ESSURE
Report
- Report Number
- 2951250-2019-06086
- Event Type
- Injury
- Date Received
- September 11, 2019
- Date of Event
- January 21, 2015
- Report Date
- November 12, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEED') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871770-NOT VALID, 091762-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM 2013 TO 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN UPPER ("STOMACH CRAMPING"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION"), LOSS OF LIBIDO ("LOSS SEX DRIVE"), FATIGUE ("FATIGUE"), PAIN IN EXTREMITY ("THIGH PAIN") AND VULVOVAGINAL DRYNESS ("VAGINAL DRYNESS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND ADENOMYOSIS ("ADENOMYOSIS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, VULVOVAGINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, LOSS OF LIBIDO, FATIGUE, ADENOMYOSIS AND PAIN IN EXTREMITY HAD RESOLVED AND THE ABDOMINAL PAIN UPPER, ALLERGY TO METALS, VAGINAL INFECTION AND VULVOVAGINAL DRYNESS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ADENOMYOSIS, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, LOSS OF LIBIDO, MENORRHAGIA, PAIN IN EXTREMITY, PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL DRYNESS AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), APAREUNIA, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEED, ADENOMYOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ADENOMYOSIS AND MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-NOV-2019: UPDATE OF BATCH INFORMATION (BATCH IS NOT VALID). NOT VALID 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEED') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871770, 091762) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM 2013 TO 2015. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION"), LOSS OF LIBIDO ("LOSS SEX DRIVE"), FATIGUE ("FATIGUE"), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), PAIN IN EXTREMITY ("THIGH PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), VULVOVAGINAL DRYNESS ("VAGINAL DRYNESS") AND ABDOMINAL PAIN UPPER ("STOMACH CRAMPING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ADENOMYOSIS ("ADENOMYOSIS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, LOSS OF LIBIDO, FATIGUE, ADENOMYOSIS, PELVIC PAIN, ABDOMINAL PAIN, VULVOVAGINAL PAIN, PAIN IN EXTREMITY AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE VAGINAL INFECTION, VULVOVAGINAL DRYNESS, ALLERGY TO METALS AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, ADENOMYOSIS, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, LOSS OF LIBIDO, MENORRHAGIA, PAIN IN EXTREMITY, PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL DRYNESS AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), APAREUNIA, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEED, ADENOMYOSIS . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ADENOMYOSIS AND MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2019: PFS AND MR RECEIVED- NEW EVENTS PELVIC PAIN, ABDOMINAL PAIN, VAGINAL PAIN, THIGH PAIN, ABNORMAL BLEEDING (VAGINAL), VAGINAL DRYNESS, NICKEL ALLERGY AND STOMACH CRAMPING WERE ADDED. HORMONAL IMBALANCE UPDATED INTO LOSS SEX DRIVE. REPORTER AND PATIENT DEMOGRAPHY ADDED. MEDICAL HISTORY, LOT NUMBER AND CONCOMITANT DRUG WERE ADDED. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL INFECTION"), FATIGUE ("FATIGUE") AND ADENOMYOSIS ("ADENOMYOSIS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("INJURIES/SYMPTOMS-HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, HORMONE LEVEL ABNORMAL, FATIGUE AND ADENOMYOSIS HAD RESOLVED AND THE VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), APAREUNIA, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEED, ADENOMYOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2015: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED. CASE BECAME INCIDENT. THE PREVIOUSLY REPORTED EVENT INJURY WAS UPDATED WITH NEW EVENTS FROM PFS: DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), APAREUNIA, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GENERAL ABNORMAL BLEED, VAGINAL INFECTION, HORMONAL CHANGES, FATIGUE, ADENOMYOSIS. OUTCOME OF PAIN AND BLEEDING WERE UPDATED. LABORATORY DATA WAS ADDED, REMOVAL DATE WITH PROCEDURE WERE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 788574 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 871770 INVALID,091762 INVALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R | ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS |