ESSURE
Report
- Report Number
- 2951250-2018-04209
- Event Type
- Injury
- Date Received
- October 2, 2018
- Date of Event
- January 1, 2012
- Report Date
- December 15, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("POSITIVE FOR NICKEL ALLERGY / METAL ALLERGY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("TWIN PREGNANCY"), TWIN PREGNANCY ("TWIN PREGNANCY"), ADNEXAL TORSION ("DIAGNOSIS OF POSSIBLE OVARIAN TORSION (RIGHT OVARY)") AND MENORRHAGIA ("ABUNDANT BLEEDING DURING MENSTRUATION") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 706581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LOE / DEVICE INEFFECTIVE." THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA AND NEPHROLITHIASIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FALLOPIAN TUBE SPASM ("FALLOPIAN TUBE SPASM"). IN 2012, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH AMENORRHOEA AND TWIN PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED ADNEXAL TORSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND BACK PAIN ("LUMBAR PAIN"). IN 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("INTENSE PAIN IN RIGHT SIDE / ACUTE STABBING PAINS"), IRON DEFICIENCY ANAEMIA ("ANEMIA DUE TO THE ABUNDANT BLEEDING DURING MENSTRUATION"), MIGRAINE ("MIGRAINES / FREQUENT MIGRAINES"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ASTHENIA ("ENERGY LOSS"), PAIN IN EXTREMITY ("LEG PAIN"), PALPITATIONS ("HEART PALPITATIONS"), GASTROINTESTINAL DISORDER ("INTESTINAL PROBLEMS"), DIZZINESS ("DIZZINESS"), NECK PAIN ("NECK PAIN"), THE FIRST EPISODE OF UTERINE LEIOMYOMA ("FIBROIDS/ MYOMATOUS UTERUS"), UTERINE POLYP ("SUSPICIOUS OF ENDOMETRIAL POLYP") AND THE SECOND EPISODE OF UTERINE LEIOMYOMA ("INTRAMURAL LEIOMYOMA"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, ADNEXAL TORSION, MENORRHAGIA, FALLOPIAN TUBE SPASM, PELVIC PAIN, BACK PAIN, IRON DEFICIENCY ANAEMIA, MIGRAINE, ARTHRALGIA, FATIGUE, ASTHENIA, PAIN IN EXTREMITY, PALPITATIONS, GASTROINTESTINAL DISORDER, DIZZINESS, NECK PAIN, UTERINE POLYP, ABDOMINAL PAIN AND THE LAST EPISODE OF UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND TWIN PREGNANCY HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXAL TORSION, ALLERGY TO METALS, ARTHRALGIA, ASTHENIA, BACK PAIN, DIZZINESS, FALLOPIAN TUBE SPASM, FATIGUE, GASTROINTESTINAL DISORDER, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PALPITATIONS, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TWIN PREGNANCY, UTERINE POLYP, THE FIRST EPISODE OF UTERINE LEIOMYOMA AND THE SECOND EPISODE OF UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ELECTIVE ABORTION OCCURRED ON (B)(6) 2012. THE PATIENT WENT TO EMERGENCY SERVICES DUE TO INTENSE PAIN IN RIGHT SIDE, SHE HAD PRESENTED RENAL LITHIASIS FOR THAT REASON SHE WENT TO CONSULTATION ASSOCIATING THE PAIN WITH THE RENAL LITHIASIS BUT THERE WERE NOT COMPLICATIONS WITH THE KIDNEY. THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE PAIN; SHE RELATES THE PAINS TO ESSURE. THE PATIENT HAS PRESENTED ANEMIA DUE TO THE ABUNDANT BLEEDING DURING MENSTRUATION. ACCORDING TO THE ECHOGRAPHY SHE PRESENTS FIBROIDS AND IS ALLERGIC TO ONE COMPONENT OF ESSURE FOR THAT REASON THE FALLOPIAN TUBES AND THE UTERUS HAVE TO BE REMOVED. THE PHYSICIAN TOLD HER THAT SHE WILL HAVE A SURGERY. (B)(6) 2016: REQUEST FOR MEDICAL SURGERY: METAL ALLERGY; DIAGNOSIS: INTRAMURAL LEIOMYOMA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2016: POSITIVE FOR NICKEL ALLERGY ULTRASOUND PELVIS - ON (B)(6) 2012: TWIN PREGNANCY WAS CONFIRMED ULTRASOUND SCAN - ON (B)(6) 2016: FIBROIDS; ON AN UNKNOWN DATE: MYOMATOUS UTERUS. SUSPICIOUS OF ENDOMETRIAL POLYP ON AN UNSPECIFIED DATE - ULTRASOUND (CONT.): BOTH ESSURES ARE IDENTIFIED IN THE USUAL POSITION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY SAFETY EVALUATION FOR 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 ALLERGY TO METALS ('POSITIVE FOR NICKEL ALLERGY / METAL ALLERGY'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('TWIN PREGNANCY'), TWIN PREGNANCY ('TWIN PREGNANCY'), ADNEXAL TORSION ('DIAGNOSIS OF POSSIBLE OVARIAN TORSION (RIGHT OVARY)'), HEAVY MENSTRUAL BLEEDING ('ABUNDANT BLEEDING DURING MENSTRUATION'), PERFORATION ('ORGAN TEARING'), DEVICE BREAKAGE ('TRAVELLING PARTS OF THE BROKEN PRODUCT INSIDE THE BODY') AND ABDOMINAL PAIN ('SERIOUS ABDOMINAL PAIN') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 706581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LOE / DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTI GRAVIDA AND NEPHROLITHIASIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED FALLOPIAN TUBE SPASM ("FALLOPIAN TUBE SPASM"). IN 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH AMENORRHOEA AND TWIN PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED ADNEXAL TORSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND BACK PAIN ("LUMBAR PAIN"). IN 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("INTENSE PAIN IN RIGHT SIDE / ACUTE STABBING PAINS"), IRON DEFICIENCY ANAEMIA ("ANEMIA DUE TO THE ABUNDANT BLEEDING DURING MENSTRUATION"), MIGRAINE ("MIGRAINES / FREQUENT MIGRAINES"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ASTHENIA ("ENERGY LOSS"), PAIN IN EXTREMITY ("LEG PAIN"), PALPITATIONS ("HEART PALPITATIONS"), GASTROINTESTINAL DISORDER ("INTESTINAL PROBLEMS"), DIZZINESS ("DIZZINESS"), NECK PAIN ("NECK PAIN"), UTERINE POLYP ("SUSPICIOUS OF ENDOMETRIAL POLYP") AND MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS") AND WAS FOUND TO HAVE UTERINE FIBROIDS ("FIBROIDS/ MYOMATOUS UTERUS") AND INTRAMURAL LEIOMYOMA OF UTERUS ("INTRAMURAL LEIOMYOMA"). THE PATIENT WAS TREATED WITH SURGERY (ORGAN REMOVAL). AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, ADNEXAL TORSION, HEAVY MENSTRUAL BLEEDING, DEVICE BREAKAGE, ABDOMINAL PAIN, FALLOPIAN TUBE SPASM, PELVIC PAIN, BACK PAIN, IRON DEFICIENCY ANAEMIA, MIGRAINE, ARTHRALGIA, FATIGUE, ASTHENIA, PAIN IN EXTREMITY, PALPITATIONS, GASTROINTESTINAL DISORDER, DIZZINESS, NECK PAIN, UTERINE FIBROIDS, UTERINE POLYP, INTRAMURAL LEIOMYOMA OF UTERUS AND MENTAL DISORDER OUTCOME WAS UNKNOWN AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND TWIN PREGNANCY HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXAL TORSION, ALLERGY TO METALS, ARTHRALGIA, ASTHENIA, BACK PAIN, DEVICE BREAKAGE, DIZZINESS, FALLOPIAN TUBE SPASM, FATIGUE, GASTROINTESTINAL DISORDER, HEAVY MENSTRUAL BLEEDING, IRON DEFICIENCY ANAEMIA, MENTAL DISORDER, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PALPITATIONS, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, TWIN PREGNANCY, UTERINE FIBROIDS, UTERINE POLYP AND INTRAMURAL LEIOMYOMA OF UTERUS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ELECTIVE ABORTION OCCURRED ON (B)(6) 2012. THE PATIENT WENT TO EMERGENCY SERVICES DUE TO INTENSE PAIN IN RIGHT SIDE, SHE HAD PRESENTED RENAL LITHIASIS FOR THAT REASON SHE WENT TO CONSULTATION ASSOCIATING THE PAIN WITH THE RENAL LITHIASIS BUT THERE WERE NOT COMPLICATIONS WITH THE KIDNEY. THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE PAIN; SHE RELATES THE PAINS TO ESSURE. THE PATIENT HAS PRESENTED ANEMIA DUE TO THE ABUNDANT BLEEDING DURING MENSTRUATION. ACCORDING TO THE ECHOGRAPHY SHE PRESENTS FIBROIDS AND IS ALLERGIC TO ONE COMPONENT OF ESSURE FOR THAT REASON THE FALLOPIAN TUBES AND THE UTERUS HAVE TO BE REMOVED. THE PHYSICIAN TOLD HER THAT SHE WILL HAVE A SURGERY. (B)(6) 2016: REQUEST FOR MEDICAL SURGERY: METAL ALLERGY; DIAGNOSIS: INTRAMURAL LEIOMYOMA. A LAWYER WITH A SUMMARY CASE REPORT (INCLUDING THIS PATIENT'S EVENTS) REQUESTED A COMPENSATION FOR EVERY PATIENT FOR DAMAGES (CHRONIC PELVIC PAIN, ABNORMAL UTERINE BLEEDINGS, DYSPAREUNIA (PAIN DURING SEXUAL INTERCOURSE); IMPORTANT FLUID RETENTION IN ABDOMEN, CHRONIC SYSTEMIC REACTIONS OR IMMUNE RESPONSES TO METAL TO THE PET FIBERS IMITATING THE SYMPTOMS AND SIGNS OF RASH; LUPUS, DEMENTIA, RHEUMATOID ARTHRITIS, SYNDROME OF CHRONIC FATIGUE; SYNDROME OF SJOGREN AND LOSS OF SEXUAL DESIRE; HAIR LOSS, FAILURE OF DEVICE (CORRECT IMPLANTATION), LEADING TO ECTOPIC PREGNANCIES, DELIVERY WITH DEAD BABY, INDUCED ABORTIONS, EARLY RUPTURE OF MEMBRANES, EARLY DELIVERY AND FETAL DEATHS; MIGRATION OR EXPULSION OF DEVICE, CAVITIES, RUPTURE OF DENTAL PIECES, LOSS OF TEETH, ENDOMETRIOSIS) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2016: RESULTS: POSITIVE FOR NICKEL ALLERGY. ULTRASOUND PELVIS - ON (B)(6) 2012: RESULTS: TWIN PREGNANCY WAS CONFIRMED. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULTS: MYOMATOUS UTERUS. SUSPICIOUS OF ENDOMETRIAL POLYP; ON (B)(6) 2016: RESULTS: FIBROIDS. DIAGNOSTIC RESULTS: ON AN UNSPECIFIED DATE - ULTRASOUND (CONT.): BOTH ESSURES ARE IDENTIFIED IN THE USUAL POSITION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: ADVERSE EVENT "PSYCHOLOGICAL PROBLEMS", "TRAVELLING PARTS OF THE BROKEN PRODUCT INSIDE THE BODY" AND "ORGAN TEARING" ADDED TO THE CASE; EVENT "ABDOMINAL PAIN" UPDATED TO "SERIOUS ABDOMINAL PAIN";REPORTER ADDED TO THE 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 ALLERGY TO METALS ('POSITIVE FOR NICKEL ALLERGY / METAL ALLERGY'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('TWIN PREGNANCY'), TWIN PREGNANCY ('TWIN PREGNANCY'), ADNEXAL TORSION ('DIAGNOSIS OF POSSIBLE OVARIAN TORSION (RIGHT OVARY)'), HEAVY MENSTRUAL BLEEDING ('ABUNDANT BLEEDING DURING MENSTRUATION'), PERFORATION ('ORGAN TEARING'), DEVICE BREAKAGE ('TRAVELLING PARTS OF THE BROKEN PRODUCT INSIDE THE BODY') AND ABDOMINAL PAIN ('SERIOUS ABDOMINAL PAIN') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 706581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LOE / DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTI GRAVIDA AND NEPHROLITHIASIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED FALLOPIAN TUBE SPASM ("FALLOPIAN TUBE SPASM"). IN 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH AMENORRHOEA AND TWIN PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED ADNEXAL TORSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND BACK PAIN ("LUMBAR PAIN"). IN 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("INTENSE PAIN IN RIGHT SIDE / ACUTE STABBING PAINS"), IRON DEFICIENCY ANAEMIA ("ANEMIA DUE TO THE ABUNDANT BLEEDING DURING MENSTRUATION"), MIGRAINE ("MIGRAINES / FREQUENT MIGRAINES"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ASTHENIA ("ENERGY LOSS"), PAIN IN EXTREMITY ("LEG PAIN"), PALPITATIONS ("HEART PALPITATIONS"), GASTROINTESTINAL DISORDER ("INTESTINAL PROBLEMS"), DIZZINESS ("DIZZINESS"), NECK PAIN ("NECK PAIN"), UTERINE POLYP ("SUSPICIOUS OF ENDOMETRIAL POLYP") AND MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS") AND WAS FOUND TO HAVE UTERINE FIBROIDS ("FIBROIDS/ MYOMATOUS UTERUS") AND INTRAMURAL LEIOMYOMA OF UTERUS ("INTRAMURAL LEIOMYOMA"). THE PATIENT WAS TREATED WITH SURGERY (ORGAN REMOVAL AND ORGAN REMOVAL). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, ADNEXAL TORSION, HEAVY MENSTRUAL BLEEDING, DEVICE BREAKAGE, ABDOMINAL PAIN, FALLOPIAN TUBE SPASM, PELVIC PAIN, BACK PAIN, IRON DEFICIENCY ANAEMIA, MIGRAINE, ARTHRALGIA, FATIGUE, ASTHENIA, PAIN IN EXTREMITY, PALPITATIONS, GASTROINTESTINAL DISORDER, DIZZINESS, NECK PAIN, UTERINE FIBROIDS, UTERINE POLYP, INTRAMURAL LEIOMYOMA OF UTERUS AND MENTAL DISORDER OUTCOME WAS UNKNOWN AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND TWIN PREGNANCY HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXAL TORSION, ALLERGY TO METALS, ARTHRALGIA, ASTHENIA, BACK PAIN, DEVICE BREAKAGE, DIZZINESS, FALLOPIAN TUBE SPASM, FATIGUE, GASTROINTESTINAL DISORDER, HEAVY MENSTRUAL BLEEDING, IRON DEFICIENCY ANAEMIA, MENTAL DISORDER, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PALPITATIONS, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, TWIN PREGNANCY, UTERINE FIBROIDS, UTERINE POLYP AND INTRAMURAL LEIOMYOMA OF UTERUS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ELECTIVE ABORTION OCCURRED ON (B)(6) 2012. THE PATIENT WENT TO EMERGENCY SERVICES DUE TO INTENSE PAIN IN RIGHT SIDE, SHE HAD PRESENTED RENAL LITHIASIS FOR THAT REASON SHE WENT TO CONSULTATION ASSOCIATING THE PAIN WITH THE RENAL LITHIASIS BUT THERE WERE NOT COMPLICATIONS WITH THE KIDNEY. THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE PAIN; SHE RELATES THE PAINS TO ESSURE. THE PATIENT HAS PRESENTED ANEMIA DUE TO THE ABUNDANT BLEEDING DURING MENSTRUATION. ACCORDING TO THE ECHOGRAPHY SHE PRESENTS FIBROIDS AND IS ALLERGIC TO ONE COMPONENT OF ESSURE FOR THAT REASON THE FALLOPIAN TUBES AND THE UTERUS HAVE TO BE REMOVED. THE PHYSICIAN TOLD HER THAT SHE WILL HAVE A SURGERY. (B)(6) 2016: REQUEST FOR MEDICAL SURGERY: METAL ALLERGY; DIAGNOSIS: INTRAMURAL LEIOMYOMA. A LAWYER WITH A SUMMARY CASE REPORT (INCLUDING THIS PATIENT'S EVENTS) REQUESTED A COMPENSATION FOR EVERY PATIENT FOR DAMAGES (CHRONIC PELVIC PAIN, ABNORMAL UTERINE BLEEDINGS, DYSPAREUNIA (PAIN DURING SEXUAL INTERCOURSE); IMPORTANT FLUID RETENTION IN ABDOMEN, CHRONIC SYSTEMIC REACTIONS OR IMMUNE RESPONSES TO METAL TO THE PET FIBERS IMITATING THE SYMPTOMS AND SIGNS OF RASH; LUPUS, DEMENTIA, RHEUMATOID ARTHRITIS, SYNDROME OF CHRONIC FATIGUE; SYNDROME OF SJOGREN AND LOSS OF SEXUAL DESIRE; HAIR LOSS, FAILURE OF DEVICE (CORRECT IMPLANTATION), LEADING TO ECTOPIC PREGNANCIES, DELIVERY WITH DEAD BABY, INDUCED ABORTIONS, EARLY RUPTURE OF MEMBRANES, EARLY DELIVERY AND FETAL DEATHS; MIGRATION OR EXPULSION OF DEVICE, CAVITIES, RUPTURE OF DENTAL PIECES, LOSS OF TEETH, ENDOMETRIOSIS). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2016: RESULTS: POSITIVE FOR NICKEL ALLERGY. ULTRASOUND PELVIS - ON (B)(6) 2012: RESULTS: TWIN PREGNANCY WAS CONFIRMED. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULTS: MYOMATOUS UTERUS. SUSPICIOUS OF ENDOMETRIAL POLYP; ON (B)(6) 2016: RESULTS: FIBROIDS. DIAGNOSTIC RESULTS: ON AN UNSPECIFIED DATE - ULTRASOUND (CONT.): BOTH ESSURES ARE IDENTIFIED IN THE USUAL POSITION. LOT NUMBER: 706581, MANUFACTURE DATE: 2010-01, AND EXPIRATION DATE: 2013-01. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-DEC-2021: QUALITY SAFETY EVALUATION OF PTC. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("POSITIVE FOR NICKEL ALLERGY / METAL ALLERGY"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("TWIN PREGNANCY"), TWIN PREGNANCY ("TWIN PREGNANCY"), ADNEXAL TORSION ("DIAGNOSIS OF POSSIBLE OVARIAN TORSION (RIGHT OVARY)") AND MENORRHAGIA ("ABUNDANT BLEEDING DURING MENSTRUATION") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 706581) INSERTED FOR BIRTH CONTROL. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LOE / DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA AND NEPHROLITHIASIS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FALLOPIAN TUBE SPASM ("FALLOPIAN TUBE SPASM"). IN 2012, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH AMENORRHOEA AND TWIN PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED BACK PAIN ("LUMBAR PAIN") AND ADNEXAL TORSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("INTENSE PAIN IN RIGHT SIDE / ACUTE STABBING PAINS"), IRON DEFICIENCY ANAEMIA ("ANEMIA DUE TO THE ABUNDANT BLEEDING DURING MENSTRUATION"), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES / FREQUENT MIGRAINES"), ARTHRALGIA ("JOINT PAIN"), FATIGUE ("FATIGUE"), ASTHENIA ("ENERGY LOSS"), PAIN IN EXTREMITY ("LEG PAIN"), PALPITATIONS ("HEART PALPITATIONS"), GASTROINTESTINAL DISORDER ("INTESTINAL PROBLEMS"), DIZZINESS ("DIZZINESS"), NECK PAIN ("NECK PAIN"), THE FIRST EPISODE OF UTERINE LEIOMYOMA ("FIBROIDS/ MYOMATOUS UTERUS"), UTERINE POLYP ("SUSPICIOUS OF ENDOMETRIAL POLYP") AND THE SECOND EPISODE OF UTERINE LEIOMYOMA ("INTRAMURAL LEIOMYOMA"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, FALLOPIAN TUBE SPASM, PELVIC PAIN, BACK PAIN, ADNEXAL TORSION, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MIGRAINE, ARTHRALGIA, FATIGUE, ASTHENIA, PAIN IN EXTREMITY, PALPITATIONS, GASTROINTESTINAL DISORDER, DIZZINESS, NECK PAIN, UTERINE POLYP, ABDOMINAL PAIN AND THE LAST EPISODE OF UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND TWIN PREGNANCY HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ABDOMINAL PAIN, ADNEXAL TORSION, ALLERGY TO METALS, ARTHRALGIA, ASTHENIA, BACK PAIN, DIZZINESS, FALLOPIAN TUBE SPASM, FATIGUE, GASTROINTESTINAL DISORDER, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PALPITATIONS, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TWIN PREGNANCY, UTERINE POLYP, THE FIRST EPISODE OF UTERINE LEIOMYOMA AND THE SECOND EPISODE OF UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ELECTIVE ABORTION OCCURRED ON (B)(6) 2012. THE PATIENT WENT TO EMERGENCY SERVICES DUE TO INTENSE PAIN IN RIGHT SIDE, SHE HAD PRESENTED RENAL LITHIASIS FOR THAT REASON SHE WENT TO CONSULTATION ASSOCIATING THE PAIN WITH THE RENAL LITHIASIS BUT THERE WERE NOT COMPLICATIONS WITH THE KIDNEY. THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE PAIN; SHE RELATES THE PAINS TO ESSURE. THE PATIENT HAS PRESENTED ANEMIA DUE TO THE ABUNDANT BLEEDING DURING MENSTRUATION. ACCORDING TO THE ECHOGRAPHY SHE PRESENTS FIBROIDS AND IS ALLERGIC TO ONE COMPONENT OF ESSURE FOR THAT REASON THE FALLOPIAN TUBES AND THE UTERUS HAVE TO BE REMOVED. THE PHYSICIAN TOLD HER THAT SHE WILL HAVE A SURGERY. ON (B)(6) 2016: REQUEST FOR MEDICAL SURGERY: METAL ALLERGY; DIAGNOSIS: INTRAMURAL LEIOMYOMA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2016: POSITIVE FOR NICKEL ALLERGY. ULTRASOUND PELVIS - ON (B)(6) 2012: TWIN PREGNANCY WAS CONFIRMED. ULTRASOUND SCAN - ON (B)(6) 2016: FIBROIDS; ON AN UNKNOWN DATE: MYOMATOUS UTERUS. SUSPICIOUS OF ENDOMETRIAL POLYP . ON AN UNSPECIFIED DATE - ULTRASOUND (CONT.): BOTH ESSURES ARE IDENTIFIED IN THE USUAL POSITION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768670 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 706581 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention| O | IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN |