ESSURE
Report
- Report Number
- 2951250-2017-10607
- Event Type
- Injury
- Date Received
- December 12, 2017
- Report Date
- May 7, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/BEING IN PAIN ALL THE TIME/SHARP PAIN ON MY LEFT SIDE NEAR OVARY AREA") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A161942-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY. CONCOMITANT PRODUCTS INCLUDED BREO ELLIPTA SINCE 2008, HYDROCHLOROTHIAZIDE SINCE 2008 AND LORATADINE (CLARITIN) SINCE 2008. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("TIRED ALL THE TIME WEIGHS ON YOUR DAY TO DAY/ WEIGHT GAIN/GAINED 70 LBS"), DEPRESSION ("DEPRESSED"), DEPRESSED MOOD ("SAD") AND FRUSTRATION TOLERANCE DECREASED ("FRUSTRATED"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("TIRED ALL THE TIME/FATIGUE,"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND MOOD SWINGS ("MOOD SWINGS"). IN 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS,"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND NAUSEA ("NAUSEA,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HAD REACTIONS,"), FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA; GOT SICK MORE"), MALAISE ("GOT SICK MORE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: MANY UPS AND DOWNS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: CHANGES IN VISION"), PAIN ("ALL OVER PAIN"), FOOD INTOLERANCE ("FOOD INTOLERANCES"), URTICARIA ("RASHES OR SKIN CONDITIONS: HIVES") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FIBROMYALGIA AND ALOPECIA WAS RESOLVING, THE ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, MALAISE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, VISUAL IMPAIRMENT, PAIN, FOOD INTOLERANCE, URTICARIA, FEELING ABNORMAL, MOOD SWINGS, DEPRESSION, DEPRESSED MOOD AND FRUSTRATION TOLERANCE DECREASED OUTCOME WAS UNKNOWN AND THE FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, BLADDER DISORDER, DEPRESSED MOOD, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, FOOD INTOLERANCE, FRUSTRATION TOLERANCE DECREASED, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MALAISE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PAIN, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. TRAILING COILS: LEFT 1, RIGHT 2. PATIENT TOLERATED PROCEDURE WELL. CURRENT WEIGHT 215 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2013: FAILURE TO OCCLUDE CLOSE) FALLOPIAN TUBES; IN (B)(6) 2013: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2013: NEGATIVE. ON (B)(6) 2017 , PATHOLOGY: SPECIMEN: UTERUS, CERVIX AND BILATERAL TUBES. PREOPERATIVE DIAGNOSIS: MENORRHAGIA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-SEP-2018: PFS RECEIVED. REPORTER INFORMATION WAS ADDED. HER HISTORICAL CONDITION WAS ADDED. HER CONCOMITANT MEDICATIONS WERE ADDED. RASHES OR SKIN CONDITIONS: HIVES; BRAIN FOG, DEPRESSED, SAD, FRUSTRATED AND MOOD SWINGS 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/BEING IN PAIN ALL THE TIME/SHARP PAIN ON MY LEFT SIDE NEAR OVARY AREA") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A161942-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HAD REACTIONS,"), FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA"), MALAISE ("GOT SICK MORE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: MANY UPS AND DOWNS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), NAUSEA ("NAUSEA,"), WEIGHT INCREASED ("TIRED ALL THE TIME WEIGHS ON YOUR DAY TO DAY/ WEIGHT GAIN"), FATIGUE ("TIRED ALL THE TIME/FATIGUE,"), ALOPECIA ("HAIR LOSS,"), VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: CHANGES IN VISION"), PAIN ("ALL OVER PAIN") AND FOOD INTOLERANCE ("FOOD INTOLARENCES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FIBROMYALGIA AND ALOPECIA WAS RESOLVING, THE ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, MALAISE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, VISUAL IMPAIRMENT, PAIN AND FOOD INTOLERANCE OUTCOME WAS UNKNOWN AND THE FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FIBROMYALGIA, FOOD INTOLERANCE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MALAISE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. TRAILING COILS: LEFT 1, RIGHT 2. PATIENT TOLERATED PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2013: FAILURE TO OCCLUDE CLOSE) FALLOPIAN TUBES; IN (B)(6) 2013: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2013: NEGATIVE. (B)(6) 2017 , PATHOLOGY: SPECIMEN: UTERUS, CERVIX AND BILATERAL TUBES. PREOPERATIVE DIAGNOSIS: MENORRHAGIA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: UPDATE OF INFORMATION (BATCH IS INVALID). 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/BEING IN PAIN ALL THE TIME/SHARP PAIN ON MY LEFT SIDE NEAR OVARY AREA') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A161942-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY. CONCOMITANT PRODUCTS INCLUDED SINCE 2008, FLUTICASONE FUROATE;VILANTEROL TRIFENATATE (BREO ELLIPTA) SINCE 2008 AND HYDROCHLOROTHIAZIDE SINCE 2008. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("TIRED ALL THE TIME WEIGHS ON YOUR DAY TO DAY/ WEIGHT GAIN/GAINED 70 LBS") AND EXPERIENCED DEPRESSION ("DEPRESSED"), DEPRESSED MOOD ("SAD") AND FRUSTRATION TOLERANCE DECREASED ("FRUSTRATED"). IN (B)(6)2013, THE PATIENT EXPERIENCED FATIGUE ("TIRED ALL THE TIME/FATIGUE,"). IN (B)(6)2013, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND MOOD SWINGS ("MOOD SWINGS"). IN 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS,"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND NAUSEA ("NAUSEA,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HAD REACTIONS,"), THE FIRST EPISODE OF FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA; GOT SICK MORE"), MALAISE ("GOT SICK MORE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: CHANGES IN VISION"), PAIN ("ALL OVER PAIN"), FOOD INTOLERANCE ("FOOD INTOLARENCES"), URTICARIA ("RASHES OR SKIN CONDITIONS: HIVES"), FEELING ABNORMAL ("BRAIN FOG"), METAL POISONING ("HEAVY METAL TOXICITY") AND THE SECOND EPISODE OF FIBROMYALGIA ("FIBROMYALGIA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: MANY UPS AND DOWNS"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ALOPECIA WAS RESOLVING, THE ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, MALAISE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, VISUAL IMPAIRMENT, PAIN, FOOD INTOLERANCE, URTICARIA, FEELING ABNORMAL, MOOD SWINGS, DEPRESSION, DEPRESSED MOOD, FRUSTRATION TOLERANCE DECREASED, METAL POISONING AND THE LAST EPISODE OF FIBROMYALGIA OUTCOME WAS UNKNOWN AND THE FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, BLADDER DISORDER, DEPRESSED MOOD, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FOOD INTOLERANCE, FRUSTRATION TOLERANCE DECREASED, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MALAISE, MENORRHAGIA, METAL POISONING, MIGRAINE, MOOD SWINGS, NAUSEA, PAIN, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT, WEIGHT INCREASED, THE FIRST EPISODE OF FIBROMYALGIA AND THE SECOND EPISODE OF FIBROMYALGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. TRAILING COILS: LEFT 1, RIGHT 2. PATIENT TOLERATED PROCEDURE WELL. CURRENT WEIGHT 215 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6)2013: RESULTS: FAILURE TO OCCLUDE CLOSE) FALLOPIAN TUBES; IN (B)(6)2013: RESULTS: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6)2013: RESULTS: NEGATIVE. (B)(6)2017 , PATHOLOGY: SPECIMEN: UTERUS, CERVIX AND BILATERAL TUBES PREOPERATIVE DIAGNOSIS: MENORRHAGIA, PELVIC PAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: CONTENT FROM SOCIAL MEDIA RECEIVED: NEW EVENTS HEAVY METAL TOXICITY AND FIBROMYALGIA WERE ADDED. REPORTER 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN/BEING IN PAIN ALL THE TIME/SHARP PAIN ON MY LEFT SIDE NEAR OVARY AREA') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A161942-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY. CONCOMITANT PRODUCTS INCLUDED SINCE 2008, FLUTICASONE FUROATE;VILANTEROL TRIFENATATE (BREO ELLIPTA) SINCE 2008 AND HYDROCHLOROTHIAZIDE SINCE 2008. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("TIRED ALL THE TIME WEIGHS ON YOUR DAY TO DAY/ WEIGHT GAIN/GAINED 70 LBS") AND EXPERIENCED DEPRESSION ("DEPRESSED"), DEPRESSED MOOD ("SAD") AND FRUSTRATION TOLERANCE DECREASED ("FRUSTRATED"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("TIRED ALL THE TIME/FATIGUE,"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND MOOD SWINGS ("MOOD SWINGS"). IN 2014, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS,"). IN 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI") AND NAUSEA ("NAUSEA,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HAD REACTIONS,"), THE FIRST EPISODE OF FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA; GOT SICK MORE"), MALAISE ("GOT SICK MORE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: CHANGES IN VISION"), PAIN ("ALL OVER PAIN"), FOOD INTOLERANCE ("FOOD INTOLARENCES"), URTICARIA ("RASHES OR SKIN CONDITIONS: HIVES"), FEELING ABNORMAL ("BRAIN FOG"), METAL POISONING ("HEAVY METAL TOXICITY") AND THE SECOND EPISODE OF FIBROMYALGIA ("FIBROMYALGIA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: MANY UPS AND DOWNS"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ALOPECIA WAS RESOLVING, THE ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, MALAISE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, VISUAL IMPAIRMENT, PAIN, FOOD INTOLERANCE, URTICARIA, FEELING ABNORMAL, MOOD SWINGS, DEPRESSION, DEPRESSED MOOD, FRUSTRATION TOLERANCE DECREASED, METAL POISONING AND THE LAST EPISODE OF FIBROMYALGIA OUTCOME WAS UNKNOWN AND THE FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, BLADDER DISORDER, DEPRESSED MOOD, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FOOD INTOLERANCE, FRUSTRATION TOLERANCE DECREASED, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MALAISE, MENORRHAGIA, METAL POISONING, MIGRAINE, MOOD SWINGS, NAUSEA, PAIN, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT, WEIGHT INCREASED, THE FIRST EPISODE OF FIBROMYALGIA AND THE SECOND EPISODE OF FIBROMYALGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. TRAILING COILS: LEFT 1, RIGHT 2. ATIENT TOLERATED PROCEDURE WELL. CURRENT WEIGHT 215 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2013: RESULTS: FAILURE TO OCCLUDE CLOSE) FALLOPIAN TUBES; IN (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2013: RESULTS: NEGATIVE. (B)(6) 2017 , PATHOLOGY: SPECIMEN: UTERUS, CERVIX AND BILATERAL TUBES PREOPERATIVE DIAGNOSIS: MENORRHAGIA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-MAY-2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/BEING IN PAIN ALL THE TIME/SHARP PAIN ON MY LEFT SIDE NEAR OVARY AREA") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A161942,) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HAD REACTIONS,"), FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA"), MALAISE ("GOT SICK MORE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: MANY UPS AND DOWNS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), NAUSEA ("NAUSEA,"), WEIGHT INCREASED ("TIRED ALL THE TIME WEIGHS ON YOUR DAY TO DAY/ WEIGHT GAIN"), FATIGUE ("TIRED ALL THE TIME/FATIGUE,"), ALOPECIA ("HAIR LOSS,"), VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: CHANGES IN VISION"), PAIN ("ALL OVER PAIN") AND FEEDING DISORDER ("FOOD INTOLERANCES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FIBROMYALGIA AND ALOPECIA WAS RESOLVING, THE ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, MALAISE, BLADDER DISORDER, URINARY TRACT DISORDER, DYSMENORRHOEA, DYSPAREUNIA, HORMONE LEVEL ABNORMAL, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NAUSEA, WEIGHT INCREASED, VISUAL IMPAIRMENT, PAIN AND FEEDING DISORDER OUTCOME WAS UNKNOWN AND THE FATIGUE HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEEDING DISORDER, FIBROMYALGIA, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MALAISE, MENORRHAGIA, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. TRAILING COILS: LEFT 1, RIGHT 2. PATIENT TOLERATED PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN JUNE 2013: FAILURE TO OCCLUDE CLOSE) FALLOPIAN TUBES; IN SEPTEMBER 2013: TOTAL BILATERAL OCCLUSION PREGNANCY TEST URINE - ON (B)(6) 2013: NEGATIVE ON (B)(6) 2017 , PATHOLOGY: SPECIMEN: UTERUS, CERVIX AND BILATERAL TUBES. PREOPERATIVE DIAGNOSIS: MENORRHAGIA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-JUN-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. EVENT ADDED AS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HAD REACTIONS, AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA; GOT SICK MORE, BLADDER OR URINARY PROBLEMS OR CHANGES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), HORMONAL CHANGES DESCRIBE: MANY UPS AND DOWNS, INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI, MIGRAINES / HEADACHES, NAUSEA, NICKEL ALLERGY, PAIN, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: BEING IN PAIN ALL THE TIME AND TIRED ALL THE TIME WEIGHS ON YOUR DAY TO DAY, VISION/EYE PROBLEMS TYPE: CHANGES IN VISION, FATIGUE, HAIR LOSS, WEIGHT GAIN. LOT NUMBER ADDED. RELEVANT LAB DATA 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 PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 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 |
|---|---|---|---|---|---|---|---|
| 889753 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A161942-NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | BREO ELLIPTA| BREO ELLIPTA| BREO ELLIPTA| CLARITIN| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS |