ESSURE
Report
- Report Number
- 2951250-2017-07835
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- October 11, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("FOREIGN BODY IN THE UTERUS- ESSURE COIL"), PELVIC PAIN ("PAIN/PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING/ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781811-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DENIES UNDERGOING AN ESSURE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANEMIA, MISCARRIAGE AND ANEMIA OF PREGNANCY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PENICILLIN AND DEPO-PROVERA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH PENICILLIN. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED BUPROPION, CLONAZEPAM, CHOLECALCIFEROL (VITAMIN D3), ESCITALOPRAM, ESTROGENS CONJUGATED (PREMARIN), FISH OIL (OMEGA 3 FISH OIL), HYDROXYZINE, LORATADINE (LOTAN), METAXALONE, OXYCOCET (PERCOCET), SERTRALINE AND VITAMINS. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE WEAK AND TIRED ALL THE TIME"). IN (B)(6)2012, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN OF 50-60 IBS"). IN (B)(6)2012, THE PATIENT EXPERIENCED ECZEMA ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN"), TOOTH FRACTURE ("DENTAL PROBLEMS DETERIORATION OF TEETH, BROKEN TEETH") AND HYPERSENSITIVITY ("ALLERGIC HYPERSENSITIVITY REACTION : LOTIONS."). IN 2012, THE PATIENT EXPERIENCED DERMATITIS CONTACT ("ALLERGIC OR HYPERSENSITIVITY REACTION: SOAPS, LOTIONS"), FOOD ALLERGY ("ALLERGIC OR HYPERSENSITIVITY REACTION: FOOD"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), PAIN OF SKIN ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN"), DRY SKIN ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN") AND ALOPECIA ("HAIR LOSS THINNING HAIR"). IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMEN PAIN"). IN (B)(6)2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY"), INSOMNIA ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY") AND IRRITABILITY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY"). IN (B)(6)2014, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS ("AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS"), MIGRAINE ("MIGRAINE/HEADACHE") AND HEADACHE ("MIGRAINE/HEADACHE THROBBING HEADACHE/HEAD PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANDROGEN DEFICIENCY ("HORMONAL CHANGES: TESTERONE DEFICIENCY"), METRORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) BREAKTHROUGH BLEEDING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS DETERIORATION OF TEETH, BROKEN TEETH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) SEVERE CRAMPS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DIARRHOEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: DIARRHEA"), UTERINE HAEMORRHAGE ("OTHER INJURIES: UTERUS WAS FILLED WITH BLOOD"), COITAL BLEEDING ("POST COITAL BLEEDING"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), NECK PAIN ("NECK PAIN"), CHEST PAIN ("CHEST PAIN"), INTRA-ABDOMINAL HAEMORRHAGE ("ABDOMINAL BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING PAIN"), PAIN ("BODY ACHES") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC PAIN, GENITAL HAEMORRHAGE, ANDROGEN DEFICIENCY, METRORRHAGIA, MENORRHAGIA, DERMATITIS CONTACT, FOOD ALLERGY, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY, RHEUMATOID ARTHRITIS, ECZEMA, PAIN OF SKIN, DRY SKIN, MIGRAINE, HEADACHE, NAUSEA, TOOTH FRACTURE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, DIARRHOEA, UTERINE HAEMORRHAGE, ALOPECIA, COITAL BLEEDING, ABDOMINAL PAIN, MOOD SWINGS, NECK PAIN, CHEST PAIN, INTRA-ABDOMINAL HAEMORRHAGE, PAIN IN EXTREMITY, BACK PAIN, PAIN, VAGINAL HAEMORRHAGE AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANDROGEN DEFICIENCY, ANXIETY, BACK PAIN, CHEST PAIN, COITAL BLEEDING, DEPRESSION, DERMATITIS CONTACT, DEVICE EXPULSION, DIARRHOEA, DRY SKIN, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FOOD ALLERGY, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, INSOMNIA, INTRA-ABDOMINAL HAEMORRHAGE, IRRITABILITY, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PAIN, PAIN IN EXTREMITY, PAIN OF SKIN, PELVIC PAIN, RHEUMATOID ARTHRITIS, TOOTH DISORDER, TOOTH FRACTURE, URINARY TRACT INFECTION, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, FATIGUE; IRRITABILITY, PELVIC PAIN, LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, WEIGHT GAIN, ALOPECIA, ANXIETY, DIARRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-OCT-2018: PFS RECEIVED. HISTORICAL CONDITION ADDED. FOLLOWING EVENT : ABNORMAL BLEEDING (VAGINAL), ALLERGIC HYPERSENSITIVITY REACTION :LOTIONS, WERE ADDED. INCIDENT: NO VALID 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("FOREIGN BODY IN THE UTERUS- ESSURE COIL"), PELVIC PAIN ("PAIN/PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING/ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781811) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PAINTIFF DENIES UNDERGOING AN ESSURE." THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANEMIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PENICILLIN AND DEPO-PROVERA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH PENICILLIN. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED BUPROPION, CLONAZEPAM, COLECALCIFEROL (VITAMIN D3), ESCITALOPRAM, ESTROGENS CONJUGATED (PREMARIN), FISH OIL (OMEGA 3 FISH OIL), HYDROXYZINE, LORATADINE (LOTAN), METAXALONE, OXYCOCET (PERCOCET), SERTRALINE AND VITAMINS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE WEAK AND TIRED ALL THE TIME"). IN 2012, THE PATIENT EXPERIENCED DERMATITIS CONTACT ("ALLERGIC OR HYPERSENSITIVITY REACTION: SOAPS, LOTIONS"), FOOD ALLERGY ("ALLERGIC OR HYPERSENSITIVITY REACTION: FOOD"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ECZEMA ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN"), PAIN OF SKIN ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN"), DRY SKIN ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN"), WEIGHT INCREASED ("WEIGHT GAIN OF 50-60 IBS") AND ALOPECIA ("HAIR LOSS THINNING HAIR"). IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMEN PAIN"). IN 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY"), INSOMNIA ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY"), IRRITABILITY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY"), RHEUMATOID ARTHRITIS ("AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS") AND HEADACHE ("MIGRAINE/HEADACHE THROBBING HEADACHE/HEAD PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANDROGEN DEFICIENCY ("HORMONAL CHANGES: TESTERONE DEFICIENCY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) BREAKTHROUGH BLEEDING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION: UTI"), MIGRAINE ("MIGRAINE/HEADACHE"), NAUSEA ("NAUSEA"), TOOTH FRACTURE ("DENTAL PROBLEMS DETERIORATION OF TEETH, BROKEN TEETH"), TOOTH DISORDER ("DENTAL PROBLEMS DETERIORATION OF TEETH, BROKEN TEETH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) SEVERE CRAMPS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DIARRHOEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: DIARRHEA"), UTERINE HAEMORRHAGE ("OTHER INJURIES: UTERUS WAS FILLED WITH BLOOD"), COITAL BLEEDING ("POST COITAL BLEEDING"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), NECK PAIN ("NECK PAIN"), CHEST PAIN ("CHEST PAIN"), INTRA-ABDOMINAL HAEMORRHAGE ("ABDOMINAL BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING PAIN") AND PAIN ("BODY ACHES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) . ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC PAIN, GENITAL HAEMORRHAGE, ANDROGEN DEFICIENCY, VAGINAL HAEMORRHAGE, MENORRHAGIA, DERMATITIS CONTACT, FOOD ALLERGY, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY, RHEUMATOID ARTHRITIS, ECZEMA, PAIN OF SKIN, DRY SKIN, MIGRAINE, HEADACHE, NAUSEA, TOOTH FRACTURE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, DIARRHOEA, UTERINE HAEMORRHAGE, ALOPECIA, COITAL BLEEDING, ABDOMINAL PAIN, MOOD SWINGS, NECK PAIN, CHEST PAIN, INTRA-ABDOMINAL HAEMORRHAGE, PAIN IN EXTREMITY, BACK PAIN AND PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANDROGEN DEFICIENCY, ANXIETY, BACK PAIN, CHEST PAIN, COITAL BLEEDING, DEPRESSION, DERMATITIS CONTACT, DEVICE EXPULSION, DIARRHOEA, DRY SKIN, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FOOD ALLERGY, GENITAL HAEMORRHAGE, HEADACHE, INSOMNIA, INTRA-ABDOMINAL HAEMORRHAGE, IRRITABILITY, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PAIN, PAIN IN EXTREMITY, PAIN OF SKIN, PELVIC PAIN, RHEUMATOID ARTHRITIS, TOOTH DISORDER, TOOTH FRACTURE, URINARY TRACT INFECTION, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, FATIGUE; IRRITABILITY, PELVIC PAIN, LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, WEIGHT GAIN, ALOPECIA, ANXIETY, DIARRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND MR RECEIVED, EVENTS PER PFS: HORMONAL CHANGES: TESTERONE DEFICIENCY; ABNORMAL BLEEDING (GENERAL); ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA); ALLERGIC OR HYPERSENSITIVITY REACTION: SOAPS, LOTIONS, AND FOODS; INFECTION: UTI; APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE); PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY; AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS; RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN; MIGRAINES/HEADACHES; NAUSEA; DENTAL PROBLEMS; DYSMENORRHEA (CRAMPING); DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE); PAIN; FATIGUE; WEIGHT GAIN; GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: DIARRHEA; OTHER INJURIES: UTERUS WAS FILLED WITH BLOOD; HAIR LOSS, BODY ACHES, PLAINTIFF DENIES UNDERGOING AN ESSURE CONFIRMATION TEST 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("FOREIGN BODY IN THE UTERUS- ESSURE COIL"), PELVIC PAIN ("PAIN/PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING/ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 781811-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DENIES UNDERGOING AN ESSURE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANEMIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PENICILLIN AND DEPO-PROVERA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED HYPERSENSITIVITY WITH PENICILLIN. CONCURRENT CONDITIONS INCLUDED CERVICITIS AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED BUPROPION, CLONAZEPAM, COLECALCIFEROL (VITAMIN D3), ESCITALOPRAM, ESTROGENS CONJUGATED (PREMARIN), FISH OIL (OMEGA 3 FISH OIL), HYDROXYZINE, LORATADINE (LOTAN), METAXALONE, OXYCOCET (PERCOCET), SERTRALINE AND VITAMINS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE WEAK AND TIRED ALL THE TIME"). IN 2012, THE PATIENT EXPERIENCED DERMATITIS CONTACT ("ALLERGIC OR HYPERSENSITIVITY REACTION: SOAPS, LOTIONS"), FOOD ALLERGY ("ALLERGIC OR HYPERSENSITIVITY REACTION: FOOD"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ECZEMA ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN"), PAIN OF SKIN ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN"), DRY SKIN ("RASHES OR SKIN CONDITIONS: ECZEMA, SEVERELY SENSITIVE, AND DRY SKIN"), WEIGHT INCREASED ("WEIGHT GAIN OF 50-60 IBS") AND ALOPECIA ("HAIR LOSS THINNING HAIR"). IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMEN PAIN"). IN 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY"), INSOMNIA ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY"), IRRITABILITY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY"), RHEUMATOID ARTHRITIS ("AUTOIMMUNE DISORDER: RHEUMATOID ARTHRITIS") AND HEADACHE ("MIGRAINE/HEADACHE THROBBING HEADACHE/HEAD PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ANDROGEN DEFICIENCY ("HORMONAL CHANGES: TESTOSTERONE DEFICIENCY"), METRORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) BREAKTHROUGH BLEEDING"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION: UTI"), MIGRAINE ("MIGRAINE/HEADACHE"), NAUSEA ("NAUSEA"), TOOTH FRACTURE ("DENTAL PROBLEMS DETERIORATION OF TEETH, BROKEN TEETH"), TOOTH DISORDER ("DENTAL PROBLEMS DETERIORATION OF TEETH, BROKEN TEETH"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) SEVERE CRAMPS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DIARRHOEA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: DIARRHEA"), UTERINE HAEMORRHAGE ("OTHER INJURIES: UTERUS WAS FILLED WITH BLOOD"), COITAL BLEEDING ("POST COITAL BLEEDING"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), NECK PAIN ("NECK PAIN"), CHEST PAIN ("CHEST PAIN"), INTRA-ABDOMINAL HAEMORRHAGE ("ABDOMINAL BLEEDING"), PAIN IN EXTREMITY ("LEG PAIN"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING PAIN") AND PAIN ("BODY ACHES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC PAIN, GENITAL HAEMORRHAGE, ANDROGEN DEFICIENCY, METRORRHAGIA, MENORRHAGIA, DERMATITIS CONTACT, FOOD ALLERGY, URINARY TRACT INFECTION, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, ANXIETY, INSOMNIA, IRRITABILITY, RHEUMATOID ARTHRITIS, ECZEMA, PAIN OF SKIN, DRY SKIN, MIGRAINE, HEADACHE, NAUSEA, TOOTH FRACTURE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, DIARRHOEA, UTERINE HAEMORRHAGE, ALOPECIA, COITAL BLEEDING, ABDOMINAL PAIN, MOOD SWINGS, NECK PAIN, CHEST PAIN, INTRA-ABDOMINAL HAEMORRHAGE, PAIN IN EXTREMITY, BACK PAIN AND PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANDROGEN DEFICIENCY, ANXIETY, BACK PAIN, CHEST PAIN, COITAL BLEEDING, DEPRESSION, DERMATITIS CONTACT, DEVICE EXPULSION, DIARRHOEA, DRY SKIN, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FOOD ALLERGY, GENITAL HAEMORRHAGE, HEADACHE, INSOMNIA, INTRA-ABDOMINAL HAEMORRHAGE, IRRITABILITY, MENORRHAGIA, METRORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PAIN, PAIN IN EXTREMITY, PAIN OF SKIN, PELVIC PAIN, RHEUMATOID ARTHRITIS, TOOTH DISORDER, TOOTH FRACTURE, URINARY TRACT INFECTION, UTERINE HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, FATIGUE; IRRITABILITY, PELVIC PAIN, LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, WEIGHT GAIN, ALOPECIA, ANXIETY, DIARRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-AUG-2018: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT: NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 835090 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 781811-NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | BUPROPION| BUPROPION| BUPROPION| CLONAZEPAM| CLONAZEPAM| CLONAZEPAM| ESCITALOPRAM| ESCITALOPRAM| ESCITALOPRAM| HYDROXYZINE| HYDROXYZINE| HYDROXYZINE| LOTAN [LORATIDINE]| LOTAN [LORATIDINE]| LOTAN [LORATIDINE]| METAXALONE| METAXALONE| METAXALONE| OMEGA 3 FISH OIL| OMEGA 3 FISH OIL| OMEGA 3 FISH OIL| PERCOCET| PERCOCET| PERCOCET| PREMARIN| PREMARIN| PREMARIN| SERTRALINE| SERTRALINE| SERTRALINE| VITAMIN D3| VITAMIN D3| VITAMIN D3| VITAMINS| VITAMINS| VITAMINS |