ESSURE
Report
- Report Number
- 2951250-2017-08318
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- May 18, 2004
- Report Date
- June 24, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION (OTHER) : UTERUS /PERFORATION (UTERUS) /MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: FUNDUS OF THE UTERUS'), DEVICE DISLOCATION ('MIGRATION OF IMPLANT / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE'), DEVICE BREAKAGE ('RETAINED FOREIGN BODY') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12241584-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, NULLIPAROUS, AUTOIMMUNE DISORDER, KNEE SURGERY NOS, CHRONIC PAIN, OSTEOARTHRITIS KNEES, LUMBAR PAIN AND ENDOMETRIAL HYPERPLASIA. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: HE HAD TO FIGURE SOMETHING ELSE OUT BECAUSE IT WAS ONLY OCCLUDED ON THE LEFT SIDE. IT WAS DECIDED TO BURN MY TUBES. ON (B)(6) 2004. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED LATEX ALLERGY, DRUG ALLERGY, ALLERGIC REACTION TO ANALGESICS, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY, DRUG HYPERSENSITIVITY, HYPERPLASIA, UTERINE BLEEDING, LEG PAIN, MORBID OBESITY, PANIC ATTACK, RESTLESS LEGS SYNDROME, ABDOMINAL HERNIA, ANEMIA, ARTHRITIS, DEEP VEIN THROMBOSIS, FIBROMYALGIA, MENOMETRORRHAGIA, HYPERPLASIA, UTERINE BLEEDING, ABDOMINAL ADHESIONS, ALLERGIC REACTION TO ANALGESICS, DRUG ALLERGY, LATEX ALLERGY, PENICILLIN ALLERGY, DRUG TOLERANCE AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED FENTANYL CITRATE (NARCO) SINCE (B)(6) 2014 FOR PAIN AS WELL AS DULOXETINE HYDROCHLORIDE (CYMBALTA), DULOXETINE SINCE (B)(6) 2014, ESOMEPRAZOLE, HEPARIN SINCE (B)(6) 2014, LIDOCAINE, LORATADINE SINCE (B)(6) 2019, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), OXYCODONE, OXYCODONE HYDROCHLORIDE;PARACETAMOL (ACETAMINOPHEN W/OXYCODONE) SINCE (B)(6) -2014, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), TOPIRAMATE (TOPAMAX) AND VITAMINS NOS (MULTIVITAMINS). IN (B)(6) 2004, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"). IN (B)(6) 2004, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON (B)(6) 2004, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 MONTHS 29 DAYS AFTER INSERTION OF ESSURE (ESS205). IN 2004, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN (B)(6) 2005, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2006, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTIS") AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTIONS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED NIGHT SWEATS ("HORMONAL CHANGES DESCRIBE: NIGHT SWEATS") AND MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("ASHES TO FEET AND HANDS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), HYPERPLASIA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: HYPEMLASIA WITHOUT ATYPIA;"), PELVIC ADHESIONS ("EXTENSIVE ADHESION"), OVARIAN CYST ("LEFT OVARIAN CYST /UNRU12TURED FOLLICULAR CYST") AND HAEMORRHAGIC CYST ("SMALL HEMORRHAGIC CYST"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HIRSUTISM ("FACIAL HAIR GROWTH"), CYSTITIS ("BLADDER INFECTIONS"), SYSTEMIC LUPUS ERYTHEMATOSUS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: LUPUS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN") AND ACNE ("ACNE") AND UNDERWENT HERNIA REPAIR ("HERNIA REPAIR"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2004- SURGICAL REMOVAL OF COIL(S /(B)(6) 2014- TOTAL HYSTERECTOMY AND ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, DEVICE BREAKAGE, NIGHT SWEATS, MOOD SWINGS, HIRSUTISM, MENORRHAGIA, URINARY TRACT INFECTION, VULVOVAGINAL MYCOTIC INFECTION, CYSTITIS, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, SYSTEMIC LUPUS ERYTHEMATOSUS, RASH, MIGRAINE, HEADACHE, HYPERPLASIA, PELVIC ADHESIONS, OVARIAN CYST, HAEMORRHAGIC CYST, DYSMENORRHOEA, HERNIA REPAIR, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, ALOPECIA, VAGINAL HAEMORRHAGE AND ACNE OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL DISCHARGE, ABDOMINAL PAIN AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ACNE, ALOPECIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMORRHAGIC CYST, HEADACHE, HERNIA REPAIR, HIRSUTISM, HYPERPLASIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NIGHT SWEATS, OVARIAN CYST, PELVIC