ESSURE
Report
- Report Number
- 2951250-2017-02605
- Event Type
- Injury
- Date Received
- July 20, 2017
- Date of Event
- January 1, 2012
- Report Date
- August 20, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") AND PSORIATIC ARTHROPATHY ("PSORIATIC ARTHRITIS") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HYPERTENSION SINCE 2009, HYPOTHYROIDISM SINCE 1999 AND SYNCOPE. CONCOMITANT PRODUCTS INCLUDED ETONOGESTREL (IMPLANON) FROM SEPTEMBER 2009 TO OCTOBER 2011 FOR BIRTH CONTROL AS WELL AS ADALIMUMAB FROM NOVEMBER 2015 TO MARCH 2016, ALPRAZOLAM SINCE NOVEMBER 2012, AMITRIPTYLINE FROM JUNE 2014 TO JANUARY 2016, AMLODIPINE FROM AUGUST 2015 TO JULY 2016, BUPROPION FROM MARCH 2012 TO MARCH 2017, CALCIUM CITRATE (CALCITRATE) FROM NOVEMBER 2015 TO MARCH 2016, CEFALEXIN (CEPHALEXIN) FROM NOVEMBER 2015 TO DECEMBER 2015, CITALOPRAM HYDROBROMIDE (CELEXA) FROM NOVEMBER 2012 TO OCTOBER 2013, COLECALCIFEROL (VITAMIN D) SINCE JUNE 2011, CYCLOBENZAPRINE FROM MAY 2014 TO JULY 2014, DOCUSATE SODIUM (DOC-Q-LACE) FROM OCTOBER 2014 TO JANUARY 2016, FOLIC ACID FROM JUNE 2015 TO APRIL 2016, HYDROCHLOROTHIAZIDE SINCE MARCH 2011, HYDROCODONE FROM MAY 2015 TO JUNE 2015, LEVOTHYROXINE FROM MARCH 2010 TO JUNE 2014, LISINOPRIL SINCE FEBRUARY 2011, METHOTREXATE FROM JUNE 2010 TO JULY 2016, METRONIDAZOLE (METROGEL) FROM MAY 2010 TO NOVEMBER 2010, NAPROXEN FROM OCTOBER 2010 TO NOVEMBER 2010, OMEPRAZOLE FROM FEBRUARY 2015 TO APRIL 2015, PHENTERMINE SINCE MARCH 2011 TO 2012, PREDNISONE FROM MAY 2015 TO JUNE 2015, SALBUTAMOL SULFATE (ALBUTEROL SULFATE) FROM NOVEMBER 2010 TO JANUARY 2016, SUMATRIPTAN FROM MAY 2015 TO NOVEMBER 2016, TRAZODONE HYDROCHLORIDE (DESYREL) FROM AUGUST 2014 TO MARCH 2017, VALACICLOVIR HYDROCHLORIDE (VALTREX) FROM APRIL 2011 TO JULY 2016 AND VENLAFAXINE FROM JULY 2014 TO JANUARY 2015. ON 24-OCT-2011, THE PATIENT HAD ESSURE INSERTED. ON 28-DEC-2011, 2 MONTHS 5 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED RASH ("RASHES"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), THE FIRST EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), HEADACHE ("HEADACHES"), NECK PAIN ("CERVICALGIA") AND THE FIRST EPISODE OF INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"). IN 2012, THE PATIENT EXPERIENCED UTERINE PAIN ("UTERINE PAIN"). IN NOVEMBER 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN 2013, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PSORIATIC ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), GASTROINTESTINAL MOTILITY DISORDER ("INCOMPLETE DEFECATION") AND IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"). IN OCTOBER 2014, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON 23-OCT-2014, THE PATIENT EXPERIENCED DYSPHONIA ("DYSPHONIA") AND CRANIAL NERVE INJURY ("NERVE DAMAGE TO VOCAL CHORDS"). IN 2015, THE PATIENT EXPERIENCED PSEUDARTHROSIS ("PSEUDOARTHROSIS OF CERVIAL SPINE"). ON 1-DEC-2015, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS/ INFLAMMATORY ARTHIRITIS"). IN 2016, THE PATIENT EXPERIENCED ANAEMIA ("ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE SECOND EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), THE SECOND EPISODE OF INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), BACK PAIN ("LOWER BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), INTRAOCULAR PRESSURE INCREASED ("VISION/EYE PROBLEMS TYPE: INCREASED INTRAOCULAR PRESSURE (VARIATION OF GLAUCOMA)"), WEIGHT INCREASED ("WEIGHT GAIN"), DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"), POST-TRAUMATIC STRESS DISORDER ("PTSD"), MENTAL DISORDER ("WORSENED PSYCHIATRIC ISSUES"), ARTHRALGIA ("JOINT PAIN"), PAIN ("SOFT TISSUE PAIN") AND PSORIASIS ("PSORIASIS"). THE PATIENT WAS TREATED WITH SURGERY (A LAPAROTOMIC REMOVAL OF BILATERAL ESSURE DEVICES). ESSURE WAS REMOVED ON 2-DEC-2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, UTERINE PAIN, RASH, ARTHRITIS, MIGRAINE, THE LAST EPISODE OF INTERVERTEBRAL DISC DEGENERATION, HEADACHE, PSEUDARTHROSIS, NECK PAIN, URINARY INCONTINENCE, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, IRRITABLE BOWEL SYNDROME, ALLERGY TO METALS, DEPRESSION, ANXIETY, INTRAOCULAR PRESSURE INCREASED, ANAEMIA, DEVICE