ESSURE
Report
- Report Number
- 2951250-2017-01452
- Event Type
- Injury
- Date Received
- April 17, 2017
- Report Date
- August 14, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: DEEP IN MY TUBES)"), PELVIC PAIN ("SEVERE PAIN"), HYPOTHYROIDISM ("AUTOIMMUNE DISORDER (GRAVES DISEASE; OVER ACTIVE THYROID)") AND BASEDOW'S DISEASE ("AUTOIMMUNE DISORDER (GRAVES DISEASE; OVER ACTIVE THYROID)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "COMPLICATIONS OR PROBLEMS OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE (IT COULD FALL OUT AND NOT FORM SCAR TISSUE TO SECURE)". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 3 (DATE OF BIRTHS: (B)(6) 2001, (B)(6) 2006, (B)(6) 2008.), ABORTION, DIARRHEA IN 2014, HYPERTENSION, HEART RATE INCREASED, D & C IN 2009, BUNIONECTOMY IN 2004 AND LITHOTRIPSY. CONCURRENT CONDITIONS INCLUDED GENERAL ANESTHESIA, AMENORRHEA, RETROVERTED UTERUS, IRREGULAR MENSTRUAL CYCLE, ABDOMINAL PAIN, SMOKER, BLEEDING MENSTRUAL HEAVY, DYSPHAGIA, HEARTBURN, HEMATURIA, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY, ALLERGIC REACTION TO ANTIBIOTICS, CONTRAST MEDIA ALLERGY, FEVER AND CHILLS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FROM 2008 TO 2009 FOR BIRTH CONTROL AS WELL AS ATENOLOL, COLECALCIFEROL (VITAMIN D) AND SULFADIMETHOXINE (METHOZOLE). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("INFECTION (BLADDER/UTIS) / BLADDER OR URINARY PROBLEMS OR CHANGES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION "), ALLERGY TO METALS ("NICKEL ALLERGY"), BACK PAIN ("MILD TO SEVERE BACK PAIN / MILD TO SEVERE BACK SIDE PAIN/ "), HEADACHE ("MIGRAINES / HEADACHES / MILD TO SEVERE HEAD PAIN "), SEBORRHOEIC DERMATITIS ("SEBORRHOEIC DERMATITIS"), MUSCULAR WEAKNESS ("WEAKNESS IN LEGS"), SKIN DISCOLOURATION ("SKIN COLOR CHANGE"), PAIN IN EXTREMITY ("LEG PAIN/LEGS PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS"), CYSTITIS ("INFECTION (BLADDER/UTIS) / BLADDER OR URINARY PROBLEMS OR CHANGES "), DRY SKIN ("DRY SKIN"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE"), ARTHRALGIA ("HIP PAIN/ MILD TO SEVERE LEFT HIP PAIN"), ASTHENIA ("FEELING WEAK"), DIZZINESS ("LIGHT HEADED / DIZZY ALL THE TIME") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SURGERY (SHE UNDERWENT LAPAROTOMY WITH REMOVAL) AND SURGERY (SHE UNDERWENT LAPAROTOMY WITH REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HYPOTHYROIDISM, BASEDOW'S DISEASE, URINARY TRACT INFECTION, DYSMENORRHOEA, HYPERSENSITIVITY, ALLERGY TO METALS, HEADACHE, SEBORRHOEIC DERMATITIS, MUSCULAR WEAKNESS, SKIN DISCOLOURATION, PAIN IN EXTREMITY, TOOTH DISORDER, CYSTITIS, DRY SKIN, MIGRAINE, NAUSEA, FATIGUE, ASTHENIA, DIZZINESS AND ALOPECIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN HAD RESOLVED AND THE BACK PAIN AND ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, ASTHENIA, BACK PAIN, BASEDOW'S DISEASE, CYSTITIS, DEVICE DISLOCATION, DIZZINESS, DRY SKIN, DYSMENORRHOEA, FATIGUE, HEADACHE, HYPERSENSITIVITY, HYPOTHYROIDISM, MIGRAINE, MUSCULAR WEAKNESS, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, SEBORRHOEIC DERMATITIS, SKIN DISCOLOURATION, TOOTH DISORDER AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE CONTINUED TO EXPERIENCE PAIN UNTIL SHE UNDERWENT REMOVAL OF ESSURE. HER SYMPTOMS RESOLVED AFTER THE SURGERY. PHYSICIAN SAID THAT THE ESSURE WERE IN PLACE AND WE NEED TO WAIT FOR THE SCAR