ESSURE
Report
- Report Number
- 2951250-2022-00334
- Event Type
- Injury
- Date Received
- March 25, 2022
- Date of Event
- October 13, 2015
- Report Date
- May 18, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('METAL FRAGMENT WAS FOUND IN THE ABDOMEN'), DEVICE DISLOCATION ('METAL FRAGMENT WAS FOUND IN THE ABDOMEN') AND PELVIC INFLAMMATORY DISEASE ('INFLAMMATION IN THE LEFT GROIN AREA') IN A 41-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: COMPLICATION OF DEVICE REMOVAL "IMAGING TESTS WITH SUSPICION OF PERSISTENCE OF AN ESSURE FRAGMENT / ESSURE FRAGMENT WAS NOT INITIALLY REMOVED". THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICAL CONIZATION IN 2011, ULCERATIVE COLITIS, NICKEL SENSITIVITY (SINCE ADOLESCENCE HAD BEEN COMPLAINING OF DISCOMFORT WITH COSTUME JEWELRY, AND PROBABLY WITH SOME METAL OBJECT, WHICH IS WHY SHE AVOIDED THEM FOR MANY YEARS), IODINE CONTRAST MEDIA ALLERGY, RHINOCONJUNCTIVITIS, ASTHMA, POLLEN ALLERGY, LOW BACK PAIN, ENTHESITIS, CYST REMOVAL, SMOKER, GRAVIDA II, PARITY 2 AND DYSPLASIA. FOLLOW-UP CONSULTATIONS PERFORMING CONTROL MYTHOLOGIES DUE TO A CERVICAL PATHOLOGY ON DATES (B)(6) 2011, (B)(6) 202012, (B)(6) 2012, (B)(6) 2013, (B)(6) 2013, (B)(6) 2014, (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, WHEN DISCHARGED WITH NEGATIVE CYTOLOGY. CONCURRENT CONDITIONS INCLUDED ANXIETY AND DEPRESSIVE DISORDER. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY / DELAYED HYPERSENSITIVITY TO NICKEL (NICKEL SULFATE)"), PELVIC PAIN ("CHRONIC PELVIC PAIN DUE TO A HISTORY OF ESSURE DEVICE USE"), ABDOMINAL PAIN ("ABDOMINAL PAIN PERSISTS WITH EVIDENCE OF FOREIGN BODY IN IMAGING TESTS"), GROIN PAIN ("GROIN PAIN / PAIN IN THE LEFT GROIN THAT RADIATED TO THE LATERAL THE ENTIRE SIDE THROUGHOUT THE FLANK"), ANXIETY ("ANXIETY IN 2014"), DEPRESSION ("DEPRESSION IN 2014"), ARTHRALGIA ("LEFT HIP PAIN / JOINT PAIN IN THE LEFT HIP"), ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN / PAIN IN THE LEFT ILIAC FOSSA"), FLANK PAIN ("PAIN IN THE LEFT FLANK"), ABDOMINAL PAIN UPPER ("PAIN IN THE SUBCOSTAL AREA OF 3 MONTHS OF EVOLUTION") AND INFLAMMATION ("INFLAMMATION OF THE PATIENT IN THE LEFT INGUINAL AREA"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2021 TO (B)(6) 2021. THE PATIENT WAS TREATED WITH MELOXICAM, REHABILITATION ACCOUNT, TREATMENT WITH SHOCK WAVES, REHABILITATION AND TREATMENT WITH SHOCK WAVES AND SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, ALLERGY TO METALS, PELVIC PAIN, ABDOMINAL PAIN, GROIN PAIN, ANXIETY, DEPRESSION, ARTHRALGIA, ABDOMINAL PAIN LOWER, FLANK PAIN, ABDOMINAL PAIN UPPER AND INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, FLANK PAIN, GROIN PAIN, INFLAMMATION, PELVIC INFLAMMATORY DISEASE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE FIRST CONSULTATION IN THE MENTAL HEALTH UNIT FOR ANXIETY-DEPRESSIVE DISORDER WAS ON (B)(6) 2009 BEFORE ESSURE, PLACED IN 2013, SO IT CANNOT BE ATTRIBUTED TO IT (ALTHOUGH, IT DOES NOT REFLECT THE MENTAL HEALTH REPORT PROVIDED IN WHICH SHE ATTENDS AND WAS TREATED IN 2014). SHE WAS EVALUATED IN THE YEARS 2014, 2015, 2016 AND 2017, BEING DISCHARGED ON (B)(6) 2017. ON (B)(6) 2013: CORRECT PLACEMENT OF THE ESSURE WAS CHECKED. PROGESTERONE WAS PRESCRIBED AND CONTINUED WITH A CONDOM. REFERRED AGAIN TO THE CERVICAL PATHOLOGY CLINIC, WHERE WAS EVALUATED ON THE FOLLOWING DATES: (B)(6) 2013, (B)(6) 2013, (B)(6) 2014, (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, WHEN WAS DISCHARGED. IN NONE OF THE CONSULTATIONS WAS THERE ANY REFERENCE TO DISCOMFORT, DEPRESSIVE OR ANXIETY SYMPTOMS, HIP PAIN, ABDOMINAL PAIN OR PAIN IN THE ILIAC FOSSA. (B)(6) 2014: SHE WAS ADMITTED TO THE TRAUMATOLOGY SERVICE, AFTER SUFFERING THE BREAKAGE OF THE PROSTHETIC MATERIAL THAT WAS IMPLANTED IN HER RIGHT HIP IN (B)(6) 2010. ON (B)(6) 