ESSURE
Report
- Report Number
- 2951250-2023-00976
- Event Type
- Injury
- Date Received
- March 7, 2023
- Date of Event
- May 19, 2023
- Report Date
- October 23, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 42 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 844600) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF POLYCYSTIC OVARIAN SYNDROME IN 2021 AND CHRONIC CERVICITIS, ADENOMYOSIS, DISCOMFORT, AUGMENTATION MAMMOPLASTY, GENERAL BODY PAIN, VAGINAL DELIVERY (SVDS: 3. LIVING), SPONTANEOUS ABORTION (SPONTANEOUS ABORTIONS: 1.), ABORTION (LIVING: 3. FULL TERM: 3.. SVDS: 3. LIVING: 3. SPONTANEOUS ABORTIONS: 1.), PARITY 3 (TERM BIRTH), MULTI GRAVIDA (4), ENDOMETRIOSIS, INFLAMMATION LOCALISED (INFLAMMATION OF HANDS AND FINGERS), WEIGHT GAIN, SEIZURES (HAS HAD INTERMITTENT SEIZURE EPISODES), PELVIC PAIN, VOMITING, NAUSEA, ABDOMINAL PAIN, VISUAL DISTURBANCE, DIZZINESS, PALPITATIONS (ABDOMEN IS FLAT, SOFT ,TENDER TO PALPITATIONS IN LEFT LOWER QUADRANT AND LEFT UPPER QUADRANT), EX-ALCOHOL USER, TOBACCO USER AND CYST REMOVAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: METFORMIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2023, 4293 DAYS AFTER ESSURE INSERTION AND 365 DAYS AFTER ITS MOST RECENT USE, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: HAS THREE CHILDREN AND DOES NOT WANT MORE CHILDREN HAS HAD FIRST LAPAROSCOPY AT THE AGE OF 18-YEAR-OLD FOR ENDOMETRIOSIS AND WAS TOLD THAT SHE WILL NEVER GET PREGNANT. LAST MENSES WAS (B)(6) 2021. MENARCHE: 14 Y.O. {ONSET} DATE OF LAST PAP: (B)(6) 2013. DATE OF LAST MAMMOGRAM: (B)(6) 2012. NO COMPLICATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [COMPUTERISED TOMOGRAM ABDOMEN] ON (B)(6) 2013: HEART SIZE IS NORMAL.LUNG BASES ARE CLEAR.OSSEOUS STRUCTURES ARE UNREMARKABLE.BILATERAL BREAST IMPLANTS ARE PRESENT. GALLBLADDER IS CONTRACTED.LIVER,PANCREAS,SPLEEN AND ADRENAL GLANDS ARE WITHIN NORMAL LIMITS.THERE IS NO PANCREATIC OR BILIARY DUCT DILATATION. KIDNEYS ARE SYMMETRIC IN SIZE,ENHANCEMENT, AND CONTRAST EXCRETION.THERE IS NO HYDRONEPHROSIS OR HYDROURETER. [COMPUTERISED TOMOGRAM PELVIS] ON (B)(6) 2013: NO ACUTE INTRA-ABDOMINAL PROCESS.NO FREE AIR OR FREE FLUID. METALLIC TUBAL CLOSURE DEVICES PRESENT BILATERALLY. THERE IS NO PELVIC FREE FLUID.THERE IS NO PELVIC OR RETROPERITONEAL ADENOPATHY.OSSEOUS STRUCTURES ARE UNREMARKABLE [MAGNETIC RESONANCE IMAGING] IN (B)(6) 2011: REPORTS HAVING AN ABNORMAL MRI [PATHOLOGY TEST] ON (B)(6) 2022: PRE-OPERATIVE DIAGNOSIS: ENCOUNTER FOR REMOVAL OF ESSURE PELVIC AND PERINEAI PAIN SPECIMENS RECEIVED: A CERVIX. UTERUS. BILATERAL FALLOPIAN TUBES FALLOPIAN TUBE. RIGHT MEASUREMENT 6.5 CM IN LENGTH X 0.7 CM IN DIAMETER. DESCRIPTION THE SEROSA IS HYPEREMIC. LOT NUMBER: 844600 MANUFACTURE DATE: 2011-03 EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 19-OCT-2023: QUALITY SAFETY EVALUATION OF PTC. 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 42 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 844600) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF POLYCYSTIC OVARIAN SYNDROME IN 2021 AND CHRONIC CERVICITIS, ADENOMYOSIS, DISCOMFORT, AUGMENTATION MAMMOPLASTY, GENERAL BODY PAIN, VAGINAL DELIVERY (SVDS: 3. LIVING), SPONTANEOUS ABORTION (SPONTANEOUS ABORTIONS: ABORTION (LIVING: 3. FULL TERM: 3. SVDS: 3. LIVING: 3. SPONTANEOUS ABORTIONS: 1.), TERM BIRTH, PARITY, MULTI GRAVIDA, ENDOMETRIOSIS, INFLAMMATION LOCALISED (INFLAMMATION OF HANDS AND FINGERS), WEIGHT GAIN, SEIZURES (HAS HAD INTERMITTENT SEIZURE EPISODES), PELVIC PAIN, VOMITING, NAUSEA, ABDOMINAL PAIN, VISUAL DISTURBANCE, DIZZINESS, PALPITATIONS (ABDOMEN IS FLAT, SOFT ,TENDER TO PALPITATIONS IN LEFT LOWER QUADRANT AND LEFT UPPER QUADRANT), EX-ALCOHOL USER, TOBACCO USER AND CYST REMOVAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: METFORMIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2023, 4293 DAYS AFTER ESSURE INSERTION AND 365 DAYS AFTER ITS MOST RECENT USE, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: HAS THREE CHILDREN AND DOES NOT WANT MORE CHILDREN HAS HAD FIRST LAPAROSCOPY AT THE AGE OF 18-YEAR-OLD FOR ENDOMETRIOSIS AND WAS TOLD THAT SHE WILL NEVER GET PREGNANT. LAST MENSES WAS (B)(6) 2021. MENARCHE: 14 Y.O. {ONSET}. DATE OF LAST PAP: (B)(7) 2013. DATE OF LAST MAMMOGRAM: (B)(6) 2012. NO COMPLICATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [COMPUTERISED TOMOGRAM ABDOMEN] ON (B)(6) 2013: HEART SIZE IS NORMAL.LUNG BASES ARE CLEAR.OSSEOUS STRUCTURES ARE UNREMARKABLE.BILATERAL BREAST IMPLANTS ARE PRESENT. GALLBLADDER IS CONTRACTED.LIVER,PANCREAS,SPLEEN AND ADRENAL GLANDS ARE WITHIN NORMAL LIMITS.THERE IS NO PANCREATIC OR BILIARY DUCT DILATATION. KIDNEYS ARE SYMMETRIC IN SIZE,ENHANCEMENT, AND CONTRAST EXCRETION.THERE IS NO HYDRONEPHROSIS OR HYDROURETER. [COMPUTERISED TOMOGRAM PELVIS] ON (B)(6) 2013: NO ACUTE INTRA-ABDOMINAL PROCESS.NO FREE AIR OR FREE FLUID. METALLIC TUBAL CLOSURE DEVICES PRESENT BILATERALLY. THERE IS NO PELVIC FREE FLUID.THERE IS NO PELVIC OR RETROPERITONEAL ADENOPATHY.OSSEOUS STRUCTURES ARE UNREMARKABLE [MAGNETIC RESONANCE IMAGING] IN JUNE 2011: REPORTS HAVING AN ABNORMAL MRI [PATHOLOGY TEST] ON (B)(6) 2022: PRE-OPERATIVE DIAGNOSIS: ENCOUNTER FOR REMOVAL OF ESSURE PELVIC AND PERINEAI PAIN SPECIMENS RECEIVED: A CERVIX. UTERUS. BILATERAL FALLOPIAN TUBES FALLOPIAN TUBE. RIGHT MEASUREMENT 6.5 CM IN LENGTH X 0.7 CM IN DIAMETER. DESCRIPTION THE SEROSA IS HYPEREMIC. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 13-SEP-2023: MR RECEIVED :LOT NUMBER AND EXPIRATION DATE ADDED, REPORTERS INFORMATION, MEDICAL HISTORY LAB DATA ADDED, RCC UPDATED. 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 42 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 30-MAR-2023: 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 42 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. 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 |
|---|---|---|---|---|---|---|---|
| 62785 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 844600 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention |