ESSURE
Report
- Report Number
- 2951250-2013-00059
- Event Type
- Death
- Date Received
- December 18, 2013
- Date of Event
- October 1, 2007
- Report Date
- May 4, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
FOLLOW UP INFORMATION RECEIVED ON 19-OCT-2015: NO NEW INFORMATION. FOLLOW-UP INFORMATION RECEIVED ON 05-DEC-2015 FROM CONSUMER VIA SOCIAL MEDIA: NO NEW CLINICAL INFORMAITON. FOLLOW-UP INFORMATION RECEIVED ON 22-DEC-2015: FOLLOW-UP ATTEMPTS HAVE BEEN PERFORMED WITH NO RESPONSE TO DATE. FOLLOW-UP RECEIVED ON 23-DEC-2015 VIA SOCIAL MEDIA: CONSUMER REPORTED THAT ESSURE COIL SLOUGH OFF IN HER BODY. FOLLOW-UP RECEIVED ON 07-JAN-2016 VIA SOCIAL MEDIA SHE STATED THAT SHE ENDED UP SCARRED FOR LIFE AND GUTTED TO REMOVE ESSURE. FOLLOW-UP INFORMATION RECEIVED ON 23-JAN-2016: CONSUMER STATED THAT ESSURE WAS POKING HER LIKE A KNIFE FOR 6 YEARS. FOLLOW-UP RECEIVED ON 09-FEB-2016: CONSUMER REPORTED VIA SOCIAL MEDIA THAT FOR 6 YEARS WITH ESSURE SHE WAS WEIGHTING (B)(6) AND HAD ANKLES THAT BIG (SWELLING). NOW, WITHOUT ESSURE, HER ANKLE HAS RECOVERED. FOLLOW-UP INFORMATION RECEIVED ON 29-FEB-2016: NEW REPORTER WAS ADDED. NO NEW CLINICAL INFORMATION WAS RECEIVED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED REPORT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED EXCESSIVE BLEED CONSTANTLY SINCE INSERTION, POISONED FOR 6 YEARS FROM ESSURE/METAL COILS RELEASED TOXINS, EVERYTIME SHE STANDS UP, SHE HAS BLEEDING AND PASSES OUT, HEMATOMA ON THE SIZE OF SOCCER HER RECTUM, PUS POURING OUT ABDOMINAL INCISION, KIDNEYS SHUT DOWN, SEPTIC SHOCK, VESOVAGINAL FISTULA, CANCEROUS TUMOR ON CERVIX, PERFORATION/MIGRATION, URINARY TRACT INFECTIONS AND DOUBLE PNEUMONIA. CONSUMER HAD A HYSTERECTOMY PERFORMED DUE TO EXCESSIVE BLEEDING. ALL THESE EVENTS WERE CONSIDERED SERIOUS. ONLY BLEEDING AND PERFORATION/MIGRATION ARE LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. TEMPORAL RELATIONSHIP BETWEEN EXCESSIVE BLEED CONSTANTLY SINCE INSERTION, POISONED FOR 6 YEARS FROM ESSURE/METAL COILS RELEASED TOXINS, EVERYTIME SHE STANDS UP, PERFORATION/MIGRATION, SHE HAS BLEEDING AND PASSES OUT AND ESSURE IS POSITIVE AND NO ALTERNATIVE EXPLANATION IS AVAILABLE FOR THEM. A CAUSAL RELATIONSHIP BETWEEN THEM CANNOT BE EXCLUDED. HEMATOMA ON THE SIZE OF SOCCER HER RECTUM, PUS POURING OUT ABDOMINAL INCISION, KIDNEYS SHUT DOWN, SEPTIC SHOCK, VESOVAGINAL FISTULA AND URINARY TRACT INFECTIONS OCCURRED AS CONSEQUENCE OF CONSUMER'S HYSTERECTOMY. A CAUSAL RELATIONSHIP BETWEEN THESE EVENTS AND ESSURE CAN BE EXCLUDED. DUE TO THEIR WELL-KNOWN PATHOPHYSIOLOGY, CANCEROUS TUMOR ON CERVIX AND DOUBLE PNEUMONIA WERE CONSIDERED UNRELATED TO ESSURE. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. PRODUCT TECHNICAL COMPLAINT INVESTIGATION: BASED ON THE AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT QUALITY DEFECT. DESPITE FOLLOW UP ATTEMPTS, NO FURTHER INFORMATION WAS OBTAINED.
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.
FOLLOW-UP INFORMATION RECEIVED ON 16-SEP-2015 FROM CONSUMER (ONLINE POSTING): CONSUMER PROVIDED A COLLECTION OF PICTURES SHOWING SOME EVENTS SHE EXPERIENCED, INCLUDING A PICTURE OF HER FEET DURING ESSURE AND AFTER ITS REMOVAL (NO FURTHER WRITTEN DETAILS WERE PROVIDED) AND OF HER FACE. SHE ALSO STATED THAT TWO YEARS AFTER HYSTO (INTERPRETED AS HYSTERECTOMY, AS SHE INFORMED ESSURE TOOK HER UTERUS, CERVIX AND TUBES) SUTURE PUSHED OUT FOREIGN BODY (INTERPRETED AS PUS POURING OUT ABDOMINAL INCISION PREVIOUSLY REPORTED). MIGRATION, PERFORATION AND DENTAL ISSUES WERE ALSO REPORTED. SHE FELT LIKE A KNIFE WAS STABBING HER FOR 6.5 YEARS. FOLLOW-UP INFORMATION RECEIVED ON 30-SEP-2015. NO NEW CLINICAL INFORMATION PROVIDED. FOLLOW-UP INFORMATION RECEIVED ON 07-OCT-2015 FROM CONSUMER VIA SOCIAL MEDIA ((B)(6)): THE CONSUMER STATED THAT ESSURE FAILED HER. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED REPORT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED EXCESSIVE BLEED CONSTANTLY SINCE INSERTION, POISONED FOR 6 YEARS FROM ESSURE/METAL COILS RELEASED TOXINS, EVERY TIME SHE STANDS UP, SHE HAS BLEEDING AND PASSES OUT, HEMATOMA ON THE SIZE OF SOCCER HER RECTUM, PUS POURING OUT ABDOMINAL INCISION, KIDNEYS SHUT DOWN, SEPTIC SHOCK, VESOVAGINAL FISTULA, CANCEROUS TUMOR ON CERVIX, PERFORATION/MIGRATION, URINARY TRACT INFECTIONS AND DOUBLE PNEUMONIA. CONSUMER HAD A HYSTERECTOMY PERFORMED DUE TO EXCESSIVE BLEEDING. ALL THESE EVENTS WERE CONSIDERED SERIOUS. ONLY BLEEDING AND PERFORATION/MIGRATION ARE LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. TEMPORAL RELATIONSHIP BETWEEN EXCESSIVE BLEED CONSTANTLY SINCE INSERTION, POISONED FOR 6 YEARS FROM ESSURE/METAL COILS RELEASED TOXINS, EVERY TIME SHE STANDS UP, PERFORATION/MIGRATION, SHE HAS BLEEDING AND PASSES OUT AND ESSURE IS POSITIVE AND NO ALTERNATIVE EXPLANATION IS AVAILABLE FOR THEM. A CAUSAL RELATIONSHIP BETWEEN THEM CANNOT BE EXCLUDED. HEMATOMA ON THE SIZE OF SOCCER HER RECTUM, PUS POURING OUT ABDOMINAL INCISION, KIDNEYS SHUT DOWN, SEPTIC SHOCK, VESOVAGINAL FISTULA AND URINARY TRACT INFECTIONS OCCURRED AS CONSEQUENCE OF CONSUMER'S HYSTERECTOMY. A CAUSAL RELATIONSHIP BETWEEN THESE EVENTS AND ESSURE CAN BE EXCLUDED. DUE TO THEIR WELL-KNOWN PATHOPHYSIOLOGY, CANCEROUS TUMOR ON CERVIX AND DOUBLE PNEUMONIA WERE CONSIDERED UNRELATED TO ESSURE. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. PRODUCT TECHNICAL COMPLAINT INVESTIGATION: BASED ON THE AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT QUALITY DEFECT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION/MIGRATION"), GENITAL HAEMORRHAGE ("EXCESSIVE BLEED CONSTANTLY SINCE INSERTION"), METAL POISONING ("POISONED FOR 6 YEARS FROM ESSURE/METAL COILS RELEASED TOXINS / TOXIC"), LOSS OF CONSCIOUSNESS ("EVERYTIME SHE STANDS UP, SHE HAS BLEEDING AND PASSES OUT"), AUTOIMMUNE DISORDER ("ALL THE SYMPTOMS OF AUTOIMMUNE DISEASES"), RECTAL HAEMORRHAGE ("HEMATOMA ON THE SIZE OF SOCCER HER RECTUM"), POSTOPERATIVE WOUND INFECTION ("PUS POURING OUT ABDOMINAL INCISION"), ACUTE KIDNEY INJURY ("KIDNEYS SHUT DOWN"), SEPTIC SHOCK ("SEPTIC SHOCK"), THE SECOND EPISODE OF UROGENITAL FISTULA ("VESICOVAGINAL FISTULA"), CERVIX CARCINOMA ("CANCEROUS TUMOR ON CERVIX"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS"), PNEUMONIA ("DOUBLE PNEUMONIA"), THE FIRST EPISODE OF UROGENITAL FISTULA ("VESICO VAGINAL FISTULA"), ABDOMINAL WOUND DEHISCENCE ("ABDOMINAL INCISION DEHISCENCE"), ABDOMINAL SEPSIS ("SEPSIS, ABDOMINAL INCISION DEHISCENCE, ABDOMINAL HEMATOMA"), INTRA-ABDOMINAL HAEMATOMA ("SEPSIS, ABDOMINAL INCISION DEHISCENCE, ABDOMINAL HEMATOMA") AND VULVOVAGINAL INJURY ("PRESUMED VAGINAL CUFF TEAR") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. (B)(4)) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ASTHMA, ANEMIA, BLOOD PRESSURE HIGH, KIDNEY INFECTION, STRESS INCONTINENCE, FEMALE, GRAVIDA I, PARITY 1 AND C-SECTION IN 1998. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORTH-NOVA ON (B)(4) 2007. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY, DRUG ALLERGY, SMOKER, ALCOHOL USE AND CONSTIPATION. FAMILY HISTORY INCLUDED BREAST CANCER (GRAND MOTHER ((MATERNAL)) AND BLOOD PRESSURE HIGH (MOTHER, GRANDMOTHER, GRANDFATHER). CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS SINCE (B)(6) 2007. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2007, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), METAL POISONING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN SINCE INSERTION") AND THE FIRST EPISODE OF ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"). IN 2009, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), ARTHRITIS ("ARTHRITIS") AND CONNECTIVE TISSUE DISORDER ("CONNECTIVE TISSUE DISORDER"). IN 2010, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), MEDICAL DEVICE DISCOMFORT ("COULD FEEL THE COILS GETTING HOTTER AND MOVING"), INTERVERTEBRAL DISC INJURY ("CAUSED DAMAGE TO DISC") AND THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN 2011, THE PATIENT EXPERIENCED THE FIRST EPISODE OF TOOTH LOSS ("TOOTH LOSS"). IN 2012, THE PATIENT EXPERIENCED RASH ("RASH ON HER FACE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND THE SECOND EPISODE OF TOOTH LOSS ("LOST A TOTAL OF 5 BACK MOLARS"). ON (B)(6) 2013, 5 YEARS 7 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED ABDOMINAL SEPSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND INTRA-ABDOMINAL HAEMATOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2013, THE PATIENT EXPERIENCED POSTOPERATIVE WOUND INFECTION (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), ACUTE KIDNEY INJURY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ATTENTION DEFICIT/HYPERACTIVITY DISORDER ("ADHD(ATTENTION DEFICIT HYPERACTIVE DISORDER)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VULVOVAGINAL INJURY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED THE FIRST EPISODE OF UROGENITAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MALAISE ("VERY SICK FROM THE DAY IT WAS IMPLANTED"), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THE FIRST EPISODE OF ANAEMIA ("ANEMIC/HEMOGLOBIN WAS 5-7") WITH ASTHENIA, FEEDING DISORDER AND VITAMIN B12 DEFICIENCY, BLADDER INJURY ("CAUSED A HOLE ON THE DOME OF THE BLADDER/PERMANENT DAMAGE TO BLADDER"), HEPATIC LESION ("LESIONS ON THE LIVER"), URETHRAL INJURY ("DAMAGED THE URETHRA") WITH URINARY RETENTION, RECTAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GASTROINTESTINAL NEOPLASM ("TUMOR ON SMALL INTESTINE"), INCISION SITE HAEMORRHAGE ("DEEP HEMATOMA/BLOOD POURING OUT ABDOMINAL INCISION"), FUNCTIONAL GASTROINTESTINAL DISORDER ("BOWELS SHUT DOWN"), SEPTIC SHOCK (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THE SECOND EPISODE OF UROGENITAL FISTULA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH URINARY INCONTINENCE, DEVICE BREAKAGE ("RIGHT COIL DID SLOUGH OFF AND PIECES WERE ALL IN HER FALLOPIAN TUBE"), CERVIX CARCINOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PNEUMONIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PYREXIA, WEIGHT ABNORMAL ("WEIGHING (B)(6)"), JOINT SWELLING ("ANKLES THAT BIG"), POST-TRAUMATIC STRESS DISORDER ("PTSD (POST TRAUMATIC STRESS DISORDER)"), FATIGUE ("CHRONIC FATIGUE"), INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), MULTIPLE CHEMICAL SENSITIVITY ("CHEMICAL AND ENVIRONMENTAL SENSITIVITIES"), THE FIRST EPISODE OF HYPERSENSITIVITY ("CHEMICAL AND ENVIRONMENTAL SENSITIVITIES"), AGEUSIA ("LOSS OF SENSE OF TASTE AND SMELL"), ANOSMIA ("LOSS OF SENSE OF TASTE AND SMELL"), DEPRESSION ("DEPRESSION"), NEURALGIA ("NEUROPATHIC PAIN"), SCIATICA ("SCIATICA"), THE SECOND EPISODE OF ANAEMIA ("ANEMIA"), MENORRHAGIA ("PAINFUL HEAVY PERIODS WITH LARGE CLOTS"), DYSMENORRHOEA ("PAINFUL HEAVY PERIODS WITH LARGE CLOTS"), ABDOMINAL WOUND DEHISCENCE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), IRRITABLE BOWEL SYNDROME ("IBS(IRRITABLE BOWEL SYNDROME)"), ALLERGY TO METALS ("NICKEL ALLERGY"), THE SECOND EPISODE OF HYPERSENSITIVITY ("HYPERSENSITIVITY REACTION") AND PAIN IN EXTREMITY ("LEG PAIN"). THE PATIENT WAS TREATED WITH BLOOD CELLS, PACKED HUMAN, OXYCOCET (PERCOCET), HYDROMORPHONE, FLUOXETINE HYDROCHLORIDE (PROZAC), HYDROCODONE, ALPRAZOLAM (XANAX), CARISOPRODOL (SOMA), OBETROL (ADDERALL), SALBUTAMOL (ALBUTEROL INHALER), HYOSCYAMINE, METAXALONE (SKELAXIN), SURGERY (TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY), SURGERY AND SURGERY (VESICO VAGINAL FISTULA REPAIR IN (B)(6)-2013). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, METAL POISONING, MALAISE, PELVIC PAIN, BACK PAIN, MEDICAL DEVICE DISCOMFORT, INTERVERTEBRAL DISC INJURY, LOSS OF CONSCIOUSNESS, THE LAST EPISODE OF TOOTH LOSS, AUTOIMMUNE DISORDER, RASH, BLADDER INJURY, HEPATIC LESION, URETHRAL INJURY, RECTAL HAEMORRHAGE, GASTROINTESTINAL NEOPLASM, POSTOPERATIVE WOUND INFECTION, INCISION SITE HAEMORRHAGE, ACUTE KIDNEY INJURY, FUNCTIONAL GASTROINTESTINAL DISORDER, SEPTIC SHOCK, THE LAST EPISODE OF UROGENITAL FISTULA, DEVICE BREAKAGE, CERVIX CARCINOMA, WEIGHT ABNORMAL, POST-TRAUMATIC STRESS DISORDER, FATIGUE, INTERVERTEBRAL DISC DEGENERATION, MULTIPLE CHEMICAL SENSITIVITY, AGEUSIA, ANOSMIA, SCIATICA, THE LAST EPISODE OF ANAEMIA, MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL WOUND DEHISCENCE, ABDOMINAL SEPSIS, INTRA-ABDOMINAL HAEMATOMA, VULVOVAGINAL INJURY, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, IRRITABLE BOWEL SYNDROME, ALLERGY TO METALS, THE LAST EPISODE OF HYPERSENSITIVITY AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN, THE LAST EPISODE OF ABDOMINAL PAIN AND JOINT SWELLING HAD RESOLVED, THE URINARY TRACT INFECTION AND PNEUMONIA HAD NOT RESOLVED AND THE DEPRESSION, ANXIETY, ARTHRITIS, CONNECTIVE TISSUE DISORDER AND NEURALGIA WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ACUTE KIDNEY INJURY, AUTOIMMUNE DISORDER, BACK PAIN, BLADDER INJURY, CERVIX CARCINOMA, DEVICE BREAKAGE, FUNCTIONAL GASTROINTESTINAL DISORDER, GASTROINTESTINAL NEOPLASM, GENITAL HAEMORRHAGE, HEPATIC LESION, INCISION SITE HAEMORRHAGE, INTERVERTEBRAL DISC INJURY, LOSS OF CONSCIOUSNESS, MALAISE, MEDICAL DEVICE DISCOMFORT, METAL POISONING, PELVIC PAIN, PNEUMONIA, POSTOPERATIVE WOUND INFECTION, RASH, RECTAL HAEMORRHAGE, SEPTIC SHOCK, URETHRAL INJURY, URINARY TRACT INFECTION, THE FIRST EPISODE OF ANAEMIA, THE SECOND EPISODE OF ABDOMINAL PAIN, THE SECOND EPISODE OF TOOTH LOSS AND THE SECOND EPISODE OF UROGENITAL FISTULA WITH ESSURE (ESS205). THE REPORTER CONSIDERED ABDOMINAL SEPSIS, ABDOMINAL WOUND DEHISCENCE, AGEUSIA, ALLERGY TO METALS, ANOSMIA, ANXIETY, ARTHRITIS, ATTENTION DEFICIT/HYPERACTIVITY DISORDER, CONNECTIVE TISSUE DISORDER, DEPRESSION, DYSMENORRHOEA, FATIGUE, INTERVERTEBRAL DISC DEGENERATION, INTRA-ABDOMINAL HAEMATOMA, IRRITABLE BOWEL SYNDROME, JOINT SWELLING, MENORRHAGIA, MULTIPLE CHEMICAL SENSITIVITY, NEURALGIA, PAIN IN EXTREMITY, POST-TRAUMATIC STRESS DISORDER, SCIATICA, UTERINE PERFORATION, VULVOVAGINAL INJURY, WEIGHT ABNORMAL, THE FIRST EPISODE OF ABDOMINAL PAIN, THE FIRST EPISODE OF HYPERSENSITIVITY, THE FIRST EPISODE OF TOOTH LOSS, THE FIRST EPISODE OF UROGENITAL FISTULA, THE SECOND EPISODE OF ANAEMIA AND THE SECOND EPISODE OF HYPERSENSITIVITY TO BE RELATED TO ESSURE (ESS205). ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S SOCIAL MEDIA LEG PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: FROM SOCIAL MEDIA LEG PAIN ARE 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.
A CONSUMER REPORTED HAVING ENSURE INSERTED. IN 2007, THE CONSUMER HAD EXCESSIVE BLEEDING CONSTANTLY SINCE INSERTION AND PELVIC PAIN. IN 2010, SHE HAD CONTINUOUS PELVIC PAIN, BACK PAIN, AND BLEEDING. SHE STATED THAT SHE COULD FEEL THE COILS GETTING HOTTER AND MOVING. IN (B)(6) 2010, SHE HAD A MICRODISCECTOMY AT L4, L5, AND S1. SHE WAS TOLD THAT METAL COILS RELEASED TOXINS AND CAUSED DAMAGED TO DISC. SHE RECEIVED STEROIDS AND A LOT OF ANTIBIOTICS. HER BLEEDING, PELVIC AND ABDOMINAL PAINS WERE CONSTANT. IN (B)(6) 2012, EVERY TIME SHE STOOD UP, SHE HAD BLEEDING AND PASSED OUT. SHE ALSO LOST A TOTAL OF 5 BACK MOLARS. SHE WAS SEEN BY A RHEUMATOLOGIST AND WAS TOLD SHE HAD ALL THE SYMPTOMS OF AUTOIMMUNE DISEASES. SHE WAS WEAK, COULD NOT EAT AND ALSO EXPERIENCED RASH ON HER FACE. SHE WAS ANEMIC AND HER HEMOGLOBIN WAS 5-7. SHE HAD B12 DEFICIENCY ANEMIA AND TOOK SHOTS FOR IT. IN (B)(6) 2013, SHE HAD A ABDOMINAL HYSTERECTOMY DUE TO EXCESSIVE BLEEDING AND NEEDED 2 UNITS OF BLOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661835 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 622306,621809 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization| O| R | ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS |