ESSURE
Report
- Report Number
- 2951250-2019-01889
- Event Type
- Injury
- Date Received
- May 13, 2019
- Date of Event
- January 1, 2012
- Report Date
- May 17, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN: PELVIC PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND OVARIAN CYSTECTOMY ("DEVELOPED CYSTS ON HER RIGHT OVARY REQUIRING REMOVAL") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871877-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL YEAST INFECTION, HEADACHE, VAGINAL BLEEDING IN 2010, MENORRHAGIA IN 2010, WEIGHT NORMAL (BMI: 23.378), GRAVIDA II, VAGINAL DISCHARGE AND CERVICITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: SEASONIQUE IN 2010. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA AND POLYMENORRHEA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("INFECTION: YEAST"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PAIN IN EXTREMITY ("PAIN: LEG PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), 1 YEAR AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN 2017, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES") AND DYSPEPSIA ("HEARTBURN"). IN 2018, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: INCONTINENCE") AND ANAEMIA ("ANEMIA") AND UNDERWENT OVARIAN CYSTECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), RANITIDINE HYDROCHLORIDE (ZANTAC) AND SURGERY (ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION, URINARY INCONTINENCE, MIGRAINE, HEADACHE, ANAEMIA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN AND THE HOT FLUSH, FATIGUE, DYSPEPSIA AND ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANAEMIA, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, OVARIAN CYSTECTOMY, PAIN IN EXTREMITY, PELVIC PAIN, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 135 LBS. INSERTION DETAIL: A NEGATIVE HYSTEROSCOPE VIEW WAS NOTED . THROUGH THE HYSTEROSCOPE THE TUBAL OCCLUSION DEVICE WERE INTRODUCED IN BOTH TUBAL OSTIA WITHOUT DIFFICULTY AFTER INSERTION THREE COILS WERE NOTED BILATERALLY THE HYSTEROSCOPE WAS REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. EVENTS: ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, URINARY INCONTINENCE, VAGINAL DISCHARGE, DYSPAREUNIA, WEIGHT GAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-MAY-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT NO 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 PELVIC PAIN ("PAIN: PELVIC PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND OVARIAN CYST ("DEVELOPED CYSTS ON HER RIGHT OVARY REQUIRING REMOVAL") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871877) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL YEAST INFECTION, HEADACHE, VAGINAL BLEEDING IN 2010, MENORRHAGIA IN 2010, WEIGHT NORMAL (BMI: 23.378), GRAVIDA II, VAGINAL DISCHARGE AND CERVICITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: SEASONIQUE IN 2010. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA AND POLYMENORRHEA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VULVOVAGINAL MYCOTIC INFECTION ("INFECTION: YEAST"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PAIN IN EXTREMITY ("PAIN: LEG PAIN"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), 1 YEAR AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN 2017, THE PATIENT EXPERIENCED HOT FLUSH ("HOT FLASHES") AND DYSPEPSIA ("HEARTBURN"). IN 2018, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: INCONTINENCE"), ANAEMIA ("ANEMIA") AND OVARIAN CYST (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), RANITIDINE HYDROCHLORIDE (ZANTAC) AND SURGERY (ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION, URINARY INCONTINENCE, MIGRAINE, HEADACHE, ANAEMIA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN AND THE HOT FLUSH, FATIGUE, DYSPEPSIA AND ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANAEMIA, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, OVARIAN CYST, PAIN IN EXTREMITY, PELVIC PAIN, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6) LBS. INSERTION DETAIL: A NEGATIVE HYSTEROSCOPE VIEW WAS NOTED. THROUGH THE HYSTEROSCOPE THE TUBAL OCCLUSION DEVICE WERE INTRODUCED IN BOTH TUBAL OSTIA WITHOUT DIFFICULTY AFTER INSERTION THREE COILS WERE NOTED BILATERALLY THE HYSTEROSCOPE WAS REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. EVENTS: ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, URINARY INCONTINENCE, VAGINAL DISCHARGE, DYSPAREUNIA, WEIGHT GAIN". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAY-2019: THE CASE IS INCIDENT. ESSURE LOT NUMBER WAS ADDED. REPORTER INFORMATION WAS ADDED. THIS CASE CONCERNS (B)(6) PATIENT. HER DEMOGRAPHICS WERE ADDED. HER HISTORICAL CONDITION/MEDICATION AND CONCURRENT MEDICATIONS WERE ADDED. HER LAB DATA WAS ADDED. ESSURE INDICATION WAS ADDED. ESSURE REMOVAL DATE WAS ADDED. TREATMENT MEDICATIONS WERE ADDED. PER PLAINTIFF FACT SHEET FOLLOWING EVENT INJURY WAS UPDATED TO MORE SPECIFIED EVENTS :PAIN: PELVIC PAIN, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), HEAVY BLEEDING, HOT FLASHES, VULVOVAGINAL MYCOTIC INFECTION (INFECTION: YEAST, VULVOVAGINAL MYCOTIC INFECTION (INFECTION: YEAST), MIGRAINE, HEADACHES, ANEMIA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, HEARTBURN, HAIR LOSS, PAIN: LEG PAIN,OVARIAN CYST. SHE HAD RECOVERED FROM PELVIC PAIN, CRAMPING, HEAVY BLEEDING AND RECOVERING FROM EVENTS: FATIGUE, HOT FLASHES, HEARTBURN HAIR LOSS. INCIDENT: 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-CONFORMANCE DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399107 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 871877-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R |