ESSURE
Report
- Report Number
- 2951250-2017-06548
- Event Type
- Injury
- Date Received
- November 15, 2017
- Date of Event
- January 1, 2012
- Report Date
- February 27, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), SEPSIS ("SEPSISMIA") AND CLOSTRIDIUM DIFFICILE INFECTION ("C DIFF; S/P IMPLANT") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TRICHOMONIASIS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, COLONIC POLYP, THYROID CYST, DYSFUNCTIONAL UTERINE BLEEDING, STREPTOCOCCAL BACTEREMIA, COLD SORES, LEUKOCYTOSIS, TOBACCO ABUSE AND HYPOKALEMIA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM SINCE 2012, COLECALCIFEROL (VITAMIN D3) SINCE 2012, GABAPENTIN SINCE 2013, INTRAUTERINE CONTRACEPTIVE DEVICE (PARAGARD), LACTULOSE SINCE 2012, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA)(B)(6) 2012 TO 2012, MULTIVITAMINS, OMEPRAZOLE SINCE 2012, ONDANSETRON HYDROCHLORIDE SINCE 2012, PROPRANOLOL SINCE 2004, RIZATRIPTAN SINCE 2012, TRAMADOL HYDROCHLORIDE (TRAMADOL HCL CF) SINCE 2013, TRAZODONE SINCE 2013, VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HCL) FROM 2012 TO 2013 AND VANCOMYCIN FROM 2012 TO 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGY TO NICKEL/ NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL"), DEPRESSION ("DEPRESSION/ WORSENED DEPRESSION"), ANXIETY ("ANXIETY/ SEVERE ANXIETY"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TOOTH FRACTURE ("DENTAL PROBLEMS:CRACKING/ CHIPPING ROOT CANALS"), HEMIANAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ARM AND LEG NUMBNESS"), MUSCLE TWITCHING ("TWITCHING OF FACE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), EYE MOVEMENT DISORDER ("VISION/EYE PROBLEMS TYPE: EYE TWITCHING"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"), DIARRHOEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: SEVERE DIARRHEA"), ALOPECIA ("HAIR LOSS"), CLOSTRIDIUM DIFFICILE INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSARTHRIA ("SLURRING SPEECH"). ON (B)(6) 2012, 3 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("LAPAROSCOPIC LYSIS OF ADHESIONS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINITIS GARDNERELLA ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: GARDNERELLA VAGINITIS"), FIBROMYALGIA ("FIBROMYALGIA"), GOITRE ("THYROID GOITER"), HYPOTHYROIDISM ("HYPOTHYROIDISM"), COGNITIVE DISORDER ("COGNITIVE DIFFICULTIES") AND IRRITABLE BOWEL SYNDROME ("IBS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT) AND SURGERY (NOVASURE ABLATION). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PERFORATION, ALLERGY TO METALS, DEPRESSION, ANXIETY, MENORRHAGIA, VAGINITIS GARDNERELLA, SEPSIS, FIBROMYALGIA, GOITRE, HYPOTHYROIDISM, HEADACHE, HEMIANAESTHESIA, MUSCLE TWITCHING, COGNITIVE DISORDER, DYSMENORRHOEA, PELVIC ADHESIONS, EYE MOVEMENT DISORDER, WEIGHT INCREASED, DIARRHOEA, IRRITABLE BOWEL SYNDROME, CLOSTRIDIUM DIFFICILE INFECTION AND DYSARTHRIA OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MIGRAINE, NAUSEA, FATIGUE AND ALOPECIA WAS RESOLVING AND THE TOOTH FRACTURE HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ANXIETY, CLOSTRIDIUM DIFFICILE INFECTION, COGNITIVE DISORDER, DEPRESSION, DIARRHOEA, DYSARTHRIA, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FATIGUE, FIBROMYALGIA, GOITRE, HEADACHE, HEMIANAESTHESIA, HYPOTHYROIDISM, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MIGRAINE, MUSCLE TWITCHING, NAUSEA, PELVIC ADHESIONS, PERFORATION, SEPSIS, TOOTH FRACTURE, VAGINAL HAEMORRHAGE, VAGINITIS GARDNERELLA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.3 KG/SQM. HYSTEROSALPINGOGRAM - ON 10-DEC-2012: TOTAL BILATERAL OCCLUSION CURRENT WEIGHT 260 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUN-2018: REPORTERS ADDED AND UPDATED PATIENT DEMOGRAPHICS. CONCOMITANT DISEASE, CONCOMITANT DRUGS AND LABORATORY DATA WERE ADDED. UPDATED SUSPECT DRUG INACTION AND LOT NUMBER. ADDED EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL, INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: GARDNERELLA VAGINITIS, INFECTION (OTHER) DESCRIBE: SEPSISMIA, AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA/THYROID -GOITER/HYPOTHYROIDISM, MIGRAINES / HEADACHES, NAUSEA, DENTAL PROBLEMS, NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ARM AND LEG NUMBNESS, TWITCHING OF FACE, COGNITIVE DIFFICULTIES, , DYSMENORRHEA (CRAMPING), LAPAROSCOPIC LYSIS OF ADHESIONS, VISION/EYE PROBLEMS TYPE: EYE TWITCHING, FATIGUE, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: SEVERE DIARRHEA, C DIFF; S/P IMPLANT; IBS, HAIR LOSS AND SLURRING SPEECH. UPDATED EVENTS AND ONSET DATES. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), SEPSIS ("SEPSISMIA") AND CLOSTRIDIUM DIFFICILE INFECTION ("C DIFF; S/P IMPLANT") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TRICHOMONIASIS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, COLONIC POLYP, THYROID CYST, DYSFUNCTIONAL UTERINE BLEEDING, STREPTOCOCCAL BACTEREMIA, COLD SORES, LEUKOCYTOSIS, TOBACCO ABUSE AND HYPOKALEMIA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM SINCE 2012, COLECALCIFEROL (VITAMIN D3) SINCE 2012, GABAPENTIN SINCE 2013, INTRAUTERINE CONTRACEPTIVE DEVICE (PARAGARD), LACTULOSE SINCE 2012, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA)10-MAY-2012 TO 2012, MULTIVITAMINS, OMEPRAZOLE SINCE 2012, ONDANSETRON HYDROCHLORIDE SINCE 2012, PROPRANOLOL SINCE 2004, RIZATRIPTAN SINCE 2012, TRAMADOL HYDROCHLORIDE (TRAMADOL HCL CF) SINCE 2013, TRAZODONE SINCE 2013, VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HCL) FROM 2012 TO 2013 AND VANCOMYCIN FROM 2012 TO 2013. IN 2012, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGY TO NICKEL/ NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL"), DEPRESSION ("DEPRESSION/ WORSENED DEPRESSION"), ANXIETY ("ANXIETY/ SEVERE ANXIETY"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TOOTH FRACTURE ("DENTAL PROBLEMS:CRACKING/ CHIPPING ROOT CANALS"), HEMIANAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ARM AND LEG NUMBNESS"), MUSCLE TWITCHING ("TWITCHING OF FACE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), EYE MOVEMENT DISORDER ("VISION/EYE PROBLEMS TYPE: EYE TWITCHING"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"), DIARRHOEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: SEVERE DIARRHEA"), ALOPECIA ("HAIR LOSS"), CLOSTRIDIUM DIFFICILE INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSARTHRIA ("SLURRING SPEECH"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 3 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("LAPAROSCOPIC LYSIS OF ADHESIONS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINITIS GARDNERELLA ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: GARDNERELLA VAGINITIS"), FIBROMYALGIA ("FIBROMYALGIA"), GOITRE ("THYROID GOITER"), HYPOTHYROIDISM ("HYPOTHYROIDISM"), COGNITIVE DISORDER ("COGNITIVE DIFFICULTIES") AND IRRITABLE BOWEL SYNDROME ("IBS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT) AND SURGERY (NOVASURE ABLATION). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PERFORATION, ALLERGY TO METALS, DEPRESSION, ANXIETY, MENORRHAGIA, VAGINITIS GARDNERELLA, SEPSIS, FIBROMYALGIA, GOITRE, HYPOTHYROIDISM, HEADACHE, HEMIANAESTHESIA, MUSCLE TWITCHING, COGNITIVE DISORDER, DYSMENORRHOEA, PELVIC ADHESIONS, EYE MOVEMENT DISORDER, WEIGHT INCREASED, DIARRHOEA, IRRITABLE BOWEL SYNDROME, CLOSTRIDIUM DIFFICILE INFECTION AND DYSARTHRIA OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MIGRAINE, NAUSEA, FATIGUE AND ALOPECIA WAS RESOLVING AND THE TOOTH FRACTURE HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ANXIETY, CLOSTRIDIUM DIFFICILE INFECTION, COGNITIVE DISORDER, DEPRESSION, DIARRHOEA, DYSARTHRIA, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FATIGUE, FIBROMYALGIA, GOITRE, HEADACHE, HEMIANAESTHESIA, HYPOTHYROIDISM, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MIGRAINE, MUSCLE TWITCHING, NAUSEA, PELVIC ADHESIONS, PERFORATION, SEPSIS, TOOTH FRACTURE, VAGINAL HAEMORRHAGE, VAGINITIS GARDNERELLA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CURRENT WEIGHT 260 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. ON 21-AUG-2018: UPON ROUTINE QUALITY MONITORING ACTIVITY, PERFORATION (PERFORATION OF ORGAN) WAS UPDATED FROM ANTICIPATED TO UNANTICIPATED. 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 FALLOPIAN TUBE PERFORATION ('PERFORATION OF ORGANS/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S) / PERFORATION (FALLOPIAN TUBE(S))'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INCORRECT POSITION IN LEFT TUBE'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)'), LARGE INTESTINE PERFORATION ('PERFORATION OF COLON'), SEPSIS ('SEPSISMIA') AND CLOSTRIDIUM DIFFICILE INFECTION ('C DIFF; S/P IMPLANT') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TRICHOMONIASIS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, COLONIC POLYP, THYROID CYST, DYSFUNCTIONAL UTERINE BLEEDING, STREPTOCOCCAL BACTEREMIA, COLD SORES, LEUKOCYTOSIS, TOBACCO ABUSE AND HYPOKALEMIA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM SINCE 2012, COLECALCIFEROL (VITAMIN D3) SINCE 2012, GABAPENTIN SINCE 2013, INTRAUTERINE CONTRACEPTIVE DEVICE (PARAGARD), LACTULOSE SINCE 2012, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA)(B)(6)2012 TO (B)(6), MULTIVITAMINS, OMEPRAZOLE SINCE 2012, ONDANSETRON HYDROCHLORIDE SINCE 2012, PROPRANOLOL SINCE 2004, RIZATRIPTAN SINCE 2012, TRAMADOL HYDROCHLORIDE (TRAMADOL HCL CF) SINCE 2013, TRAZODONE SINCE 2013, VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HCL) FROM (B)(6) TO (B)(6) AND VANCOMYCIN FROM 2012 TO 2013. ON(B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGY TO NICKEL/ NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL"), DEPRESSION ("DEPRESSION/ WORSENED DEPRESSION"), ANXIETY ("ANXIETY/ SEVERE ANXIETY"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TOOTH FRACTURE ("DENTAL PROBLEMS:CRACKING/ CHIPPING ROOT CANALS"), HEMIANAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ARM AND LEG NUMBNESS"), MUSCLE TWITCHING ("TWITCHING OF FACE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), EYE MOVEMENT DISORDER ("VISION/EYE PROBLEMS TYPE: EYE TWITCHING"), FATIGUE ("FATIGUE"), DIARRHOEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: SEVERE DIARRHEA"), ALOPECIA ("HAIR LOSS"), CLOSTRIDIUM DIFFICILE INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSARTHRIA ("SLURRING SPEECH") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6)2012, THE PATIENT EXPERIENCED SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 3 DAYS AFTER INSERTION OF ESSURE. ON (B)(6)2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6)2013, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("LAPAROSCOPIC LYSIS OF ADHESIONS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINITIS GARDNERELLA ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: GARDNERELLA VAGINITIS"), FIBROMYALGIA ("FIBROMYALGIA"), GOITRE ("THYROID GOITER"), HYPOTHYROIDISM ("HYPOTHYROIDISM"), COGNITIVE DISORDER ("COGNITIVE DIFFICULTIES"), IRRITABLE BOWEL SYNDROME ("IBS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ARTHRALGIA ("JOINT PAIN"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION AND TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, LARGE INTESTINE PERFORATION, ALLERGY TO METALS, DEPRESSION, ANXIETY, MENORRHAGIA, VAGINITIS GARDNERELLA, SEPSIS, FIBROMYALGIA, GOITRE, HYPOTHYROIDISM, HEADACHE, HEMIANAESTHESIA, MUSCLE TWITCHING, COGNITIVE DISORDER, DYSMENORRHOEA, PELVIC ADHESIONS, EYE MOVEMENT DISORDER, WEIGHT INCREASED, DIARRHOEA, IRRITABLE BOWEL SYNDROME, CLOSTRIDIUM DIFFICILE INFECTION, DYSARTHRIA, ABDOMINAL PAIN AND ARTHRALGIA OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MIGRAINE, NAUSEA, FATIGUE AND ALOPECIA WAS RESOLVING AND THE TOOTH FRACTURE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, CLOSTRIDIUM DIFFICILE INFECTION, COGNITIVE DISORDER, DEPRESSION, DEVICE DISLOCATION, DIARRHOEA, DYSARTHRIA, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FALLOPIAN TUBE PERFORATION, FATIGUE, FIBROMYALGIA, GOITRE, HEADACHE, HEMIANAESTHESIA, HYPOTHYROIDISM, IRRITABLE BOWEL SYNDROME, LARGE INTESTINE PERFORATION, MENORRHAGIA, MIGRAINE, MUSCLE TWITCHING, NAUSEA, PELVIC ADHESIONS, SEPSIS, TOOTH FRACTURE, VAGINAL HAEMORRHAGE, VAGINITIS GARDNERELLA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2012: RESULTS: TOTAL BILATERAL OCCLUSION. CURRENT WEIGHT 260 LBS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. EVENTS ADDED FROM PFS- MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INCORRECT POSITION IN LEFT TUBE, ABDOMINAL PAIN, JOINT PAIN. EVENT PERFORATION UPDATED TO FALLOPIAN TUBE PERFORATION. AKA NAME WERE ADDED. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION OF ORGANS/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S) / PERFORATION (FALLOPIAN TUBE(S))'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: INCORRECT POSITION IN LEFT TUBE'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND LARGE INTESTINE PERFORATION ('PERFORATION OF COLON') IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 940970) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TRICHOMONIASIS. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, COLONIC POLYP, THYROID CYST, DYSFUNCTIONAL UTERINE BLEEDING, STREPTOCOCCAL BACTEREMIA, COLD SORES, LEUKOCYTOSIS, TOBACCO ABUSE AND HYPOKALEMIA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM SINCE 2012, COLECALCIFEROL (VITAMIN D3) SINCE 2012, GABAPENTIN SINCE 2013, INTRAUTERINE CONTRACEPTIVE DEVICE (PARAGARD), LACTULOSE SINCE 2012, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) (B)(6) 2012, OMEPRAZOLE SINCE 2012, ONDANSETRON HYDROCHLORIDE SINCE 2012, PROPRANOLOL SINCE 2004, RIZATRIPTAN SINCE 2012, TRAMADOL HYDROCHLORIDE (TRAMADOL HCL CF) SINCE 2013, TRAZODONE SINCE 2013, VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HCL) FROM 2012 TO 2013, VANCOMYCIN FROM 2012 TO 2013 AND VITAMINS NOS (MULTIVITAMINS). IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGY TO NICKEL/ NICKEL ALLERGY/ ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: NICKEL"), DEPRESSION ("DEPRESSION/ WORSENED DEPRESSION"), ANXIETY ("ANXIETY/ SEVERE ANXIETY"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TOOTH FRACTURE ("DENTAL PROBLEMS:CRACKING/ CHIPPING ROOT CANALS"), HEMIANAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: ARM AND LEG NUMBNESS"), MUSCLE TWITCHING ("TWITCHING OF FACE"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), EYE MOVEMENT DISORDER ("VISION/EYE PROBLEMS TYPE: EYE TWITCHING"), FATIGUE ("FATIGUE"), DIARRHOEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: SEVERE DIARRHEA"), ALOPECIA ("HAIR LOSS"), CLOSTRIDIUM DIFFICILE INFECTION ("C DIFF; S/P IMPLANT") AND DYSARTHRIA ("SLURRING SPEECH") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED SEPSIS ("SEPSISMIA"), 3 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON 29-APR-2013, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("LAPAROSCOPIC LYSIS OF ADHESIONS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINITIS GARDNERELLA ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: GARDNERELLA VAGINITIS"), FIBROMYALGIA ("FIBROMYALGIA"), GOITRE ("THYROID GOITER"), HYPOTHYROIDISM ("HYPOTHYROIDISM"), COGNITIVE DISORDER ("COGNITIVE DIFFICULTIES"), IRRITABLE BOWEL SYNDROME ("IBS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ARTHRALGIA ("JOINT PAIN"). THE PATIENT WAS TREATED WITH SURGERY (NOVASURE ABLATION AND TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, LARGE INTESTINE PERFORATION, ALLERGY TO METALS, DEPRESSION, ANXIETY, MENORRHAGIA, VAGINITIS GARDNERELLA, SEPSIS, FIBROMYALGIA, GOITRE, HYPOTHYROIDISM, HEADACHE, HEMIANAESTHESIA, MUSCLE TWITCHING, COGNITIVE DISORDER, DYSMENORRHOEA, PELVIC ADHESIONS, EYE MOVEMENT DISORDER, WEIGHT INCREASED, DIARRHOEA, IRRITABLE BOWEL SYNDROME, CLOSTRIDIUM DIFFICILE INFECTION, DYSARTHRIA, ABDOMINAL PAIN AND ARTHRALGIA OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MIGRAINE, NAUSEA, FATIGUE AND ALOPECIA WAS RESOLVING AND THE TOOTH FRACTURE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, CLOSTRIDIUM DIFFICILE INFECTION, COGNITIVE DISORDER, DEPRESSION, DEVICE DISLOCATION, DIARRHOEA, DYSARTHRIA, DYSMENORRHOEA, EYE MOVEMENT DISORDER, FALLOPIAN TUBE PERFORATION, FATIGUE, FIBROMYALGIA, GOITRE, HEADACHE, HEMIANAESTHESIA, HYPOTHYROIDISM, IRRITABLE BOWEL SYNDROME, LARGE INTESTINE PERFORATION, MENORRHAGIA, MIGRAINE, MUSCLE TWITCHING, NAUSEA, PELVIC ADHESIONS, SEPSIS, TOOTH FRACTURE, VAGINAL HAEMORRHAGE, VAGINITIS GARDNERELLA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. CURRENT WEIGHT 260 LBS. LOT NUMBER: 940970. MANUFACTURING DATE: 2012-01. EXPIRATION DATE: 2015-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. 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 PERFORATION ("PERFORATION OF ORGANS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ALLERGY TO METALS ("ALLERGY TO NICKEL"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PERFORATION, ALLERGY TO METALS, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, DEPRESSION AND PERFORATION TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813060 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 940970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other| R | ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| GABAPENTIN| GABAPENTIN| GABAPENTIN| GABAPENTIN| LACTULOSE| LACTULOSE| LACTULOSE| LACTULOSE| MULTIVITAMINS| MULTIVITAMINS| MULTIVITAMINS| MULTIVITAMINS [VITAMINS NOS]| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| ONDANSETRON HYDROCHLORIDE| ONDANSETRON HYDROCHLORIDE| ONDANSETRON HYDROCHLORIDE| ONDANSETRON HYDROCHLORIDE| PARAGARD| PARAGARD| PARAGARD| PARAGARD| PROPRANOLOL| PROPRANOLOL| PROPRANOLOL| PROPRANOLOL| RIZATRIPTAN| RIZATRIPTAN| RIZATRIPTAN| RIZATRIPTAN| TRAMADOL HCL CF| TRAMADOL HCL CF| TRAMADOL HCL CF| TRAMADOL HCL CF| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE| VANCOMYCIN| VANCOMYCIN| VANCOMYCIN| VANCOMYCIN| VANCOMYCIN HCL| VANCOMYCIN HCL| VANCOMYCIN HCL| VANCOMYCIN HCL| VITAMIN D3| VITAMIN D3| VITAMIN D3| VITAMIN D3 |