ESSURE
Report
- Report Number
- 2951250-2017-04721
- Event Type
- Injury
- Date Received
- October 16, 2017
- Date of Event
- September 1, 2011
- Report Date
- April 24, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN/ PAIN SEVERE LOWER ABDOMINAL PAIN"), MENORRHAGIA ("ABNORMAL HEAVY MENSTRUAL BLEEDING/ PROLONGED MENSES /ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), PELVIC PAIN ("PAIN/CHRONIC PELVIC PAIN"), ENDOMETRIAL HYPERPLASIA ("ENDOMETRIAL HYPERPLASIA") AND CERVIX CAUTERY ("CRYOCAUTERIZATION OF CERVIX") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE SINCE (B)(6)2014, MENSTRUATION ABNORMAL SINCE (B)(6)2014, MENSTRUATION ABNORMAL SINCE (B)(6)2014, LOW GRADE SQUAMOUS INTRAEPITHELIAL LESION, VAGINAL ITCHING, ABDOMINAL BLOATING, GENITAL BLEEDING, ASTHMA, HYPERCHOLESTEROLEMIA, DIABETES, BLOOD PRESSURE HIGH AND TACHYCARDIA. CONCOMITANT PRODUCTS INCLUDED FUROSEMIDE (LASIX), INSULIN, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA), METFORMIN, METOPROLOL, PREGABALIN (LYRICA), SALBUTAMOL (ALBUTEROL), SIMVASTATIN (ZOCOR) AND VITAMIN D NOS (VITAMIN D). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE /VAGINAL DISCHARGE"), ALLERGY TO METALS ("NICKEL ALLERGY /NICKEL ALLERGY"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN /DYSMENORRHEA (CRAMPING)"), BACK PAIN ("SEVERE BACK PAIN/ SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES /MIGRAINES / HEADACHES"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND POLYCYSTIC OVARIES ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BILATERAL PCOD POLYCYSTIC OVARY DISEASE"). ON (B)(6)2013, THE PATIENT UNDERWENT CERVIX CAUTERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 1 YEAR 7 MONTHS AFTER INSERTION OF ESSURE. IN 2013, THE PATIENT EXPERIENCED ENDOMETRIAL HYPERPLASIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VULVOVAGINAL CANDIDIASIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: CANDIDAL VULVOVAGINITIS / IRREGULAR VAGINAL INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN CYST ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION:RIGHT OVARIAN CYST"), PELVIC ADHESIONS ("PELVIC ADHESIONS") AND ABDOMINAL PAIN ("ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), MEDROXYPROGESTERONE ACETATE (PROVERA) AND SURGERY (ABLATION ON (B)(6)2013, DILATION AND CURETTAGE AND BILATERAL TUBAL LIGATION AND ESSURE COIL REMOVAL). ESSURE WAS REMOVED ON (B)(6)2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, MENORRHAGIA, PELVIC PAIN, ENDOMETRIAL HYPERPLASIA, VAGINAL DISCHARGE, ALLERGY TO METALS, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, MIGRAINE, ALOPECIA, VAGINAL HAEMORRHAGE, VULVOVAGINAL CANDIDIASIS, POLYCYSTIC OVARIES, OVARIAN CYST, PELVIC ADHESIONS AND ABDOMINAL PAIN HAD RESOLVED AND THE CERVIX CAUTERY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, CERVIX CAUTERY, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL HYPERPLASIA, MENORRHAGIA, MIGRAINE, OVARIAN CYST, PELVIC ADHESIONS, PELVIC PAIN, POLYCYSTIC OVARIES, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A PROCEDURE TO EFFECTUATE REMOVAL OF HER DEVICE AND TO RELIEVE HER OF POST-IMPLANTATION SYMPTOMS, INCLUDING BILATERAL TUBAL LIGATION AND ESSURE COIL REMOVAL. TUBAL LIGATION ON (B)(6)2015 TO PRESENT, REASON FOR USE - ESSURE REMOVAL AND PERMANENT BIRTH CONTROL. ON (B)(6)2014, SURGICAL HISTORY : HYSTEROSCOPY WITH INSERT OF DEVICE TO OCCLUDE FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2011: RESULTS: CONFIRMING BILATERAL TUBAL OCCLUSION; TUBES WERE BLOCKED AND ESSURE WAS IN PLACE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHOEA, MENORRHAGIA AND PELVIC PAIN. LOT NUMBER: 822374, MANUFACTURE DATE: 2011-01, EXPIRATION DATE: 2014-01 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-APR-2019: QUALITY SAFETY EVALUATION OF PTC. AFTER INTERVAL REVIEW, "CRYOCAUTERIZATION OF CERVIX" PREVIOUSLY REGARDED AS SURGICAL TREATMENT FOR VAGINAL DISCHARGE, WAS ADDED AS EVENT, AND VAGINAL DISCHARGE WAS DOWNGRADED TO NON-SERIOUS. EVENTS VAGINAL INFECTION AND VULVOVAGINAL CANDIDIASIS WERE CLUBBED. EVENTS MIGRAINE AND HEADACHE WERE CLUBBED. WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WAS 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 ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN/ PAIN SEVERE LOWER ABDOMINAL PAIN, SEVERE BACK PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE /VAGINAL DISCHARGE"), MENORRHAGIA ("ABNORMAL HEAVY MENSTRUAL BLEEDING/ PROLONGED MENSES /ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND ENDOMETRIAL HYPERPLASIA ("ENDOMETRIAL HYPERPLASIA") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED PREMENOPAUSE SINCE (B)(6) 2014, MENSTRUATION ABNORMAL SINCE (B)(6) 2014 AND MENSTRUATION ABNORMAL SINCE (B)(6) 2014. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL DISCHARGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN /DYSMENORRHEA (CRAMPING)"), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE BACK PAIN/ PAIN SEVERE LOWER ABDOMINAL PAIN, SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES /MIGRAINES / HEADACHES"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HEADACHE ("MIGRAINES / HEADACHES") AND POLYCYSTIC OVARIES ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BILATERAL PCOD POLYCYSTIC OVARY DISEASE"). IN 2013, THE PATIENT EXPERIENCED VULVOVAGINAL CANDIDIASIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: CANDIDAL VULVOVAGINITIS") AND ENDOMETRIAL HYPERPLASIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY /NICKEL ALLERGY"), VAGINAL INFECTION ("IRREGULAR VAGINAL INFECTION"), OVARIAN CYST ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION:RIGHT OVARIAN CYST"), PELVIC PAIN ("PAIN"), PELVIC ADHESIONS ("PELVIC ADHESIONS") AND ABDOMINAL PAIN ("ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), MEDROXYPROGESTERONE ACETATE (PROVERA), SURGERY (BILATERAL TUBAL LIGATION AND ESSURE COIL REMOVAL), SURGERY (ON (B)(6) 2013, CRYOCAUTERIZATION OF CERVIX), SURGERY (ABLATION ON (B)(6) 2013) AND SURGERY (DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, ALLERGY TO METALS, VAGINAL DISCHARGE, DYSMENORRHOEA, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE, ALOPECIA, VAGINAL HAEMORRHAGE, VULVOVAGINAL CANDIDIASIS, HEADACHE, POLYCYSTIC OVARIES, OVARIAN CYST, PELVIC PAIN, ENDOMETRIAL HYPERPLASIA, PELVIC ADHESIONS AND ABDOMINAL PAIN HAD RESOLVED AND THE VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIAL HYPERPLASIA, HEADACHE, MENORRHAGIA, MIGRAINE, OVARIAN CYST, PELVIC ADHESIONS, PELVIC PAIN, POLYCYSTIC OVARIES, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A PROCEDURE TO EFFECTUATE REMOVAL OF HER DEVICE AND TO RELIEVE HER OF POST-IMPLANTATION SYMPTOMS, INCLUDING BILATERAL TUBAL LIGATION AND ESSURE COIL REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: CONFIRMING BILATERAL TUBAL OCCLUSION TUBAL LIGATION ON (B)(6) 2015 TO PRESENT, REASON FOR USE-ESSURE REMOVAL AND PERMANENT BIRTH CONTROL. ON (B)(6) 2011, HYSTEROSALPINGOGRAM (HSG), TOTAL BILATERAL OCCLUSION, TUBES WERE BLOCKED AND ESSURE WAS IN PLACE. ON (B)(6) 2014, SURGICAL HISTORY : HYSTEROSCOPY WITH INSERT OF DEVICE TO OCCLUDE FALLOPIAN TUBE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHOEA, MENORRHAGIA AND PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PFS RECEIVED. REPORTER WAS ADDED. PATIENT DETAILS, TREATMENT DRUGS AND UNSTRUCTURED RELEVANT TESTS WERE ADDED. ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: CANDIDAL VULVOVAGINITIS, MIGRAINES / HEADACHES, REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BILATERAL PCOD POLYCYSTIC OVARY DISEASE AND RIGHT OVARIAN CYST, PAIN, ENDOMETRIAL HYPERPLASIA, PELVIC ADHESIONS AND ABDOMEN PAIN WERE ADDED AS EVENTS. LOT NUMBER OF ESSURE RECEIVED. ON 27-FEB-2018: MR RECEIVED. REPORTER WAS ADDED. PATIENT¿S CONCOMITANT DISEASE AND UNSTRUCTURED RELEVANT TESTS WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), VAGINAL INFECTION ("IRREGULAR VAGINAL INFECTION"), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("ABNORMAL HEAVY MENSTRUAL BLEEDING/ PROLONGED MENSES"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), MIGRAINE ("MIGRAINES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL TUBAL LIGATION AND ESSURE COIL REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, ALLERGY TO METALS, VAGINAL DISCHARGE, VAGINAL INFECTION, DYSMENORRHOEA, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MIGRAINE, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A PROCEDURE TO EFFECTUATE REMOVAL OF HER DEVICE AND TO RELIEVE HER OF POST-IMPLANTATION SYMPTOMS, INCLUDING BILATERAL TUBAL LIGATION AND ESSURE COIL REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: CONFIRMING BILATERAL TUBAL OCCLUSION. 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 |
|---|---|---|---|---|---|---|---|
| 730734 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | ALBUTEROL.| DEPO PROVERA,| INSULIN,| LASIX [FUROSEMIDE],| LYRICA,| METFORMIN,| METOPROLOL,| VITAMIN D [VITAMIN D NOS],| ZOCOR, |