ESSURE
Report
- Report Number
- 2951250-2017-10262
- Event Type
- Injury
- Date Received
- December 7, 2017
- Report Date
- October 5, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901330, 919033) INSERTED FOR FEMALE STERILIZATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/HEAVY MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), WEIGHT INCREASED ("WEIGHT GAIN"), HIRSUTISM ("HAIR ON FACE"), OVARIAN CYST ("MULTIPLE SMALL CYSTS WITHIN OVARIES") AND MENSTRUATION IRREGULAR ("IRREGULAR MENSES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, WEIGHT INCREASED, HIRSUTISM, OVARIAN CYST AND MENSTRUATION IRREGULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, HIRSUTISM, MENORRHAGIA, MENSTRUATION IRREGULAR, OVARIAN CYST, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD THE NEED FOR ADDITIONAL SURGERY. PER MR: INSERTION DETAILS: HYSTEROSCOPIC STERILIZATION PROCEDURE FOR ELECTIVE PERMANENT STERILIZATION. IT WENT QUITE WELL. WE HAD ONE RING PRESENT ON THE RIGHT. TWO RINGS PRESENT ON THE LEFT. EASY PLACEMENT NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2014: SHOWED A CYST ON THE RIGHT OVARY AT 5-6 CM HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION ULTRASOUND PELVIS TRANSABDOMINAL AND TRANSVAGINAL REVEALED ENDOMETRIAL STRIPE MEASURES 5 MM. NO MYOMETRIAL MASS. RIGHT OVARY CONTAINS A CYST OR MORE LIKELY DOMINANT FOLLICLE MEASURING 2.4 X 2.5 X 2.4 CM. NORMAL LEFT OVARY. NO FREE FLUID. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: CONFIRMING PELVIC PAIN." LOT NUMBER: 901330, MAN DATE: SEP-2011, EXP DATE: SEP-2014. LOT NUMBER: 919033, MAN DATE: NOV-2011, EXP DATE: NOV-2014, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901330, 919033) INSERTED FOR FEMALE STERILIZATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/HEAVY MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), WEIGHT INCREASED ("WEIGHT GAIN"), HIRSUTISM ("HAIR ON FACE"), OVARIAN CYST ("MULTIPLE SMALL CYSTS WITHIN OVARIES") AND MENSTRUATION IRREGULAR ("IRREGULAR MENSES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, WEIGHT INCREASED, HIRSUTISM, OVARIAN CYST AND MENSTRUATION IRREGULAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, HIRSUTISM, MENORRHAGIA, MENSTRUATION IRREGULAR, OVARIAN CYST, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD THE NEED FOR ADDITIONAL SURGERY. PER MR: INSERTION DETAILS: HYSTEROSCOPIC STERILIZATION PROCEDURE FOR ELECTIVE PERMANENT STERILIZATION. IT WENT QUITE WELL. WE HAD ONE RING PRESENT ON THE RIGHT. TWO RINGS PRESENT ON THE LEFT. EASY PLACEMENT NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2014: SHOWED A CYST ON THE RIGHT OVARY AT 5-6 CM HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION ULTRASOUND PELVIS TRANSABDOMINAL AND TRANSVAGINAL REVEALED ENDOMETRIAL STRIPE MEASURES 5 MM. NO MYOMETRIAL MASS. RIGHT OVARY CONTAINS A CYST OR MORE LIKELY DOMINANT FOLLICLE MEASURING 2.4 X 2.5 X 2.4 CM. NORMAL LEFT OVARY. NO FREE FLUID. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: CONFIRMING PELVIC PAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: REPORTER INFORMATION WAS ADDED. THIS CASE CONCERNS ADULT PATIENT. LAB DATA WAS ADDED. ESSURE INSERTION AND REMOVAL DATE WAS ADDED. ESSURE LOT NUMBER WAS ADDED. ESSURE INDICATION WAS ADDED. PER PFS: FOLLOWING EVENTS: ABNORMAL BLEEDING (MENORRHAGIA)/HEAVY MENSES, IRREGULAR MENSES; ABNORMAL BLEEDING (VAGINAL), DYSMENORRHEA (CRAMPING), WEIGHT GAIN, HAIR ON FACE AND MULTIPLE SMALL CYSTS WITHIN OVARIES 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 ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901330, 919033) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/HEAVY MENSES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), WEIGHT INCREASED ("WEIGHT GAIN"), HIRSUTISM ("HAIR ON FACE"), OVARIAN CYST ("MULTIPLE SMALL CYSTS WITHIN OVARIES"), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), URINARY TRACT INFECTION ("UTI"), KIDNEY INFECTION ("KIDNEY INFECTIONS"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC VAGINAL HYSTERECTOMY BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, WEIGHT INCREASED, HIRSUTISM, OVARIAN CYST, MENSTRUATION IRREGULAR, URINARY TRACT INFECTION, KIDNEY INFECTION AND MIGRAINE OUTCOME WAS UNKNOWN AND THE HEADACHE, BACK PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, HEADACHE, HIRSUTISM, KIDNEY INFECTION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, OVARIAN CYST, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD THE NEED FOR ADDITIONAL SURGERY. PER MR: INSERTION DETAILS: HYSTEROSCOPIC STERILIZATION PROCEDURE FOR ELECTIVE PERMANENT STERILIZATION. IT WENT QUITE WELL. WE HAD ONE RING PRESENT ON THE RIGHT. TWO RINGS PRESENT ON THE LEFT. EASY PLACEMENT NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2014: SHOWED A CYST ON THE RIGHT OVARY AT 5-6 CM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. ULTRASOUND PELVIS TRANSABDOMINAL AND TRANSVAGINAL REVEALED ENDOMETRIAL STRIPE MEASURES 5 MM. NO MYOMETRIAL MASS. RIGHT OVARY CONTAINS A CYST OR MORE LIKELY DOMINANT FOLLICLE MEASURING 2.4 X 2.5 X 2.4 CM. NORMAL LEFT OVARY. NO FREE FLUID. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS MEDICAL RECORD: CONFIRMING PELVIC PAIN." LOT NUMBER: 901330 MAN DATE: SEP-2011, EXP DATE: SEP-2014. LOT NUMBER: 919033 MAN DATE: NOV-2011, EXP DATE: NOV-2014. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2018: PFS RECEIVED:EVENT UTI, KIDNEY INFECTIONS, MIGRAINES, HEADACHES, BACK PAIN, ABDOMINAL PAIN ADDED.EVENTS OUTCOME 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD THE 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 |
|---|---|---|---|---|---|---|---|
| 876233 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 901330, 919033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |