ESSURE
Report
- Report Number
- 2951250-2021-02242
- Event Type
- Injury
- Date Received
- May 17, 2021
- Date of Event
- January 1, 2014
- Report Date
- January 1, 2025
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE FIBROID, OVARIAN CYST, ANXIETY DISORDER, DEPRESSIVE DISORDER, ATTENTION DEFICIT DISORDER, HYPERTENSION, SLEEP APNEA, HYPOTHYROIDISM, ADENOMYOSIS, PELVIC PAIN, ADNEXA UTERI CYST, ABNORMAL UTERINE BLEEDING, INTRAMURAL LEIOMYOMA OF UTERUS, CYSTADENOFIBROMA OF FALLOPIAN TUBE, PARATUBAL CYST AND ENDOMETRIOSIS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON AN UNKNOWN DATE: THE UTERUS MEASURES 8.9 X 5_3 X 5.0 UN. THE UTERUS IS ANTEVERTED, WITH A HETEROGENEOUS MYOMETRIUM AND A 2.0 X 1.3 X 1.0 CM SUSPECTED FIBROID IN THE POSTERIOR MYOMETRIUM. THE ENDOMETRIUM MEASURES APPROXIMATELY MM. BILATERAL ESSURE DEVICES ARE VISUALIZED IN AN APPROPRIATE POSITION. BOTH OVARIES APPEAR NORMAL AS SEEN. A 3.5 X 2.8 X 3,4 CM SIMPLE QI IS VISUALIZED IN THE RIGHT ADNEXA. A 3.1 X 2.2 X 2.7 CM SIMPLE CYST IS VISUALIZED IN THE LEFT ADNEXA. THE OVARIES BOTH DEMONSTRATE APPROPRIATE MOTILITY, AND MOVE INDEPENDENTLY FROM THE ADNEXAL CYSTS. NO PELVIC MASSES OR FREE FOIE ARE VISUALIZED.. 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JUN-2021: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT 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 ("ESSURE REMOVAL") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF HIVES, DIFFICULTY BREATHING, COUGH, ALLERGY TO CHEMICALS, SKIN BREAKOUT AND INSOMNIA IN 2021 AND SWELLING NOS, ENDOMETRIOSIS, PARATUBAL CYST, CYSTADENOFIBROMA OF FALLOPIAN TUBE, INTRAMURAL LEIOMYOMA OF UTERUS, ABNORMAL UTERINE BLEEDING, ADNEXA UTERI CYST, PELVIC PAIN, ADENOMYOSIS, HYPOTHYROIDISM, SLEEP APNEA, HYPERTENSION, ATTENTION DEFICIT DISORDER, DEPRESSIVE DISORDER, ANXIETY DISORDER, OVARIAN CYST AND UTERINE FIBROID. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: GEODON AND RISPERIDONE. CONCURRENT CONDITIONS WERE LISTED AS DRUG ALLERGY SINCE 2021 AS WELL AS HEADACHE (RISPERIDONE ALLERGY), SKIN BREAKOUT (SULFUR; REACTION) AND INSOMNIA (CORTICOSTEROIDS ALLERGY). ESSURE WAS REMOVED ON (B)(6) 2021. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ULTRASOUND PELVIS] (DATE UNKNOWN): THE UTERUS MEASURES 8.9 X 5_3 X 5.0 UN. THE UTERUS IS ANTEVERTED, WITH A HETEROGENEOUS MYOMETRIUM AND A 2.0 X 1.3 X 1.0 CM SUSPECTED FIBROID IN THE POSTERIOR MYOMETRIUM. THE ENDOMETRIUM MEASURES APPROXIMATELY MM. BILATERAL ESSURE DEVICES ARE VISUALIZED IN AN APPROPRIATE POSITION. BOTH OVARIESAPPEAR NORMAL AS SEEN. A 3.5 X 2.8 X 3,4 CM SIMPLE QI IS VISUALIZED IN THE RIGHT ADNEXA. A 3.1 X 2.2 X 2.7 CM SIMPLE CYST IS VISUALIZED IN THE LEFT ADNEXA. THE OVARIES BOTH DEMONSTRATE APPROPRIATE MOTILITY, AND MOVE INDEPENDENTLY FROM THE ADNEXAL CYSTS. NO PELVIC MASSES OR FREE FOIE ARE VISUALIZED. 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: 04-JUN-2021: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 04-MAR-2022: MR RECEIVED. PATIENT MEDICAL HISTORY, PRODUCT INDICATION ADDED. 07-DEC-2022: PLAINTIFF FACT SHEET RECEIVED. REPORTER ADDED. ESSURE INSERTION DATE UPDATED. 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.
BAYER CASE NUMBER: (B)(4). NUMEROUS PAIN AND SUFFERING IN REGARD TO MY HEALTH [PELVIC PAIN FEMALE] , SUFFERING MAJOR HEATH PROBLEMS DUE TO FRAGMENTS LEFT BY THIS PRODUCT [DEVICE BREAKAGE] LOSING MY TEETH INCLUDING MY FRONT ONES JUST FALLING OUT [LOOSE TOOTH], JOINT DEGENERATIVE DISEASE [DEGENERATIVE JOINT DISEASE] , HASHIMOTO'S THYROIDITIS [HASHIMOTO'S THYROIDITIS] , EMPHEDEMA [LYMPHEDEMA] , FATIGUE SYNDROME [CHRONIC FATIGUE SYNDROME] , WENT FROM 155 160 IN 2020 AND I'M NOW ALMOST 300 LB AND CONTINUING TO GO UP [WEIGHT GAIN]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY (REFERENCE NUMBER: MW5162745) ON 04-MAY-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 11-DEC-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("NUMEROUS PAIN AND SUFFERING IN REGARD TO MY HEALTH") AND DEVICE BREAKAGE ("SUFFERING MAJOR HEATH PROBLEMS DUE TO FRAGMENTS LEFT BY THIS PRODUCT") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B42242, 22200DD) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF HIVES, DIFFICULTY BREATHING, COUGH, ALLERGY TO CHEMICALS, SKIN BREAKOUT AND INSOMNIA ON (B)(6)2021, SWELLING NOS, ENDOMETRIOSIS, PARATUBAL CYST, CYSTADENOFIBROMA OF FALLOPIAN TUBE, INTRAMURAL LEIOMYOMA OF UTERUS, ABNORMAL UTERINE BLEEDING, ADNEXA UTERI CYST, PELVIC PAIN, ADENOMYOSIS, HYPOTHYROIDISM, SLEEP APNEA, HYPERTENSION, ATTENTION DEFICIT DISORDER, DEPRESSIVE DISORDER, ANXIETY DISORDER, OVARIAN CYST AND UTERINE FIBROID. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: ZIPRASIDONE AND RISPERIDONE. CONCURRENT CONDITIONS WERE LISTED AS DRUG ALLERGY SINCE (B)(6) 2021, HEADACHE (RISPERIDONE ALLERGY), SKIN BREAKOUT (SULFUR; REACTION) AND INSOMNIA (CORTICOSTEROIDS ALLERGY). CONCOMITANT PRODUCTS INCLUDED VITAMIN D (ERGOCALCIFEROL), VITAMIN C (ASCORBIC ACID), SEROQUEL XR (QUETIAPINE FUMARATE), MARIJUANA, LOSARTAN (LOSARTAN POTASSIUM), IBUPROFEN, GABAPENTIN STAT RX, CANNABIDIOL AND BUPROPION (BUPROPION HYDROCHLORIDE). IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), LOOSE TOOTH ("LOSING MY TEETH INCLUDING MY FRONT ONES JUST FALLING OUT"), OSTEOARTHRITIS ("JOINT DEGENERATIVE DISEASE"), AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S THYROIDITIS"), LYMPHOEDEMA ("EMPHEDEMA") AND CHRONIC FATIGUE SYNDROME ("FATIGUE SYNDROME") AND WAS FOUND TO HAVE WEIGHT INCREASED (", WENT FROM 155 160 IN 2020 AND I'M NOW ALMOST 300 LB AND CONTINUING TO GO UP"). ON UNKNOWN DATE SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE THYROIDITIS, CHRONIC FATIGUE SYNDROME, DEVICE BREAKAGE, LOOSE TOOTH, LYMPHOEDEMA, OSTEOARTHRITIS, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: I WAS IMPLANTED WITH THE ESSURE DEVICE (B)(6) 2013 BY MY DOCTOR WHO HAD NO BUSINESS TO DO SO! I WENT TO GET MY TUBE TIED AND WAS CONVINCED BY (B)(6) AT THE (B)(6) HERE IN (B)(6) TO GET THE PERFECT NO COST TO ME ESSURE INSTEAD. UNBEKNOWNST TO ME THE BEGINNING OF 2014 THINGS STARTED CHANGING IN MY BODY. LOSING MY TEETH INCLUDING MY FRONT ONES JUST FALLING OUT, NUMEROUS PAIN AND SUFFERING IN REGARD TO MY HEALTH. JOINT DEGENERATIVE DISEASE, HASHIMOTO'S THYROIDITIS, EMPHEDEMA, MAJOR FATIGUE SYNDROME, TEETH AND MAJOR WEIGHT GAIN, WENT FROM 155 160 IN 2020 AND I'M NOW ALMOST 300 LB AND CONTINUING TO GO UP! I HAD TO HAVE MAJOR SURGERY IN (B)(6) 2021 TO BE EXACT, AT THE SAME PLACE THAT PUT MY ESSURE IN 2013! UNBEKNOWNST TO ME MY DOCTORS AT THE (B)(6) WE'RE WORKING BEHIND MY BACK WITH DIFFERENT DOCTORS AND I FEEL COVERING UP MISCONDUCT AND MALPRACTICE SUITS! I HAD TO HAVE A COMPLETE HYSTERECTOMY REMOVING EVERYTHING SUPPOSEDLY BUT MY OVARIES! I SPECIFICALLY I'VE ASKED MY DOCTORS TO DO TESTS TO SEE ABOUT FRAGMENTS LEFT IN MY BODY! THESE TESTS CAME BACK RESULTS AND JUST GENERAL INFORMATION AND THIS HAS HAPPENED TO ME A COUPLE TIMES BY MY DOCTOR PCP (B)(6) AT (B)(6). MY DOCTORS HAVE COVERED UP INFORMATION AND LIED TO MY FACE ABOUT MY ILLNESSES. I WAS NEVER TOLD BY MY DOCTOR ABOUT THE RECALL OF ESSURE OR THE POTENTIAL HARM IT COULD DO TO MYSELF AND MY BODY. (B)(6) HAS BEEN PAID BY (B)(6) MULTIPLE TIMES FOR DIFFERENT PRODUCTS SHE USED ON HER PATIENTS. I'M STILL SUFFERING MAJOR HEATH PROBLEMS DUE TO FRAGMENTS LEFT BY THIS PRODUCT. I HAVE A REPORT FROM MY HYSTERECTOMY THAT CLEARLY STATES I HAVE FRAGMENTS LEFT IN MY BODY. I CAN'T GET ALL MY HEATH RECORDS AND THERE IS A LOT PERTAINING TO MY HYSTERECTOMY AND THE NOTES AND PROCESS OF (B)(6) AND THE PROCEDURE THAT WAS DONE IN (B)(6) 2013. I FEEL I HAVE RECORDS PERTAINING TO HEALTHCARE FRAUD WITH PROCEDURES THAT WEREN'T DONE OR POSSIBLY A HIGHER PAY OF A SURGERY THAT DIDN'T TAKE PLACE. I WAS DUPED BY MY HEALTHCARE AND MY ATTORNEY WHO FRAUDULENTLY COVERED UP MY LAWSUIT AND LIED ABOUT THE AMOUNT AND THE TRUE SCENARIO OF WHAT WAS TAKING PLACE. OHP ((B)(6) HEALTH PLAN) "THE (B)(6) HEALTH PLAN" (B)(6) LIED TO ME ABOUT NOT TAKING MONEY OUT OF MY CLAIM, THEY DID! NO ONE IN (B)(6) WHO MY CONTRACT FOR MY ATTORNEY IN (B)(6) SAYS WAS OUT OF (B)(6) IN (B)(6) COURT. I HAD CALLED THE STATE BAR AND THE COURTHOUSE THAT WAS SUPPOSED TO BE OVERLOOKING MY ATTORNEY WHO TOOK (B)(6) IN SETTLEMENT FUNDS AND DISTRIBUTED OUT AS HE PLEASE IN THE (B)(6) COURTS. NO ONE IN THE STATE BAR OR IN THE COURT REPORTER'S OFFICE KNEW OF ME OR MY ATTORNEY (B)(6) OPERATING IN ANY OF THEIR COURTS. I WAS TOLD TO FILE A COMPLAINT WITH THE STATE BAR FOR A-LICENSED ATTORNEY IN (B)(6). I HAD DONE SO AND WAS TOLD BY THE STATE BAR THAT HE WAS PRO HAVOC SO MY COMPLAINT REALLY DIDN'T MATTER BECAUSE IT WASN'T THE PROPER COMPLAINT FORM. THE STATE BAR TOLD ME THAT THEY DID TELL THE (B)(6) STATE BAR THAT THERE WAS SOME MISCONDUCT BUT THERE WAS NOTHING THAT (B)(6) CAN DO BECAUSE HE WASN'T A LICENSE ATTORNEY IN (B)(6)! HERE IS MY PROBLEM, I AM SUFFERING TREMENDOUSLY WITH NO RELIEF FOR REAL INFORMATION ON HELPING ME FIX WHAT'S GOING ON WITH ME AND THIS STUPID PRODUCT THAT WAS SOLD TO MEDICAID AND MEDICARE FOR CHEAP AND THEN TURN AROUND AND HARM ME TO NO END ONLY TO BE LIED ABOUT THE PRODUCT AND IT'S HARM AND YOU HAVE TO PAY FOR THAT HARM IT DONE TO ME! I KNOW FOR A FACT THAT MY HEALTHCARE INSURANCE VIOLATED MY HIPAA RIGHTS AND CONTINUE TO DO SO. PLEASE SOMEONE HELP ME TO FIGURE OUT HOW TO MOVE FORWARD. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ULTRASOUND PELVIS] (DATE UNKNOWN): THE UTERUS MEASURES 8.9 X 5_3 X 5.0 UN. THE UTERUS IS ANTEVERTED, WITH A HETEROGENEOUS MYOMETRIUM AND A 2.0 X 1.3 X 1.0 CM SUSPECTED FIBROID IN THE POSTERIOR MYOMETRIUM. THE ENDOMETRIUM MEASURES APPROXIMATELY MM. BILATERAL ESSURE DEVICES ARE VISUALIZED IN AN APPROPRIATE POSITION. BOTH OVARIES APPEAR NORMAL AS SEEN. A 3.5 X 2.8 X 3,4 CM SIMPLE QI IS VISUALIZED IN THE RIGHT ADNEXA. A 3.1 X 2.2 X 2.7 CM SIMPLE CYST IS VISUALIZED IN THE LEFT ADNEXA. THE OVARIES BOTH DEMONSTRATE APPROPRIATE MOTILITY AND MOVE INDEPENDENTLY FROM THE ADNEXAL CYSTS. NO PELVIC MASSES OR FREE FOIE ARE VISUALIZED. 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: 11-DEC-2024: EVENT MEDICAL DEVICE REMOVAL IS REPLACED WITH EVENT DEVICE BREAKAGE. NEW EVENTS LOOSE TEETH, PELVIC PAIN, OSTEOARTHRITIS, HASHIMOTOS THYROIDITIS, FATIGUE, LYMPHEDEMA & WEIGHT GAIN WERE ADDED. ESSURE REMOVAL SURGERY DETAILS UPDATED. ESSURE INSERTION DATE UPDATED. REPORTER CAUSALITY COMMENT UPDATED. NEW REPORTER (REGULATORY AUTHORITY) ADDED. PATIENT DETAILS AGE & ADDRESS UPDATED. CONCOMITANT DRUGS WERE ADDED. CASE COMMENTS: 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.
BAYER CASE NUMBER: (B)(4). NUMEROUS PAIN AND SUFFERING IN REGARDS TO MY HEALTH [PELVIC PAIN FEMALE] SUFFERING MAJOR HEATH PROBLEMS DUE TO FRAGMENTS LEFT BY THIS PRODUCT [DEVICE BREAKAGE] LOSING MY TEETH INCLUDING MY FRONT ONES JUST FALLING OUT [LOOSE TOOTH] JOINT DEGENERATIVE DISEASE [DEGENERATIVE JOINT DISEASE] HASHIMOTO'S THYROIDITIS [HASHIMOTO'S THYROIDITIS] EMPHEDEMA [LYMPHEDEMA] FATIGUE SYNDROME [CHRONIC FATIGUE SYNDROME] , WENT FROM 155 160 IN 2020 AND I'M NOW ALMOST 300 LB AND CONTINUING TO GO UP [WEIGHT GAIN] CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY (REFERENCE NUMBER: MW5162745) ON 04-MAY-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 31-DEC-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("NUMEROUS PAIN AND SUFFERING IN REGARDS TO MY HEALTH") AND DEVICE BREAKAGE ("SUFFERING MAJOR HEATH PROBLEMS DUE TO FRAGMENTS LEFT BY THIS PRODUCT") IN A 44 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B42242) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF HIVES, DIFFICULTY BREATHING, COUGH, ALLERGY TO CHEMICALS, SKIN BREAKOUT AND INSOMNIA ON 18-MAR-2021, SWELLING NOS, ENDOMETRIOSIS, PARATUBAL CYST, CYSTADENOFIBROMA OF FALLOPIAN TUBE, INTRAMURAL LEIOMYOMA OF UTERUS, ABNORMAL UTERINE BLEEDING, ADNEXA UTERI CYST, PELVIC PAIN, ADENOMYOSIS, HYPOTHYROIDISM, SLEEP APNEA, HYPERTENSION, ATTENTION DEFICIT DISORDER, DEPRESSIVE DISORDER, ANXIETY DISORDER, OVARIAN CYST AND UTERINE FIBROID. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: ZIPRASIDONE AND RISPERIDONE. CONCURRENT CONDITIONS WERE LISTED AS DRUG ALLERGY SINCE 18-MAR-2021, HEADACHE (RISPERIDONE ALLERGY), SKIN BREAKOUT (SULFUR; REACTION) AND INSOMNIA (CORTICOSTEROIDS ALLERGY). CONCOMITANT PRODUCTS INCLUDED VITAMIN D (ERGOCALCIFEROL), VITAMIN C (ASCORBIC ACID), SEROQUEL XR (QUETIAPINE FUMARATE), MARIJUANA, LOSARTAN (LOSARTAN POTASSIUM), IBUPROFEN, GABAPENTIN STAT RX, CANNABIDIOL AND BUPROPION (BUPROPION HYDROCHLORIDE). IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), LOOSE TOOTH ("LOSING MY TEETH INCLUDING MY FRONT ONES JUST FALLING OUT"), OSTEOARTHRITIS ("JOINT DEGENERATIVE DISEASE"), AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S THYROIDITIS"), LYMPHOEDEMA ("EMPHEDEMA") AND CHRONIC FATIGUE SYNDROME ("FATIGUE SYNDROME") AND WAS FOUND TO HAVE WEIGHT INCREASED (", WENT FROM 155 160 IN 2020 AND I'M NOW ALMOST 300 LB AND CONTINUING TO GO UP"). ESSURE WAS REMOVED ON (B)(6) 2021. ON UNKNOWN DATE SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE THYROIDITIS, CHRONIC FATIGUE SYNDROME, DEVICE BREAKAGE, LOOSE TOOTH, LYMPHOEDEMA, OSTEOARTHRITIS, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: I WAS IMPLANTED WITH THE ESSURE DEVICE (B)(6) 2013 BY MY DOCTOR WHO HAD NO BUSINESS TO DO SO! I WENT TO GET MY TUBE TIED AND WAS CONVINCED BY (B)(6) AT THE (B)(6) HERE IN (B)(6) TO GET THE PERFECT NO COST TO ME ESSURE INSTEAD. UNBEKNOWNST TO ME THE BEGINNING OF 2014 THINGS STARTED CHANGING IN MY BODY. LOSING MY TEETH INCLUDING MY FRONT ONES JUST FALLING OUT, NUMEROUS PAIN AND SUFFERING IN REGARDS TO MY HEALTH. JOINT DEGENERATIVE DISEASE, HASHIMOTO'S THYROIDITIS, EMPHEDEMA, MAJOR FATIGUE SYNDROME, TEETH AND MAJOR WEIGHT GAIN, WENT FROM 155 160 IN 2020 AND I'M NOW ALMOST 300 LB AND CONTINUING TO GO UP! I HAD TO HAVE MAJOR SURGERY IN (B)(6) 2021 TO BE EXACT, AT THE SAME PLACE THAT PUT MY ESSURE IN 2013! UNBEKNOWNST TO ME MY DOCTORS AT THE (B)(6) WE'RE WORKING BEHIND MY BACK WITH DIFFERENT DOCTORS AND I FEEL COVERING UP MISCONDUCT AND MALPRACTICE SUITS! I HAD TO HAVE A COMPLETE HYSTERECTOMY REMOVING EVERYTHING SUPPOSEDLY BUT MY OVARIES! I SPECIFICALLY I'VE ASKED MY DOCTORS TO DO TESTS TO SEE ABOUT FRAGMENTS LEFT IN MY BODY! THESE TESTS CAME BACK RESULTS AND JUST GENERAL INFORMATION AND THIS HAS HAPPENED TO ME A COUPLE TIMES BY MY DOCTOR PCP (B)(6) AT (B)(6). MY DOCTORS HAVE COVERED UP INFORMATION AND LIED TO MY FACE ABOUT MY ILLNESSES. I WAS NEVER TOLD BY MY DOCTOR ABOUT THE RECALL OF ESSURE OR THE POTENTIAL HARM IT COULD DO TO MYSELF AND MY BODY. (B)(6) HAS BEEN PAID BY (B)(6) MULTIPLE TIMES FOR DIFFERENT PRODUCTS SHE USED ON HER PATIENTS. I'M AM STILL SUFFERING MAJOR HEATH PROBLEMS DUE TO FRAGMENTS LEFT BY THIS PRODUCT. I HAVE A REPORT FROM MY HYSTERECTOMY THAT CLEARLY STATES I HAVE FRAGMENTS LEFT IN MY BODY. I CAN'T GET ALL MY HEATH RECORDS AND THERE IS A LOT PERTAINING TO MY HYSTERECTOMY AND THE NOTES AND PROCESS OF (B)(6) AND THE PROCEDURE THAT WAS DONE IN (B)(6) 2013. I FEEL I HAVE RECORDS PERTAINING TO HEALTHCARE FRAUD WITH PROCEDURES THAT WEREN'T DONE OR POSSIBLY A HIGHER PAY OF A SURGERY THAT DIDN'T TAKE PLACE. I WAS DUPED BY MY HEALTHCARE AND MY ATTORNEY WHO FRAUDULENTLY COVERED UP MY LAWSUIT AND LIED ABOUT THE AMOUNT AND THE TRUE SCENARIO OF WHAT WAS TAKING PLACE. OHP ((B)(6) HEALTH PLAN) "THE (B)(6) HEALTH PLAN" (B)(6) LIED TO ME ABOUT NOT TAKING MONEY OUT OF MY CLAIM, THEY DID! NO ONE IN (B)(6) WHO MY CONTRACT FOR MY ATTORNEY IN (B)(6) SAYS WAS OUT OF (B)(6) IN (B)(6) COURT. I HAD CALLED THE STATE BAR AND THE COURTHOUSE THAT WAS SUPPOSED TO BE OVERLOOKING MY ATTORNEY WHO TOOK (B)(6) IN SETTLEMENT FUNDS AND DISTRIBUTED OUT AS HE PLEASE IN THE (B)(6) COURTS. NO ONE IN THE STATE BAR OR IN THE COURT REPORTER'S OFFICE KNEW OF ME OR MY ATTORNEY (B)(6) OPERATING IN ANY OF THEIR COURTS. I WAS TOLD TO FILE A COMPLAINT WITH THE STATE BAR FOR A-LICENSED ATTORNEY IN (B)(6). I HAD DONE SO AND WAS TOLD BY THE STATE BAR THAT HE WAS PRO HAVOC SO MY COMPLAINT REALLY DIDN'T MATTER BECAUSE IT WASN'T THE PROPER COMPLAINT FORM. THE STATE BAR TOLD ME THAT THEY DID TELL THE (B)(6) STATE BAR THAT THERE WAS SOME MISCONDUCT BUT THERE WAS NOTHING THAT (B)(6) CAN DO BECAUSE HE WASN'T A LICENSE ATTORNEY IN (B)(6)! HERE IS MY PROBLEM, I AM SUFFERING TREMENDOUSLY WITH NO RELIEF FOR REAL INFORMATION ON HELPING ME FIX WHAT'S GOING ON WITH ME AND THIS STUPID PRODUCT THAT WAS SOLD TO MEDICAID AND MEDICARE FOR CHEAP AND THEN TURN AROUND AND HARM ME TO NO END ONLY TO BE LIED ABOUT THE PRODUCT AND IT'S HARM AND YOU HAVE TO PAY FOR THAT HARM IT DONE TO ME! I KNOW FOR A FACT THAT MY HEALTHCARE INSURANCE VIOLATED MY HIPAA RIGHTS AND CONTINUE TO DO SO. PLEASE SOMEONE HELP ME TO FIGURE OUT HOW TO MOVE FORWARD. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ULTRASOUND PELVIS] (DATE UNKNOWN): THE UTERUS MEASURES 8.9 X 5_3 X 5.0 UN. THE UTERUS IS ANTEVERTED, WITH A HETEROGENEOUS MYOMETRIUM AND A 2.0 X 1.3 X 1.0 CM SUSPECTED FIBROID IN THE POSTERIOR MYOMETRIUM. THE ENDOMETRIUM MEASURES APPROXIMATELY MM. BILATERAL ESSURE DEVICES ARE VISUALIZED IN AN APPROPRIATE POSITION. BOTH OVARIES APPEAR NORMAL AS SEEN. A 3.5 X 2.8 X 3,4 CM SIMPLE QI IS VISUALIZED IN THE RIGHT ADNEXA. A 3.1 X 2.2 X 2.7 CM SIMPLE CYST IS VISUALIZED IN THE LEFT ADNEXA. THE OVARIES BOTH DEMONSTRATE APPROPRIATE MOTILITY, AND MOVE INDEPENDENTLY FROM THE ADNEXAL CYSTS. NO PELVIC MASSES OR FREE FOIE ARE VISUALIZED. LOT NUMBER: B42242 MANUFACTURE DATE: 2013-06 EXPIRATION DATE: 2016-06. BATCH IS NOT VALID: 22200DD. 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: 31-DEC-2024: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: 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 MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE FIBROID, OVARIAN CYST, ANXIETY DISORDER, DEPRESSIVE DISORDER, ATTENTION DEFICIT DISORDER, HYPERTENSION, SLEEP APNEA, HYPOTHYROIDISM, ADENOMYOSIS, PELVIC PAIN, ADNEXA UTERI CYST, ABNORMAL UTERINE BLEEDING, INTRAMURAL LEIOMYOMA OF UTERUS, CYSTADENOFIBROMA OF FALLOPIAN TUBE, PARATUBAL CYST AND ENDOMETRIOSIS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON AN UNKNOWN DATE: THE UTERUS MEASURES 8.9 X 5_3 X 5.0 UN. THE UTERUS IS ANTEVERTED, WITH A HETEROGENEOUS MYOMETRIUM AND A 2.0 X 1.3 X 1.0 CM SUSPECTED FIBROID IN THE POSTERIOR MYOMETRIUM. THE ENDOMETRIUM MEASURES APPROXIMATELY MM. BILATERAL ESSURE DEVICES ARE VISUALIZED IN AN APPROPRIATE POSITION. BOTH OVARIES APPEAR NORMAL AS SEEN. A 3.5 X 2.8 X 3,4 CM SIMPLE QI IS VISUALIZED IN THE RIGHT ADNEXA. A 3.1 X 2.2 X 2.7 CM SIMPLE CYST IS VISUALIZED IN THE LEFT ADNEXA. THE OVARIES BOTH DEMONSTRATE APPROPRIATE MOTILITY, AND MOVE INDEPENDENTLY FROM THE ADNEXAL CYSTS. NO PELVIC MASSES OR FREE FOIE ARE VISUALIZED.. 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. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 732507 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B42242 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention| O | BUPROPION (BUPROPION HYDROCHLORIDE),| BUPROPION (BUPROPION HYDROCHLORIDE),| CANNABIDIOL (CANNABIDIOL),| CANNABIDIOL (CANNABIDIOL),| GABAPENTIN STAT RX (GABAPENTIN),| GABAPENTIN STAT RX (GABAPENTIN),| IBUPROFEN (IBUPROFEN),| IBUPROFEN (IBUPROFEN),| LOSARTAN (LOSARTAN POTASSIUM),| LOSARTAN (LOSARTAN POTASSIUM),| MARIJUANA (MARIJUANA),| MARIJUANA (MARIJUANA),| SEROQUEL XR (QUETIAPINE FUMARATE),| SEROQUEL XR (QUETIAPINE FUMARATE),| VITAMIN C (ASCORBIC ACID),| VITAMIN C (ASCORBIC ACID),| VITAMIN D (ERGOCALCIFEROL),| VITAMIN D (ERGOCALCIFEROL), |