ESSURE
Report
- Report Number
- 2951250-2019-09201
- Event Type
- Injury
- Date Received
- October 2, 2019
- Report Date
- July 22, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') AND CERVIX CARCINOMA ('CANCER (UNSPECIFIED)/ TUMOR / TERATOMA / CANCER TYPE:CERVICAL CANCER') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA (BLEEDING BETWEEN PERIODS)"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI (URINARY TRACT INFECTION)/ INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), FIBROCYSTIC BREAST DISEASE ("FIBROCYSTIC BREAST DISEASE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN") AND WAS FOUND TO HAVE CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, INTERMENSTRUAL BLEEDING, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE CERVIX CARCINOMA, ALLERGY TO METALS, HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, FATIGUE, HORMONE LEVEL ABNORMAL, HEADACHE, NAUSEA, FIBROCYSTIC BREAST DISEASE, VAGINAL HAEMORRHAGE AND HEAVY MENSTRUAL BLEEDING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, CERVIX CARCINOMA, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FIBROCYSTIC BREAST DISEASE, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INTERMENSTRUAL BLEEDING, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS" CHRONIC PELVIC PAIN, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ABDOMINAL, PSYCH INJURY, URINARY PROBLEMS., BLADDER INFECTION, UTI (URINARY TRACT INFECTION), VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, HORMONAL CHANGES, HEADACHES, NAUSEA AND CANCER". DISCREPANCY NOTED :AS PER MR, ESSURE WAS REMOVED ON (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: (UNSPECIFIED): BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN THE PATIENT'S MEDICAL RECORDS : ABDOMINAL PAIN,PELVIC PAIN, QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS CASE FOUND TO BE DUPLICATE OF CASE (B)(4) , HENCE THIS CASE SHOULD BE DELETED FROM ARGUS CENTRAL (NULLIFICATION REASON : DUPLICATE CASE IS IDENTIFIED WITH FU INFORMATION). NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT 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 ('CHRONIC PELVIC PAIN'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') AND CERVIX CARCINOMA ('CANCER (UNSPECIFIED)/ TUMOR / TERATOMA / CANCER TYPE:CERVICAL CANCER') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") 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), ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING BETWEEN PERIODS)"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI (URINARY TRACT INFECTION)/ INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), FIBROCYSTIC BREAST DISEASE ("FIBROCYSTIC BREAST DISEASE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN") AND WAS FOUND TO HAVE CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, METRORRHAGIA, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE CERVIX CARCINOMA, ALLERGY TO METALS, HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, FATIGUE, HORMONE LEVEL ABNORMAL, HEADACHE, NAUSEA, FIBROCYSTIC BREAST DISEASE, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, CERVIX CARCINOMA, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FIBROCYSTIC BREAST DISEASE, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENORRHAGIA, METRORRHAGIA, NAUSEA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS" CHRONIC PELVIC PAIN, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ABDOMINAL, PSYCH INJURY, URINARY PROBLEMS., BLADDER INFECTION, UTI (URINARY TRACT INFECTION), VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, HORMONAL CHANGES, HEADACHES, NAUSEA AND CANCER". DISCREPANCY NOTED : AS PER MR, ESSURE WAS REMOVED ON (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2011: (UNSPECIFIED): BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN THE PATIENT'S MEDICAL RECORDS : ABDOMINAL PAIN,PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAR-2020: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED : LOT NUMBER ADDED. REPORTER INFORMATION UPDATED. EVENTS ADDED- VAGINAL HAEMORRHAGE, MENORRHAGIA, ABDOMINAL PAIN LOWER. EVENT ¿NEOPLASM MALIGNANT¿ UPDATED TO ¿CERVIX CARCINOMA¿. LAB TEST ADDED. CONCOMITANT PRODUCT ADDED. 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 RELEVANT 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 ('CHRONIC PELVIC PAIN'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') AND NEOPLASM MALIGNANT ('CANCER (UNSPECIFIED)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY. ON (B)(6) 2011, 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), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), METRORRHAGIA ("METRORRHAGIA (BLEEDING BETWEEN PERIODS)"), ALLERGY TO METALS ("NICKEL ALLERGY"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI (URINARY TRACT INFECTION)"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND FIBROCYSTIC BREAST DISEASE ("FIBROCYSTIC BREAST DISEASE") AND WAS FOUND TO HAVE NEOPLASM MALIGNANT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, METRORRHAGIA, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE NEOPLASM MALIGNANT, ALLERGY TO METALS, HYPERSENSITIVITY, PSYCHOLOGICAL TRAUMA, FATIGUE, HORMONE LEVEL ABNORMAL, HEADACHE, NAUSEA AND FIBROCYSTIC BREAST DISEASE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FIBROCYSTIC BREAST DISEASE, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, METRORRHAGIA, NAUSEA, NEOPLASM MALIGNANT, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS" CHRONIC PELVIC PAIN, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ABDOMINAL, PSYCH INJURY, URINARY PROBLEMS., BLADDER INFECTION, UTI (URINARY TRACT INFECTION), VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, HORMONAL CHANGES, HEADACHES, NAUSEA AND CANCER". DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2011: (UNSPECIFIED): BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PLAINTIFF FACT SHEET RECEIVED. THE CASE IS INCIDENT. PREVIOUSLY REPORTED EVENT ¿INJURY¿ WAS UPDATED TO MORE SPECIFIED EVENT¿ CHRONIC PELVIC, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ABDOMINAL PAIN, MENORRHAGIA (BLEEDING BETWEEN PERIODS), GENERAL ABNORMAL BLEEDING, NICKEL ALLERGY, HYPERSENSITIVITY, PSYCH INJURY, URINARY PROBLEMS, BLADDER INFECTION, UTI (URINARY TRACT INFECTION), VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, HORMONAL CHANGES, HEADACHES, NAUSEA, CANCER (UNSPECIFIED) AND FIBROCYSTIC BREAST DISEASE¿. REPORTER¿S INFORMATION, DEMOGRAPHICS, MEDICAL HISTORY, LAB DATA, ESSURE INDICATION (AMENDED), AND ESSURE INSERTION/REMOVAL DATE WERE ADDED. INCIDENT: NO 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 939744 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802744 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | MIRENA INTRAUTERINE DEVICE| MIRENA INTRAUTERINE DEVICE |