ESSURE
Report
- Report Number
- 2951250-2017-11106
- Event Type
- Injury
- Date Received
- December 26, 2017
- Report Date
- April 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
REPORT WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5032721) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 02-JUL-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND PERSISTENT PAIN/PAIN UNTL MY HYSTO"), COELIAC DISEASE ("POSSIBLE CELIAC DISEASE DUE TO CONSTANT MALABSORPTION OF VITAMINS B12, FOLIC ACID, AND IRON"), MYASTHENIA GRAVIS ("MYASTHENIA GRAVIS"), BASEDOW'S DISEASE ("LOW THYROID GRAVES DISEASE") AND AUTOIMMUNE THYROIDITIS ("HASHIMOTOS DISEASE") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: PATIENT-DEVICE INCOMPATIBILITY "COILS STATING THAT HE BELIEVED MY BODY WAS REJECTING THEM" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST \ SHE WAS NOT TOLD THAT SHE HAD TO HAVE A CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 ((B)(6) 1997, (B)(6) 1999 AND (B)(6) 2011), CHOLECYSTECTOMY (GALL STONES) IN 2006, CENTRAL LINE PLACEMENT (VEINS WERE COLLAPSING FROM CONSTANT USE FOR IVIG AND IV IRON INFUSIONS) IN 2014, STERNOTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016 AND THYMECTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY: NUVA RING FROM 2008 TO 2010. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY AND FEMALE CONDOM (MARRIAGE, PREGNANCIES). CONCOMITANT PRODUCTS INCLUDED SACCHARATED IRON OXIDE (VENOFER) SINCE 2008 FOR ANEMIA, ALPRAZOLAM (XANAX) FOR ANXIETY, GABAPENTIN FOR FIBROMYALGIA, SUMATRIPTAN SINCE (B)(6) 2012 FOR MIGRAINE, VICODIN (NORCO) SINCE 2015 FOR MYASTHENIA AND FIBROMYALGIA, IMMUNOGLOBULIN FOR MYASTHENIA GRAVIS AND IBUPROFEN (MOTRIN) SINCE (B)(6) 2011 FOR MYASTHENIA, HEADACHE AND FIBROMYALGIA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PAIN ("CONSTANT PAIN \ CONSTANT OVERALL BODY PAIN") AND MIGRAINE ("SEVERE/CHRONIC MIGRAINE"). ON (B)(6) 2013, 2 YEARS 4 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MYASTHENIA GRAVIS (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT) WITH NEUROMYOPATHY, MUSCULAR WEAKNESS, VISION BLURRED, DIPLOPIA AND MULTIFOCAL MOTOR NEUROPATHY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COELIAC DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE CRAMPING"), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH ANXIETY AND ALOPECIA, AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH WEIGHT INCREASED, SWELLING, FATIGUE AND DEPRESSION, POLLAKIURIA ("FREQUENT URINATION"), ANAEMIA ("ANEMIA"), HEADACHE ("SEVERE/CHRONIC HEADACHE"), FIBROMYALGIA ("FIBROMYALGIA") WITH ARTHRALGIA, ASTHENIA ("WEAKNESS"), TOOTH FRACTURE ("TOOTH BREAKAGE"), MENORRHAGIA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), DYSMENORRHOEA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), FUNGAL INFECTION ("YEAST INFECTIONS BURNING AND ITCHING") AND ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL") WITH RASH PRURITIC. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), NAUSEA ("NAUSEA") AND DRY MOUTH ("CONSTANT DRY MOUTH"). THE PATIENT WAS HOSPITALIZED SOMETIME IN (B)(6) 2017. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, MYASTHENIA GRAVIS, PAIN, POLLAKIURIA AND ANAEMIA HAD NOT RESOLVED, THE COELIAC DISEASE, ABDOMINAL PAIN, BASEDOW'S DISEASE, AUTOIMMUNE THYROIDITIS, MIGRAINE, HEADACHE, FIBROMYALGIA, ASTHENIA, MENORRHAGIA, DYSMENORRHOEA, FUNGAL INFECTION AND ALLERGY TO METALS OUTCOME WAS UNKNOWN, THE BACK PAIN OUTCOME WAS UNKNOWN AND THE NAUSEA AND DRY MOUTH HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ANAEMIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BASEDOW'S DISEASE, DRY MOUTH, MYASTHENIA GRAVIS, NAUSEA, PAIN AND POLLAKIURIA WITH ESSURE. THE REPORTER CONSIDERED ALLERGY TO METALS, ASTHENIA, COELIAC DISEASE, DYSMENORRHOEA, FIBROMYALGIA, FUNGAL INFECTION, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND TOOTH FRACTURE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE COIL IS IN PATIENT'S POSSESSION. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONCES WERE DESCRIBED IN PATIENT'S SOCIAL MEDIA: WEIGHT GAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5032721) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-MAR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE AND PERSISTENT PAIN/PAIN UNTL MY HYSTO'), COELIAC DISEASE ('POSSIBLE CELIAC DISEASE DUE TO CONSTANT MALABSORPTION OF VITAMINS B12, FOLIC ACID, AND IRON'), MYASTHENIA GRAVIS ('MYASTHENIA GRAVIS'), BASEDOW'S DISEASE ('LOW THYROID GRAVES DISEASE') AND AUTOIMMUNE THYROIDITIS ('HASHIMOTOS DISEASE') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: PATIENT-DEVICE INCOMPATIBILITY "COILS STATING THAT HE BELIEVED MY BODY WAS REJECTING THEM" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST \ SHE WAS NOT TOLD THAT SHE HAD TO HAVE A CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED STERNOTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016, THYMECTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016, CENTRAL LINE PLACEMENT (VEINS WERE COLLAPSING FROM CONSTANT USE FOR IVIG AND IV IRON INFUSIONS) IN 2014, CHOLECYSTECTOMY (GALL STONES) IN 2006 AND PARITY 3 ((B)(6) 1997, (B)(6) 1999 AND (B)(6) 2011). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY: NUVA RING FROM 2008 TO 2010. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY, FEMALE CONDOM (MARRIAGE, PREGNANCIES), UTERINE BLEEDING, CHRONIC ANEMIA, HASHIMOTO'S THYROIDITIS AND VAGINAL BLEEDING. CONCOMITANT PRODUCTS INCLUDED SACCHARATED IRON OXIDE (VENOFER) SINCE 2008 FOR ANEMIA, ALPRAZOLAM (XANAX) FOR ANXIETY, GABAPENTIN FOR FIBROMYALGIA AND MOTOR PERIPHERAL NEUROPATHY, SUMATRIPTAN SINCE (B)(6) 2012 FOR MIGRAINE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) SINCE 2015 FOR MYASTHENIA AND FIBROMYALGIA, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN) FOR MYASTHENIA GRAVIS AS WELL AS SINCE (B)(6) 2011. IN 2011, THE PATIENT EXPERIENCED PAIN ("CONSTANT PAIN \ CONSTANT OVERALL BODY PAIN") AND MIGRAINE ("SEVERE/CHRONIC MIGRAINE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MYASTHENIA GRAVIS (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT) WITH NEUROMYOPATHY, MUSCULAR WEAKNESS, VISION BLURRED, DIPLOPIA AND MULTIFOCAL MOTOR NEUROPATHY, 2 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COELIAC DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE CRAMPING"), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH ANXIETY AND ALOPECIA, AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH WEIGHT INCREASED, SWELLING, FATIGUE AND DEPRESSION, NAUSEA ("NAUSEA"), DRY MOUTH ("CONSTANT DRY MOUTH"), POLLAKIURIA ("FREQUENT URINATION"), ANAEMIA ("ANEMIA"), HEADACHE ("SEVERE/CHRONIC HEADACHE"), FIBROMYALGIA ("FIBROMYALGIA") WITH ARTHRALGIA, ASTHENIA ("WEAKNESS"), TOOTH FRACTURE ("TOOTH BREAKAGE"), MENORRHAGIA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), DYSMENORRHOEA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), FUNGAL INFECTION ("YEAST INFECTIONS BURNING AND ITCHING"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL") WITH RASH PRURITIC, COLD SWEAT ("COLD SWEAT") AND INSOMNIA ("INSOMNIA") AND EXPERIENCED BACK PAIN ("BACK PAIN"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2017. THE PATIENT WAS TREATED WITH TOPIRAMATE (TOPAMAX), SURGERY (HYSTERECTOMY) AND AT THE TIME OF THE REPORT, THE PELVIC PAIN, MYASTHENIA GRAVIS, PAIN, NAUSEA, DRY MOUTH, POLLAKIURIA AND ANAEMIA HAD NOT RESOLVED, THE COELIAC DISEASE, ABDOMINAL PAIN, BASEDOW'S DISEASE, AUTOIMMUNE THYROIDITIS, MIGRAINE, HEADACHE, FIBROMYALGIA, ASTHENIA, MENORRHAGIA, DYSMENORRHOEA, FUNGAL INFECTION, ALLERGY TO METALS, COLD SWEAT AND INSOMNIA OUTCOME WAS UNKNOWN AND THE BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, ASTHENIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BASEDOW'S DISEASE, COELIAC DISEASE, COLD SWEAT, DRY MOUTH, DYSMENORRHOEA, FIBROMYALGIA, FUNGAL INFECTION, HEADACHE, INSOMNIA, MENORRHAGIA, MIGRAINE, MYASTHENIA GRAVIS, NAUSEA, PAIN, PELVIC PAIN, POLLAKIURIA AND TOOTH FRACTURE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE COIL IS IN PATIENT'S POSSESSION . TRAILING COILS LEFT 2 AND RIGHT 1. DISCREPANCY IN ESSURE IMPLANT DATE (B)(6) AND (B)(6). HAIR GROWN BACK WAS REPORTED. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONCES WERE DESCRIBED IN PATIENT'S SOCIAL MEDIA: WEIGHT GAIN, DYSMENORRHEA, HASHIMOTO'S THYROIDITIS, DYSPAREUNIA, MYASTHENIA GRAVIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: CONTENT FROM SOCIAL MEDIA RECEIVED. INSOMNIA & COLD SWEAT WERE REPORTED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5032721) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-MAR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE AND PERSISTENT PAIN/PAIN UNTL MY HYSTO'), DEVICE BREAKAGE ('BREAKAGE'), COELIAC DISEASE ('POSSIBLE CELIAC DISEASE DUE TO CONSTANT MALABSORPTION OF VITAMINS B12, FOLIC ACID, AND IRON'), MYASTHENIA GRAVIS ('MYASTHENIA GRAVIS'), BASEDOW'S DISEASE ('LOW THYROID GRAVES DISEASE') AND AUTOIMMUNE THYROIDITIS ('HASHIMOTOS DISEASE') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) 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 "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST \ SHE WAS NOT TOLD THAT SHE HAD TO HAVE A CONFIRMATION TEST" AND PATIENT-DEVICE INCOMPATIBILITY "COILS STATING THAT HE BELIEVED MY BODY WAS REJECTING THEM". THE PATIENT'S MEDICAL HISTORY INCLUDED STERNOTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016 THYMECTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016 CENTRAL LINE PLACEMENT (VEINS WERE COLLAPSING FROM CONSTANT USE FOR IVIG AND IV IRON INFUSIONS) IN 2014, CHOLECYSTECTOMY (GALL STONES) IN 2006 AND PARITY 3 ((B)(6) 2016 1997, (B)(6) 2016 1999 AND (B)(6) 2016 2011). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY: NUVA RING FROM 2008 TO 2010. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY, FEMALE CONDOM (MARRIAGE, PREGNANCIES), UTERINE BLEEDING, CHRONIC ANEMIA, HASHIMOTO'S THYROIDITIS AND VAGINAL BLEEDING. CONCOMITANT PRODUCTS INCLUDED SACCHARATED IRON OXIDE (VENOFER) SINCE 2008 FOR ANEMIA, ALPRAZOLAM (XANAX) FOR ANXIETY, GABAPENTIN FOR FIBROMYALGIA AND MOTOR PERIPHERAL NEUROPATHY, SUMATRIPTAN SINCE (B)(6) 2012 FOR MIGRAINE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) SINCE 2015 FOR MYASTHENIA AND FIBROMYALGIA, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN) FOR MYASTHENIA GRAVIS AS WELL AS SINCE (B)(6) 2011. IN 2011, THE PATIENT EXPERIENCED PAIN ("CONSTANT PAIN \ CONSTANT OVERALL BODY PAIN") AND MIGRAINE ("SEVERE/CHRONIC MIGRAINE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MYASTHENIA GRAVIS (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT) WITH NEUROMYOPATHY, MUSCULAR WEAKNESS, VISION BLURRED, DIPLOPIA AND MULTIFOCAL MOTOR NEUROPATHY, 2 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION ("COIL MIGRATION"), COELIAC DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE CRAMPING"), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH ANXIETY AND ALOPECIA, AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH WEIGHT INCREASED, SWELLING, FATIGUE AND DEPRESSION, NAUSEA ("NAUSEA"), DRY MOUTH ("CONSTANT DRY MOUTH"), POLLAKIURIA ("FREQUENT URINATION"), ANAEMIA ("ANEMIA"), HEADACHE ("SEVERE/CHRONIC HEADACHE"), FIBROMYALGIA ("FIBROMYALGIA") WITH ARTHRALGIA, ASTHENIA ("WEAKNESS"), TOOTH FRACTURE ("TOOTH BREAKAGE"), MENORRHAGIA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), DYSMENORRHOEA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), FUNGAL INFECTION ("YEAST INFECTIONS BURNING AND ITCHING"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL") WITH RASH PRURITIC, COLD SWEAT ("COLD SWEAT"), INSOMNIA ("INSOMNIA"), DENTAL CARIES ("TOOTH DECAY"), GENITAL HAEMORRHAGE ("BLEEDING") AND DISABILITY ("DISABILITY") AND EXPERIENCED BACK PAIN ("BACK PAIN"). THE PATIENT WAS HOSPITALIZED ON MAY 2017. THE PATIENT WAS TREATED WITH TOPIRAMATE (TOPAMAX), , , SURGERY (HYSTERECTOMY), AND . AT THE TIME OF THE REPORT, THE PELVIC PAIN, MYASTHENIA GRAVIS, PAIN, NAUSEA, DRY MOUTH, POLLAKIURIA AND ANAEMIA HAD NOT RESOLVED, THE DEVICE BREAKAGE, DEVICE DISLOCATION, COELIAC DISEASE, ABDOMINAL PAIN, BASEDOW'S DISEASE, AUTOIMMUNE THYROIDITIS, MIGRAINE, HEADACHE, FIBROMYALGIA, ASTHENIA, MENORRHAGIA, DYSMENORRHOEA, FUNGAL INFECTION, ALLERGY TO METALS, COLD SWEAT, INSOMNIA, DENTAL CARIES, GENITAL HAEMORRHAGE AND DISABILITY OUTCOME WAS UNKNOWN AND THE BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, ASTHENIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BASEDOW'S DISEASE, COELIAC DISEASE, COLD SWEAT, DENTAL CARIES, DEVICE BREAKAGE, DEVICE DISLOCATION, DISABILITY, DRY MOUTH, DYSMENORRHOEA, FIBROMYALGIA, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, INSOMNIA, MENORRHAGIA, MIGRAINE, MYASTHENIA GRAVIS, NAUSEA, PAIN, PELVIC PAIN, POLLAKIURIA AND TOOTH FRACTURE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE COIL IS IN PATIENT'S POSSESSION . TRAILING COILS LEFT 2 AND RIGHT 1. DISCREPANCY IN ESSURE IMPLANT DATE (B)(6) HAIR GROWN BACK WAS REPORTED, CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONCES WERE DESCRIBED IN PATIENT'S SOCIAL MEDIA: WEIGHT GAIN, DYSMENORRHEA, HASHIMOTO'S THYROIDITIS, DYSPAREUNIA, MYASTHENIA GRAVIS, TOOTH DECAY, DEVICE DISLOCATION, DISABILITY, GENITAL BLEEDING, DEVICE BREAKAGE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA CONTENT FROM PFS RECEIVED: EVENTS BREAKAGE, TOOTH DECAY, BLEEDING, COIL MIGRATION WERE ADDED. REPORTER ADDED. ON 20-MAR-2020: FU17 AND 18 PROCESSED TOGETHER. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5032721) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 24-APR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BREAKAGE'), DEVICE DISLOCATION ('COIL MIGRATION'), PELVIC PAIN ('SEVERE AND PERSISTENT PAIN/PAIN UNTL MY HYSTO'), MYASTHENIA GRAVIS ('MYASTHENIA GRAVIS'), BASEDOW'S DISEASE ('LOW THYROID GRAVES DISEASE') AND AUTOIMMUNE THYROIDITIS ('HASHIMOTOS DISEASE') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) 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 "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST \ SHE WAS NOT TOLD THAT SHE HAD TO HAVE A CONFIRMATION TEST" AND PATIENT-DEVICE INCOMPATIBILITY "COILS STATING THAT HE BELIEVED MY BODY WAS REJECTING THEM". THE PATIENT'S MEDICAL HISTORY INCLUDED STERNOTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016, THYMECTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016, CENTRAL LINE PLACEMENT (VEINS WERE COLLAPSING FROM CONSTANT USE FOR IVIG AND IV IRON INFUSIONS) IN 2014, CHOLECYSTECTOMY (GALL STONES) IN 2006 AND PARITY 3 ((B)(6) 1997, (B)(6) 1999 AND (B)(6) 2011). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY: NUVA RING FROM 2008 TO 2010. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY, FEMALE CONDOM (MARRIAGE, PREGNANCIES), UTERINE BLEEDING, CHRONIC ANEMIA, HASHIMOTO'S THYROIDITIS AND VAGINAL BLEEDING. CONCOMITANT PRODUCTS INCLUDED SACCHARATED IRON OXIDE (VENOFER) SINCE 2008 FOR ANEMIA, ALPRAZOLAM (XANAX) FOR ANXIETY, GABAPENTIN FOR FIBROMYALGIA AND MOTOR PERIPHERAL NEUROPATHY, SUMATRIPTAN SINCE (B)(6) 2012 FOR MIGRAINE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) SINCE 2015 FOR MYASTHENIA AND FIBROMYALGIA, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN) FOR MYASTHENIA GRAVIS AS WELL AS SINCE (B)(6) 2011. IN 2011, THE PATIENT EXPERIENCED PAIN ("CONSTANT PAIN \ CONSTANT OVERALL BODY PAIN") AND MIGRAINE ("SEVERE/CHRONIC MIGRAINE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MYASTHENIA GRAVIS (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT) WITH NEUROMYOPATHY, MUSCULAR WEAKNESS, VISION BLURRED, DIPLOPIA AND MULTIFOCAL MOTOR NEUROPATHY, 2 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COELIAC DISEASE ("POSSIBLE CELIAC DISEASE DUE TO CONSTANT MALABSORPTION OF VITAMINS B12, FOLIC ACID, AND IRON"), ABDOMINAL PAIN ("SEVERE CRAMPING"), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH ANXIETY AND ALOPECIA, AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH WEIGHT INCREASED, SWELLING, FATIGUE AND DEPRESSION, NAUSEA ("NAUSEA"), DRY MOUTH ("CONSTANT DRY MOUTH"), POLLAKIURIA ("FREQUENT URINATION"), ANAEMIA ("ANEMIA"), HEADACHE ("SEVERE/CHRONIC HEADACHE"), FIBROMYALGIA ("FIBROMYALGIA") WITH ARTHRALGIA, ASTHENIA ("WEAKNESS"), TOOTH FRACTURE ("TOOTH BREAKAGE"), MENORRHAGIA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), DYSMENORRHOEA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), FUNGAL INFECTION ("YEAST INFECTIONS BURNING AND ITCHING"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL") WITH RASH PRURITIC, COLD SWEAT ("COLD SWEAT"), INSOMNIA ("INSOMNIA"), DENTAL CARIES ("TOOTH DECAY"), GENITAL HAEMORRHAGE ("BLEEDING"), DISABILITY ("DISABILITY"), DRY EYE ("DRY EYES"), MUSCULOSKELETAL PAIN ("PAIN IN BUTT"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE"), GASTRIC DISORDER ("MAKE ME SICK TO MY STOMACH") AND VOMITING ("VOMITED") AND EXPERIENCED BACK PAIN ("BACK PAIN"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2017. THE PATIENT WAS TREATED WITH TOPIRAMATE (TOPAMAX), , , SURGERY (HYSTERECTOMY), AND . AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, COELIAC DISEASE, ABDOMINAL PAIN, BASEDOW'S DISEASE, AUTOIMMUNE THYROIDITIS, MIGRAINE, HEADACHE, FIBROMYALGIA, ASTHENIA, MENORRHAGIA, DYSMENORRHOEA, FUNGAL INFECTION, ALLERGY TO METALS, COLD SWEAT, INSOMNIA, DENTAL CARIES, GENITAL HAEMORRHAGE, DISABILITY, DRY EYE, MUSCULOSKELETAL PAIN, AUTOIMMUNE DISORDER, GASTRIC DISORDER AND VOMITING OUTCOME WAS UNKNOWN, THE PELVIC PAIN, MYASTHENIA GRAVIS, PAIN, NAUSEA, DRY MOUTH, POLLAKIURIA AND ANAEMIA HAD NOT RESOLVED AND THE BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, ASTHENIA, AUTOIMMUNE DISORDER, AUTOIMMUNE THYROIDITIS, BACK PAIN, BASEDOW'S DISEASE, COELIAC DISEASE, COLD SWEAT, DENTAL CARIES, DEVICE BREAKAGE, DEVICE DISLOCATION, DISABILITY, DRY EYE, DRY MOUTH, DYSMENORRHOEA, FIBROMYALGIA, FUNGAL INFECTION, GASTRIC DISORDER, GENITAL HAEMORRHAGE, HEADACHE, INSOMNIA, MENORRHAGIA, MIGRAINE, MUSCULOSKELETAL PAIN, MYASTHENIA GRAVIS, NAUSEA, PAIN, PELVIC PAIN, POLLAKIURIA, TOOTH FRACTURE AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE COIL IS IN PATIENT'S POSSESSION . TRAILING COILS LEFT 2 AND RIGHT 1. DISCREPANCY IN ESSURE IMPLANT DATE 26 NOV AND 23-NOV. HAIR GROWN BACK WAS REPORTED. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONCES WERE DESCRIBED IN PATIENT'S SOCIAL MEDIA: WEIGHT GAIN, DYSMENORRHEA, HASHIMOTO'S THYROIDITIS, DYSPAREUNIA, MYASTHENIA GRAVIS, TOOTH DECAY, DEVICE DISLOCATION, DISABILITY, GENITAL BLEEDING, DEVICE BREAKAGE LOT NUMBER: 822374 MANUFACTURING DATE: 2011-01 EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-APR-2020: QUALITY-SAFETY EVALUATION OF PTC. ON 23-MAR-2020: INFORMATION FROM SOCIAL MEDIA WAS RECEIVED: NEW REPORTER AND NEW EVENTS WERE ADDED ( AUTOIMMUNE DISORDER, GASTRIC DISORDER AND VOMITING ) FU23+24 PROCESSED TOGETHER. WE RECEIVED A LOT NUMBER IN THIS CASE. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5032721) ON (B)(6) 2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 23-MAR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BREAKAGE'), DEVICE DISLOCATION ('COIL MIGRATION'), PELVIC PAIN ('SEVERE AND PERSISTENT PAIN/PAIN UNTL MY HYSTO'), MYASTHENIA GRAVIS ('MYASTHENIA GRAVIS'), BASEDOW'S DISEASE ('LOW THYROID GRAVES DISEASE') AND AUTOIMMUNE THYROIDITIS ('HASHIMOTOS DISEASE') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) 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 "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST \ SHE WAS NOT TOLD THAT SHE HAD TO HAVE A CONFIRMATION TEST" AND PATIENT-DEVICE INCOMPATIBILITY "COILS STATING THAT HE BELIEVED MY BODY WAS REJECTING THEM". THE PATIENT'S MEDICAL HISTORY INCLUDED STERNOTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016, THYMECTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016, CENTRAL LINE PLACEMENT (VEINS WERE COLLAPSING FROM CONSTANT USE FOR IVIG AND IV IRON INFUSIONS) IN 2014, CHOLECYSTECTOMY (GALL STONES) IN 2006 AND PARITY 3 ((B)(6) 1997, (B)(6) 1999 AND (B)(6) 2011). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY: NUVA RING FROM 2008 TO 2010. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY, FEMALE CONDOM (MARRIAGE, PREGNANCIES), UTERINE BLEEDING, CHRONIC ANEMIA, HASHIMOTO'S THYROIDITIS AND VAGINAL BLEEDING. CONCOMITANT PRODUCTS INCLUDED SACCHARATED IRON OXIDE (VENOFER) SINCE 2008 FOR ANEMIA, ALPRAZOLAM (XANAX) FOR ANXIETY, GABAPENTIN FOR FIBROMYALGIA AND MOTOR PERIPHERAL NEUROPATHY, SUMATRIPTAN SINCE (B)(6) 2012 FOR MIGRAINE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) SINCE 2015 FOR MYASTHENIA AND FIBROMYALGIA, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN) FOR MYASTHENIA GRAVIS AS WELL AS SINCE (B)(6) 2011. IN 2011, THE PATIENT EXPERIENCED PAIN ("CONSTANT PAIN \ CONSTANT OVERALL BODY PAIN") AND MIGRAINE ("SEVERE/CHRONIC MIGRAINE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MYASTHENIA GRAVIS (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT) WITH NEUROMYOPATHY, MUSCULAR WEAKNESS, VISION BLURRED, DIPLOPIA AND MULTIFOCAL MOTOR NEUROPATHY, 2 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COELIAC DISEASE ("POSSIBLE CELIAC DISEASE DUE TO CONSTANT MALABSORPTION OF VITAMINS B12, FOLIC ACID, AND IRON"), ABDOMINAL PAIN ("SEVERE CRAMPING"), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH ANXIETY AND ALOPECIA, AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH WEIGHT INCREASED, SWELLING, FATIGUE AND DEPRESSION, NAUSEA ("NAUSEA"), DRY MOUTH ("CONSTANT DRY MOUTH"), POLLAKIURIA ("FREQUENT URINATION"), ANAEMIA ("ANEMIA"), HEADACHE ("SEVERE/CHRONIC HEADACHE"), FIBROMYALGIA ("FIBROMYALGIA") WITH ARTHRALGIA, ASTHENIA ("WEAKNESS"), TOOTH FRACTURE ("TOOTH BREAKAGE"), MENORRHAGIA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), DYSMENORRHOEA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), FUNGAL INFECTION ("YEAST INFECTIONS BURNING AND ITCHING"), ALLERGY TO METALS ("HYPERSENSITIVITY REACTION TO NICKEL") WITH RASH PRURITIC, COLD SWEAT ("COLD SWEAT"), INSOMNIA ("INSOMNIA"), DENTAL CARIES ("TOOTH DECAY"), GENITAL HAEMORRHAGE ("BLEEDING"), DISABILITY ("DISABILITY"), DRY EYE ("DRY EYES") AND MUSCULOSKELETAL PAIN ("PAIN IN BUTT") AND EXPERIENCED BACK PAIN ("BACK PAIN"). THE PATIENT WAS HOSPITALIZED ON (B)(6) 2017. THE PATIENT WAS TREATED WITH TOPIRAMATE (TOPAMAX), , , SURGERY (HYSTERECTOMY), AND . AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, COELIAC DISEASE, ABDOMINAL PAIN, BASEDOW'S DISEASE, AUTOIMMUNE THYROIDITIS, MIGRAINE, HEADACHE, FIBROMYALGIA, ASTHENIA, MENORRHAGIA, DYSMENORRHOEA, FUNGAL INFECTION, ALLERGY TO METALS, COLD SWEAT, INSOMNIA, DENTAL CARIES, GENITAL HAEMORRHAGE, DISABILITY, DRY EYE AND MUSCULOSKELETAL PAIN OUTCOME WAS UNKNOWN, THE PELVIC PAIN, MYASTHENIA GRAVIS, PAIN, NAUSEA, DRY MOUTH, POLLAKIURIA AND ANAEMIA HAD NOT RESOLVED AND THE BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, ASTHENIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BASEDOW'S DISEASE, COELIAC DISEASE, COLD SWEAT, DENTAL CARIES, DEVICE BREAKAGE, DEVICE DISLOCATION, DISABILITY, DRY EYE, DRY MOUTH, DYSMENORRHOEA, FIBROMYALGIA, FUNGAL INFECTION, GENITAL HAEMORRHAGE, HEADACHE, INSOMNIA, MENORRHAGIA, MIGRAINE, MUSCULOSKELETAL PAIN, MYASTHENIA GRAVIS, NAUSEA, PAIN, PELVIC PAIN, POLLAKIURIA AND TOOTH FRACTURE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE COIL IS IN PATIENT'S POSSESSION . TRAILING COILS LEFT 2 AND RIGHT 1. DISCREPANCY IN ESSURE IMPLANT DATE (B)(6) AND (B)(6). HAIR GROWN BACK WAS REPORTED, CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONCE'S WERE DESCRIBED IN PATIENT'S SOCIAL MEDIA: WEIGHT GAIN, DYSMENORRHEA, HASHIMOTO'S THYROIDITIS, DYSPAREUNIA, MYASTHENIA GRAVIS, TOOTH DECAY, DEVICE DISLOCATION, DISABILITY, GENITAL BLEEDING, DEVICE BREAKAGE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. REPORTER ADDED. EVENT DRY EYES, PAIN IN BUTT ADDED. ON 23-MAR-2020: REPORTER INFORMATION WERE UPDATED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY FOOD AND DRUG ADMINISTRATION (REFERENCE NUMBER: MW5032721) ON 13-JAN-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-NOV-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND PERSISTENT PAIN"), COELIAC DISEASE ("POSSIBLE CELIAC DISEASE DUE TO CONSTANT MALABSORPTION OF VITAMINS B12, FOLIC ACID, AND IRON"), MYASTHENIA GRAVIS ("MYASTHENIA GRAVIS"), BASEDOW'S DISEASE ("LOW THYROID GRAVES DISEASE") AND AUTOIMMUNE THYROIDITIS ("HASHIMOTOS DISEASE") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) 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 "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST \ SHE WAS NOT TOLD THAT SHE HAD TO HAVE A CONFIRMATION TEST" AND PATIENT-DEVICE INCOMPATIBILITY "COILS STATING THAT HE BELIEVED MY BODY WAS REJECTING THEM". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 ((B)(6)), CHOLECYSTECTOMY (GALL STONES) IN 2006, CENTRAL LINE PLACEMENT (VEINS WERE COLLAPSING FROM CONSTANT USE FOR IVIG AND IV IRON INFUSIONS) IN 2014, STERNOTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016 AND THYMECTOMY (IN HOPES OF REDUCING OR ELIMINATING SYMPTOMS OF MYASTHENIA GRAVIS) ON (B)(6) 2016. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY: NUVA RING FROM 2008 TO 2010. CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY AND CONDOM (MARRIAGE, PREGNANCIES). CONCOMITANT PRODUCTS INCLUDED SACCHARATED IRON OXIDE (VENOFER) IN 2008 FOR ANEMIA, SUMATRIPTAN IN (B)(6) 2012 FOR MIGRAINE, VICODIN (NORCO) IN 2015 FOR MYASTHENIA AND FIBROMYALGIA, IMMUNOGLOBULIN FOR MYASTHENIA GRAVIS AND IBUPROFEN (MOTRIN) IN (B)(6) 2011 FOR MYASTHENIA, HEADACHE AND FIBROMYALGIA. GABAPENTIN FOR FIBROMYALGIA. ALPRAZOLAM (XANAX) FOR ANXIETY IN 2011, 8 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED PAIN ("CONSTANT PAIN \ CONSTANT OVERALL BODY PAIN") AND MIGRAINE ("SEVERE/CHRONIC MIGRAINE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MYASTHENIA GRAVIS (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT) WITH NEUROMYOPATHY, MUSCULAR WEAKNESS, VISION BLURRED, DIPLOPIA AND MULTIFOCAL MOTOR NEUROPATHY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COELIAC DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE CRAMPING"), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH ANXIETY AND ALOPECIA, AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH WEIGHT INCREASED, SWELLING, FATIGUE AND DEPRESSION, POLLAKIURIA ("FREQUENT URINATION"), ANAEMIA ("ANEMIA"), HEADACHE ("SEVERE/CHRONIC HEADACHE"), FIBROMYALGIA ("FIBROMYALGIA") WITH ARTHRALGIA, ASTHENIA ("WEAKNESS"), TOOTH FRACTURE ("TOOTH BREAKAGE"), MENORRHAGIA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), DYSMENORRHOEA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), FUNGAL INFECTION ("YEAST INFECTIONS BURNING AND ITCHING") AND HYPERSENSITIVITY ("HYPERSENSITIVITY REACTION TO NICKEL") WITH RASH. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), NAUSEA ("NAUSEA") AND DRY MOUTH ("CONSTANT DRY MOUTH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COELIAC DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("SEVERE CRAMPING"), BASEDOW'S DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH ANXIETY AND ALOPECIA, AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH WEIGHT INCREASED, SWELLING, FATIGUE AND DEPRESSION, POLLAKIURIA ("FREQUENT URINATION"), ANAEMIA ("ANEMIA"), HEADACHE ("SEVERE/CHRONIC HEADACHE"), FIBROMYALGIA ("FIBROMYALGIA") WITH ARTHRALGIA, ASTHENIA ("WEAKNESS"), TOOTH FRACTURE ("TOOTH BREAKAGE"), MENORRHAGIA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), DYSMENORRHOEA ("HEAVY PAINFUL NEVER ENDING MENSTRUAL CYCLE"), FUNGAL INFECTION ("YEAST INFECTIONS BURNING AND ITCHING") AND HYPERSENSITIVITY ("HYPERSENSITIVITY REACTION TO NICKEL") WITH RASH. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN"), NAUSEA ("NAUSEA") AND DRY MOUTH ("CONSTANT DRY MOUTH"). THE PATIENT WAS HOSPITALIZED SOMETIME IN (B)(6) 2017. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, MYASTHENIA GRAVIS, PAIN, POLLAKIURIA AND ANAEMIA HAD NOT RESOLVED, THE COELIAC DISEASE, ABDOMINAL PAIN, BASEDOW'S DISEASE, AUTOIMMUNE THYROIDITIS, MIGRAINE, HEADACHE, FIBROMYALGIA, ASTHENIA, MENORRHAGIA, DYSMENORRHOEA, FUNGAL INFECTION AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN, THE BACK PAIN OUTCOME WAS UNKNOWN AND THE NAUSEA AND DRY MOUTH HAD NOT RESOLVED. THE REPORTER CONSIDERED ASTHENIA, COELIAC DISEASE, DYSMENORRHOEA, FIBROMYALGIA, FUNGAL INFECTION, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND TOOTH FRACTURE TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ANAEMIA, AUTOIMMUNE THYROIDITIS, BACK PAIN, BASEDOW'S DISEASE, DRY MOUTH, MYASTHENIA GRAVIS, NAUSEA, PAIN AND POLLAKIURIA WITH ESSURE. THE REPORTER COMMENTED: ONE COIL IS IN PATIENT'S POSSESSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-NOV-2017: CASE BECAME INCIDENT IN THE FOLLOW UP. REPORTER ADDED, PATIENT'S MEDICAL AND CONCOMITANT HISTORY ADDED, CONCOMITANT DRUG AND HISTORICAL DRUG ADDED.LOT NUMBER UPDATED.EVNTS ADDED AS FOLLOWS:-PELVIC PAIN,MIGRAIN,HEADACHE,FIBROMYALGIA,ASTHENIA,MILTIFOCAL MOTOR NEUROPATHY,RASH(SYMPTOM),TOOTH FRACTURE,COELIAC DISEASE,PATIENT-DEVICE INCOMPATIBILITY,ARTHALGIA,DEVICE MONITORING PROCEDURE NOT PERFORMED, MENORRHAGIA,DYSMENORRHAGIA,FUNGAL INFECTION,HYPERSENSITIVITY. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 924579 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization| O| R | GABAPENTIN| GABAPENTIN| GABAPENTIN| GABAPENTIN| GABAPENTIN| GABAPENTIN| IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]| IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]| IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]| IMMUNOGLOBULIN [IMMUNOGLOBULINS NOS]| IMMUNOGLOBULIN [IMMUNOGLOBULIN]| IMMUNOGLOBULIN [IMMUNOGLOBULIN]| MOTRIN| MOTRIN| NORCO| NORCO| NORCO| NORCO| NORCO| NORCO| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| VENOFER| VENOFER| VENOFER| VENOFER| VENOFER| VENOFER| XANAX| XANAX| XANAX| XANAX| XANAX| XANAX| GABAPENTIN| IMMUNOGLOBULIN [IMMUNOGLOBULIN]| MOTRIN| NORCO| SUMATRIPTAN| VENOFER| XANAX |