2014 SHE UNDERWENT A SURGERY, AND UNDERGOING A CHANGE OF PROSTHESIS WHICH WAS UNEVENTFUL. (B)(6) 2018: DIAGNOSIS OF MILD OCCASIONAL MERALGIA PARESTHETICA AND ASSOCIATED TROCHANTERITIS WAS ESTABLISHED, AND IMPROVED AFTER SHOCK WAVES. (B)(6) 2018: ASSESSMENT IN REHABILITATION- REFERRED IMPROVEMENT, BUT DISCOMFORT PERSISTS, WHICH SAID LIMITED HER FOR WORK. THE EXAMINATION SHOWED FREE LEFT HIP, NO PAIN, NO PAIN ON PALPATION OF THE TROCHANTER. NEGATIVE LASEGUE AND BRAGARD. REGULAR PHYSICAL ACTIVITY WAS RECOMMENDED. THEREFORE, WAS DISCHARGED FROM REHABILITATION SERVICE FOR IMPROVEMENT, BEFORE THE REMOVAL OF ESSURE. ESSURE REMOVAL ON (B)(6) 2019, WITHOUT INCIDENTS, WITH INTRAOPERATIVE RADIOGRAPHY TAKING PLACE, WHERE THE COMPLETE REMOVAL OF THE DEVICES WAS VERIFIED. IN (B)(6) 2019, METAL FRAGMENT WAS FOUND IN THE ABDOMEN. EXPLORATORY LAPAROSCOPY WAS PERFORMED. SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON RIGHT HEMIPELVIS POSSIBLY FROM EXTERNAL ARTIFACT. NO OTHER SIGNIFICANT FINDINGS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2019: SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON THE RIGHT HEMIPELVIS, POSSIBLY FROM AN EXTERNAL ARTIFACT; ON (B)(6) 2020: A METALLIC DENSITY IMAGE OF APPROXIMATELY 4 MM IN DIAMETER, EXTRA-INTESTINAL, COMPATIBLE WITH METALLIC FOREIGN BODY. IT IS ESTABLISHED AS CLINICAL JUDGEMENT THAT IT IS A 'SUSPECTED PERSISTENCE OF ESSURE FRAGMENT'. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2019: WITHOUT ALTERATIONS. THE DIAGNOSIS OF OCCASIONAL MILD MERALGIA PARESTHETICA AND ENTERITIS OF THE GLUTEUS MEDIUS WITH LATERAL FLEXOR TENSION AND ASSOCIATED TROCHANTERITIS WAS ESTABLISHED. PATHOLOGY TEST - ON (B)(6) 2019: THE PATHOLOGICAL ANATOMY REPORT INDICATED THE ABSENCE OF SIGNIFICANT HISTOLOGICAL ALTERATIONS IN BOTH FALLOPIAN TUBES. ULTRASOUND PELVIS - ON (B)(6) 2020: AN IMAGE OF METAL DENSITY OF APPROXIMATELY 4 MM IN DIAMETER, EXTRAINTESTINAL, COMPATIBLE WITH A METALLIC FOREIGN BODY. IT WAS ESTABLISHED AS A CLINICAL JUDGMENT, ¿SUSPICION PERSISTENCE OF ESSURE FRAGMENT.¿. ULTRASOUND SCAN - ON (B)(6) 2018: PAIN IN THE LEFT GROIN THAT RADIATED TO THE SIDE THROUGHOUT THE FLANK. UTERUS WITH SECRETORY ENDOMETRIUM. OVARIES WITHOUT ALTERATIONS. ESSURE NORMOINSERTED. THERE WAS NO SCIENTIFIC EVIDENCE TO JUSTIFY THE APPEARANCE OF PAIN AFTER 7 YEARS OF ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: GROIN PAIN, ALLERGY TO METALS, DEVICE BREAKAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AND ARTHRALGIA. 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 22-MAR-2022: PLAINTIFF FACT SHEET (PFS) AND MEDICAL RECORDS (MR) RECEIVED: REPORTER'S INFORMATION WAS UPDATED AND NEW REPORTERS WERE ADDED. PATIENT¿S INFORMATION AND LAB DATA WERE ADDED, START AND STOP DATE, AND INDICATION FOR ESSURE WERE PROVIDED, AND MELOXICAM ADDED AS TREATMENT MEDICATION. FURTHERMORE, THE EVENTS COMPLICATION OF DEVICE REMOVAL, ARTHRALGIA, ABDOMINAL PAIN LOWER, FLANK PAIN, ABDOMINAL PAIN UPPER AND INFLAMMATION WERE ADDED. 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("METAL FRAGMENT WAS FOUND IN THE ABDOMEN"), DEVICE DISLOCATION ("METAL FRAGMENT WAS FOUND IN THE ABDOMEN") AND PELVIC INFLAMMATORY DISEASE ("INFLAMMATION IN THE LEFT GROIN AREA") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 50673912) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: CONTRACEPTIVE DEVICE REMOVAL INCOMPLETE ("IMAGING TESTS WITH SUSPICION OF PERSISTENCE OF AN ESSURE FRAGMENT / ESSURE FRAGMENT WAS NOT INITIALLY REMOVED"). THE PATIENT HAD A MEDICAL HISTORY OF CERVICAL CONIZATION IN 2011 AND RESPIRATORY INFECTION, ABDOMINAL PAIN, GASTROENTERITIS, VOMITING, VAGINITIS, LOW BACK PAIN, URINARY INCONTINENCE, PAIN IN HIP, TROCHANTERIC SYNDROME, COXALGIA, DERMATITIS, DYSPLASIA, PARITY 2, GRAVIDA II, SMOKER, CYST REMOVAL, ENTHESITIS, LOW