ESSURE
Report
- Report Number
- 2951250-2019-09850
- Event Type
- Injury
- Date Received
- October 8, 2019
- Report Date
- May 24, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 678811) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAND MULTIPARITY AND FITZ-HUGH-CURTIS SYNDROME. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ALLERGY TO METALS ("NICKEL ALLERGY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA AND HEAVY MENSTRUAL BLEEDING HAD RESOLVED AND THE ALLERGY TO METALS, CYSTITIS, URINARY TRACT INFECTION, VAGINAL DISCHARGE, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, ALOPECIA, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2010, SHE IMPLANTED ESSURE (AS REPORTED IN PPF,DISCREPANCY NOTED). SHE RECEIVED TREATMENTS FOR EVENTS DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEED. LOT NUMBER: 678811, MANUFACTURING DATE: 2009-09, EXPIRATION DATE: 2012-09. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. 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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 678811) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAND MULTIPARITY AND FITZ-HUGH-CURTIS SYNDROME. IN (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ALLERGY TO METALS ("NICKEL ALLERGY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA AND HEAVY MENSTRUAL BLEEDING HAD RESOLVED AND THE ALLERGY TO METALS, CYSTITIS, URINARY TRACT INFECTION, VAGINAL DISCHARGE, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, ALOPECIA, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2010, SHE IMPLANTED ESSURE (AS REPORTED IN PPF,DISCREPANCY NOTED). SHE RECEIVED TREATMENTS FOR EVENTS DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAY-2021: MR RECEIVED. LOT NUMBER, MEDICAL HISTORY AND REPORTER WAS ADDED, CASE BECAME MEDICALLY CONFIRMED. 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 ('GENERAL ABNORMAL BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2009, 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"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ALLERGY TO METALS ("NICKEL ALLERGY"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA AND MENORRHAGIA HAD RESOLVED AND THE ALLERGY TO METALS, CYSTITIS, URINARY TRACT INFECTION, VAGINAL DISCHARGE, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, ALOPECIA, WEIGHT INCREASED AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2010, SHE IMPLANTED ESSURE (AS REPORTED IN PPF,DISCREPANCY NOTED). SHE RECEIVED TREATMENTS FOR EVENTS DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),GENERAL ABNORMAL BLEED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2019: REPORTER¿S DETAILS UPDATED AND PATIENT DEMOGRAPHICS WERE ADDED. ESSURE INDICATION UPDATED. ON (B)(6) 2017, SHE EXPLANTED ESSURE. INJURY EVENTS WAS UPDATED TO DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEED, NICKEL ALLERGY, BLADDER INFECTION, UTI, VAGINAL DISCHARGE, MIGRAINE, HEADACHES, NAUSEA, FATIGUE, HAIR LOSS, WEIGHT GAIN, WEIGHT LOSS. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 960902 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 678811 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |