ESSURE
Report
- Report Number
- 2951250-2018-03542
- Event Type
- Injury
- Date Received
- August 15, 2018
- Date of Event
- January 1, 2012
- Report Date
- April 26, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), URTICARIA ("HIVES"), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY WITH BILATERAL ROBOTIC SALPINGECTOMY AND CORNEAL RESECTION AND REPAIR). ESSURE WAS REMOVED IN (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, URTICARIA, MENORRHAGIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND URTICARIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR THESE SYMPTOMS. ON (B)(6) 2018 SHE WAS ADVISED THAT HER ADVERSE SYMPTOMS WERE AS A DIRECT RESULT OF THE ESSURE DEVICE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-NOV-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 ("PELVIC PAIN/PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863670, 58565) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TENOSYNOVITIS, HEMORRHOIDECTOMY, UTERINE FIBROID, ULTRASOUND PELVIS, VULVOVAGINAL CANDIDIASIS, VAGINITIS BACTERIAL, INFREQUENT MENSTRUATION, UTERINE BLEEDING, CRYING, HOT FLASHES, SWEATY AND ADENOMYOSIS. URINE PREGNANCY TEST: A URINE PREGNANCY TEST WAS PERFORMED TODAY AND THE RESULT WAS NEGATIVE,. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TORADOL AND BIRTH CONTROL PILLS. CONCURRENT CONDITIONS INCLUDED VAGINAL DISCHARGE ABNORMALITY, VULVAL ITCHING, TOBACCO USER, PAPILLOMA VIRAL INFECTION, MENSES IRREGULAR, VAGINAL ODOR, BLEEDING INTERMENSTRUAL, VULVAL BURNING SENSATION, MALIGNANT BREAST NEOPLASM AND BLEEDING INTERMENSTRUAL. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA/DYSMENORRHEA (CRAMPING),"), MENORRHAGIA ("MENORRHAGIA"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: SEVERE MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND FATIGUE ("FATIGUE"), 4 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2016, THE PATIENT EXPERIENCED URTICARIA ("HIVES/ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HIVES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED") AND PROCEDURAL PAIN ("STATING SHE HAD MILD CRAMPS AT MOST"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY WITH BILATERAL ROBOTIC SALPINGECTOINY AND CORNEAL RESECTION AND REPAIR). ESSURE WAS REMOVED IN (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, URTICARIA, MENORRHAGIA, ANXIETY, DEPRESSION, MOOD SWINGS, VAGINAL HAEMORRHAGE, FATIGUE, WEIGHT INCREASED AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PROCEDURAL PAIN, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR THESE SYMPTOMS. ON (B)(6) 2018 . SHE WAS ADVISED THAT HER ADVERSE SYMPTOMS WERE AS A DIRECT RESULT OF THE ESSURE DEVICE. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 154LBS. THE POSITION OF THE ESSURE MICRO-INSERT WAS ASSESSED. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 5. NO ATTEMPTS WERE DONE TO INSERT IN THE LEFT TUBE AS WAS REMOVED SHE TOLERATED THE PROCEDURE WELL, STATING SHE HAD ONLY MILD CRAMPS AT MOST. DISCREPANCY NOTED IN ESSURE REMOVAL DETAILS: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2011: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-APR-2019: PFS AND MR RECEIVED - NEW EVENT GENITAL HEMORRHAGE, MOOD SWINGS, VAGINAL HEMORRHAGE, FATIGUE, WEIGHT INCREASED AND PROCEDURAL PAIN WERE ADDED. EVENT ONSET DATE OF PELVIC PAIN, DYSMENORRHEA, URTICARIA AND MENORRHAGIA WERE ADDED. SEVERITY OF PELVIC PAIN (SEVER) WERE ADDED. LOT NUMBER, INDICATION AND ESSURE IMPLANTED DATE WERE ADDED. NEW REPORTER AND CONSUMER ADDRESS WERE ADDED. PATIENT INFORMATION DATE OF BIRTH, WEIGHT AND HEIGHT WERE ADDED. CONCOMITANT MEDICATION (PROVERA) WERE ADDED. LAB DATA WERE ADDED. 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-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/PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863670-INVALID,58565-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TENOSYNOVITIS, HEMORRHOIDECTOMY, UTERINE FIBROID, ULTRASOUND PELVIS, VULVOVAGINAL CANDIDIASIS, VAGINITIS BACTERIAL, MENSTRUATION FREQUENT, UTERINE BLEEDING, CRYING, HOT FLASHES, SWEATY AND ADENOMYOSIS. URINE PREGNANCY TEST: A URINE PREGNANCY TEST WAS PERFORMED TODAY AND THE RESULT WAS NEGATIVE,. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TORADOL AND BIRTH CONTROL PILLS. CONCURRENT CONDITIONS INCLUDED VAGINAL DISCHARGE ABNORMALITY, VULVAL ITCHING, TOBACCO USER, PAPILLOMA VIRAL INFECTION, MENSES IRREGULAR, VAGINAL ODOR, BLEEDING INTERMENSTRUAL, VULVAL BURNING SENSATION, MALIGNANT BREAST NEOPLASM AND BLEEDING INTERMENSTRUAL. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA/DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: SEVERE MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND FATIGUE ("FATIGUE"), 4 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2016, THE PATIENT EXPERIENCED URTICARIA ("HIVES/ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HIVES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED") AND PROCEDURAL PAIN ("STATING SHE HAD MILD CRAMPS AT MOST"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY WITH BILATERAL ROBOTIC SALPINGECTOMY AND CORNEAL RESECTION AND REPAIR). ESSURE WAS REMOVED IN (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, URTICARIA, MENORRHAGIA, ANXIETY, DEPRESSION, MOOD SWINGS, VAGINAL HAEMORRHAGE, FATIGUE, WEIGHT INCREASED AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, PROCEDURAL PAIN, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR THESE SYMPTOMS. ON (B)(6) 2018. SHE WAS ADVISED THAT HER ADVERSE SYMPTOMS WERE AS A DIRECT RESULT OF THE ESSURE DEVICE. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 154LBS. THE POSITION OF THE ESSURE MICRO-INSERT WAS ASSESSED. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 5. NO ATTEMPTS WERE DONE TO INSERT IN THE LEFT TUBE AS WAS REMOVED SHE TOLERATED THE PROCEDURE WELL, STATING SHE HAD ONLY MILD CRAMPS AT MOST. DISCREPANCY NOTED IN ESSURE REMOVAL DETAILS: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2011: NEGATIVE. LOT NUMBERS REPORTED 863670 AND 58565 ARE INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-APR-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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), URTICARIA ("HIVES"), MENORRHAGIA ("MENORRHAGIA"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY WITH BILATERAL ROBOTIC SALPINGECTOMY AND CORNEAL RESECTION AND REPAIR). ESSURE WAS REMOVED IN (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, URTICARIA, MENORRHAGIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND URTICARIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE OCCASIONS FOR THESE SYMPTOMS. ON (B)(6) 2018, SHE WAS ADVISED THAT HER ADVERSE SYMPTOMS WERE AS A DIRECT RESULT OF THE ESSURE DEVICE. 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 |
|---|---|---|---|---|---|---|---|
| 628360 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863670-INVALID,58565-INVALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other| R | PROVERA| PROVERA |