS OF APPETITE"), ABDOMINAL PAIN ("ABDOMEN PAIN"), BACK PAIN ("LOWER BACK PAIN, IRRADIATING TO LEGS") AND NEURALGIA ("NERVE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE EXPULSION, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DECREASED APPETITE AND BACK PAIN OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABDOMINAL DISTENSION, DYSMENORRHOEA, ABDOMINAL PAIN AND NEURALGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DECREASED APPETITE, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, NEURALGIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. MIRENA USE -THE ESSURE WAS NO LONGER IN PLACE. DIAGNOSTIC RESULTS: (B)(6) 2013: HYSTEROSALPINGOGRAM: TOTAL BILATERAL OCCLUSION, EVERYTHING LOOKS GOOD. IMPRESSION: SATISFACTORY POSITION OF ESSURE IMPLANTS BOTH SIDES. COMPLETE OCCLUSION OF BOTH FALLOPIAN TUBES. NORMAL ENDOMETRIAL SPACE (AS PER MR). SURGICAL PATHOLOGY: FINAL PATHOLOGIC DIAGNOSIS: A UTERUS (161 GRAMS) AND BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: MILD CHRONIC CERVICITIS WITH PROMINENT NABOTHIAN CYSTS AND SQUAMOUS METAPLASIA. SECRETORY ENDOMETRIUM. INTRAMURAL ADENOMYOMAS, UP TO 2.8 CM IN GREATEST DIMENSION, BENIGN. BENIGN FALLOPIAN TUBES. SMALL METALLIC SURGICAL COILS (2), GROSS ONLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS:MENORRHAGIA, DYSMENORRHEA,LOSS OF APPETITE, DEVICE DISLOCATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-AUG-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 DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING") AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, DEVICE DISLOCATION AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. 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 |
|---|---|---|---|---|---|---|---|
| 835205 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 955814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | MIRENA| MIRENA |