ESSURE
Report
- Report Number
- 2951250-2018-01553
- Event Type
- Injury
- Date Received
- April 9, 2018
- Date of Event
- April 1, 2016
- Report Date
- December 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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 PELVIC PAIN ("PELVIC PAIN"), DEVICE EXPULSION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C55833) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ABDOMINAL ADHESIONS AND CHRONIC CHOLECYSTITIS. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT AND INFECTED DERMAL CYST. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA(INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH CO-TRIMOXAZOLE (BACTRIM), PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), SURGERY (ESSURE COILS REMOVAL/HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE EXPULSION, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 14.7 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-OCT-2018: PFS RECEIVED WITH HER DEMOGRAPHIC CONDITION. FOLLOWING EVENTS WERE ADDED: ABNORMAL BLEEDING(VAGINAL), MENORRHAGIA, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT, APAREUNIA(INABILITY TO HAVE SEXUAL INTERCOURSE), MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), WEIGHT GAIN, STOMACH PAIN AND SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST. LOT NUMBER ADDED. HISTORICAL AND CONCOMITANT CONDITIONS WERE ADDED. TREATMENT DRUGS 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), DEVICE EXPULSION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C55833) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ABDOMINAL ADHESIONS AND CHRONIC CHOLECYSTITIS. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT AND INFECTED DERMAL CYST. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA(INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH CO-TRIMOXAZOLE (BACTRIM), PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), SURGERY (ESSURE COILS REMOVAL/HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE EXPULSION, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 14.7 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-OCT-2018: QUALITY SAFETY EVALUATION OF PTC. 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 ("PELVIC PAIN"), DEVICE EXPULSION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATORY DISEASE"), MENORRHAGIA ("MENORRHAGIA") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C55833) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ABDOMINAL ADHESIONS, CHRONIC CHOLECYSTITIS, PAIN EPIGASTRIC, RUQ PAIN, ANAPHYLAXIS AND MULTIPAROUS. SHE HAD NEGATIVE GC CHLAMYDIA SCREENING. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, INFECTED DERMAL CYST, INGUINAL PAIN, TENDERNESS, CYSTITIS INTERSTITIAL, DEPRESSION AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX), ANTIBIOTICS, BETA-LACTAMASE SENSITIVE PENICILLINS AND IBUPROFEN. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA(INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND SURGERY (ESSURE COILS REMOVAL/HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY, HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY AND ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, MENORRHAGIA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PROCEDURE: THE ESSURE COILS INSERTION PROCEDURE WAS PERFORMED AS PER PROTOCOL WITHOUT ANY COMPLICATIONS. THE PATIENT TOLERATED THE SURGERY WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 14.7 KG/SQM. PATHOLOGY TEST - ON (B)(6) 2016: RESULT: CLINICAL HISTORY: CHRONIC PELVIC PAIN , DYSPAREUNIA. SPECIMEN: 1. UTERUS, CERVIX, LEFT FALLOPIAN TUBE. GROSS DESCRIPTION: THE SPECIMEN CONSISTING OF A UTERUS WITH DETACHED FALLOPIAN TUBE AND SMALL AMOUNT OF EXTRUDED PINK-RED MUCINOUS MATERIAL. THE UTERINE SEROSA APPEARS WITHIN NORMAL LIMITS AS DOES THE CERVIX. ENDOMETRIUM IS SCANT FLESHY TAN. THERE IS A COILED SPRING WITH A BENT SILVER WIRE IN THE MID PORTION. THE ENDS OF THE COILED SPRING INSERT INTO BILATERAL FALLOPIAN TUBE OSTIA. NO TISSUE IS SEEN ADHERENT TO THE COIL AND NO MALODOR IS DETECTED. THE FALLOPIAN TUBE APPEARS TO HAVE A BLUNTED TIP IN THE MID PORTION. MICROSCOPIC DESCRIPTION: THERE IS MILD CHRONIC CERVICITIS AND ENDOCERVICITIS. ENDOMETRIUM IS SCANT WITH A WEAK PROLIFERATIVE PATTERN WITH FOCAL DISORDERLY ARRANGEMENT CHARACTERIZED BY OCCASIONALLY IRREGULAR DILATED GLANDS. FALLOPIAN TUBE SEGMENT IS BENIGN. NO MALIGNANCY IS IDENTIFIED. FINAL DIAGNOSIS: UTERUS AND LEFT FALLOPIAN TUBE, HYSTERECTOMY AND LEFT SALPINGECTOMY: - INTACT FOREIGN BODY INTRAUTERINE DEVICE (ESSURE), ENDOMETRIAL CAVITY, UTERUS - CHANGES CONSISTENT WITH PREVIOUS LIGATION, LEFT FALLOPIAN TUBE. PREGNANCY TEST - ON (B)(6) 2016: RESULT: NEGATIVE. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULT: SHOWED THE ESSURE DEVICES BUT WAS OTHERWISE UNREMARKABLE; ON (B)(6) 2015: RESULT: GALLSTONES. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS ARE: ABDOMINAL PAIN, DYSPAREUNIA, ABDOMINAL PAIN LOWER, URINARY TRACT INFECTION AND PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-NOV-2018: PFS RECEIVED. EVENT ADDED: PELVIC INFLAMMATORY DISEASE. ABLATION SURGERY ADDED FOR MENORRHAGIA. MEDICAL HISTORY ADDED. CONCOMITANT MEDICATIONS ADDED. RACE INFORMATION ADDED. OTHER HCP ADDED. LAB DATA ADDED. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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 PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2016, 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"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE COILS REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, PELVIC PAIN AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 251163 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C55833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | ANTIBIOTICS| BETA-LACTAMASE SENSITIVE PENICILLINS| IBUPROFEN| XANAX| XANAX| XANAX| XANAX |