ESSURE
Report
- Report Number
- 2951250-2018-01284
- Event Type
- Injury
- Date Received
- March 27, 2018
- Report Date
- June 26, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE/ ONE DEVICE BROKE INTO PIECES AT REMOVAL(RIGHT SIDE)'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ ONE ESSURE DEVICE HAD MIGRATED INTO MY UTERUS'), PELVIC PAIN ('CHRONIC PELVIC PAIN/PELVIC PAIN'), DERMATOMYOSITIS ('AUTOIMMUNE DISORDER-DERMATOMYOSITIS / GOTTRON'S PAPULE') AND SCLERITIS ('AUTOIMMUNE DISORDER- TYPE OF DISOREDER: EYE SCLERISIS') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DR. HAD A DIFFICULT TIME GETTING ONE ESSURE COIL IN ONE FALLOPIAN TUBE" ON (B)(6) 2012. THE PATIENT'S MEDICAL HISTORY INCLUDED INSOMNIA, ALLERGIC RHINITIS, ANKLE SPRAIN, BREAST PROSTHESIS IMPLANTATION, CESAREAN DELIVERY, WITHOUT MENTION OF INDICATION, HDL INCREASED, HYPERCHOLESTEROLEMIA, SPLENIC CYST, SULFONAMIDE ALLERGY, PAINFUL INTERCOURSE, SCALP DISORDER, ALOPECIA, MOOD SWINGS, CONSTIPATION, STRESS, PALPITATIONS AGGRAVATED, EXCESS SWEATING, GRAVIDA II, PARITY 2, HYPOTHYROIDISM, INTERVERTEBRAL DISC OPERATION ( (B)(6) 2009), IRREGULAR PERIODS, URINE INCONTINENCE, PREGNANCY INDUCED HYPERTENSION, INTRAOPERATIVE HYPERTENSION, SORE MOUTH AND PARATUBAL CYST. CURRENT WEIGHT 133 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CYTOMEL, KLONOPIN, SYNTHROID, ZOLOFT, XELODA AND LEXAPRO. CONCURRENT CONDITIONS INCLUDED HYPERTENSION (FATHER AND GRAND FATHER), CONGENITAL CYSTIC KIDNEY DISEASE, SINUS DISORDER, HYPERPLASIA, ALDOSTERONISM, ENDOCRINE HYPERTENSION, RETIRED, FORGETFULNESS, INTERMITTENT HEADACHE, DIZZY, BLOATING, ANKLES SWELLING, HAND SWELLING, PALPITATION, RAISED TRIGLYCERIDES, FLOATERS, SENSATION OF PRESSURE IN EYE, YEAST INFECTION, VITREOUS DEGENERATION, FACIAL PAIN, THROAT SECRETION INCREASED, SORE THROAT, VITREOUS OPACITIES, VAGINAL DISCHARGE ABNORMALITY, ABDOMINAL PAIN LOWER, SOMNOLENCE, OPHTHALMIC MIGRAINE, BLURRY VISION, VISUAL DISTURBANCE, VAGINITIS, VULVOVAGINITIS, BURNING MICTURITION, SINUS INFECTION, VAGINAL PAIN, VAGINAL REDNESS, MUSCLE CRAMPS, NAUSEA, VAGINAL IRRITATION, UNSPECIFIED VITAMIN D DEFICIENCY, DYSURIA, RENAL CYST NOS, PERIPHERAL VASCULAR DISEASE, BLOTCHY, THRUSH, ACTINIC KERATOSIS, COUGH, JOINT STIFFNESS, PARAESTHESIA, FLANK PAIN, HEPATIC CYST, HIATAL HERNIA, SKIN LESION, DERMATITIS, LIVEDO RETICULARIS, RAYNAUDS, HEARTBURN, EPISCLERITIS, HOT FLASHES, CLAMMINESS, VITILIGO AND ECZEMA. FAMILY HISTORY INCLUDED HYPERTENSION, HIGH CHOLESTEROL, DIABETES (GRAND MOTHER) AND HEART DISEASE, UNSPECIFIED. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ) SINCE 2007 TO (B)(6) 2012 FOR BIRTH CONTROL AS WELL AS ALLOPURINOL (ELAVIL), AMITRIPTYLINE SINCE 2013, AMOXICILLIN, AMOXICILLIN;CLAVULANIC ACID (AUGMENTIN BAMBINI), ANTAZOLINE PHOSPHATE;NAPHAZOLINE HYDROCHLORIDE (REFRESH EYE ALLERGY RELIEF), AZELASTINE HYDROCHLORIDE, AZELASTINE SINCE 2013, AZITHROMYCIN, AZITHROMYCIN (ZITHROMAX Z-PACK), AZITHROMYCIN (ZITHROMAX), BUPROPION, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2011, CALCIUM, CLONAZEPAM, CLONAZEPAM (CLONOPIN), CLONAZEPAM (KLONOPIN) FROM 2012 TO 2015, CYCLOBENZAPRINE, DIFLUPREDNATE (DUREZOL), FISH OIL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) SINCE 2008, IBUPROFEN, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), LEVOTHYROXINE SODIUM (THYROXINE), LIOTHYRONINE SODIUM (CYTOMEL), LISINOPRIL SINCE 2009, LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY), MELATONIN, METHYLPREDNISOLONE (MEDROL), METOPROLOL, METRONIDAZOLE (METROGEL), MICONAZOLE NITRATE (MONISTAT), MOMETASONE FUROATE, MOMETASONE FUROATE (NASONEX), MONTELUKAST, MONTELUKAST SODIUM (SINGULAIR) SINCE 2008, NYSTATIN, PREDNISONE, RANITIDINE, SENNOSIDE A+B (SENNOKOTT), SERTRALINE HYDROCHLORIDE (ZOLOFT) AND VERAPAMIL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"), COITAL BLEEDING ("ABNORMAL BLEEDING AFTER INTERCOURSE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED RASH ("RASHES/RASHES ON MY FACE, CHEEKS /RASHES ON FINGERS, TOES, ELBOWS, ARMS, KNUCKLES AND HAND PAPULES"), EYELID RASH ("RASHES OR SKIN CONDITIONS TYPE: EYELIDS") AND ROSACEA ("RASHES OR SKIN CONDITIONS TYPE: ROSACEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND REFLUX LARYNGITIS ("LARYNGOPHARYNGEAL REFLUX"). IN (B)(6) 2016, THE PATIENT EXPERIENCED RASH PAPULAR ("RASHES OR SKIN CONDITIONS-TYPE: RASHES ON FINGERS, TOES, ELBOWS, ARMS, KNUCKLES AND HAND PAPULES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DERMATOMYOSITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND ANXIETY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND ANXIETY") AND GASTROOESOPHAGEAL REFLUX DISEASE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: ACID REFLUX/ GASTROESOPHAGEL REFLUX DISORDER"). ON (B)(6) 2017, THE PATIENT EXPERIENCED PYREXIA ("LOW GRADE FEVER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("JOINT PAIN"), LIVEDO RETICULARIS ("LIVEDO RETICULARIS") AND MYDRIASIS ("DILATED EYES"). THE PATIENT WAS TREATED WITH DULOXETINE HYDROCHLORIDE (CYMBALTA), FAMOTIDINE, IMMUNOGLOBULIN G HUMAN (IZ IVIG), MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT), PAP SMEAR, SURGERY (OPERATIVE LAPAROSCOPY WITH REMOVAL OF THE ESSURE DEVICES AND BILATERAL SALPINGECTOMY AND HYSTERECTOMY AND BILATERAL SALPINGECTOMY), BONE MARROW BIOPSY AND PERFORMED SHAVE BIOPSY. ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, PELVIC PAIN, DERMATOMYOSITIS, SCLERITIS, FATIGUE, ARTHRALGIA, PYREXIA, HEADACHE, RASH, DEPRESSION, ANXIETY, EYELID RASH, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, ROSACEA, LIVEDO RETICULARIS, REFLUX LARYNGITIS, MYDRIASIS AND RASH PAPULAR OUTCOME WAS UNKNOWN AND THE MIGRAINE, MENORRHAGIA, COITAL BLEEDING AND VAGINAL HAEMORRHAGE WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, ARTHRALGIA, COITAL BLEEDING, DEPRESSION, DERMATOMYOSITIS, DEVICE BREAKAGE, DEVICE EXPULSION, EYELID RASH, FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, LIVEDO RETICULARIS, MENORRHAGIA, MIGRAINE, MYDRIASIS, PELVIC PAIN, PYREXIA, RASH, RASH PAPULAR, REFLUX LARYNGITIS, ROSACEA, SCLERITIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT 3, RIGHT 4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2017: CONCLUSION: 1. UNREMARKABLE CT OF THE CHEST. 2. DECREASED SPLENIC CYST NOW MEASURING 3.1 CM IN MAXIMAL AXIAL DIMENSION AS COMPARED TO 6.1. CM PREVIOUSLY. 3. PROBABLE HEPATIC AND RENAL CYSTS, WITH MINIMAL CHANGE. 4. POTENTIAL SMALL HIATAL HERNIA.. NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2013: IMPRESSION:- MRI OF THE BRAIN WITHIN NORMAL LIMITS. PATHOLOGY TEST - ON (B)(6) 2017: DIAGNOSIS: 1.SUBMITTED AS ¿ESSURE DEVICE IN RIGHT FALLOPIAN TUBE¿, EXPLANTED SURGICAL HARDWARE (GROSS ONLY). 2.FALLOPIAN TUBE, RIGHT, SALPINGECTOMY: FALLOPIAN TUBE WITH NO SIGNIFICANT PATHOLOGIC ABNORMALITY. 3.SUBMITTED AS ¿ESSURE DEVICE IN LEFT FALLOPIAN TUBE¿, EXPLANTED SURGICAL HARDWARE (GROSS ONLY). 4.FALLOPIAN TUBE, LEFT, SALPINGECTOMY: FALLOPIAN TUBE WITH BENIGN PARATUBAL SEROUS CYSTS, OTHERWISE UNREMARKABLE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: RASH, DEPRESSION, ANXIETY, VAGINAL BLEEDING, PELVIC PAIN, WEIGHT INCREASED, FATIGUE, MIGRAINE, REFLUX LARYNGITIS, MENORRHAGIA, ROSACEA, PYREXIA,DEVICE BREAKAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2019: PFS AND MR RECEIVED- NEW EVENTS ¿¿DEPRESSION, ANXIETY, ROSACEA, DERMATOMYOSITIS, HEADACHES, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ ONE ESSURE DEVICE HAD MIGRATED INTO MY UTERUS, DEVICE BREAKAGE/ ONE DEVICE BROKE INTO PIECES AT REMOVAL(RIGHT SIDE),WEIGHT GAIN, ACID REFLUX, EYELID RASH, LARYNGOPHARYNGEAL REFLUX DISORDER, LIVEDO RETICULARI'S, EYE SCLERITIS, ABNORMAL BLEEDING AFTER INTERCOURSE, DILATED EYES, DR. HAD A DIFFICULT TIME GETTING ONE ESSURE COIL IN ONE FALLOPIAN TUBE¿, REPORTER, LOT NUMBER, CONCOMITANT AND HISTORICAL DRUG, MEDICAL HISTORY, LAB DATA, PATIENT INFORMATION ADDED. EVENTS- ¿MIGRAINE, MENORRHAGIA, ABNORMAL BLEEDING AFTER INTERCOURSE¿ OUTCOME UPDATED TO ¿RECOVERING/RESOLVING.¿ INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE/ ONE DEVICE BROKE INTO PIECES AT REMOVAL(RIGHT SIDE)'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ ONE ESSURE DEVICE HAD MIGRATED INTO MY UTERUS'), PELVIC PAIN ('CHRONIC PELVIC PAIN/PELVIC PAIN'), DERMATOMYOSITIS ('AUTOIMMUNE DISORDER-DERMATOMYOSITIS / GOTTRON'S PAPULE') AND SCLERITIS ('AUTOIMMUNE DISORDER- TYPE OF DISOREDER: EYE SCLERISIS') IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DR. HAD A DIFFICULT TIME GETTING ONE ESSURE COIL IN ONE FALLOPIAN TUBE" ON 4-MAY-2012. THE PATIENT'S MEDICAL HISTORY INCLUDED INSOMNIA, ALLERGIC RHINITIS, ANKLE SPRAIN, BREAST PROSTHESIS IMPLANTATION, CESAREAN DELIVERY, WITHOUT MENTION OF INDICATION, HDL INCREASED, HYPERCHOLESTEROLEMIA, SPLENIC CYST, SULFONAMIDE ALLERGY, PAINFUL INTERCOURSE, SCALP DISORDER, ALOPECIA, MOOD SWINGS, CONSTIPATION, STRESS, PALPITATIONS AGGRAVATED, EXCESS SWEATING, GRAVIDA II, PARITY 2, HYPOTHYROIDISM, INTERVERTEBRAL DISC OPERATION (APR2009), IRREGULAR PERIODS, URINE INCONTINENCE, PREGNANCY INDUCED HYPERTENSION, INTRAOPERATIVE HYPERTENSION, SORE MOUTH AND PARATUBAL CYST. CURRENT WEIGHT 133 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CYTOMEL, KLONOPIN, SYNTHROID, ZOLOFT, XELODA AND LEXAPRO. CONCURRENT CONDITIONS INCLUDED HYPERTENSION (FATHER AND GRAND FATHER), CONGENITAL CYSTIC KIDNEY DISEASE, SINUS DISORDER, HYPERPLASIA, ALDOSTERONISM, ENDOCRINE HYPERTENSION, RETIRED, FORGETFULNESS, INTERMITTENT HEADACHE, DIZZY, BLOATING, ANKLES SWELLING, HAND SWELLING, PALPITATION, RAISED TRIGLYCERIDES, FLOATERS, SENSATION OF PRESSURE IN EYE, YEAST INFECTION, VITREOUS DEGENERATION, FACIAL PAIN, THROAT SECRETION INCREASED, SORE THROAT, VITREOUS OPACITIES, VAGINAL DISCHARGE ABNORMALITY, ABDOMINAL PAIN LOWER, SOMNOLENCE, OPHTHALMIC MIGRAINE, BLURRY VISION, VISUAL DISTURBANCE, VAGINITIS, VULVOVAGINITIS, BURNING MICTURITION, SINUS INFECTION, VAGINAL PAIN, VAGINAL REDNESS, MUSCLE CRAMPS, NAUSEA, VAGINAL IRRITATION, UNSPECIFIED VITAMIN D DEFICIENCY, DYSURIA, RENAL CYST NOS, PERIPHERAL VASCULAR DISEASE, BLOTCHY, THRUSH, ACTINIC KERATOSIS, COUGH, JOINT STIFFNESS, PARAESTHESIA, FLANK PAIN, HEPATIC CYST, HIATAL HERNIA, SKIN LESION, DERMATITIS, LIVEDO RETICULARIS, RAYNAUDS, HEARTBURN, EPISCLERITIS, HOT FLASHES, CLAMMINESS, VITILIGO AND ECZEMA. FAMILY HISTORY INCLUDED HYPERTENSION, HIGH CHOLESTEROL, DIABETES (GRAND MOTHER) AND HEART DISEASE, UNSPECIFIED. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ) SINCE 2007 TO AUGUST 2012 FOR BIRTH CONTROL AS WELL AS ALLOPURINOL (ELAVIL), AMITRIPTYLINE SINCE 2013, AMOXICILLIN, AMOXICILLIN;CLAVULANIC ACID (AUGMENTIN BAMBINI), ANTAZOLINE PHOSPHATE;NAPHAZOLINE HYDROCHLORIDE (REFRESH EYE ALLERGY RELIEF), AZELASTINE HYDROCHLORIDE, AZELASTINE SINCE 2013, AZITHROMYCIN, AZITHROMYCIN (ZITHROMAX Z-PACK), AZITHROMYCIN (ZITHROMAX), BUPROPION, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE 2011, CALCIUM, CLONAZEPAM, CLONAZEPAM (CLONOPIN), CLONAZEPAM (KLONOPIN) FROM 2012 TO 2015, CYCLOBENZAPRINE, DIFLUPREDNATE (DUREZOL), FISH OIL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) SINCE 2008, IBUPROFEN, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), LEVOTHYROXINE (L-THYROXINE), LIOTHYRONINE SODIUM (CYTOMEL), LISINOPRIL SINCE 2009, LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY), MELATONIN, METHYLPREDNISOLONE (MEDROL), METOPROLOL, METRONIDAZOLE (METROGEL), MICONAZOLE NITRATE (MONISTAT), MOMETASONE FUROATE, MOMETASONE FUROATE (NASONEX), MONTELUKAST, MONTELUKAST SODIUM (SINGULAIR) SINCE 2008, NYSTATIN, PREDNISONE, RANITIDINE, SENNOSIDE A+B (SENNOKOTT), SERTRALINE HYDROCHLORIDE (ZOLOFT) AND VERAPAMIL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN JULY 2012, THE PATIENT EXPERIENCED MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"), COITAL BLEEDING ("ABNORMAL BLEEDING AFTER INTERCOURSE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN AUGUST 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN SEPTEMBER 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN APRIL 2013, THE PATIENT EXPERIENCED RASH ("RASHES/RASHES ON MY FACE, CHEEKS /RASHES ON FINGERS, TOES, ELBOWS, ARMS, KNUCKLES AND HAND PAPULES"), EYELID RASH ("RASHES OR SKIN CONDITIONS TYPE: EYELIDS") AND ROSACEA ("RASHES OR SKIN CONDITIONS TYPE: ROSACEA"). IN MAY 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND REFLUX LARYNGITIS ("LARYNGOPHARYNGEAL REFLUX"). IN MAY 2016, THE PATIENT EXPERIENCED RASH PAPULAR ("RASHES OR SKIN CONDITIONS-TYPE: RASHES ON FINGERS, TOES, ELBOWS, ARMS, KNUCKLES AND HAND PAPULES"). IN SEPTEMBER 2016, THE PATIENT EXPERIENCED DERMATOMYOSITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND ANXIETY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION AND ANXIETY") AND GASTROOESOPHAGEAL REFLUX DISEASE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: ACID REFLUX/ GASTROESOPHAGEL REFLUX DISORDER"). ON (B)(6) 2017, THE PATIENT EXPERIENCED PYREXIA ("LOW GRADE FEVER"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("JOINT PAIN"), LIVEDO RETICULARIS ("LIVEDO RETICULARIS") AND MYDRIASIS ("DILATED EYES"). THE PATIENT WAS TREATED WITH DULOXETINE HYDROCHLORIDE (CYMBALTA), FAMOTIDINE, IMMUNOGLOBULIN G HUMAN (IZ IVIG), MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT), PAP SMEAR, SURGERY (OPERATIVE LAPAROSCOPY WITH REMOVAL OF THE ESSURE DEVICES AND BILATERAL SALPINGECTOMY AND HYSTERECTOMY AND BILATERAL SALPINGECTOMY), BONE MARROW BIOPSY AND PERFORMED SHAVE BIOPSY. ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, PELVIC PAIN, DERMATOMYOSITIS, SCLERITIS, FATIGUE, ARTHRALGIA, PYREXIA, HEADACHE, RASH, DEPRESSION, ANXIETY, EYELID RASH, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE, ROSACEA, LIVEDO RETICULARIS, REFLUX LARYNGITIS, MYDRIASIS AND RASH PAPULAR OUTCOME WAS UNKNOWN AND THE MIGRAINE, MENORRHAGIA, COITAL BLEEDING AND VAGINAL HAEMORRHAGE WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, ARTHRALGIA, COITAL BLEEDING, DEPRESSION, DERMATOMYOSITIS, DEVICE BREAKAGE, DEVICE EXPULSION, EYELID RASH, FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, HEADACHE, LIVEDO RETICULARIS, MENORRHAGIA, MIGRAINE, MYDRIASIS, PELVIC PAIN, PYREXIA, RASH, RASH PAPULAR, REFLUX LARYNGITIS, ROSACEA, SCLERITIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT 3, RIGHT 4. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23 KG/SQM. COMPUTERISED TOMOGRAM ABDOMEN - ON 06-MAY-2017: CONCLUSION: 1. UNREMARKABLE CT OF THE CHEST. 2. DECREASED SPLENIC CYST NOW MEASURING 3.1 CM IN MAXIMAL AXIAL DIMENSION AS COMPARED TO 6.1 CM PREVIOUSLY. 3. PROBABLE HEPATIC AND RENAL CYSTS, WITH MINIMAL CHANGE. 4. POTENTIAL SMALL HIATAL HERNIA.. NUCLEAR MAGNETIC RESONANCE IMAGING - ON 01-AUG-2013: IMPRESSION:- MRI OF THE BRAIN WITHIN NORMAL LIMITS. PATHOLOGY TEST - ON 07-AUG-2017: DIAGNOSIS: 1.SUBMITTED AS ¿ESSURE DEVICE IN RIGHT FALLOPIAN TUBE¿, EXPLANTED SURGICAL HARDWARE (GROSS ONLY) 2.FALLOPIAN TUBE, RIGHT, SALPINGECTOMY: FALLOPIAN TUBE WITH NO SIGNIFICANT PATHOLOGIC ABNORMALITY. 3.SUBMITTED AS ¿ESSURE DEVICE IN LEFT FALLOPIAN TUBE¿, EXPLANTED SURGICAL HARDWARE (GROSS ONLY). 4.FALLOPIAN TUBE, LEFT, SALPINGECTOMY: FALLOPIAN TUBE WITH BENIGN PARATUBAL SEROUS CYSTS, OTHERWISE UNREMARKABLE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: RASH, DEPRESSION, ANXIETY, VAGINAL BLEEDING, PELVIC PAIN, WEIGHT INCREASED, FATIGUE, MIGRAINE, REFLUX LARYNGITIS, MENORRHAGIA, ROSACEA, PYREXIA,DEVICE BREAKAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUN-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC 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) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE"), ARTHRALGIA ("JOINT PAIN"), PYREXIA ("LOW GRADE FEVER"), MIGRAINE ("MIGRAINES"), MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION") AND RASH ("RASHES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE, ARTHRALGIA, PYREXIA, MIGRAINE, MENORRHAGIA AND RASH OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, FATIGUE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PYREXIA AND RASH TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ON (B)(6) 2012, HYSTEROSALPINGOGRAM TEST CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. 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 |
|---|---|---|---|---|---|---|---|
| 216909 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R | AMITRIPTYLINE| AMITRIPTYLINE| AMOXICILLIN| AMOXICILLIN| AUGMENTIN BAMBINI| AUGMENTIN BAMBINI| AZELASTINE| AZELASTINE| AZELASTINE HYDROCHLORIDE| AZELASTINE HYDROCHLORIDE| AZITHROMYCIN| AZITHROMYCIN| BUPROPION| BUPROPION| CALCIUM| CALCIUM| CLARITIN-D ALLERGY| CLARITIN-D ALLERGY| CLONAZEPAM| CLONAZEPAM| CLONOPIN| CLONOPIN| CYCLOBENZAPRINE| CYCLOBENZAPRINE| CYTOMEL| CYTOMEL| DUREZOL| DUREZOL| ELAVIL [ALLOPURINOL]| ELAVIL [ALLOPURINOL]| FISH OIL| FISH OIL| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| KLONOPIN| KLONOPIN| L-THYROXINE [LEVOTHYROXINE]| LISINOPRIL| LISINOPRIL| MEDROL [METHYLPREDNISOLONE]| MEDROL [METHYLPREDNISOLONE]| MELATONIN| MELATONIN| METOPROLOL| METOPROLOL| METROGEL| METROGEL| MOMETASONE FUROATE| MOMETASONE FUROATE| MONISTAT| MONISTAT| MONTELUKAST| MONTELUKAST| NASONEX| NASONEX| NYSTATIN| NYSTATIN| PREDNISONE| PREDNISONE| RANITIDINE| RANITIDINE| REFRESH EYE ALLERGY RELIEF| REFRESH EYE ALLERGY RELIEF| SENNOKOTT| SENNOKOTT| SINGULAIR| SINGULAIR| THYROXINE| VERAPAMIL| VERAPAMIL| WELLBUTRIN| WELLBUTRIN| XYZAL| XYZAL| YAZ| YAZ| ZITHROMAX| ZITHROMAX| ZITHROMAX Z-PACK| ZITHROMAX Z-PACK| ZOLOFT| ZOLOFT |