ADHESIONS, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2004: RESULTS: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAY-2019: PFS RECEIVED. REPORTERS INFORMATION UPDATED. EVENTS: HORMONAL CHANGES DESCRIBE: NIGHT SWEATS, MOOD SWINGS, FACIAL HAIR GROWTH, ACNE, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTIS, YEAST INFECTIONS, BLADDER INFECTIONS APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, ANXIETY, AUTOIMMUNE DISORDER TYPE OF DISORDER: LUPUS, RASHES OR SKIN CONDITIONS TYPE: RASHES TO FEET AND HANDS, MIGRAINES ,HEADACHES, REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: HY12EMLASIA WITHOUT ATYPIA; EXTENSIVE ADHESION; LEFT OVARIAN CYST WITH SMALL HEMORRHAGIC CYST/UNRU12TURED FOLLICULAR CYST; RETAINED OF FOREIGN BODY, DYSMENORRHEA (CRAMPING), HERNIA REPAIR, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PAIN: LOW BACK PAIN , ABDOMINAL PAIN , VAGINAL DISCHARGE, FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S), FATIGUE, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN, HAIR LOSS, RETAINED FOREIGN BODY , ACNE WERE ADDED. MEDICAL HISTORY ,CONCOMITANT DRUGS, LAB DATA WERE ADDED. ON 3-JUN-2019: MR RECEIVED. NEW REPORTERS, CONCOMITANT CONDITIONS AND DRUGS ADDED. HISTORICAL CONDITIONS ADDED. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (OTHER): UTERUS"), DEVICE DISLOCATION ("MIGRATION OF IMPLANT / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12241584) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND NULLIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED LATEX ALLERGY, DRUG ALLERGY, ALLERGIC REACTION TO ANALGESICS, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY, DRUG HYPERSENSITIVITY, HYPERPLASIA AND UTERINE BLEEDING. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH EXTENSIVE LYSIS OF ADHESIONS) AND SURGERY (TO REMOVE THE ESSURE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2004. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2004: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS RECEIVED: NEW EVENT "PERFORATION (OTHER): UTERUS, VAGINAL DISCHARGE" WERE ADDED. LOT NUMBER WAS ADDED. PRODUCT EXPLANT DATE WAS UPDATED. NEW REPORTER WERE ADDED. HISTORICAL AND CONCOMITANT CONDITIONS WERE 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 UTERINE PERFORATION ('PERFORATION (OTHER) : UTERUS /PERFORATION (UTERUS) /MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: FUNDUS OF THE UTERUS'), DEVICE DISLOCATION ('MIGRATION OF IMPLANT / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE'), DEVICE BREAKAGE ('RETAINED FOREIGN BODY') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12241584) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, NULLIPAROUS, AUTOIMMUNE DISORDER, KNEE SURGERY NOS, CHRONIC PAIN, OSTEOARTHRITIS KNEES, LUMBAR PAIN AND ENDOMETRIAL HYPERPLASIA. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: HE HAD TO FIGURE SOMETHING ELSE OUT BECAUSE IT WAS ONLY OCCLUDED ON THE LEFT SIDE. IT WAS DECIDED TO BURN MY TUBES. (B)(6) 2004. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED LATEX ALLERGY, DRUG ALLERGY, ALLERGIC REACTION TO ANALGESICS, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY, DRUG HYPERSENSITIVITY, HYPERPLASIA, UTERINE BLEEDING, LEG PAIN, MORBID OBESITY, PANIC ATTACK, RESTLESS LEGS SYNDROME, ABDOMINAL HERNIA, ANEMIA, ARTHRITIS, DEEP VEIN THROMBOSIS, FIBROMYALGIA, MENOMETRORRHAGIA, HYPERPLASIA, UTERINE BLEEDING, ABDOMINAL ADHESIONS, ALLERGIC REACTION TO ANALGESICS, DRUG ALLERGY, LATEX ALLERGY, PENICILLIN ALLERGY, DRUG TOLERANCE AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED FENTANYL CITRATE (NARCO) SINCE (B)(6) 2014 FOR PAIN AS WELL AS DULOXETINE HYDROCHLORIDE (CYMBALTA), DULOXETINE SINCE (B)(6) 2014, ESOMEPRAZOLE, HEPARIN SINCE (B)(6) 2014, LIDOCAINE, LORATADINE SINCE (B)(6) 2019, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), OXYCODONE, OXYCODONE HYDROCHLORIDE;PARACETAMOL (ACETAMINOPHEN W/OXYCODONE) SINCE (B)(6) 2014, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), TOPIRAMATE (TOPAMAX) AND VITAMINS NOS (MULTIVITAMINS). IN (B)(6) 2004, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"). IN (B)(6) 2004, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON (B)(6) 2004, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 MONTHS 29 DAYS AFTER INSERTION OF ESSURE (ESS205). IN 2004, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN (B)(6) 2005, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2006, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTIS") AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTIONS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED NIGHT SWEATS ("HORMONAL CHANGES DESCRIBE: NIGHT SWEATS") AND MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("ASHES TO FEET AND HANDS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), HYPERPLASIA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: HYPERPLASIA WITHOUT ATYPIA;"), ADHESION ("EXTENSIVE ADHESION"), OVARIAN CYST ("LEFT OVARIAN CYST /UNRUPTURED FOLLICULAR CYST") AND HAEMORRHAGIC CYST ("SMALL HEMORRHAGIC CYST"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HIRSUTISM ("FACIAL HAIR GROWTH"), CYSTITIS ("BLADDER INFECTIONS"), SYSTEMIC LUPUS ERYTHEMATOSUS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: LUPUS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN") AND ACNE ("ACNE") AND UNDERWENT HERNIA REPAIR ("HERNIA REPAIR"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2004- SURGICAL REMOVAL OF COIL(S /(B)(6) 2014- TOTAL HYSTERECTOMY AND ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, DEVICE BREAKAGE, NIGHT SWEATS, MOOD SWINGS, HIRSUTISM, MENORRHAGIA, URINARY TRACT INFECTION, VULVOVAGINAL MYCOTIC INFECTION, CYSTITIS, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, SYSTEMIC LUPUS ERYTHEMATOSUS, RASH, MIGRAINE, HEADACHE, HYPERPLASIA, ADHESION, OVARIAN CYST, HAEMORRHAGIC CYST, DYSMENORRHOEA, HERNIA REPAIR, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, ALOPECIA, VAGINAL HAEMORRHAGE AND ACNE OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL DISCHARGE, ABDOMINAL PAIN AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ACNE, ADHESION, ALOPECIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMORRHAGIC CYST, HEADACHE, HERNIA REPAIR, HIRSUTISM, HYPERPLASIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NIGHT SWEATS, OVARIAN CYST, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2004: RESULTS: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). LOT NUMBER 12241584 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2019: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (OTHER) : UTERUS"), DEVICE DISLOCATION ("MIGRATION OF IMPLANT / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12241584-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND NULLIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED LATEX ALLERGY, DRUG ALLERGY, ALLERGIC REACTION TO ANALGESICS, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY, DRUG HYPERSENSITIVITY, HYPERPLASIA AND UTERINE BLEEDING. ON (B)(6)2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH EXTENSIVE LYSIS OF ADHESIONS) AND SURGERY (TO REMOVE THE ESSURE). ESSURE (ESS205) WAS REMOVED ON (B)(6)2004. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, UTERINE PERFORATION AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2004: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED) QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT 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 UTERINE PERFORATION ('PERFORATION (OTHER) : UTERUS /PERFORATION (UTERUS) /MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: FUNDUS OF THE UTERUS'), DEVICE DISLOCATION ('MIGRATION OF IMPLANT / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE'), DEVICE BREAKAGE ('RETAINED FOREIGN BODY') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12241584-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, NULLIPAROUS, AUTOIMMUNE DISORDER, KNEE SURGERY NOS, CHRONIC PAIN, OSTEOARTHRITIS KNEES, LUMBAR PAIN AND ENDOMETRIAL HYPERPLASIA. ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: HE HAD TO FIGURE SOMETHING ELSE OUT BECAUSE IT WAS ONLY OCCLUDED ON THE LEFT SIDE. IT WAS DECIDED TO BURN MY TUBES. (B)(6) 2004. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED LATEX ALLERGY, DRUG ALLERGY, ALLERGIC REACTION TO ANALGESICS, ALLERGIC REACTION TO ANALGESICS, DRUG HYPERSENSITIVITY, DRUG HYPERSENSITIVITY, HYPERPLASIA, UTERINE BLEEDING, LEG PAIN, MORBID OBESITY, PANIC ATTACK, RESTLESS LEGS SYNDROME, ABDOMINAL HERNIA, ANEMIA, ARTHRITIS, DEEP VEIN THROMBOSIS, FIBROMYALGIA, MENOMETRORRHAGIA, HYPERPLASIA, UTERINE BLEEDING, ABDOMINAL ADHESIONS, ALLERGIC REACTION TO ANALGESICS, DRUG ALLERGY, LATEX ALLERGY, PENICILLIN ALLERGY, DRUG TOLERANCE AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED FENTANYL CITRATE (NARCO) SINCE (B)(6) 2014 FOR PAIN AS WELL AS DULOXETINE HYDROCHLORIDE (CYMBALTA), DULOXETINE SINCE (B)(6) 2014, ESOMEPRAZOLE, HEPARIN SINCE (B)(6) 2014, LIDOCAINE, LORATADINE SINCE (B)(6) 2019, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), OXYCODONE, OXYCODONE HYDROCHLORIDE;PARACETAMOL (ACETAMINOPHEN W/OXYCODONE) SINCE (B)(6) 2014, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), TOPIRAMATE (TOPAMAX) AND VITAMINS NOS (MULTIVITAMINS). IN (B)(6) 2004, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"). IN (B)(6) 2004, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). ON (B)(6) 2004, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 MONTHS 29 DAYS AFTER INSERTION OF ESSURE (ESS205). IN 2004, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN (B)(6) 2005, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2006, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTIS") AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTIONS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2010, THE PATIENT EXPERIENCED NIGHT SWEATS ("HORMONAL CHANGES DESCRIBE: NIGHT SWEATS") AND MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("ASHES TO FEET AND HANDS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), HYPERPLASIA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: HY12EMLASIA WITHOUT ATYPIA;"), ADHESION ("EXTENSIVE ADHESION"), OVARIAN CYST ("LEFT OVARIAN CYST /UNRU12TURED FOLLICULAR CYST") AND HAEMORRHAGIC CYST ("SMALL HEMORRHAGIC CYST"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HIRSUTISM ("FACIAL HAIR GROWTH"), CYSTITIS ("BLADDER INFECTIONS"), SYSTEMIC LUPUS ERYTHEMATOSUS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: LUPUS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("LOWER BACK PAIN") AND ACNE ("ACNE") AND UNDERWENT HERNIA REPAIR ("HERNIA REPAIR"). THE PATIENT WAS TREATED WITH SURGERY (B)(6) 2004- SURGICAL REMOVAL OF COIL(S /(B)(6) 2014- TOTAL HYSTERECTOMY AND ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, DEVICE BREAKAGE, NIGHT SWEATS, MOOD SWINGS, HIRSUTISM, MENORRHAGIA, URINARY TRACT INFECTION, VULVOVAGINAL MYCOTIC INFECTION, CYSTITIS, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, SYSTEMIC LUPUS ERYTHEMATOSUS, RASH, MIGRAINE, HEADACHE, HYPERPLASIA, ADHESION, OVARIAN CYST, HAEMORRHAGIC CYST, DYSMENORRHOEA, HERNIA REPAIR, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, ALOPECIA, VAGINAL HAEMORRHAGE AND ACNE OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, VAGINAL DISCHARGE, ABDOMINAL PAIN AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ACNE, ADHESION, ALOPECIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMORRHAGIC CYST, HEADACHE, HERNIA REPAIR, HIRSUTISM, HYPERPLASIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NIGHT SWEATS, OVARIAN CYST, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2004: RESULTS: UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). LOT NUMBER 12241584 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (B)(4) INSERTED. IN (B)(6) 2004, THE PATIENT HAD ESSURE (B)(4) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY ( TO REMOVE THE ESSURE). ESSURE (B)(4) WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE (B)(4). THE REPORTER COMMENTED: SHE NEED FOR ADDITIONAL SURGERY. 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 |
|---|---|---|---|---|---|---|---|
| 834395 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 12241584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | ACETAMINOPHEN W/OXYCODONE| ACETAMINOPHEN W/OXYCODONE| ACETAMINOPHEN W/OXYCODONE| CYMBALTA| CYMBALTA| CYMBALTA| DEPOPROVERA| DEPOPROVERA| DEPOPROVERA| DULOXETINE| DULOXETINE| DULOXETINE| ESOMEPRAZOLE| ESOMEPRAZOLE| ESOMEPRAZOLE| HEPARIN| HEPARIN| HEPARIN| LIDOCAINE| LIDOCAINE| LIDOCAINE| LORATADINE| LORATADINE| LORATADINE| MULTIVITAMINS [VITAMINS NOS]| MULTIVITAMINS [VITAMINS NOS]| MULTIVITAMINS [VITAMINS NOS]| NARCO| NARCO| NARCO| OXYCODONE| OXYCODONE| OXYCODONE| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| TOPAMAX| TOPAMAX| TOPAMAX |