ESSURE
Report
- Report Number
- 2951250-2020-14817
- Event Type
- Injury
- Date Received
- October 9, 2020
- Date of Event
- January 1, 2018
- Report Date
- October 18, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (3) AND PARITY 3. IN (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA ("EXTREMELY HEAVY MENSTRUAL BLEEDING, DISRUPTED MENSTRUATION CYCLE, FEATURING VERY FREQUENT INTERMITTENT BLEEDING, VIRTUALLY CONTINUOUS MENSTRUATION"), BACK PAIN ("LUMBAR BACK PAIN"), HYPOAESTHESIA ("NUMBNESS"), FEELING COLD ("FEELS COLD UNUSUALLY OFTEN") AND ABDOMINAL PAIN UPPER ("UPSET STOMACH, CRAMP-LIKE PAINS IN STOMACH"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED IN (B)(6) 2020. IN 2020, THE MENOMETRORRHAGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, HYPOAESTHESIA, FEELING COLD AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, BACK PAIN, FEELING COLD, HYPOAESTHESIA AND MENOMETRORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE INSERTION PROCEDURE TOOK BARELY 10 MINUTES. WOMAN REPORTED IN LAYPRESS, THAT AFTER HAVING HER IMPLANTS REMOVED, SHE GAINED A NEW LIFE, HER LUMBAR BACK PAIN AND HER HEAVY PERIODS HAD SUBSIDED; HER MENSTRUAL CYCLE HAD RETURNED TO NORMAL FURTHER COMPANY FOLLOW-UP WITH THE NON-HEALTH PROFESSIONAL IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-SEP-2020: NO NEW INFORMATION. AMENDMENT: THE REPORT WAS ALSO AMENDED FOR THE FOLLOWING REASON: THIS RECORD WAS DETECTED TO BE A DUPLICATE OF RECORD # (B)(4) (MEDWATCH 3500A MFR NUMBER 2951250-2020-14819) AND (B)(4) (MEDWATCH 3500A MFR NUMBER 2951250-2020-14820) WHICH WILL BE DELETED FROM BAYER SAFETY DATABASE AFTER ALL INFORMATION WAS TRANSFERRED TO THIS DUPLICATE RECORD # (B)(4) WHICH WILL BE RETAINED. NEW: CONSUMER REPORTER DATA AND INITIALS WERE ADDED. HISTORY ADDED: GRAVIDA 3; PARITY 3. ESSURE INSERTION WAS IN (B)(4) 2017. NEW EVENT ADDED: ABDOMINAL PAIN UPPPER (CHANGED FROM ABDOMINAL DISCOMFORT). START DATE OF EVENTS WAS 2017. COMMENT AMENDED WITH " THE INSERTION PROCEDURE TOOK BARELY 10 MINUTES. SHE GAINED A NEW LIFE SINCE ESSURE REMOVAL". BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('ABDOMINAL PAIN, THE PAIN WAS SO SEVERE AND COULD BE COMPARED TO STRONG LABOUR PAINS') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "MECHANICAL COMPLICATIONS WITH INTRAUTERINE CONTRACEPTIVE" IN (B)(6) 2019. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (3), PARITY 3, MENSES PAINFUL ((MILD)) AND HYPOMENORRHEA (MINOR). ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED BACK PAIN ("LUMBAR BACK PAIN"), ABDOMINAL PAIN UPPER ("UPSET STOMACH, CRAMP-LIKE PAINS IN STOMACH"), HYPOAESTHESIA ("NUMBNESS") AND FEELING COLD ("FEELS COLD UNUSUALLY OFTEN"). ON (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA ("EXTREMELY HEAVY MENSTRUAL BLEEDING, DISRUPTED MENSTRUATION CYCLE, FEATURING VERY FREQUENT INTERMITTENT BLEEDING, VIRTUALLY CONTINUOUS MENSTRUATION/PERIOD TWICE A MONTH WITH PROFUSE BLEEDING"), HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING"), DYSMENORRHOEA ("PAIN DURING MENSTRUATION"), ADNEXA UTERI PAIN ("¿BURNING¿ OF MY FALLOPIAN TUBES"), HEADACHE ("HEADACHE") AND NAUSEA ("NAUSEA"), 11 MONTHS 27 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2019, THE PATIENT WAS FOUND TO HAVE CERVIX NEOPLASM ("POPULATION-BASED SCREENING DUE TO TUMOR IN CERVIX"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADNEXA UTERI CYST ("PARAOVARIAN CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL VIA LAPAROSCOPIC SAPINGECTOMY AND EXTIRPATION OF PARAOVARIAN CYSTS ON (B)(6) 2020 AND PARTS OF VAGINAL PORTION OF CERVIX REOVED IN (B)(6) 2019). ESSURE WAS REMOVED ON (B)(6) 2020. IN 2020, THE BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN UPPER, HYPOAESTHESIA, FEELING COLD, CERVIX NEOPLASM, ADNEXA UTERI CYST AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN, THE MENOMETRORRHAGIA WAS RESOLVING AND THE HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, HEADACHE AND NAUSEA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ADNEXA UTERI CYST, ADNEXA UTERI PAIN, BACK PAIN, CERVIX NEOPLASM, DYSMENORRHOEA, FEELING COLD, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPOAESTHESIA, MENOMETRORRHAGIA, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INITIALLY WOMAN REPORTED IN LAYPRESS, THAT THE INSERTION PROCEDURE TOOK BARELY 10 MINUTES. AFTER HAVING HER IMPLANTS REMOVED, SHE GAINED A NEW LIFE, HER LUMBAR BACK PAIN AND HER HEAVY PERIODS HAD SUBSIDED; HER MENSTRUAL CYCLE HAD RETURNED TO NORMAL. FOLLOW UP REPORT WAS RECEIVED AS CLAIM TO INSURANCE: NOTICE OF SIDE EFFECTS ON (B)(6) 2018, SOUGHT MEDICAL ATTENTION DUE TO SIDE EFFECTS IN (B)(6) 2018. AFTER ESSURE REMOVAL, BLEEDING HAS GOT SIGNIFICANTLY BETTER, BUT PAIN HAS NOT GOT NOTABLY BETTER, ON MANY OCCASIONS BEDRIDDEN FOR 1-2 DAYS AT THE BEGINNING OF PERIOD, ALSO GETS A LOT OF HEADACHES AND NAUSEA. CONSUMER THINKS THE EVENT(S) ARE PERMANENT BECAUSE IT HAS LASTED FOR MANY YEARS NOW AND THERE HAS BEEN NO NOTEWORTHY IMPROVEMENT. THE ONLY IMPROVEMENT WAS THAT OVERALL BLEEDING LESS, BUT THERE ARE STILL MENSTRUATIONS 'WHERE I BLEED SO MUCH THAT I NEED TO STAY HOME. I WORK FLEXITIME. THIS GIVES ME THE POSSIBILITY OF PLANNING SO I CAN WORK FROM HOME OR TAKE TIME OFF IF I HAVE SEVERE BLEEDING AND PAIN. IN THE END, I¿VE STILL GOT PROBLEMS THAT I DIDN¿T HAVE BEFORE ESSURE WAS INSERTED' DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BIOPSY - IN (B)(6) 2019: CERVIX CELL SAMPLES TAKEN: HAD TO HAVE PROCEDURE TO REMOVE PARTS OF THE VAGINAL PORTION OF THE CERVIX. SMEAR TEST - IN (B)(6) 2019: CELL CHANGES. SPECIALIST CONSULTATION - IN (B)(6) 2019: DIAGNOSED WITH MECHANICAL COMPLICATIONS WITH INTRAUTERINE CONTRACEPTIVE AND POPULATION-BASED SCREENING DUE TO TUMOR IN CERVIX. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITH THE NON-HEALTH PROFESSIONAL, NON-HEALTH PROFESSIONAL OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: FOLLOW UP INFORMATION WAS RECEIVED AND THIS REPORT WAS DETECTED TO BE A DUPLICATE TO RECORD # (B)(4) (MEDWATCH 3500A MFR NUMBER (B)(4)) WHICH WILL BE DELETED IN BAYER SAFETY DATABASE AFTER ALL INFORMATION WAS TRANSFERRED TO THIS DUPLICATE RECORD # (B)(4) WHICH WILL BE RETAINED. NEW: REPORTING PATIENT'S NAME, INITIALS WERE AMENDED, ADDRESS WAS ADDED. REPORTER WAS ADDED: INSURANCE, THEY HAD RECEIVED A CLAIM. DATE OF BIRTH (NEW: EVENTS STARTED AGE 29), MEDICAL HISTORY (DYSMENORRHEA, HYPOMENORRHEA) ADDED. ESSURE INSERTION AND REMOVAL DATES WERE SPECIFIED, SURGERY WAS SPECIFIED: ESSURE REMOVAL VIA LAPAROSCOPIC SAPINGECTOMY AND EXTIRPATION OF PARAOVARIAN CYSTS ON (B)(6) 2020. COMMENT WAS ADDED. NEW EVENTS: DEVICE PHYSICAL PROPERTY ISSUE, ADNEXA UTERI CYST, ADNEXA UTERI PAIN, CERVIX NEOPLASM, DYSMENORRHOEA, HEAVY MENSTRUAL BLEEDING, HEADACHE, NAUSEA. THE EVENT ABDOMINAL PAIN WAS SPECIFIED TO PELVIC PAIN BECAUSE IT 'COULD BE COMPARED TO STRONG LABOUR PAINS'. TEST RESULTS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('ABDOMINAL PAIN, THE PAIN WAS SO SEVERE AND COULD BE COMPARED TO STRONG LABOUR PAINS') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "MECHANICAL COMPLICATIONS WITH INTRAUTERINE CONTRACEPTIVE" IN (B)(6) 2019. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (3), PARITY 3, MENSES PAINFUL ((MILD)) AND HYPOMENORRHEA (MINOR). ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED BACK PAIN ("LUMBAR BACK PAIN"), ABDOMINAL PAIN UPPER ("UPSET STOMACH, CRAMP-LIKE PAINS IN STOMACH"), HYPOAESTHESIA ("NUMBNESS") AND FEELING COLD ("FEELS COLD UNUSUALLY OFTEN"). ON (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA ("EXTREMELY HEAVY MENSTRUAL BLEEDING, DISRUPTED MENSTRUATION CYCLE, FEATURING VERY FREQUENT INTERMITTENT BLEEDING, VIRTUALLY CONTINUOUS MENSTRUATION/PERIOD TWICE A MONTH WITH PROFUSE BLEEDING"), HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING"), DYSMENORRHOEA ("PAIN DURING MENSTRUATION"), ADNEXA UTERI PAIN ("¿BURNING¿ OF MY FALLOPIAN TUBES"), HEADACHE ("HEADACHE") AND NAUSEA ("NAUSEA"), 11 MONTHS 27 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2019, THE PATIENT WAS FOUND TO HAVE CERVIX NEOPLASM ("POPULATION-BASED SCREENING DUE TO TUMOR IN CERVIX"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADNEXA UTERI CYST ("PARAOVARIAN CYSTS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL VIA LAPAROSCOPIC SAPINGECTOMY AND EXTIRPATION OF PARAOVARIAN CYSTS ON (B)(6) 2020 AND PARTS OF VAGINAL PORTION OF CERVIX REMOVED IN (B)(6) 2019). ESSURE WAS REMOVED ON (B)(6) 2020. IN 2020, THE BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN UPPER, HYPOAESTHESIA, FEELING COLD, CERVIX NEOPLASM, ADNEXA UTERI CYST AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN, THE MENOMETRORRHAGIA WAS RESOLVING AND THE HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, HEADACHE AND NAUSEA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ADNEXA UTERI CYST, ADNEXA UTERI PAIN, BACK PAIN, CERVIX NEOPLASM, DYSMENORRHOEA, FEELING COLD, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPOAESTHESIA, MENOMETRORRHAGIA, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INITIALLY WOMAN REPORTED IN LAYPRESS, THAT THE INSERTION PROCEDURE TOOK BARELY 10 MINUTES. AFTER HAVING HER IMPLANTS REMOVED, SHE GAINED A NEW LIFE, HER LUMBAR BACK PAIN AND HER HEAVY PERIODS HAD SUBSIDED; HER MENSTRUAL CYCLE HAD RETURNED TO NORMAL. FOLLOW UP REPORT WAS RECEIVED AS CLAIM TO INSURANCE: NOTICE OF SIDE EFFECTS ON (B)(6) 2018, SOUGHT MEDICAL ATTENTION DUE TO SIDE EFFECTS IN (B)(6) 2018. AFTER ESSURE REMOVAL, BLEEDING HAS GOT SIGNIFICANTLY BETTER, BUT PAIN HAS NOT GOT NOTABLY BETTER, ON MANY OCCASIONS BEDRIDDEN FOR 1-2 DAYS AT THE BEGINNING OF PERIOD, ALSO GETS A LOT OF HEADACHES AND NAUSEA. CONSUMER THINKS THE EVENT(S) ARE PERMANENT BECAUSE IT HAS LASTED FOR MANY YEARS NOW AND THERE HAS BEEN NO NOTEWORTHY IMPROVEMENT. THE ONLY IMPROVEMENT WAS THAT OVERALL BLEEDING LESS, BUT THERE ARE STILL MENSTRUATIONS 'WHERE I BLEED SO MUCH THAT I NEED TO STAY HOME. I WORK FLEXITIME. THIS GIVES ME THE POSSIBILITY OF PLANNING SO I CAN WORK FROM HOME OR TAKE TIME OFF IF I HAVE SEVERE BLEEDING AND PAIN. IN THE END, I¿VE STILL GOT PROBLEMS THAT I DIDN¿T HAVE BEFORE ESSURE WAS INSERTED' DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BIOPSY - IN (B)(6) 2019: CERVIX CELL SAMPLES TAKEN: HAD TO HAVE PROCEDURE TO REMOVE PARTS OF THE VAGINAL PORTION OF THE CERVIX. SMEAR TEST - IN (B)(6) 2019: CELL CHANGES. SPECIALIST CONSULTATION - IN (B)(6) 2019: DIAGNOSED WITH MECHANICAL COMPLICATIONS WITH INTRAUTERINE CONTRACEPTIVE AND POPULATION-BASED SCREENING DUE TO TUMOR IN CERVIX. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. FURTHER COMPANY FOLLOW-UP WITH THE NON-HEALTH PROFESSIONAL, NON-HEALTH PROFESSIONAL OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2021: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (3) AND PARITY 3. IN (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA ("EXTREMELY HEAVY MENSTRUAL BLEEDING, DISRUPTED MENSTRUATION CYCLE, FEATURING VERY FREQUENT INTERMITTENT BLEEDING, VIRTUALLY CONTINUOUS MENSTRUATION"), BACK PAIN ("LUMBAR BACK PAIN"), ABDOMINAL PAIN UPPER ("UPSET STOMACH, CRAMP-LIKE PAINS IN STOMACH"), HYPOAESTHESIA ("NUMBNESS") AND FEELING COLD ("FEELS COLD UNUSUALLY OFTEN"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED IN (B)(6) 2020. IN 2020, THE MENOMETRORRHAGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, HYPOAESTHESIA AND FEELING COLD OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, BACK PAIN, FEELING COLD, HYPOAESTHESIA AND MENOMETRORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE INSERTION PROCEDURE TOOK BARELY 10 MINUTES. WOMAN REPORTED IN (B)(6), THAT AFTER HAVING HER IMPLANTS REMOVED, SHE GAINED A NEW LIFE, HER LUMBAR BACK PAIN AND HER HEAVY PERIODS HAD SUBSIDED; HER MENSTRUAL CYCLE HAD RETURNED TO NORMAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE NON-HEALTH PROFESSIONAL, NON-HEALTH PROFESSIONAL OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-FEB-2021: QUALITY ANALYSIS DEPARTMENT REPORTED THAT NO NEW PRODUCT TECHNICAL COMPLAINT INVESTIGATION (PTC) IS MADE (NO PTC RELEVANT FOLLOW-UP AFTER LAST PTC RESULTS WERE ENTERED), THIS REPORT IS FINAL. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (3) AND PARITY 3. IN (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA ("EXTREMELY HEAVY MENSTRUAL BLEEDING, DISRUPTED MENSTRUATION CYCLE, FEATURING VERY FREQUENT INTERMITTENT BLEEDING, VIRTUALLY CONTINUOUS MENSTRUATION"), BACK PAIN ("LUMBAR BACK PAIN"), HYPOAESTHESIA ("NUMBNESS"), FEELING COLD ("FEELS COLD UNUSUALLY OFTEN") AND ABDOMINAL PAIN UPPER ("UPSET STOMACH, CRAMP-LIKE PAINS IN STOMACH"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED IN (B)(6) 2020. IN 2020, THE MENOMETRORRHAGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, HYPOAESTHESIA, FEELING COLD AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, BACK PAIN, FEELING COLD, HYPOAESTHESIA AND MENOMETRORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE INSERTION PROCEDURE TOOK BARELY 10 MINUTES. WOMAN REPORTED IN LAYPRESS, THAT AFTER HAVING HER IMPLANTS REMOVED, SHE GAINED A NEW LIFE, HER LUMBAR BACK PAIN AND HER HEAVY PERIODS HAD SUBSIDED; HER MENSTRUAL CYCLE HAD RETURNED TO NORMAL. FURTHER COMPANY FOLLOW-UP WITH THE NON-HEALTH PROFESSIONAL IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-SEP-2020: NO NEW INFORMATION. AMENDMENT: THE REPORT WAS ALSO AMENDED FOR THE FOLLOWING REASON: THIS RECORD WAS DETECTED TO BE A DUPLICATE OF RECORD # (B)(4) (MEDWATCH 3500A MFR NUMBER 2951250-2020-14819) AND (B)(4) (MEDWATCH 3500A MFR NUMBER 2951250-2020-14820) WHICH WILL BE DELETED FROM BAYER SAFETY DATABASE AFTER ALL INFORMATION WAS TRANSFERRED TO THIS DUPLICATE RECORD # (B)(4) WHICH WILL BE RETAINED. NEW: CONSUMER REPORTER DATA AND INITIALS WERE ADDED. HISTORY ADDED: GRAVIDA 3; PARITY 3. ESSURE INSERTION WAS IN (B)(6) 2017. NEW EVENT ADDED: ABDOMINAL PAIN UPPER (CHANGED FROM ABDOMINAL DISCOMFORT). START DATE OF EVENTS WAS 2017. COMMENT AMENDED WITH " THE INSERTION PROCEDURE TOOK BARELY 10 MINUTES. SHE GAINED A NEW LIFE SINCE ESSURE REMOVAL". BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A NON-HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('ABDOMINAL PAIN') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. 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 ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA ("EXTREMELY HEAVY MENSTRUAL BLEEDING, DISRUPTED MENSTRUATION CYCLE, FEATURING VERY FREQUENT INTERMITTENT BLEEDING, VIRTUALLY CONTINUOUS MENSTRUATION"), BACK PAIN ("LUMBAR BACK PAIN"), HYPOAESTHESIA ("NUMBNESS"), FEELING COLD ("FEELS COLD UNUSUALLY OFTEN") AND ABDOMINAL DISCOMFORT ("UPSET STOMACH"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED IN (B)(6) 2020. IN 2020, THE MENOMETRORRHAGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, HYPOAESTHESIA, FEELING COLD AND ABDOMINAL DISCOMFORT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL PAIN, BACK PAIN, FEELING COLD, HYPOAESTHESIA AND MENOMETRORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: WOMAN REPORTED IN LAYPRESS, THAT AFTER HAVING HER IMPLANTS REMOVED, HER LUMBAR BACK PAIN AND HER HEAVY PERIODS HAD SUBSIDED; HER MENSTRUAL CYCLE HAD RETURNED TO NORMAL. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1118663 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R |