ESSURE
Report
- Report Number
- 2951250-2017-05600
- Event Type
- Injury
- Date Received
- October 27, 2017
- Report Date
- June 25, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DYSMENORRHEA (PAST GYNECOLOGICAL HISTORY: PATIENT HAS HAD DYSMENORRHEA THAT HAD BEEN REFRACTORY TO BIRTH CONTROL PILLS, NONSTEROIDAL ANTI-INFLAMMATORIES.). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NONSTEROIDAL ANTI-INFLAMMATORIES AND BIRTH CONTROL PILLS. CONCURRENT CONDITIONS INCLUDED ABDOMINAL PAIN SINCE (B)(6) 2016. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, 28 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2008, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2008, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH PAPULAR ("RASHES OR SKIN CONDITIONS: ITCHY BUMPS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) (EVENT SPLITTED FOR CODING)"), HEADACHE ("MIGRAINES /HEADACHES (EVENT SPLITTED FOR CODING)"), MIGRAINE ("MIGRAINES /HEADACHES (EVENT SPLITTED FOR CODING)"), WEIGHT INCREASED ("WEIGHT GAIN") AND DEPRESSION ("HORMONAL CHANGES DESCRIBE: DEPRESSION"). IN (B)(6) 2009, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) (EVENT SPLITTED FOR CODING)"), RASH ("RASHES OR SKIN CONDITIONS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES (EVENT SPLITTED FOR CODING)"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES (EVENT SPLITTED FOR CODING)"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) (EVENT SPLITTED FOR CODING)") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANTS,HYSTERECTOMY (FULL) AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED, THE GENITAL HAEMORRHAGE, RASH PAPULAR AND DEPRESSION OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, RASH, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, BLADDER DISORDER, URINARY TRACT DISORDER, HORMONE LEVEL ABNORMAL, CYSTITIS, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, HEADACHE, MIGRAINE, NAUSEA, FATIGUE, WEIGHT INCREASED AND ALOPECIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, RASH PAPULAR, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.8 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: POSITIVE DATE OF RESULT: (B)(6) 2016. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 150 LBS. ON (B)(6) 2016, PELVIC SONOGRAM. INDICATION: ABDOMINAL PAIN. IMPRESSION: BILATERAL ESSURE DEVICES AT THE CORNUA/ PROXIMAL FALLOPIAN TUBE REGIONS. SMALL BILATERAL COMPLEX CYSTS OF THE OVARIES. ON (B)(6) 2016, PATHOLOGY REPORT: FINAL DIAGNOSIS: UTERUS, CERVIX, AND TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY; PROLIFERATIVE: ENDOMETRIUM WITH NO EVIDENCE OF HYPERPLASIA OR CARCINOMA. -RIGHT FALLOPIAN TUBE WITH BENIGN PARA TUBAL CYST. --LEFT FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. CLINICAL INFORMATION : DYSMENORRHEA. ON THE SAME DAY OPERATIVE REPORT: PRE AND POST OPERATIVE DIAGNOSIS: CHRONIC PELVIC PAIN. PROCEDURE: LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. FINDINGS: LAPAROSCOPICALLY, THERE WAS EVIDENCE OF A NORMAL BILATERAL ADNEXA WITH NORMAL BILATERAL FALLOPIAN TUBES. NO EVIDENCE OF EXTRUSION OR PERFORATION OF THE ESSURE DEVICES. (B)(6) 2016; TYPE OF TEST: TRANSVAGINAL ULTRASOUND (TVU). RESULT: POSITIVE DATE OF RESULT: (B)(6) 2016 (AS WRITTEN). THAT THE ESSURE DEVICE WAS BILATERAL, AND DATE(S) OF COMMUNICATION (B)(6) 2016. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN AND ABDOMINAL PAIN LOWER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-MAY-2018: PFS RECEIVED: DEPRESSION, RASH POPULAR WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DYSMENORRHEA (PAST GYNECOLOGICAL HISTORY: PATIENT HAS HAD DYSMENORRHEA THAT HAD BEEN REFRACTORY TO BIRTH CONTROL PILLS, NONSTEROIDAL ANTI-INFLAMMATORIES.). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NONSTEROIDAL ANTI-INFLAMMATORIES AND BIRTH CONTROL PILLS. CONCURRENT CONDITIONS INCLUDED ABDOMINAL PAIN SINCE (B)(6) 2016. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, 28 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2008, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) (EVENT SPLITTED FOR CODING)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) (EVENT SPLITTED FOR CODING)"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) (EVENT SPLITTED FOR CODING)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), RASH ("RASHES OR SKIN CONDITIONS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES (EVENT SPLITTED FOR CODING)"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES (EVENT SPLITTED FOR CODING)"), MIGRAINE ("MIGRAINES /HEADACHES (EVENT SPLITTED FOR CODING)"), HEADACHE ("MIGRAINES /HEADACHES (EVENT SPLITTED FOR CODING)"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANTS,HYSTERECTOMY (FULL) AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, FATIGUE, WEIGHT INCREASED, ALOPECIA, DYSMENORRHOEA AND ABDOMINAL PAIN LOWER HAD NOT RESOLVED AND THE GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.8 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: POSITIVE DATE OF RESULT: (B)(6) 2016 APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 150 LBS. ON (B)(6) 2016, PELVIC SONOGRAM INDICATION: ABDOMINAL PAIN. IMPRESSION: BILATERAL ESSURE DEVICES AT THE CORNUA/ PROXIMAL FALLOPIAN TUBE REGIONS. SMALL BILATERAL COMPLEX CYSTS OF THE OVARIES. ON (B)(6) 2016, PATHOLOGY REPORT: FINAL DIAGNOSIS: UTERUS, CERVIX, AND TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY; PROLIFERATIVE: ENDOMETRIUM WITH NO EVIDENCE OF HYPERPLASIA OR CARCINOMA. -RIGHT FALLOPIAN TUBE WITH BENIGN PARA TUBAL CYST. --LEFT FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. CLINICAL INFORMATION : DYSMENORRHEA ON THE SAME DAY OPERATIVE REPORT: PRE AND POST OPERATIVE DIAGNOSIS: CHRONIC PELVIC PAIN. PROCEDURE: LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY. FINDINGS: LAPAROSCOPICALLY, THERE WAS EVIDENCE OF A NORMAL BILATERAL ADNEXA WITH NORMAL BILATERAL FALLOPIAN TUBES. NO EVIDENCE OF EXTRUSION OR PERFORATION OF THE ESSURE DEVICES. (B)(6) 2016; TYPE OF TEST: TRANSVAGINAL ULTRASOUND (TVU) RESULT: POSITIVE DATE OF RESULT: (B)(6) 2016 (AS WRITTEN) THAT THE ESSURE DEVICE WAS BILATERAL, AND DATE(S) OF COMMUNICATION (B)(6) 2016 CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN AND ABDOMINAL PAIN LOWER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND MR RECEIVED. REPORTERS WERE ADDED. PATIENT DETAILS, HISTORICAL CONDITION, HISTORICAL DRUG,CONCOMITANT DISEASE, LAB DATA AND UNSTRUCTURED RELEVANT TESTS WERE ADDED. ESSURE INDICATION WAS ADDED. START DATE WAS CHANGED. HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/URINARY TRACT/VAGINAL), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), RASHES OR SKIN CONDITIONS, BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES /HEADACHES, NAUSEA, FATIGUE, WEIGHT GAIN, HAIR LOSS, DYSMENORRHEA (CRAMPING) AND LOWER ABDOMINAL PAIN WERE ADDED AS EVENTS. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANTS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 765126 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R |