EXPULSION, POST-TRAUMATIC STRESS DISORDER, DYSPHONIA, CRANIAL NERVE INJURY, MENTAL DISORDER AND ARTHRALGIA OUTCOME WAS UNKNOWN AND THE LAST EPISODE OF FIBROMYALGIA, RHEUMATOID ARTHRITIS, PSORIATIC ARTHROPATHY, BACK PAIN, WEIGHT INCREASED AND PSORIASIS HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ANAEMIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, CRANIAL NERVE INJURY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPHONIA, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, HEADACHE, INTRAOCULAR PRESSURE INCREASED, IRRITABLE BOWEL SYNDROME, MENTAL DISORDER, MIGRAINE, NECK PAIN, PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PSEUDARTHROSIS, PSORIASIS, PSORIATIC ARTHROPATHY, RASH, RHEUMATOID ARTHRITIS, URINARY INCONTINENCE, UTERINE PAIN, WEIGHT INCREASED, THE FIRST EPISODE OF FIBROMYALGIA, THE FIRST EPISODE OF INTERVERTEBRAL DISC DEGENERATION, THE SECOND EPISODE OF FIBROMYALGIA AND THE SECOND EPISODE OF INTERVERTEBRAL DISC DEGENERATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. ON 01-FEB-2012, HYSTEROSALPINGOGRAM TEST CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. CURRENT WEIGHT 195 LBS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: REPORTERS ADDED AND UPDATED PATIENT DEMOGRAPHICS. CONCOMITANT DISEASE, LABORATORY DATA, CONCOMITANT MEDICATIONS WERE ADDED. UPDATED SUSPECT DRUG INDICATION AND LOT NUMBER. ADDED EVENTS INFLAMMATORY ARTHRITIS (PSORIATIC AND RHEUMATOID), URINARY INCONTINENCE, DYSMENORRHEA (CRAMPING), EXPULSION OF ESSURE DEVICE, FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: INCOMPLETE DEFECATION, IRRITABLE BOWEL SYNDROME, NICKEL ALLERGY, HEADACHES, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION WITH ANXIETY, PTSD, BILATERAL TUBOUTERINE IMPLANTATION, ACDF C4-7 SPINAL FUSION, RETROPUBIC MIDEURETHRAL SLING, CYSTOURETHROSCOPY, POSTERIOR COLPORRHAPHY, ENTEROCELE REPAIR , INCREASED INTRAOCULAR PRESSURE (VARIATION OF GLAUCOMA), WEIGHT GAIN, FIBROMYALGIA, PSEUDOARTHROSIS OF CERVIAL SPINE, CERVICALGIA (CAUSED BY) DEGENERATIVE DISC DISEASE, ANEMIA, BACK PAIN, DYSPHONIA, PSORIASIS. UPDATED EVENTS, ONSET DATE AND OUTCOMES OF EVENTS. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS"), PSORIATIC ARTHROPATHY ("PSORIATIC ARTHRITIS"), THE FIRST EPISODE OF INCOMPLETE SPINAL FUSION ("PSEUDOARTHROSIS OF CERVIAL SPINE"), CERVICAL SPINAL STENOSIS ("CERVICAL SPINE STENOSIS"), RECTOCELE REPAIR ("RECTOCELE REPAIR"), INTERVERTEBRAL DISC OPERATION ("ANTERIOR CERVICAL DISCECTOMY AND FUSION C4-C7") AND THE SECOND EPISODE OF INCOMPLETE SPINAL FUSION ("PSEUDO ARTHROSIS OF CERVICAL SPINE") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SPINAL FUSION SURGERY IN 2014. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HYPERTENSION SINCE 2009, HYPOTHYROIDISM SINCE 1999, SYNCOPE, FOLLICULITIS, ABNORMAL WEIGHT GAIN, METABOLIC SYNDROME, POLYPHAGIA, ANXIETY, DEPRESSION, HYPERLIPIDEMIA, HYPOTHYROIDISM, VITAMIN D DEFICIENCY, OVERWEIGHT, PSORIASIS, CERVICALGIA, EPICONDYLITIS, MYALGIA, HYPOTHYROIDISM, PAIN ANKLE, MUSCLE SPASM, ARTHRALGIA, ARTHRITIS, MUSCULAR PAIN, BLOATING, MYOFASCIAL PAIN SYNDROME, DIARRHEA, DYSLIPIDEMIA, HYPOVITAMINOSIS, DYSPEPSIA, COUGH, MYOFASCIAL PAIN SYNDROME, GASTROESOPHAGEAL REFLUX, FIBROMYALGIA, SLEEP DISORDER, MEMORY LOSS, MOOD CHANGE, STRESS URINARY INCONTINENCE, RECTOCELE, ENTEROCELE, PAIN IN ARM, MENOPAUSE, GROIN PAIN, PAIN IN ARM, NUMBNESS, TINGLING, NECK PAIN, PSORIASIS, JOINT PAIN, INFLAMMATORY ARTHRITIS, METATARSAL HEAD EXCISION, HYPERTRIGLYCERIDEMIA, DYSPHONIA, MYALGIA, MYOSITIS, HEARTBURN, BOWEL CRAMPS, LOOSE STOOLS, BOWEL CRAMPS, LIBIDO DECREASED, NERVOUSNESS AND MUSCLE WEAKNESS. CONCOMITANT PRODUCTS INCLUDED ETONOGESTREL (IMPLANON) FROM SEPTEMBER 2009 TO OCTOBER 2011 FOR BIRTH CONTROL AS WELL AS ADALIMUMAB FROM NOVEMBER 2015 TO MARCH 2016, ALPRAZOLAM SINCE (B)(6) 2012, AMITRIPTYLINE FROM JUNE 2014 TO JANUARY 2016, AMLODIPINE FROM AUGUST 2015 TO JULY 2016, BUPROPION FROM MARCH 2012 TO MARCH 2017, CALCIUM CITRATE (CALCITRATE) FROM NOVEMBER 2015 TO MARCH 2016, CEFALEXIN (CEPHALEXIN) FROM NOVEMBER 2015 TO DECEMBER 2015, CITALOPRAM HYDROBROMIDE (CELEXA) FROM NOVEMBER 2012 TO OCTOBER 2013, COLECALCIFEROL (VITAMIN D) SINCE JUNE 2011, CYCLOBENZAPRINE FROM MAY 2014 TO JULY 2014, DOCUSATE SODIUM (DOC-Q-LACE) FROM OCTOBER 2014 TO JANUARY 2016, FOLIC ACID FROM JUNE 2015 TO APRIL 2016, HYDROCHLOROTHIAZIDE SINCE MARCH 2011, HYDROCODONE FROM MAY 2015 TO JUNE 2015, LEVOTHYROXINE FROM MARCH 2010 TO JUNE 2014, LISINOPRIL SINCE FEBRUARY 2011, METHOTREXATE FROM JUNE 2010 TO JULY 2016, METRONIDAZOLE (METROGEL) FROM MAY 2010 TO NOVEMBER 2010, NAPROXEN FROM OCTOBER 2010 TO NOVEMBER 2010, OMEPRAZOLE FROM FEBRUARY 2015 TO APRIL 2015, PHENTERMINE SINCE MARCH 2011 TO 2012, PREDNISONE FROM MAY 2015 TO JUNE 2015, SALBUTAMOL SULFATE (ALBUTEROL SULFATE) FROM NOVEMBER 2010 TO JANUARY 2016, SUMATRIPTAN FROM MAY 2015 TO NOVEMBER 2016, TRAZODONE HYDROCHLORIDE (DESYREL) FROM AUGUST 2014 TO MARCH 2017, VALACICLOVIR HYDROCHLORIDE (VALTREX) FROM APRIL 2011 TO JULY 2016 AND VENLAFAXINE FROM JULY 2014 TO JANUARY 2015. ON(B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 2 MONTHS 5 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED RASH ("RASHES"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), THE FIRST EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), HEADACHE ("HEADACHES"), NECK PAIN ("CERVICALGIA") AND THE FIRST EPISODE OF INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"). IN 2012, THE PATIENT EXPERIENCED UTERINE PAIN ("UTERINE PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY/ SEVERE ANXIETY"). IN 2013, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PSORIATIC ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), GASTROINTESTINAL MOTILITY DISORDER ("INCOMPLETE DEFECATION") AND IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"). IN (B)(6) 2014, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DYSPHONIA ("DYSPHONIA") AND CRANIAL NERVE INJURY ("NERVE DAMAGE TO VOCAL CHORDS"). IN 2015, THE PATIENT EXPERIENCED THE FIRST EPISODE OF INCOMPLETE SPINAL FUSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS/ INFLAMMATORY ARTHIRITIS"). IN 2016, THE PATIENT EXPERIENCED ANAEMIA ("ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE SECOND EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), THE SECOND EPISODE OF INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), BACK PAIN ("LOWER BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), INTRAOCULAR PRESSURE INCREASED ("VISION/EYE PROBLEMS TYPE: INCREASED INTRAOCULAR PRESSURE (VARIATION OF GLAUCOMA)"), WEIGHT INCREASED ("WEIGHT GAIN"), DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"), POST-TRAUMATIC STRESS DISORDER ("PTSD"), MENTAL DISORDER ("WORSENED PSYCHIATRIC ISSUES"), ARTHRALGIA ("JOINT PAIN"), PAIN ("SOFT TISSUE PAIN/ PAIN ALL OVER MY BODY"), PSORIASIS ("PSORIASIS"), ACNE ("ACNE"), FEELING ABNORMAL ("BRAIN FOG"), MEDICAL DEVICE SITE INFLAMMATION ("MORE INFLAMMATION AROUND ESSURE"), MASTITIS BACTERIAL ("STAPH INFECTION IN BREAST/ CULTURE CAME BACK AS POSITIVE FOR STAPH") WITH BREAST PAIN, ERYTHEMA AND BREAST DISCHARGE, BREAST MASS ("HARDENED AREA OR A LUMP (BREAST)"), VITAMIN B12 DEFICIENCY ("VIT B12 DEFICIENCY"), CERVICAL SPINAL STENOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE"), OVARIAN CYST ("OVARIAN CYSTS"), GROIN PAIN ("GROIN PAIN"), INSOMNIA ("INSOMNIA"), URINARY BLADDER SUSPENSION ("BLADDER SLING"), RECTOCELE REPAIR (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INTERVERTEBRAL DISC OPERATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THE SECOND EPISODE OF DYSPHONIA ("DYSPHONIA") AND THE SECOND EPISODE OF INCOMPLETE SPINAL FUSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (A LAPAROTOMIC REMOVAL OF BILATERAL ESSURE DEVICES), SURGERY (3 LEVEL SPINAL FUSION SURGERY) AND SURGERY (THREE HERNIATED DISCS IN CERVICAL SPINE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, UTERINE PAIN, RASH, ARTHRITIS, MIGRAINE, THE LAST EPISODE OF INTERVERTEBRAL DISC DEGENERATION, HEADACHE, NECK PAIN, URINARY INCONTINENCE, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, IRRITABLE BOWEL SYNDROME, ALLERGY TO METALS, DEPRESSION, ANXIETY, INTRAOCULAR PRESSURE INCREASED, ANAEMIA, DEVICE EXPULSION, POST-TRAUMATIC STRESS DISORDER, CRANIAL NERVE INJURY, ARTHRALGIA, ACNE, MEDICAL DEVICE SITE INFLAMMATION, MASTITIS BACTERIAL, BREAST MASS, VITAMIN B12 DEFICIENCY, CERVICAL SPINAL STENOSIS, BLOOD PRESSURE INCREASED, OVARIAN CYST, GROIN PAIN, INSOMNIA, URINARY BLADDER SUSPENSION, RECTOCELE REPAIR, INTERVERTEBRAL DISC OPERATION, THE LAST EPISODE OF DYSPHONIA AND THE LAST EPISODE OF INCOMPLETE SPINAL FUSION OUTCOME WAS UNKNOWN, THE LAST EPISODE OF FIBROMYALGIA, RHEUMATOID ARTHRITIS, PSORIATIC ARTHROPATHY, BACK PAIN, WEIGHT INCREASED AND PSORIASIS HAD RESOLVED AND THE MENTAL DISORDER AND FEELING ABNORMAL WAS RESOLVING. THE REPORTER CONSIDERED ACNE, ALLERGY TO METALS, ANAEMIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, BLOOD PRESSURE INCREASED, BREAST MASS, CERVICAL SPINAL STENOSIS, CRANIAL NERVE INJURY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, FATIGUE, FEELING ABNORMAL, GASTROINTESTINAL MOTILITY DISORDER, GROIN PAIN, HEADACHE, INSOMNIA, INTERVERTEBRAL DISC OPERATION, INTRAOCULAR PRESSURE INCREASED, IRRITABLE BOWEL SYNDROME, MASTITIS BACTERIAL, MEDICAL DEVICE SITE INFLAMMATION, MENTAL DISORDER, MIGRAINE, NECK PAIN, OVARIAN CYST, PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PSORIASIS, PSORIATIC ARTHROPATHY, RASH, RECTOCELE REPAIR, RHEUMATOID ARTHRITIS, URINARY BLADDER SUSPENSION, URINARY INCONTINENCE, UTERINE PAIN, VITAMIN B12 DEFICIENCY, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPHONIA, THE FIRST EPISODE OF FIBROMYALGIA, THE FIRST EPISODE OF INCOMPLETE SPINAL FUSION, THE FIRST EPISODE OF INTERVERTEBRAL DISC DEGENERATION, THE SECOND EPISODE OF DYSPHONIA, THE SECOND EPISODE OF FIBROMYALGIA, THE SECOND EPISODE OF INCOMPLETE SPINAL FUSION AND THE SECOND EPISODE OF INTERVERTEBRAL DISC DEGENERATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. ON (B)(6) 2012, HYSTEROSALPINGOGRAM TEST CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. CURRENT WEIGHT 195 LBS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: ACNE, FEELING ABNORMAL, SALPINGITIS, STAPHYLOCOCCAL INFECTION, BREAST PAIN, ERYTHEMA, BREAST MASS, BREAST DISCHARGE, VITAMIN B12 DEFICIENCY, CERVICAL SPINAL STENOSIS, BLOOD PRESSURE INCREASED, OVARIAN CYST, GROIN PAIN, INSOMNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT ADDED: BLADDER SLING, RECTOCELE REPAIR, ANTERIOR CERVICAL DISCECTOMY AND FUSION C4-C7, DYSPHONIA, PSEUDO ARTHROSIS OF CERVICAL SPINE. 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 PELVIC PAIN ("PELVIC PAIN/ PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS"), PSORIATIC ARTHROPATHY ("PSORIATIC ARTHRITIS"), INCOMPLETE SPINAL FUSION ("PSEUDOARTHROSIS OF CERVIAL SPINE") AND CERVICAL SPINAL STENOSIS ("CERVICAL SPINE STENOSIS") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SPINAL FUSION SURGERY IN 2014. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HYPERTENSION SINCE 2009, HYPOTHYROIDISM SINCE 1999, SYNCOPE, FOLLICULITIS, ABNORMAL WEIGHT GAIN, METABOLIC SYNDROME, POLYPHAGIA, ANXIETY, DEPRESSION, HYPERLIPIDEMIA, HYPOTHYROIDISM, VITAMIN D DEFICIENCY, OVERWEIGHT, PSORIASIS, CERVICALGIA, EPICONDYLITIS, MYALGIA, HYPOTHYROIDISM, PAIN ANKLE, MUSCLE SPASM, ARTHRALGIA, ARTHRITIS, MUSCULAR PAIN, BLOATING, MYOFASCIAL PAIN SYNDROME, DIARRHEA, DYSLIPIDEMIA, HYPOVITAMINOSIS, DYSPEPSIA, COUGH, MYOFASCIAL PAIN SYNDROME, GASTROESOPHAGEAL REFLUX, FIBROMYALGIA, SLEEP DISORDER, MEMORY LOSS, MOOD CHANGE, STRESS URINARY INCONTINENCE, RECTOCELE, ENTEROCELE, PAIN IN ARM, MENOPAUSE, GROIN PAIN, PAIN IN ARM, NUMBNESS, TINGLING, NECK PAIN, PSORIASIS, JOINT PAIN, INFLAMMATORY ARTHRITIS, METATARSAL HEAD EXCISION, HYPERTRIGLYCERIDEMIA, DYSPHONIA, MYALGIA, MYOSITIS, HEARTBURN, BOWEL CRAMPS, LOOSE STOOLS, BOWEL CRAMPS, LIBIDO DECREASED, NERVOUSNESS AND MUSCLE WEAKNESS. CONCOMITANT PRODUCTS INCLUDED ETONOGESTREL (IMPLANON) FROM SEPTEMBER 2009 TO OCTOBER 2011 FOR BIRTH CONTROL AS WELL AS ADALIMUMAB FROM NOVEMBER 2015 TO MARCH 2016, ALPRAZOLAM SINCE NOVEMBER 2012, AMITRIPTYLINE FROM JUNE 2014 TO JANUARY 2016, AMLODIPINE FROM AUGUST 2015 TO JULY 2016, BUPROPION FROM MARCH 2012 TO MARCH 2017, CALCIUM CITRATE (CALCITRATE) FROM NOVEMBER 2015 TO MARCH 2016, CEFALEXIN (CEPHALEXIN) FROM NOVEMBER 2015 TO DECEMBER 2015, CITALOPRAM HYDROBROMIDE (CELEXA) FROM NOVEMBER 2012 TO OCTOBER 2013, COLECALCIFEROL (VITAMIN D) SINCE JUNE 2011, CYCLOBENZAPRINE FROM MAY 2014 TO JULY 2014, DOCUSATE SODIUM (DOC-Q-LACE) FROM OCTOBER 2014 TO JANUARY 2016, FOLIC ACID FROM JUNE 2015 TO APRIL 2016, HYDROCHLOROTHIAZIDE SINCE MARCH 2011, HYDROCODONE FROM MAY 2015 TO JUNE 2015, LEVOTHYROXINE FROM MARCH 2010 TO JUNE 2014, LISINOPRIL SINCE FEBRUARY 2011, METHOTREXATE FROM JUNE 2010 TO JULY 2016, METRONIDAZOLE (METROGEL) FROM MAY 2010 TO NOVEMBER 2010, NAPROXEN FROM OCTOBER 2010 TO NOVEMBER 2010, OMEPRAZOLE FROM FEBRUARY 2015 TO APRIL 2015, PHENTERMINE SINCE MARCH 2011 TO 2012, PREDNISONE FROM MAY 2015 TO JUNE 2015, SALBUTAMOL SULFATE (ALBUTEROL SULFATE) FROM NOVEMBER 2010 TO JANUARY 2016, SUMATRIPTAN FROM MAY 2015 TO NOVEMBER 2016, TRAZODONE HYDROCHLORIDE (DESYREL) FROM AUGUST 2014 TO MARCH 2017, VALACICLOVIR HYDROCHLORIDE (VALTREX) FROM APRIL 2011 TO JULY 2016 AND VENLAFAXINE FROM JULY 2014 TO JANUARY 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 2 MONTHS 5 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED RASH ("RASHES"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), THE FIRST EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), HEADACHE ("HEADACHES"), NECK PAIN ("CERVICALGIA") AND THE FIRST EPISODE OF INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"). IN 2012, THE PATIENT EXPERIENCED UTERINE PAIN ("UTERINE PAIN"). IN NOVEMBER 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY/ SEVERE ANXIETY"). IN 2013, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PSORIATIC ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), GASTROINTESTINAL MOTILITY DISORDER ("INCOMPLETE DEFECATION") AND IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"). IN OCTOBER 2014, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPHONIA ("DYSPHONIA") AND CRANIAL NERVE INJURY ("NERVE DAMAGE TO VOCAL CHORDS"). IN 2015, THE PATIENT EXPERIENCED INCOMPLETE SPINAL FUSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON 1-DEC-2015, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS/ INFLAMMATORY ARTHIRITIS"). IN 2016, THE PATIENT EXPERIENCED ANAEMIA ("ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE SECOND EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), THE SECOND EPISODE OF INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), BACK PAIN ("LOWER BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), INTRAOCULAR PRESSURE INCREASED ("VISION/EYE PROBLEMS TYPE: INCREASED INTRAOCULAR PRESSURE (VARIATION OF GLAUCOMA)"), WEIGHT INCREASED ("WEIGHT GAIN"), DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"), POST-TRAUMATIC STRESS DISORDER ("PTSD"), MENTAL DISORDER ("WORSENED PSYCHIATRIC ISSUES"), ARTHRALGIA ("JOINT PAIN"), PAIN ("SOFT TISSUE PAIN/ PAIN ALL OVER MY BODY"), PSORIASIS ("PSORIASIS"), ACNE ("ACNE"), FEELING ABNORMAL ("BRAIN FOG"), SALPINGITIS ("MORE INFLAMMATION AROUND ESSURE"), STAPHYLOCOCCAL INFECTION ("STAPH INFECTION IN BREAST/ CULTURE CAME BACK AS POSITIVE FOR STAPH") WITH BREAST PAIN, ERYTHEMA AND BREAST DISCHARGE, BREAST MASS ("HARDENED AREA OR A LUMP (BREAST)"), VITAMIN B12 DEFICIENCY ("VIT B12 DEFICIENCY"), CERVICAL SPINAL STENOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE"), OVARIAN CYST ("OVARIAN CYSTS"), GROIN PAIN ("GROIN PAIN") AND INSOMNIA ("INSOMNIA"). THE PATIENT WAS TREATED WITH SURGERY (A LAPAROTOMIC REMOVAL OF BILATERAL ESSURE DEVICES), SURGERY (3 LEVEL SPINAL FUSION SURGERY) AND SURGERY (THREE HERNIATED DISCS IN CERVICAL SPINE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, UTERINE PAIN, RASH, ARTHRITIS, MIGRAINE, THE LAST EPISODE OF INTERVERTEBRAL DISC DEGENERATION, HEADACHE, INCOMPLETE SPINAL FUSION, NECK PAIN, URINARY INCONTINENCE, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, IRRITABLE BOWEL SYNDROME, ALLERGY TO METALS, DEPRESSION, ANXIETY, INTRAOCULAR PRESSURE INCREASED, ANAEMIA, DEVICE EXPULSION, POST-TRAUMATIC STRESS DISORDER, DYSPHONIA, CRANIAL NERVE INJURY, ARTHRALGIA, ACNE, SALPINGITIS, STAPHYLOCOCCAL INFECTION, BREAST MASS, VITAMIN B12 DEFICIENCY, CERVICAL SPINAL STENOSIS, BLOOD PRESSURE INCREASED, OVARIAN CYST, GROIN PAIN AND INSOMNIA OUTCOME WAS UNKNOWN, THE LAST EPISODE OF FIBROMYALGIA, RHEUMATOID ARTHRITIS, PSORIATIC ARTHROPATHY, BACK PAIN, WEIGHT INCREASED AND PSORIASIS HAD RESOLVED AND THE MENTAL DISORDER AND FEELING ABNORMAL WAS RESOLVING. THE REPORTER CONSIDERED ACNE, ALLERGY TO METALS, ANAEMIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, BLOOD PRESSURE INCREASED, BREAST MASS, CERVICAL SPINAL STENOSIS, CRANIAL NERVE INJURY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPHONIA, FATIGUE, FEELING ABNORMAL, GASTROINTESTINAL MOTILITY DISORDER, GROIN PAIN, HEADACHE, INCOMPLETE SPINAL FUSION, INSOMNIA, INTRAOCULAR PRESSURE INCREASED, IRRITABLE BOWEL SYNDROME, MENTAL DISORDER, MIGRAINE, NECK PAIN, OVARIAN CYST, PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PSORIASIS, PSORIATIC ARTHROPATHY, RASH, RHEUMATOID ARTHRITIS, SALPINGITIS, STAPHYLOCOCCAL INFECTION, URINARY INCONTINENCE, UTERINE PAIN, VITAMIN B12 DEFICIENCY, WEIGHT INCREASED, THE FIRST EPISODE OF FIBROMYALGIA, THE FIRST EPISODE OF INTERVERTEBRAL DISC DEGENERATION, THE SECOND EPISODE OF FIBROMYALGIA AND THE SECOND EPISODE OF INTERVERTEBRAL DISC DEGENERATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. ON (B)(6) 2012, HYSTEROSALPINGOGRAM TEST CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. CURRENT WEIGHT 195 LBS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: ACNE, FEELING ABNORMAL, SALPINGITIS, STAPHYLOCOCCAL INFECTION, BREAST PAIN, ERYTHEMA, BREAST MASS, BREAST DISCHARGE, VITAMIN B12 DEFICIENCY, CERVICAL SPINAL STENOSIS, BLOOD PRESSURE INCREASED, OVARIAN CYST, GROIN PAIN, INSOMNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: INFORMATION RECEIVED FROM SOCIAL MEDIA: REPORTER INFORMATION UPDATED. EVENTS PAIN ALL OVER MY BODY, SEVERE ANXIETY WERE CLUBBED WITH PREVIOUSLY REPORTED EVENTS. EVENTS ACNE, FEELING ABNORMAL, SALPINGITIS, STAPHYLOCOCCAL INFECTION, BREAST PAIN, ERYTHEMA, BREAST MASS, BREAST DISCHARGE, VITAMIN B12 DEFICIENCY, CERVICAL SPINAL STENOSIS, BLOOD PRESSURE INCREASED, OVARIAN CYST, GROIN PAIN, INSOMNIA WERE NEWLY 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 ("PELVIC PAIN/ PAIN"), RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS"), PSORIATIC ARTHROPATHY ("PSORIATIC ARTHRITIS"), INCOMPLETE SPINAL FUSION ("PSEUDOARTHROSIS OF CERVIAL SPINE") AND CERVICAL SPINAL STENOSIS ("CERVICAL SPINE STENOSIS") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SPINAL FUSION SURGERY IN 2014. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, HYPERTENSION SINCE 2009, HYPOTHYROIDISM SINCE 1999, SYNCOPE, FOLLICULITIS, ABNORMAL WEIGHT GAIN, METABOLIC SYNDROME, POLYPHAGIA, ANXIETY, DEPRESSION, HYPERLIPIDEMIA, HYPOTHYROIDISM, VITAMIN D DEFICIENCY, OVERWEIGHT, PSORIASIS, CERVICALGIA, EPICONDYLITIS, MYALGIA, HYPOTHYROIDISM, PAIN ANKLE, MUSCLE SPASM, ARTHRALGIA, ARTHRITIS, MUSCULAR PAIN, BLOATING, MYOFASCIAL PAIN SYNDROME, DIARRHEA, DYSLIPIDEMIA, HYPOVITAMINOSIS, DYSPEPSIA, COUGH, MYOFASCIAL PAIN SYNDROME, GASTROESOPHAGEAL REFLUX, FIBROMYALGIA, SLEEP DISORDER, MEMORY LOSS, MOOD CHANGE, STRESS URINARY INCONTINENCE, RECTOCELE, ENTEROCELE, PAIN IN ARM, MENOPAUSE, GROIN PAIN, PAIN IN ARM, NUMBNESS, TINGLING, NECK PAIN, PSORIASIS, JOINT PAIN, INFLAMMATORY ARTHRITIS, METATARSAL HEAD EXCISION, HYPERTRIGLYCERIDEMIA, DYSPHONIA, MYALGIA, MYOSITIS, HEARTBURN, BOWEL CRAMPS, LOOSE STOOLS, BOWEL CRAMPS, LIBIDO DECREASED, NERVOUSNESS AND MUSCLE WEAKNESS. CONCOMITANT PRODUCTS INCLUDED ETONOGESTREL (IMPLANON) FROM (B)(6) 2009 TO (B)(6) 2011 FOR BIRTH CONTROL AS WELL AS ADALIMUMAB FROM (B)(6) 2015 TO (B)(6) 2016, ALPRAZOLAM SINCE (B)(6) 2012, AMITRIPTYLINE FROM (B)(6) 2014 TO(B)(6) 2016, AMLODIPINE FROM (B)(6) 2015 TO (B)(6) 2016, BUPROPION FROM (B)(6) 2012 TO (B)(6) 2017, CALCIUM CITRATE (CALCITRATE) FROM (B)(6) 2015 TO (B)(6) 2016, CEFALEXIN (CEPHALEXIN) FROM (B)(6) 2015 TO (B)(6) 2015, CITALOPRAM HYDROBROMIDE (CELEXA) FROM (B)(6) 2012 TO (B)(6) 2013, COLECALCIFEROL (VITAMIN D) SINCE (B)(6) 2011, CYCLOBENZAPRINE FROM (B)(6) 2014 TO (B)(6) 2014, DOCUSATE SODIUM (DOC-Q-LACE) FROM (B)(6) 2014 TO (B)(6) 2016, FOLIC ACID FROM (B)(6) 2015 TO (B)(6) 2016, HYDROCHLOROTHIAZIDE SINCE (B)(6) 2011, HYDROCODONE FROM (B)(6) 2015 TO (B)(6) 2015, LEVOTHYROXINE FROM (B)(6) 2010 TO(B)(6) 2014, LISINOPRIL SINCE (B)(6) 2011, METHOTREXATE FROM (B)(6) 2010 TO (B)(6) 2016, METRONIDAZOLE (METROGEL) FROM (B)(6) 2010 TO (B)(6) 2010, NAPROXEN FROM (B)(6) 2010 TO (B)(6) 2010, OMEPRAZOLE FROM (B)(6) 2015 TO (B)(6) 2015, PHENTERMINE SINCE (B)(6) 2011 TO 2012, PREDNISONE FROM (B)(6) 2015 TO (B)(6) 2015, SALBUTAMOL SULFATE (ALBUTEROL SULFATE) FROM (B)(6) 2010 TO (B)(6) 2016, SUMATRIPTAN FROM (B)(6) 2015 TO (B)(6) 2016, TRAZODONE HYDROCHLORIDE (DESYREL) FROM (B)(6) 2014 TO (B)(6) 2017, VALACICLOVIR HYDROCHLORIDE (VALTREX) FROM (B)(6) 2011 TO (B)(6) 2016 AND VENLAFAXINE FROM (B)(6) 2014 TO (B)(6) 2015. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 2 MONTHS 5 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED RASH ("RASHES"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), THE FIRST EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), HEADACHE ("HEADACHES"), NECK PAIN ("CERVICALGIA") AND THE FIRST EPISODE OF INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"). IN 2012, THE PATIENT EXPERIENCED UTERINE PAIN ("UTERINE PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY/ SEVERE ANXIETY"). IN 2013, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PSORIATIC ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), GASTROINTESTINAL MOTILITY DISORDER ("INCOMPLETE DEFECATION") AND IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"). IN (B)(6) 2014, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("URINARY INCONTINENCE"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPHONIA ("DYSPHONIA") AND CRANIAL NERVE INJURY ("NERVE DAMAGE TO VOCAL CHORDS"). IN 2015, THE PATIENT EXPERIENCED INCOMPLETE SPINAL FUSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON 1(B)(6) 2015, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS/ INFLAMMATORY ARTHIRITIS"). IN 2016, THE PATIENT EXPERIENCED ANAEMIA ("ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE SECOND EPISODE OF FIBROMYALGIA ("FIBROMYALGIA"), THE SECOND EPISODE OF INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), BACK PAIN ("LOWER BACK PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), INTRAOCULAR PRESSURE INCREASED ("VISION/EYE PROBLEMS TYPE: INCREASED INTRAOCULAR PRESSURE (VARIATION OF GLAUCOMA)"), WEIGHT INCREASED ("WEIGHT GAIN"), DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE"), POST-TRAUMATIC STRESS DISORDER ("PTSD"), MENTAL DISORDER ("WORSENED PSYCHIATRIC ISSUES"), ARTHRALGIA ("JOINT PAIN"), PAIN ("SOFT TISSUE PAIN/ PAIN ALL OVER MY BODY"), PSORIASIS ("PSORIASIS"), ACNE ("ACNE"), FEELING ABNORMAL ("BRAIN FOG"), MEDICAL DEVICE SITE INFLAMMATION ("MORE INFLAMMATION AROUND ESSURE"), MASTITIS BACTERIAL ("STAPH INFECTION IN BREAST/ CULTURE CAME BACK AS POSITIVE FOR STAPH") WITH BREAST PAIN, ERYTHEMA AND BREAST DISCHARGE, BREAST MASS ("HARDENED AREA OR A LUMP (BREAST)"), VITAMIN B12 DEFICIENCY ("VIT B12 DEFICIENCY"), CERVICAL SPINAL STENOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLOOD PRESSURE INCREASED ("INCREASED BLOOD PRESSURE"), OVARIAN CYST ("OVARIAN CYSTS"), GROIN PAIN ("GROIN PAIN") AND INSOMNIA ("INSOMNIA"). THE PATIENT WAS TREATED WITH SURGERY (A LAPAROTOMIC REMOVAL OF BILATERAL ESSURE DEVICES), SURGERY (3 LEVEL SPINAL FUSION SURGERY) AND SURGERY (THREE HERNIATED DISCS IN CERVICAL SPINE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, UTERINE PAIN, RASH, ARTHRITIS, MIGRAINE, THE LAST EPISODE OF INTERVERTEBRAL DISC DEGENERATION, HEADACHE, INCOMPLETE SPINAL FUSION, NECK PAIN, URINARY INCONTINENCE, FATIGUE, GASTROINTESTINAL MOTILITY DISORDER, IRRITABLE BOWEL SYNDROME, ALLERGY TO METALS, DEPRESSION, ANXIETY, INTRAOCULAR PRESSURE INCREASED, ANAEMIA, DEVICE EXPULSION, POST-TRAUMATIC STRESS DISORDER, DYSPHONIA, CRANIAL NERVE INJURY, ARTHRALGIA, ACNE, MEDICAL DEVICE SITE INFLAMMATION, MASTITIS BACTERIAL, BREAST MASS, VITAMIN B12 DEFICIENCY, CERVICAL SPINAL STENOSIS, BLOOD PRESSURE INCREASED, OVARIAN CYST, GROIN PAIN AND INSOMNIA OUTCOME WAS UNKNOWN, THE LAST EPISODE OF FIBROMYALGIA, RHEUMATOID ARTHRITIS, PSORIATIC ARTHROPATHY, BACK PAIN, WEIGHT INCREASED AND PSORIASIS HAD RESOLVED AND THE MENTAL DISORDER AND FEELING ABNORMAL WAS RESOLVING. THE REPORTER CONSIDERED ACNE, ALLERGY TO METALS, ANAEMIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, BLOOD PRESSURE INCREASED, BREAST MASS, CERVICAL SPINAL STENOSIS, CRANIAL NERVE INJURY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPHONIA, FATIGUE, FEELING ABNORMAL, GASTROINTESTINAL MOTILITY DISORDER, GROIN PAIN, HEADACHE, INCOMPLETE SPINAL FUSION, INSOMNIA, INTRAOCULAR PRESSURE INCREASED, IRRITABLE BOWEL SYNDROME, MASTITIS BACTERIAL, MEDICAL DEVICE SITE INFLAMMATION, MENTAL DISORDER, MIGRAINE, NECK PAIN, OVARIAN CYST, PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PSORIASIS, PSORIATIC ARTHROPATHY, RASH, RHEUMATOID ARTHRITIS, URINARY INCONTINENCE, UTERINE PAIN, VITAMIN B12 DEFICIENCY, WEIGHT INCREASED, THE FIRST EPISODE OF FIBROMYALGIA, THE FIRST EPISODE OF INTERVERTEBRAL DISC DEGENERATION, THE SECOND EPISODE OF FIBROMYALGIA AND THE SECOND EPISODE OF INTERVERTEBRAL DISC DEGENERATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. ON (B)(6) 2012, HYSTEROSALPINGOGRAM TEST CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. CURRENT WEIGHT 195 LBS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: ACNE, FEELING ABNORMAL, SALPINGITIS, STAPHYLOCOCCAL INFECTION, BREAST PAIN, ERYTHEMA, BREAST MASS, BREAST DISCHARGE, VITAMIN B12 DEFICIENCY, CERVICAL SPINAL STENOSIS, BLOOD PRESSURE INCREASED, OVARIAN CYST, GROIN PAIN, INSOMNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED UTERINE PAIN ("UTERINE PAIN"), RASH ("RASHES") AND ARTHRITIS ("ARTHRITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FIBROMYALGIA ("FIBROMYALGIA"), MIGRAINE ("MIGRAINES"), INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE") AND INJURY ("PERSONAL INJURIES"). THE PATIENT WAS TREATED WITH SURGERY (A LAPAROTOMIC REMOVAL OF BILATERAL ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE PAIN, RASH, ARTHRITIS, FIBROMYALGIA, MIGRAINE, INTERVERTEBRAL DISC DEGENERATION AND INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRITIS, FIBROMYALGIA, INJURY, INTERVERTEBRAL DISC DEGENERATION, MIGRAINE, PELVIC PAIN, RASH AND UTERINE PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: NEW EVENTS UTERINE PAIN, PELVIC PAIN, RASHES, FIBROMYALGIA, MIGRAINES, DEGENERATIVE DISC DISEASE, AND "ARTHRITIS" WERE ADDED. PRODUCT START DATE AND STOP DATE AND INDICATION WAS ADDED. CASE IS UPDATED FROM INVALID TO VALID. 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 |
|---|---|---|---|---|---|---|---|
| 509353 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 852005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | ADALIMUMAB.| ADALIMUMAB.| ADALIMUMAB.| ADALIMUMAB.| ALBUTEROL SULFATE.| ALBUTEROL SULFATE.| ALBUTEROL SULFATE.| ALBUTEROL SULFATE.| ALPRAZOLAM.| ALPRAZOLAM.| ALPRAZOLAM.| ALPRAZOLAM.| AMITRIPTYLINE.| AMITRIPTYLINE.| AMITRIPTYLINE.| AMITRIPTYLINE.| AMLODIPINE.| AMLODIPINE.| AMLODIPINE.| AMLODIPINE.| BUPROPION.| BUPROPION.| BUPROPION.| BUPROPION.| CALCITRATE.| CALCITRATE.| CALCITRATE.| CALCITRATE.| CELEXA.| CELEXA.| CELEXA.| CELEXA.| CEPHALEXIN.| CEPHALEXIN.| CEPHALEXIN.| CEPHALEXIN.| CYCLOBENZAPRINE.| CYCLOBENZAPRINE.| CYCLOBENZAPRINE.| CYCLOBENZAPRINE.| DESYREL.| DESYREL.| DESYREL.| DESYREL.| DOC-Q-LACE.| DOC-Q-LACE.| DOC-Q-LACE.| DOC-Q-LACE.| FOLIC ACID.| FOLIC ACID.| FOLIC ACID.| FOLIC ACID.| HYDROCHLOROTHIAZIDE.| HYDROCHLOROTHIAZIDE.| HYDROCHLOROTHIAZIDE.| HYDROCHLOROTHIAZIDE.| HYDROCODONE.| HYDROCODONE.| HYDROCODONE.| HYDROCODONE.| IMPLANON.| IMPLANON.| IMPLANON.| IMPLANON.| LEVOTHYROXINE.| LEVOTHYROXINE.| LEVOTHYROXINE.| LEVOTHYROXINE.| LISINOPRIL.| LISINOPRIL.| LISINOPRIL.| LISINOPRIL.| METHOTREXATE.| METHOTREXATE.| METHOTREXATE.| METHOTREXATE.| METROGEL.| METROGEL.| METROGEL.| METROGEL.| NAPROXEN.| NAPROXEN.| NAPROXEN.| NAPROXEN.| OMEPRAZOLE.| OMEPRAZOLE.| OMEPRAZOLE.| OMEPRAZOLE..| PHENTERMINE.| PHENTERMINE.| PHENTERMINE.| PHENTERMINE.| PREDNISONE.| PREDNISONE.| PREDNISONE.| PREDNISONE.| SUMATRIPTAN.| SUMATRIPTAN.| SUMATRIPTAN.| SUMATRIPTAN.| VALTREX.| VALTREX.| VALTREX.| VALTREX.| VENLAFAXINE.| VENLAFAXINE.| VENLAFAXINE.| VENLAFAXINE.| VITAMIN D [COLECALCIFEROL]| VITAMIN D [COLECALCIFEROL].| VITAMIN D [COLECALCIFEROL].| VITAMIN D [COLECALCIFEROL]. |