BACK PAIN, POLLEN ALLERGY, ASTHMA, RHINOCONJUNCTIVITIS, IODINE CONTRAST MEDIA ALLERGY, NICKEL SENSITIVITY (SINCE ADOLESCENCE HAD BEEN COMPLAINING OF DISCOMFORT WITH COSTUME JEWELRY, AND PROBABLY WITH SOME METAL OBJECT, WHICH IS WHY SHE AVOIDED THEM FOR MANY YEARS) AND ULCERATIVE COLITIS. FOLLOW-UP CONSULTATIONS PERFORMING CONTROL MYTHOLOGIES DUE TO A CERVICAL PATHOLOGY ON DATES (B)(6) 2011, (B)(6) 2012, (B)(6) 2012, (B)(6) 2013, (B)(6) 2013, (B)(6) 2014, (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, WHEN DISCHARGED WITH NEGATIVE CYTOLOGY. CONCURRENT CONDITIONS WERE LISTED AS SORE THROAT, RUNNY NOSE, HEADACHE, ERYTHEMA, DEPRESSIVE DISORDER AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE, NOLOTIL COMPOSITUM (HYOSCINE BUTYLBROMIDE;METAMIZOLE MAGNESIUM), AMOXICILLIN, METAMIZOLE, DIAZEPAM AND ENANTYUM (DEXKETOPROFEN TROMETAMOL). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 942 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY / DELAYED HYPERSENSITIVITY TO NICKEL (NICKEL SULFATE)"), PELVIC PAIN ("CHRONIC PELVIC PAIN DUE TO A HISTORY OF ESSURE DEVICE USE"), ABDOMINAL PAIN ("ABDOMINAL PAIN PERSISTS WITH EVIDENCE OF FOREIGN BODY IN IMAGING TESTS"), GROIN PAIN ("GROIN PAIN / PAIN IN THE LEFT GROIN THAT RADIATED TO THE LATERAL THE ENTIRE SIDE THROUGHOUT THE FLANK"), ANXIETY ("ANXIETY IN 2014"), DEPRESSION ("DEPRESSION IN 2014"), ARTHRALGIA ("LEFT HIP PAIN / JOINT PAIN IN THE LEFT HIP"), ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN / PAIN IN THE LEFT ILIAC FOSSA"), FLANK PAIN ("PAIN IN THE LEFT FLANK"), ABDOMINAL PAIN UPPER ("PAIN IN THE SUBCOSTAL AREA OF 3 MONTHS OF EVOLUTION") AND INFLAMMATION ("INFLAMMATION OF THE PATIENT IN THE LEFT INGUINAL AREA"). THE PATIENT WAS HOSPITALIZED FROM(B)(6) 2021 TO (B)(6) 2021. THE PATIENT WAS TREATED WITH MELOXICAM AS WELL AS SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY) AND NON-DRUG THERAPY (REHABILITATION ACCOUNT, TREATMENT WITH SHOCK WAVES AND REHABILITATION AND TREATMENT WITH SHOCK WAVES). AT THE TIME OF THE REPORT, NONE OF THE OUTCOMES FOR THESE EVENTS WERE KNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, FLANK PAIN, GROIN PAIN, INFLAMMATION, PELVIC INFLAMMATORY DISEASE AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE FIRST CONSULTATION IN THE MENTAL HEALTH UNIT FOR ANXIETY-DEPRESSIVE DISORDER WAS ON (B)(6) 2009 BEFORE ESSURE, PLACED IN 2013, SO IT CANNOT BE ATTRIBUTED TO IT (ALTHOUGH, IT DOES NOT REFLECT THE MENTAL HEALTH REPORT PROVIDED IN WHICH SHE ATTENDS AND WAS TREATED IN 2014). SHE WAS EVALUATED IN THE YEARS 2014, 2015, 2016 AND 2017, BEING DISCHARGED ON (B)(6) 2017. ON (B)(6) 2013: CORRECT PLACEMENT OF THE ESSURE WAS CHECKED. PROGESTERONE WAS PRESCRIBED AND CONTINUED WITH A CONDOM. REFERRED AGAIN TO THE CERVICAL PATHOLOGY CLINIC, WHERE WAS EVALUATED ON THE FOLLOWING DATES: (B)(6) 2013, (B)(6) 2013, (B)(6) 2014, (B)(6) 2014, 1(B)(6) 2015, AND (B)(6) 2015, WHEN WAS DISCHARGED. IN NONE OF THE CONSULTATIONS WAS THERE ANY REFERENCE TO DISCOMFORT, DEPRESSIVE OR ANXIETY SYMPTOMS, HIP PAIN, ABDOMINAL PAIN OR PAIN IN THE ILIAC FOSSA. 0(B)(6) 2014: SHE WAS ADMITTED TO THE TRAUMATOLOGY SERVICE, AFTER SUFFERING THE BREAKAGE OF THE PROSTHETIC MATERIAL THAT WAS IMPLANTED IN HER RIGHT HIP IN (B)(6) 2010. ON (B)(6) 2014 SHE UNDERWENT A SURGERY, AND UNDERGOING A CHANGE OF PROSTHESIS WHICH WAS UNEVENTFUL. (B)(6) 2018: DIAGNOSIS OF MILD OCCASIONAL MERALGIA PARESTHETICA AND ASSOCIATED TROCHANTERITIS WAS ESTABLISHED, AND IMPROVED AFTER SHOCK WAVES. (B)(6) 2018: ASSESSMENT IN REHABILITATION- REFERRED IMPROVEMENT, BUT DISCOMFORT PERSISTS, WHICH SAID LIMITED HER FOR WORK. THE EXAMINATION SHOWED FREE LEFT HIP, NO PAIN, NO PAIN ON PALPATION OF THE TROCHANTER. NEGATIVE LASEGUE AND BRAGARD. REGULAR PHYSICAL ACTIVITY WAS RECOMMENDED. THEREFORE, WAS DISCHARGED FROM REHABILITATION SERVICE FOR IMPROVEMENT, BEFORE THE REMOVAL OF ESSURE. ESSURE REMOVAL ON (B)(6) 2019, WITHOUT INCIDENTS, WITH INTRAOPERATIVE RADIOGRAPHY TAKING PLACE, WHERE THE COMPLETE REMOVAL OF THE DEVICES WAS VERIFIED. IN (B)(6) 2019, METAL FRAGMENT WAS FOUND IN THE ABDOMEN. EXPLORATORY LAPAROSCOPY WAS PERFORMED. SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON RIGHT HEMIPELVIS POSSIBLY FROM EXTERNAL ARTIFACT. NO OTHER SIGNIFICANT FINDINGS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [COMPUTERISED TOMOGRAM ABDOMEN] ON 01-SEP-2019: SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON THE RIGHT HEMIPELVIS, POSSIBLY FROM AN EXTERNAL ARTIFACT; ON (B)(6) 2020: A METALLIC DENSITY IMAGE OF APPROXIMATELY 4 MM IN DIAMETER, EXTRA-INTESTINAL, COMPATIBLE WITH METALLIC FOREIGN BODY. IT IS ESTABLISHED AS CLINICAL JUDGEMENT THAT IT IS A 'SUSPECTED PERSISTENCE OF ESSURE FRAGMENT'. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2019: WITHOUT ALTERATIONS. THE DIAGNOSIS OF OCCASIONAL MILD MERALGIA PARESTHETICA AND ENTERITIS OF THE GLUTEUS MEDIUS WITH LATERAL FLEXOR TENSION AND ASSOCIATED TROCHANTERITIS WAS ESTABLISHED [PATHOLOGY TEST] ON (B)(6) 2019: THE PATHOLOGICAL ANATOMY REPORT INDICATED THE ABSENCE OF SIGNIFICANT HISTOLOGICAL ALTERATIONS IN BOTH FALLOPIAN TUBES [ULTRASOUND PELVIS] ON (B)(6) 2020: AN IMAGE OF METAL DENSITY OF APPROXIMATELY 4 MM IN DIAMETER, EXTRAINTESTINAL, COMPATIBLE WITH A METALLIC FOREIGN BODY. IT WAS ESTABLISHED AS A CLINICAL JUDGMENT, ¿SUSPICION PERSISTENCE OF ESSURE FRAGMENT.¿ [ULTRASOUND SCAN] ON (B)(6) 2018: PAIN IN THE LEFT GROIN THAT RADIATED TO THE SIDE THROUGHOUT THE FLANK. UTERUS WITH SECRETORY ENDOMETRIUM. OVARIES WITHOUT ALTERATIONS. ESSURE NORMOINSERTED. THERE WAS NO SCIENTIFIC EVIDENCE TO JUSTIFY THE APPEARANCE OF PAIN AFTER 7 YEARS OF ESSURE; ON (B)(6) 2019: CM UTERUS WITH SECRETORY ENDOMETRIUM. RIGHT AND LEFT OVARY WITHOUT ALTERATIONS. ESSURES NORMALLY INSERTED.; (DATE UNKNOWN): INTRATUBAL DEVICES REMOVED, CONTROL. FINDINGS: COMPLETE REMOVAL OF THE DEVICES. SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON THE RIGHT HEMIPELVIS, POSSIBLY DUE TO EXTERNAL ARTIFACT. NO OTHER SIGNIFICANT FINDINGS OF MENTION. [X-RAY] ON (B)(6) 2019: NO ESSURE FINDINGS; ON 04-OCT-2019: X-RAY REPORT WITHOUT ALTERATIONS, WITHOUT ESSURE. IMAGE OF ALLEGED METALLIC PARTICLE, IT IS NOT POSSIBLE TO KNOW IF IT IS EXTERNAL OR INTRACORPOREAL CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: GROIN PAIN, ALLERGY TO METALS, DEVICE BREAKAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AND ARTHRALGIA. LOT NUMBER: 50673912 MANUFACTURE DATE:2012-07 EXPIRATION DATE: 2015-07. 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: 18-MAY-2022: 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('METAL FRAGMENT WAS FOUND IN THE ABDOMEN'), DEVICE DISLOCATION ('METAL FRAGMENT WAS FOUND IN THE ABDOMEN') AND PELVIC INFLAMMATORY DISEASE ('INFLAMMATION IN THE LEFT GROIN AREA') IN A 41-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: COMPLICATION OF DEVICE REMOVAL "IMAGING TESTS WITH SUSPICION OF PERSISTENCE OF AN ESSURE FRAGMENT / ESSURE FRAGMENT WAS NOT INITIALLY REMOVED". THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICAL CONIZATION IN 2011, ULCERATIVE COLITIS, NICKEL SENSITIVITY (SINCE ADOLESCENCE HAD BEEN COMPLAINING OF DISCOMFORT WITH COSTUME JEWELRY, AND PROBABLY WITH SOME METAL OBJECT, WHICH IS WHY SHE AVOIDED THEM FOR MANY YEARS), IODINE CONTRAST MEDIA ALLERGY, RHINOCONJUNCTIVITIS, ASTHMA, POLLEN ALLERGY, LOW BACK PAIN, ENTHESITIS, CYST REMOVAL, SMOKER, GRAVIDA II, PARITY 2 AND DYSPLASIA. FOLLOW-UP CONSULTATIONS PERFORMING CONTROL MYTHOLOGIES DUE TO A CERVICAL PATHOLOGY ON DATES (B)(6) 2011, (B)(6) 2012, (B)(6) 2012, (B)(6) 2013, (B)(6) 2013, (B)(6) 2014, (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, WHEN DISCHARGED WITH NEGATIVE CYTOLOGY. CONCURRENT CONDITIONS INCLUDED ANXIETY AND DEPRESSIVE DISORDER. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY / DELAYED HYPERSENSITIVITY TO NICKEL (NICKEL SULFATE)"), PELVIC PAIN ("CHRONIC PELVIC PAIN DUE TO A HISTORY OF ESSURE DEVICE USE"), ABDOMINAL PAIN ("ABDOMINAL PAIN PERSISTS WITH EVIDENCE OF FOREIGN BODY IN IMAGING TESTS"), GROIN PAIN ("GROIN PAIN / PAIN IN THE LEFT GROIN THAT RADIATED TO THE LATERAL THE ENTIRE SIDE THROUGHOUT THE FLANK"), ANXIETY ("ANXIETY IN 2014"), DEPRESSION ("DEPRESSION IN 2014"), ARTHRALGIA ("LEFT HIP PAIN / JOINT PAIN IN THE LEFT HIP"), ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN / PAIN IN THE LEFT ILIAC FOSSA"), FLANK PAIN ("PAIN IN THE LEFT FLANK"), ABDOMINAL PAIN UPPER ("PAIN IN THE SUBCOSTAL AREA OF 3 MONTHS OF EVOLUTION") AND INFLAMMATION ("INFLAMMATION OF THE PATIENT IN THE LEFT INGUINAL AREA"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2021 TO (B)(6) 2021. THE PATIENT WAS TREATED WITH MELOXICAM, REHABILITATION ACCOUNT, TREATMENT WITH SHOCK WAVES, REHABILITATION AND TREATMENT WITH SHOCK WAVES AND SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, ALLERGY TO METALS, PELVIC PAIN, ABDOMINAL PAIN, GROIN PAIN, ANXIETY, DEPRESSION, ARTHRALGIA, ABDOMINAL PAIN LOWER, FLANK PAIN, ABDOMINAL PAIN UPPER AND INFLAMMATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, FLANK PAIN, GROIN PAIN, INFLAMMATION, PELVIC INFLAMMATORY DISEASE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE FIRST CONSULTATION IN THE MENTAL HEALTH UNIT FOR ANXIETY-DEPRESSIVE DISORDER WAS ON (B)(6) 2009 BEFORE ESSURE, PLACED IN 2013, SO IT CANNOT BE ATTRIBUTED TO IT (ALTHOUGH, IT DOES NOT REFLECT THE MENTAL HEALTH REPORT PROVIDED IN WHICH SHE ATTENDS AND WAS TREATED IN 2014). SHE WAS EVALUATED IN THE YEARS 2014, 2015, 2016 AND 2017, BEING DISCHARGED ON (B)(6) 2017. ON (B)(6) 2013: CORRECT PLACEMENT OF THE ESSURE WAS CHECKED. PROGESTERONE WAS PRESCRIBED AND CONTINUED WITH A CONDOM. REFERRED AGAIN TO THE CERVICAL PATHOLOGY CLINIC, WHERE WAS EVALUATED ON THE FOLLOWING DATES: (B)(6) 2013, (B)(6) 2013, (B)(6) 2014, (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, WHEN WAS DISCHARGED. IN NONE OF THE CONSULTATIONS WAS THERE ANY REFERENCE TO DISCOMFORT, DEPRESSIVE OR ANXIETY SYMPTOMS, HIP PAIN, ABDOMINAL PAIN OR PAIN IN THE ILIAC FOSSA. (B)(6) 2014: SHE WAS ADMITTED TO THE TRAUMATOLOGY SERVICE, AFTER SUFFERING THE BREAKAGE OF THE PROSTHETIC MATERIAL THAT WAS IMPLANTED IN HER RIGHT HIP IN (B)(6) 2010. ON (B)(6) 2014 SHE UNDERWENT A SURGERY, AND UNDERGOING A CHANGE OF PROSTHESIS WHICH WAS UNEVENTFUL. (B)(6) 2018: DIAGNOSIS OF MILD OCCASIONAL MERALGIA PARESTHETICA AND ASSOCIATED TROCHANTERITIS WAS ESTABLISHED, AND IMPROVED AFTER SHOCK WAVES. (B)(6) 2018: ASSESSMENT IN REHABILITATION- REFERRED IMPROVEMENT, BUT DISCOMFORT PERSISTS, WHICH SAID LIMITED HER FOR WORK. THE EXAMINATION SHOWED FREE LEFT HIP, NO PAIN, NO PAIN ON PALPATION OF THE TROCHANTER. NEGATIVE LASEGUE AND BRAGARD. REGULAR PHYSICAL ACTIVITY WAS RECOMMENDED. THEREFORE, WAS DISCHARGED FROM REHABILITATION SERVICE FOR IMPROVEMENT, BEFORE THE REMOVAL OF ESSURE. ESSURE REMOVAL ON (B)(6) 2019, WITHOUT INCIDENTS, WITH INTRAOPERATIVE RADIOGRAPHY TAKING PLACE, WHERE THE COMPLETE REMOVAL OF THE DEVICES WAS VERIFIED. IN (B)(6) 2019, METAL FRAGMENT WAS FOUND IN THE ABDOMEN. EXPLORATORY LAPAROSCOPY WAS PERFORMED. SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON RIGHT HEMIPELVIS POSSIBLY FROM EXTERNAL ARTIFACT. NO OTHER SIGNIFICANT FINDINGS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2019: SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON THE RIGHT HEMIPELVIS, POSSIBLY FROM AN EXTERNAL ARTIFACT; ON (B)(6) 2020: A METALLIC DENSITY IMAGE OF APPROXIMATELY 4 MM IN DIAMETER, EXTRA-INTESTINAL, COMPATIBLE WITH METALLIC FOREIGN BODY. IT IS ESTABLISHED AS CLINICAL JUDGEMENT THAT IT IS A 'SUSPECTED PERSISTENCE OF ESSURE FRAGMENT'.. MAGNETIC RESONANCE IMAGING - ON (B)(6) 2019: WITHOUT ALTERATIONS. THE DIAGNOSIS OF OCCASIONAL MILD MERALGIA PARESTHETICA AND ENTERITIS OF THE GLUTEUS MEDIUS WITH LATERAL FLEXOR TENSION AND ASSOCIATED TROCHANTERITIS WAS ESTABLISHED. PATHOLOGY TEST - ON (B)(6) 2019: THE PATHOLOGICAL ANATOMY REPORT INDICATED THE ABSENCE OF SIGNIFICANT HISTOLOGICAL ALTERATIONS IN BOTH FALLOPIAN TUBES. ULTRASOUND PELVIS - ON (B)(6) 2020: AN IMAGE OF METAL DENSITY OF APPROXIMATELY 4 MM IN DIAMETER, EXTRAINTESTINAL, COMPATIBLE WITH A METALLIC FOREIGN BODY. IT WAS ESTABLISHED AS A CLINICAL JUDGMENT, ¿SUSPICION PERSISTENCE OF ESSURE FRAGMENT.¿. ULTRASOUND SCAN - ON (B)(6) 2018: PAIN IN THE LEFT GROIN THAT RADIATED TO THE SIDE THROUGHOUT THE FLANK. UTERUS WITH SECRETORY ENDOMETRIUM. OVARIES WITHOUT ALTERATIONS. ESSURE NORMOINSERTED. THERE WAS NO SCIENTIFIC EVIDENCE TO JUSTIFY THE APPEARANCE OF PAIN AFTER 7 YEARS OF ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: GROIN PAIN, ALLERGY TO METALS, DEVICE BREAKAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AND ARTHRALGIA. 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 12-APR-2022: 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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("METAL FRAGMENT WAS FOUND IN THE ABDOMEN"), DEVICE DISLOCATION ("METAL FRAGMENT WAS FOUND IN THE ABDOMEN") AND PELVIC INFLAMMATORY DISEASE ("INFLAMMATION IN THE LEFT GROIN AREA") IN A 41 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 50673912) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: CONTRACEPTIVE DEVICE REMOVAL INCOMPLETE ("IMAGING TESTS WITH SUSPICION OF PERSISTENCE OF AN ESSURE FRAGMENT / ESSURE FRAGMENT WAS NOT INITIALLY REMOVED"). THE PATIENT HAD A MEDICAL HISTORY OF CERVICAL CONIZATION IN 2011 AND RESPIRATORY INFECTION, ABDOMINAL PAIN, GASTROENTERITIS, VOMITING, VAGINITIS, LOW BACK PAIN, URINARY INCONTINENCE, PAIN IN HIP, TROCHANTERIC SYNDROME, COXALGIA, DERMATITIS, DYSPLASIA, PARITY 2, GRAVIDA II, SMOKER, CYST REMOVAL, ENTHESITIS, LOW BACK PAIN, POLLEN ALLERGY, ASTHMA, RHINOCONJUNCTIVITIS, IODINE CONTRAST MEDIA ALLERGY, NICKEL SENSITIVITY (SINCE ADOLESCENCE HAD BEEN COMPLAINING OF DISCOMFORT WITH COSTUME JEWELRY, AND PROBABLY WITH SOME METAL OBJECT, WHICH IS WHY SHE AVOIDED THEM FOR MANY YEARS) AND ULCERATIVE COLITIS. FOLLOW-UP CONSULTATIONS PERFORMING CONTROL MYTHOLOGIES DUE TO A CERVICAL PATHOLOGY ON DATES (B)(6) 2011, (B)(6) 202012, (B)(6) 2012, (B)(6) 2013, (B)(6) 2013, (B)(6) 2014, (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, WHEN DISCHARGED WITH NEGATIVE CYTOLOGY. CONCURRENT CONDITIONS WERE LISTED AS SORE THROAT, RUNNY NOSE, HEADACHE, ERYTHEMA, DEPRESSIVE DISORDER AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE, NOLOTIL COMPOSITUM (HYOSCINE BUTYLBROMIDE;METAMIZOLE MAGNESIUM), AMOXICILLIN, METAMIZOLE, DIAZEPAM AND ENANTYUM (DEXKETOPROFEN TROMETAMOL). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 942 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY / DELAYED HYPERSENSITIVITY TO NICKEL (NICKEL SULFATE)"), PELVIC PAIN ("CHRONIC PELVIC PAIN DUE TO A HISTORY OF ESSURE DEVICE USE"), ABDOMINAL PAIN ("ABDOMINAL PAIN PERSISTS WITH EVIDENCE OF FOREIGN BODY IN IMAGING TESTS"), GROIN PAIN ("GROIN PAIN / PAIN IN THE LEFT GROIN THAT RADIATED TO THE LATERAL THE ENTIRE SIDE THROUGHOUT THE FLANK"), ANXIETY ("ANXIETY IN 2014"), DEPRESSION ("DEPRESSION IN 2014"), ARTHRALGIA ("LEFT HIP PAIN / JOINT PAIN IN THE LEFT HIP"), ABDOMINAL PAIN LOWER ("LEFT LOWER QUADRANT PAIN / PAIN IN THE LEFT ILIAC FOSSA"), FLANK PAIN ("PAIN IN THE LEFT FLANK"), ABDOMINAL PAIN UPPER ("PAIN IN THE SUBCOSTAL AREA OF 3 MONTHS OF EVOLUTION") AND INFLAMMATION ("INFLAMMATION OF THE PATIENT IN THE LEFT INGUINAL AREA"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2021 TO (B)(6) 2021. THE PATIENT WAS TREATED WITH MELOXICAM AS WELL AS SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY) AND NON-DRUG THERAPY (REHABILITATION ACCOUNT, TREATMENT WITH SHOCK WAVES AND REHABILITATION AND TREATMENT WITH SHOCK WAVES). AT THE TIME OF THE REPORT, NONE OF THE OUTCOMES FOR THESE EVENTS WERE KNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALLERGY TO METALS, ANXIETY, ARTHRALGIA, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, FLANK PAIN, GROIN PAIN, INFLAMMATION, PELVIC INFLAMMATORY DISEASE AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE FIRST CONSULTATION IN THE MENTAL HEALTH UNIT FOR ANXIETY-DEPRESSIVE DISORDER WAS ON (B)(6) 2009 BEFORE ESSURE, PLACED IN 2013, SO IT CANNOT BE ATTRIBUTED TO IT (ALTHOUGH, IT DOES NOT REFLECT THE MENTAL HEALTH REPORT PROVIDED IN WHICH SHE ATTENDS AND WAS TREATED IN 2014). SHE WAS EVALUATED IN THE YEARS 2014, 2015, 2016 AND 2017, BEING DISCHARGED ON (B)(6) 2017. ON 18JUN2013: CORRECT PLACEMENT OF THE ESSURE WAS CHECKED. PROGESTERONE WAS PRESCRIBED AND CONTINUED WITH A CONDOM. REFERRED AGAIN TO THE CERVICAL PATHOLOGY CLINIC, WHERE WAS EVALUATED ON THE FOLLOWING DATES: (B)(6) 2013, (B)(6) 2013, (B)(6) 2014, (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, WHEN WAS DISCHARGED. IN NONE OF THE CONSULTATIONS WAS THERE ANY REFERENCE TO DISCOMFORT, DEPRESSIVE OR ANXIETY SYMPTOMS, HIP PAIN, ABDOMINAL PAIN OR PAIN IN THE ILIAC FOSSA. (B)(6) 2014: SHE WAS ADMITTED TO THE TRAUMATOLOGY SERVICE, AFTER SUFFERING THE BREAKAGE OF THE PROSTHETIC MATERIAL THAT WAS IMPLANTED IN HER RIGHT HIP IN (B)(6) 2010. ON (B)(6) 2014 SHE UNDERWENT A SURGERY, AND UNDERGOING A CHANGE OF PROSTHESIS WHICH WAS UNEVENTFUL. (B)(6) 2018: DIAGNOSIS OF MILD OCCASIONAL MERALGIA PARESTHETICA AND ASSOCIATED TROCHANTERITIS WAS ESTABLISHED, AND IMPROVED AFTER SHOCK WAVES. (B)(6) 2018: ASSESSMENT IN REHABILITATION- REFERRED IMPROVEMENT, BUT DISCOMFORT PERSISTS, WHICH SAID LIMITED HER FOR WORK. THE EXAMINATION SHOWED FREE LEFT HIP, NO PAIN, NO PAIN ON PALPATION OF THE TROCHANTER. NEGATIVE LASEGUE AND BRAGARD. REGULAR PHYSICAL ACTIVITY WAS RECOMMENDED. THEREFORE, WAS DISCHARGED FROM REHABILITATION SERVICE FOR IMPROVEMENT, BEFORE THE REMOVAL OF ESSURE. ESSURE REMOVAL ON (B)(6) 2019, WITHOUT INCIDENTS, WITH INTRAOPERATIVE RADIOGRAPHY TAKING PLACE, WHERE THE COMPLETE REMOVAL OF THE DEVICES WAS VERIFIED. IN (B)(6) 2019, METAL FRAGMENT WAS FOUND IN THE ABDOMEN. EXPLORATORY LAPAROSCOPY WAS PERFORMED. SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON RIGHT HEMIPELVIS POSSIBLY FROM EXTERNAL ARTIFACT. NO OTHER SIGNIFICANT FINDINGS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [COMPUTERISED TOMOGRAM ABDOMEN] ON (B)(6) 2019: SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON THE RIGHT HEMIPELVIS, POSSIBLY FROM AN EXTERNAL ARTIFACT; ON (B)(6) 2020: A METALLIC DENSITY IMAGE OF APPROXIMATELY 4 MM IN DIAMETER, EXTRA-INTESTINAL, COMPATIBLE WITH METALLIC FOREIGN BODY. IT IS ESTABLISHED AS CLINICAL JUDGEMENT THAT IT IS A 'SUSPECTED PERSISTENCE OF ESSURE FRAGMENT'. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2019: WITHOUT ALTERATIONS. THE DIAGNOSIS OF OCCASIONAL MILD MERALGIA PARESTHETICA AND ENTERITIS OF THE GLUTEUS MEDIUS WITH LATERAL FLEXOR TENSION AND ASSOCIATED TROCHANTERITIS WAS ESTABLISHED [PATHOLOGY TEST] ON (B)(6) 2019: THE PATHOLOGICAL ANATOMY REPORT INDICATED THE ABSENCE OF SIGNIFICANT HISTOLOGICAL ALTERATIONS IN BOTH FALLOPIAN TUBES [ULTRASOUND PELVIS] ON (B)(6) 2020: AN IMAGE OF METAL DENSITY OF APPROXIMATELY 4 MM IN DIAMETER, EXTRAINTESTINAL, COMPATIBLE WITH A METALLIC FOREIGN BODY. IT WAS ESTABLISHED AS A CLINICAL JUDGMENT, ¿SUSPICION PERSISTENCE OF ESSURE FRAGMENT.¿ [ULTRASOUND SCAN] ON (B)(6) 2018: PAIN IN THE LEFT GROIN THAT RADIATED TO THE SIDE THROUGHOUT THE FLANK. UTERUS WITH SECRETORY ENDOMETRIUM. OVARIES WITHOUT ALTERATIONS. ESSURE NORMOINSERTED. THERE WAS NO SCIENTIFIC EVIDENCE TO JUSTIFY THE APPEARANCE OF PAIN AFTER 7 YEARS OF ESSURE; ON (B)(6) 2019: CM UTERUS WITH SECRETORY ENDOMETRIUM. RIGHT AND LEFT OVARY WITHOUT ALTERATIONS. ESSURES NORMALLY INSERTED.; (DATE UNKNOWN): INTRATUBAL DEVICES REMOVED, CONTROL. FINDINGS: COMPLETE REMOVAL OF THE DEVICES. SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON THE RIGHT HEMIPELVIS, POSSIBLY DUE TO EXTERNAL ARTIFACT. NO OTHER SIGNIFICANT FINDINGS OF MENTION. [X-RAY] ON (B)(6) 2019: NO ESSURE FINDINGS; ON (B)(6) 2019: X-RAY REPORT WITHOUT ALTERATIONS, WITHOUT ESSURE. IMAGE OF ALLEGED METALLIC PARTICLE, IT IS NOT POSSIBLE TO KNOW IF IT IS EXTERNAL OR INTRACORPOREAL CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: GROIN PAIN, ALLERGY TO METALS, DEVICE BREAKAGE, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, AND ARTHRALGIA. 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-MAY-2022: MEDICAL RECORD RECEIVED. LOT NUMBER ADDED., MEDICAL HISTORY CONCOMITANT CONDITIONS CONCOMITANT DRUGS WERE ADDED. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('METAL FRAGMENT WAS FOUND IN THE ABDOMEN'), DEVICE DISLOCATION ('METAL FRAGMENT WAS FOUND IN THE ABDOMEN') AND PELVIC INFLAMMATORY DISEASE ('INFLAMMATION IN THE LEFT GROIN AREA') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ULCERATIVE COLITIS, NICKEL SENSITIVITY, IODINE CONTRAST MEDIA ALLERGY, RHINOCONJUNCTIVITIS, ASTHMA, POLLEN ALLERGY, LOW BACK PAIN, ENTHESITIS, CYST REMOVAL, SMOKER, GRAVIDA II AND PARITY 2. CONCURRENT CONDITIONS INCLUDED ANXIETY AND DEPRESSIVE DISORDER. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY"), PELVIC PAIN ("CHRONIC PELVIC PAIN DUE TO A HISTORY OF ESSURE DEVICE USE"), ABDOMINAL PAIN ("ABDOMINAL PAIN PERSISTS WITH EVIDENCE OF FOREIGN BODY IN IMAGING TESTS"), GROIN PAIN ("GROIN PAIN "), ANXIETY ("ANXIETY IN 2014") AND DEPRESSION ("DEPRESSION IN 2014"). THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2021 TO (B)(6) 2021. THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, ALLERGY TO METALS, PELVIC PAIN, ABDOMINAL PAIN, GROIN PAIN, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, GROIN PAIN, PELVIC INFLAMMATORY DISEASE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE FIRST CONSULTATION IN THE MENTAL HEALTH UNIT FOR ANXIETY-DEPRESSIVE DISORDER WAS ON (B)(6) 2009 BEFORE THE IMPLANTATION OF THE ESSURE DEVICE, WHICH TOOK PLACE IN 2013, SO IT CANNOT BE ATTRIBUTED TO IT (ALTHOUGH, IT DOES NOT REFLECT THE MENTAL HEALTH REPORT PROVIDED IN THIS LAWSUIT IN WHICH SHE ATTENDS AND IS TREATED IN 2014). ESSURE DEVICE REMOVAL WAS PERFORMED IN (B)(6) 2019. IN (B)(6) 2019, METAL FRAGMENT WAS FOUND IN THE ABDOMEN. EXPLORATORY LAPAROSCOPY WAS PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2019: SMALL IMAGE OF METALLIC DENSITY SUPERIMPOSED ON THE RIGHT HEMIPELVIS, POSSIBLY FROM AN EXTERNAL ARTIFACT.; ON (B)(6) 2020: A METALLIC DENSITY IMAGE OF APPROXIMATELY 4 MM IN DIAMETER, EXTRA-INTESTINAL, COMPATIBLE WITH METALLIC FOREIGN BODY. IT IS ESTABLISHED AS CLINICAL JUDGEMENT THAT IT IS A 'SUSPECTED PERSISTENCE OF ESSURE FRAGMENT'.. 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 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 |
|---|---|---|---|---|---|---|---|
| 1009364 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 50673912 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention| O| H | AMOXICILLIN| AMOXICILLIN| DIAZEPAM| DIAZEPAM| ENANTYUM| ENANTYUM| FLUCONAZOLE| FLUCONAZOLE| METAMIZOLE| METAMIZOLE| NOLOTIL COMPOSITUM| NOLOTIL COMPOSITUM |