TISSUE TO FORM AROUND IT IN 2009. INSPECTION OF THE CAVITY REVEALED NORMAL ANATOMY AND OPTIMUM DEVICE PLACEMENT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2010: NORMAL ESSURE PLACEMENT ULTRASOUND SCAN - ON (B)(6) 2010: ON (B)(6) 2016: SURGICAL PATHOLOGY REPORT: ESSURE COILS: FRAGMENTS OF BENIGN ENDO AND MYOMETRIAL TISSUE ARE SEEN. TWO PIECES OF COIL ARE ALSO SEEN GROSSLY GROSS DESCRIPTION: CONTAINER IS LABELED WITH THE PATIENT'S NAME AND "ESSURE COILS." SPECIMEN IS RECEIVED 10 FORMALIN AND CONSISTS OF TWO COILS, THE LARGER MEASURING 4.5 CM IN LENGTH AND MULTIPLE TAN-WHITE SORT TISSUE FRAGMENTS IN AN AGGREGATE MEASUREMENT OF 1.5 )( 1.5)( 0.5 CM. THE COILS ARE FOR GROSS DESCRIPTION ONLY 2009:TRANSVAGINAL ULTRASOUND (TVU): TOTAL BILATERAL OCCLUSION. URINE HCG: NEGATIVE. TRANSVAGINAL ULTRASOUND : BIMANUAL EXAM REVEALED A RETROVERTED UTERUS THAT WAS MOBILE, REGULAR AND NONTENDER. TRANSVAGINAL ULTRASOUND: REVEALED A RETROVERTED UTERUS WITH ATROPHIC APPEARING ENDOMETRIUM. MEASURING ONLY 4.7 MMS IN AP DIMENSION. BOTH ESSURE PLUGS WERE VISUALIZED. BOTH OVARIES WERE ALSO VISUALIZED AND WITHOUT PATHOLOGY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S CRAMPING , MIGRAINES. WEAKNESS,FATIGUE , PELVIC PAIN , NICKEL ALLERGY, MIGRAINE HEADACHE . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: DEEP IN MY TUBES)"), PELVIC PAIN ("SEVERE PAIN"), HYPOTHYROIDISM ("AUTOIMMUNE DISORDER (GRAVES DISEASE; OVER ACTIVE THYROID)") AND BASEDOW'S DISEASE ("AUTOIMMUNE DISORDER (GRAVES DISEASE; OVER ACTIVE THYROID)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "COMPLICATIONS OR PROBLEMS OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE (IT COULD FALL OUT AND NOT FORM SCAR TISSUE TO SECURE)". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 3 (DATE OF BIRTHS: (B)(6) 2001, (B)(6) 2006, (B)(6) 2008.), ABORTION, DIARRHEA IN 2014, HYPERTENSION, HEART RATE INCREASED, D & C IN 2009, BUNIONECTOMY IN 2004 AND LITHOTRIPSY. CONCURRENT CONDITIONS INCLUDED GENERAL ANESTHESIA, AMENORRHEA, RETROVERTED UTERUS, IRREGULAR MENSTRUAL CYCLE, ABDOMINAL PAIN, SMOKER, BLEEDING MENSTRUAL HEAVY, DYSPHAGIA, HEARTBURN, HEMATURIA, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY, ALLERGIC REACTION TO ANTIBIOTICS, CONTRAST MEDIA ALLERGY, FEVER AND CHILLS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FROM 2008 TO 2009 FOR BIRTH CONTROL AS WELL AS ATENOLOL, COLECALCIFEROL (VITAMIN D) AND SULFADIMETHOXINE (METHOZOLE). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPOTHYROIDISM (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("INFECTION (BLADDER/UTIS) / BLADDER OR URINARY PROBLEMS OR CHANGES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION "), ALLERGY TO METALS ("NICKEL ALLERGY"), BACK PAIN ("MILD TO SEVERE BACK PAIN / MILD TO SEVERE BACK SIDE PAIN/ "), HEADACHE ("MIGRAINES / HEADACHES / MILD TO SEVERE HEAD PAIN "), SEBORRHOEIC DERMATITIS ("SEBORRHOEIC DERMATITIS"), MUSCULAR WEAKNESS ("WEAKNESS IN LEGS"), SKIN DISCOLOURATION ("SKIN COLOR CHANGE"), PAIN IN EXTREMITY ("LEG PAIN/LEGS PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS"), CYSTITIS ("INFECTION (BLADDER/UTIS) / BLADDER OR URINARY PROBLEMS OR CHANGES "), DRY SKIN ("DRY SKIN"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), FATIGUE ("FATIGUE"), ARTHRALGIA ("HIP PAIN/ MILD TO SEVERE LEFT HIP PAIN"), ASTHENIA ("FEELING WEAK"), DIZZINESS ("LIGHT HEADED / DIZZY ALL THE TIME") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SURGERY (SHE UNDERWENT LAPAROTOMY WITH REMOVAL) AND SURGERY (SHE UNDERWENT LAPAROTOMY WITH REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HYPOTHYROIDISM, BASEDOW'S DISEASE, URINARY TRACT INFECTION, DYSMENORRHOEA, HYPERSENSITIVITY, ALLERGY TO METALS, HEADACHE, SEBORRHOEIC DERMATITIS, MUSCULAR WEAKNESS, SKIN DISCOLOURATION, PAIN IN EXTREMITY, TOOTH DISORDER, CYSTITIS, DRY SKIN, MIGRAINE, NAUSEA, FATIGUE, ASTHENIA, DIZZINESS AND ALOPECIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN HAD RESOLVED AND THE BACK PAIN AND ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, ASTHENIA, BACK PAIN, BASEDOW'S DISEASE, CYSTITIS, DEVICE DISLOCATION, DIZZINESS, DRY SKIN, DYSMENORRHOEA, FATIGUE, HEADACHE, HYPERSENSITIVITY, HYPOTHYROIDISM, MIGRAINE, MUSCULAR WEAKNESS, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, SEBORRHOEIC DERMATITIS, SKIN DISCOLOURATION, TOOTH DISORDER AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE CONTINUED TO EXPERIENCE PAIN UNTIL SHE UNDERWENT REMOVAL OF ESSURE. HER SYMPTOMS RESOLVED AFTER THE SURGERY. PHYSICIAN SAID THAT THE ESSURE WERE IN PLACE AND WE NEED TO WAIT FOR THE SCAR TISSUE TO FORM AROUND IT IN 2009. INSPECTION OF THE CAVITY REVEALED NORMAL ANATOMY AND OPTIMUM DEVICE PLACEMENT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN FEBRUARY 2010: NORMAL ESSURE PLACEMENT ULTRASOUND SCAN - ON (B)(6) 2010: ON (B)(6) 2016: SURGICAL PATHOLOGY REPORT: ESSURE COILS: FRAGMENTS OF BENIGN ENDO AND MYOMETRIAL TISSUE ARE SEEN. TWO PIECES OF COIL ARE ALSO SEEN GROSSLY. GROSS DESCRIPTION: CONTAINER IS LABELED WITH THE PATIENT'S NAME AND "ESSURE COILS." SPECIMEN IS RECEIVED 10 FORMALIN AND CONSISTS OF TWO COILS, THE LARGER MEASURING 4.5 CM IN LENGTH AND MULTIPLE TAN-WHITE SORT TISSUE FRAGMENTS IN AN AGGREGATE MEASUREMENT OF 1.5 )( 1.5)( 0.5 CM. THE COILS ARE FOR GROSS DESCRIPTION ONLY. 2009:TRANSVAGINAL ULTRASOUND (TVU): TOTAL BILATERAL OCCLUSION. URINE HCG: NEGATIVE. TRANSVAGINAL ULTRASOUND : BIMANUAL EXAM REVEALED A RETROVERTED UTERUS THAT WAS MOBILE, REGULAR AND NONTENDER. TRANSVAGINAL ULTRASOUND: REVEALED A RETROVERTED UTERUS WITH ATROPHIC APPEARING ENDOMETRIUM. MEASURING ONLY 4.7 MMS IN AP DIMENSION. BOTH ESSURE PLUGS WERE VISUALIZED. BOTH OVARIES WERE ALSO VISUALIZED AND WITHOUT PATHOLOGY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S CRAMPING , MIGRAINES. WEAKNESS,FATIGUE , PELVIC PAIN , NICKEL ALLERGY, MIGRAINE HEADACHE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. REPORTER ADDED. PRODUCT START DATE, STOP DATE UPDATED. LOT NUMBER ADDED. 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE (LOCATION OF DEVICE: DEEP IN MY TUBES)"), PELVIC PAIN ("SEVERE PAIN"), HYPERTHYROIDISM ("AUTOIMMUNE DISORDER (GRAVES DISEASE; OVER ACTIVE THYROID)") AND BASEDOW'S DISEASE ("AUTOIMMUNE DISORDER (GRAVES DISEASE; OVER ACTIVE THYROID)") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "COMPLICATIONS OR PROBLEMS OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE (IT COULD FALL OUT AND NOT FORM SCAR TISSUE TO SECURE)" IN (B)(6) 2009. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 3 (DATE OF BIRTHS: (B)(6) 2001, (B)(6) 2006, (B)(6) 2008.), ABORTION, DIARRHEA IN 2014, HYPERTENSION, HEART RATE INCREASED, D & C IN 2009, BUNIONECTOMY IN 2004 AND LITHOTRIPSY. CONCURRENT CONDITIONS INCLUDED GENERAL ANESTHESIA, AMENORRHEA, RETROVERTED UTERUS, IRREGULAR MENSTRUAL CYCLE, ABDOMINAL PAIN, SMOKER, BLEEDING MENSTRUAL HEAVY, DYSPHAGIA, HEARTBURN, HEMATURIA, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY, DRUG ALLERGY, CONTRAST MEDIA ALLERGY, FEVER AND CHILLS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FROM 2008 TO 2009 FOR BIRTH CONTROL AS WELL AS ATENOLOL, COLECALCIFEROL (VITAMIN D) AND SULFADIMETHOXINE (METHOZOLE). IN 2009, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HYPERTHYROIDISM (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION ("INFECTION (BLADDER/UTIS) / BLADDER OR URINARY PROBLEMS OR CHANGES "), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION "), ALLERGY TO METALS ("NICKEL ALLERGY"), BACK PAIN ("MILD TO SEVERE BACK PAIN / MILD TO SEVERE BACK SIDE PAIN/ "), HEADACHE ("MIGRAINES / HEADACHES / MILD TO SEVERE HEAD PAIN "), SEBORRHOEIC DERMATITIS ("SEBORRHOEIC DERMATITIS"), MUSCULAR WEAKNESS ("WEAKNESS IN LEGS"), SKIN DISCOLOURATION ("SKIN COLOR CHANGE"), PAIN IN EXTREMITY ("LEG PAIN/LEGS PAIN"), TOOTH DISORDER ("DENTAL PROBLEMS"), CYSTITIS ("INFECTION (BLADDER/UTIS) / BLADDER OR URINARY PROBLEMS OR CHANGES "), DRY SKIN ("DRY SKIN"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), ARTHRALGIA ("HIP PAIN/ MILD TO SEVERE LEFT HIP PAIN "), ASTHENIA ("FEELING WEAK"), DIZZINESS ("LIGHT HEADED / DIZZY ALL THE TIME") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SURGERY (SHE UNDERWENT LAPAROTOMY WITH REMOVAL) AND SURGERY (SHE UNDERWENT LAPAROTOMY WITH REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, HYPERTHYROIDISM, BASEDOW'S DISEASE, URINARY TRACT INFECTION, DYSMENORRHOEA, HYPERSENSITIVITY, ALLERGY TO METALS, HEADACHE, SEBORRHOEIC DERMATITIS, MUSCULAR WEAKNESS, SKIN DISCOLOURATION, PAIN IN EXTREMITY, TOOTH DISORDER, CYSTITIS, DRY SKIN, MIGRAINE, NAUSEA, FATIGUE, ASTHENIA, DIZZINESS AND ALOPECIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN HAD RESOLVED AND THE BACK PAIN AND ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, ASTHENIA, BACK PAIN, BASEDOW'S DISEASE, CYSTITIS, DEVICE DISLOCATION, DIZZINESS, DRY SKIN, DYSMENORRHOEA, FATIGUE, HEADACHE, HYPERSENSITIVITY, HYPERTHYROIDISM, MIGRAINE, MUSCULAR WEAKNESS, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, SEBORRHOEIC DERMATITIS, SKIN DISCOLOURATION, TOOTH DISORDER AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE CONTINUED TO EXPERIENCE PAIN UNTIL SHE UNDERWENT REMOVAL OF ESSURE. HER SYMPTOMS RESOLVED AFTER THE SURGERY. PHYSICIAN SAID THAT THE ESSURE WERE IN PLACE AND WE NEED TO WAIT FOR THE SCAR TISSUE TO FORM AROUND IT IN 2009. INSPECTION OF THE CAVITY REVEALED NORMAL ANATOMY AND OPTIMUM DEVICE PLACEMENT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2010: NORMAL ESSURE PLACEMENT. ULTRASOUND SCAN - ON (B)(6) 2010: ON (B)(6) 2016: SURGICAL PATHOLOGY REPORT: ESSURE COILS: FRAGMENTS OF BENIGN ENDO AND MYOMETRIAL TISSUE ARE SEEN. TWO PIECES OF COIL ARE ALSO SEEN GROSSLY GROSS DESCRIPTION: CONTAINER IS LABELED WITH THE PATIENT'S NAME AND "ESSURE COILS." SPECIMEN IS RECEIVED 10 FORMALIN AND CONSISTS OF TWO COILS, THE LARGER MEASURING 4.5 CM IN LENGTH AND MULTIPLE TAN-WHITE SORT TISSUE FRAGMENTS IN AN AGGREGATE MEASUREMENT OF 1.5 )( 1.5)( 0.5 CM. THE COILS ARE FOR GROSS DESCRIPTION ONLY 2009:TRANSVAGINAL ULTRASOUND (TVU): TOTAL BILATERAL OCCLUSION. URINE HCG: NEGATIVE. TRANSVAGINAL ULTRASOUND : BIMANUAL EXAM REVEALED A RETROVERTED UTERUS THAT WAS MOBILE, REGULAR AND NONTENDER. TRANSVAGINAL ULTRASOUND: REVEALED A RETROVERTED UTERUS WITH ATROPHIC APPEARING ENDOMETRIUM. MEASURING ONLY 4.7 MMS IN AP DIMENSION. BOTH ESSURE PLUGS WERE VISUALIZED. BOTH OVARIES WERE ALSO VISUALIZED AND WITHOUT PATHOLOGY. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT¿S CRAMPING , MIGRAINES. WEAKNESS,FATIGUE , PELVIC PAIN , NICKEL ALLERGY, MIGRAINE HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-FEB-2018: PLANTIFF FACT SHEET & MEDICAL RECORD RECEIVED. EVENTS HYPERSENSITIVITY REACTION ,GRAVES DISEASE; OVERACTIVE THYROID, DRY SKIN, SEBORRHEIC DERMATITIS, SKIN COLOR CHANG, MIGRAINES / HEADACHES, MIGRATION OF ESSURE, NAUSEA, DENTAL PROBLEMS, NICKEL ALLERGY, DYSMENORRHEA, FATIGUE,BACK PAIN, LEG PAIN, HIP PAIN, FEELING WEAK, FEELING WEAK, DIZZY, HAIR LOSS, WEAKNESS IN LEGS, INSSERTION DIFFFICULT. LAB DATA UPDATED. CONCOMITANT & HISTORICAL CONDITION AND DRUG ARE ADDED. PRODUCT , PATIENT & REPORTER INFORMATION UPDATED.¿ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY¿ INCIDENT : NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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 PELVIC PAIN ("SEVERE PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROTOMY WITH REMOVAL OF ESSURE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE CONTINUED TO EXPERIENCE PAIN UNTIL SHE UNDERWENT REMOVAL OF ESSURE. HER SYMPTOMS RESOLVED AFTER THE SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2010: NORMAL ESSURE PLACEMENT. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-APR-2017: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT. THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON(B)(6) 2009, AND REPORTED SEVERE PAIN (SEEN AS PELVIC PAIN) STARTING MONTHS AFTER INSERTION. THE PLAINTIFF HAD LAPAROTOMY WITH REMOVAL OF ESSURE ON (B)(6) 2016. THE PAIN RESOLVED AFTER ESSURE REMOVAL. PELVIC PAIN OF VARYING INTENSITY AND DURATION MAY OCCUR AND PERSIST AFTER ESSURE INSERTION. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE A DEVICE REMOVAL WAS REQUIRED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PAIN") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILIZATION. ON (B)(6) 2009, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROTOMY WITH REMOVAL OF ESSURE ON (B)(6) 2016). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) CONTINUED TO EXPERIENCE PAIN UNTIL SHE UNDERWENT REMOVAL OF ESSURE. (B)(6) SYMPTOMS RESOLVED AFTER THE SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IN (B)(6) 2010: HYSTEROSALPINGOGRAM RESULT WAS NORMAL ESSURE PLACEMENT. COMPANY CAUSALITY COMMENT: THIS LITIGATION CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2009, AND REPORTED SEVERE PAIN (SEEN AS PELVIC PAIN) STARTING MONTHS AFTER INSERTION. THE PLAINTIFF HAD LAPAROTOMY WITH REMOVAL OF ESSURE ON (B)(6) 2016. THE PAIN RESOLVED AFTER ESSURE REMOVAL. PELVIC PAIN OF VARYING INTENSITY AND DURATION MAY OCCUR AND PERSIST AFTER ESSURE INSERTION. THIS CASE WAS CLASSIFIED AS INCIDENT SINCE A DEVICE REMOVAL WAS REQUIRED. FOLLOW-UP INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279820 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R | ATENOLOL.| ATENOLOL.| ATENOLOL.| DEPO PROVERA.| DEPO PROVERA.| DEPO PROVERA.| METHOZOLE.| METHOZOLE.| METHOZOLE.| VITAMIN D.| VITAMIN D.| VITAMIN D. |