ESSURE
Report
- Report Number
- 2951250-2017-05595
- Event Type
- Injury
- Date Received
- October 27, 2017
- Date of Event
- January 1, 2011
- Report Date
- August 31, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)"), ABDOMINAL PAIN LOWER ("LOWER QUADRANT PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), UTERINE HAEMORRHAGE ("ABNORMAL, UTERINE BLEEDING WITH MENORRHAGIA."), GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") AND CELLULITIS ("INFECTION (OTHER) DESCRIBE: ABDOMINAL WALL CELLULITIS") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628434) INSERTED FOR BIRTH CONTROL. 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". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 2 (TOTAL NUMBER OF LIVE BIRTHS: 2 ((B)(6) 1990, (B)(6) 2007)), RECURRENT ABORTION (7 TERMINATIONS), AMNIOCENTESIS, PNEUMONIA (MEDICATION-2013. PERSISTENT RECURRENT PNEUMONIA, LEFT LOWER LOBE, WITH ATELECTASIS.), AXILLARY ABSCESS, DRAINAGE OF ABSCESS (I&D 2 DAYS), KNEE PAIN (PAIN SCORE: KNEE PAIN (07), SORENESS), BACK PAIN (PAIN SCORE: BACK (5). SORENESS IN BOTH), DYSURIA, VAGINAL ITCHING, TRANSFUSION, CESAREAN SECTION IN 2007, TUBAL LIGATION IN 2008, LUNG LOBECTOMY IN (B)(6) 2013, HYSTEROSCOPY IN 2008 AND FIBROIDS. NO HISTORY OF DIABETES, CORONARY ARTERY DISEASE (CAD), OR SLEEP APNEA, DRUG USE - NONE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: DEPO PROVERA FROM 2007 TO 2009; FOR AN UNREPORTED INDICATION: NSAID. CONCURRENT CONDITIONS INCLUDED OBESITY, HYPERTENSION, GESTATIONAL DIABETES, VAGINAL YEAST INFECTION, HEAVY PERIODS (VERY HEAVY PERIODS; THERE ARE ,7 DAYS WITH CLOTS), ANEMIA (SUBSEQUENT ,ANEMIA SECONDARY TO MENORRHAGIA), COUGHING, CONGESTION NASAL, FEVER CHILLS, ATELECTASIS (PERSISTENT RECURRENT PNEUMONIA, LEFT LOWER LOBE, WITH ATELECTASIS), HYPERKALEMIA, NONSMOKER, SLEEP APNEA, SEASONAL ALLERGY, SHORTNESS OF BREATH, SEPSIS, ALCOHOL USE AND INSOMNIA. FAMILY HISTORY INCLUDED HYPERTENSION (FATHER AND MOTHER) AND DIABETES MELLITUS (FATHER AND MOTHER). CONCOMITANT PRODUCTS INCLUDED AMLODIPINE (NORVASC) SINCE 2008 AND HYDROCHLOROTHIAZIDE SINCE 2008 FOR HYPERTENSION AS WELL AS IBUPROFEN SINCE 2010, IRON, ORAL ANTIDIABETICS SINCE 2007 AND TOPIRAMATE (TOPAMAX). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2009, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2009, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VULVOVAGINAL CANDIDIASIS ("CANDIDIASIS OF VAGINA"). ON (B)(6) 2010, THE PATIENT EXPERIENCED CELLULITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL MASS ("ABDOMINAL MASS IN STOMACH"). THE PATIENT WAS TREATED WITH CIPROFLOXACIN, METRONIDAZOLE (FLAGYL), FLUCONAZOLE (DIFLUCAN), BACTRIM (SEPTRAN), DOXYCYCLINE, KETOROLAC TROMETHAMINE (TORADOL), PROMETHAZINE (PHENERGAN), PHENTERMINE (ADIPEX), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY) AND ALTERNATIVE THERAPY (CALORIE CONTROL AND FOOD DIARY). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE MENORRHAGIA, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, UTERINE HAEMORRHAGE, GENITAL HAEMORRHAGE, HEADACHE, URINARY TRACT INFECTION, CELLULITIS, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS, MIGRAINE, WEIGHT INCREASED AND ABDOMINAL MASS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL MASS, ABDOMINAL PAIN LOWER, CELLULITIS, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, URINARY TRACT INFECTION, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE DID NOT CLAIMED THAT ESSURE CAUSED BIRTH DEFECTS. AFTER PLACEMENT, THERE WERE 7 COILS EXTANT CAVITY IN THE RIGHT SIDE AND 13 COILS EXTANT IN THE LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.3 KG/SQM. (B)(6) 2009, KNEE AP/LAT/OBL MIN 3 VIEWS HPN LEFT: IMPRESSION:UNREMARKABLE LEFT KNEE EXAMINATION. (B)(6) 2009, LUMBAR SPINE 2-3 VWS HPN: IMPRESSION: SLIGHT CURVATURE CONVEXED TO THE "LEFT SIDE WITHOUT DEGENERATIVE CHANGES AT THE LUMBOSACRAL JUNCTION. (B)(6) 2012, CHEST 2 VIEWS PA AND LAT HPC: IMPRESSION: INFILTRATE AND WHAT MAY BE SOME PLEURAL REACTIVE CHANGE NOTED AT THE LEFT LUNG BASE CONSISTENT WITH PNEUMONITIS. (B)(6) 2013, CTA CHEST EXAMINATION: IMPRESSION: RIGHT LOWER LOBE SEGMENTAL VOLUME LOSS, THE ETIOLOGY OF WHICH IS INDETERMINATE. A DISCRETE MASS IS NOT EVIDENT. NO PULMONARY EMBOLISM IDENTIFIED. (B)(6) 2013, LUNG, LEFT LOWER LOBE, ENDOBRONCHIAL BIOPSY: PREDOMINANTLY AGGREGATES OF DEGENERATIVE EOSINOPHILS. SCANT BENIGN GLANDULAR EPITHELIAL CELLS PRESENT. (B)(6) 2013, BRONCHIAL WASHING, CYTOLOGY: EOSINOPHILIC DEBRIS, SUGGESTIVE OF NUMEROUS DEGENERATING EOSINOPHILS. MALIGNANT CELLS ARE NOT DETECTED. (B)(6) 2015, CHEST 2 VIEW FRONTAL LATERAL: IMPRESSION: UNREMARKABLE CHEST EXAMINATION. (B)(6) 2015, MG-SCREENING DIGITAL MAMMOGRAM AND CAD: IMPRESSION: A NEGATIVE MAMMOGRAM SHOULD NON PERVERT BIOPSY OF A CLINICALLY SUSPICIOUS OR PALPABLE MASS. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ¿UTERINE HAEMORRHAGE¿ 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 MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)"), ABDOMINAL PAIN LOWER ("LOWER QUADRANT PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), UTERINE HAEMORRHAGE ("ABNORMAL, UTERINE BLEEDING WITH MENORRHAGIA."), GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") AND CELLULITIS ("INFECTION (OTHER) DESCRIBE: ABDOMINAL WALL CELLULITIS") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628434) INSERTED FOR BIRTH CONTROL. 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". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 2 (TOTAL NUMBER OF LIVE BIRTHS: 2 ((B)(6) 1990, (B)(6) 2007)), RECURRENT ABORTION (7 TERMINATIONS), AMNIOCENTESIS, PNEUMONIA (MEDICATION-2013. PERSISTENT RECURRENT PNEUMONIA, LEFT LOWER LOBE, WITH ATELECTASIS.), AXILLARY ABSCESS, DRAINAGE OF ABSCESS (I&D 2 DAYS), KNEE PAIN (PAIN SCORE: KNEE PAIN (07), SORENESS), BACK PAIN (PAIN SCORE: BACK (5). SORENESS IN BOTH), DYSURIA, VAGINAL ITCHING, TRANSFUSION, CESAREAN SECTION IN 2007, TUBAL LIGATION IN 2008, LUNG LOBECTOMY IN (B)(6) 2013, HYSTEROSCOPY IN 2008 AND FIBROIDS. NO HISTORY OF DIABETES, CORONARY ARTERY DISEASE (CAD), OR SLEEP APNEA, DRUG USE - NONE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: DEPO PROVERA FROM 2007 TO 2009; FOR AN UNREPORTED INDICATION: NSAID. CONCURRENT CONDITIONS INCLUDED OBESITY, HYPERTENSION, GESTATIONAL DIABETES, VAGINAL YEAST INFECTION, HEAVY PERIODS (VERY HEAVY PERIODS; THERE ARE ,7 DAYS WITH CLOTS), ANEMIA (SUBSEQUENT ,ANEMIA SECONDARY TO MENORRHAGIA), COUGHING, CONGESTION NASAL, FEVER CHILLS, ATELECTASIS (PERSISTENT RECURRENT PNEUMONIA, LEFT LOWER LOBE, WITH ATELECTASIS), HYPERKALEMIA, NONSMOKER, SLEEP APNEA, SEASONAL ALLERGY, SHORTNESS OF BREATH, SEPSIS, ALCOHOL USE AND INSOMNIA. FAMILY HISTORY INCLUDED HYPERTENSION (FATHER AND MOTHER) AND DIABETES MELLITUS (FATHER AND MOTHER). CONCOMITANT PRODUCTS INCLUDED AMLODIPINE (NORVASC) SINCE 2008 AND HYDROCHLOROTHIAZIDE SINCE 2008 FOR HYPERTENSION AS WELL AS IBUPROFEN SINCE 2010, IRON, ORAL ANTIDIABETICS SINCE 2007 AND TOPIRAMATE (TOPAMAX). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED CELLULITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VULVOVAGINAL CANDIDIASIS ("CANDIDIASIS OF VAGINA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES"), WEIGHT INCREASED ("WEIGHT GAIN") AND ABDOMINAL MASS ("ABDOMINAL MASS IN STOMACH"). THE PATIENT WAS TREATED WITH CIPROFLOXACIN, METRONIDAZOLE (FLAGYL), FLUCONAZOLE (DIFLUCAN), BACTRIM (SEPTRAN), DOXYCYCLINE, KETOROLAC TROMETHAMINE (TORADOL), PROMETHAZINE (PHENERGAN), PHENTERMINE (ADIPEX), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY) AND ALTERNATIVE THERAPY (CALORIE CONTROL AND FOOD DIARY). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE MENORRHAGIA, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, UTERINE HAEMORRHAGE, GENITAL HAEMORRHAGE, HEADACHE, URINARY TRACT INFECTION, CELLULITIS, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS, MIGRAINE, WEIGHT INCREASED AND ABDOMINAL MASS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL MASS, ABDOMINAL PAIN LOWER, CELLULITIS, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, URINARY TRACT INFECTION, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE DID NOT CLAIMED THAT ESSURE CAUSED BIRTH DEFECTS. AFTER PLACEMENT, THERE WERE 7 COILS EXTANT CAVITY IN THE RIGHT SIDE AND 13 COILS EXTANT IN THE LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.3 KG/SQM. (B)(6) 2009, KNEE AP/LAT/OBL MIN 3 VIEWS HPN LEFT: IMPRESSION:UNREMARKABLE LEFT KNEE EXAMINATION. (B)(6) 2009, LUMBAR SPINE 2-3 VWS HPN: IMPRESSION: SLIGHT CURVATURE CONVEXED TO THE "LEFT SIDE WITHOUT DEGENERATIVE CHANGES AT THE LUMBOSACRAL JUNCTION. (B)(6) 2012, CHEST 2 VIEWS PA AND LAT HPC: IMPRESSION: INFILTRATE AND WHAT MAY BE SOME PLEURAL REACTIVE CHANGE NOTED AT THE LEFT LUNG BASE CONSISTENT WITH PNEUMONITIS. (B)(6) 2013, CTA CHEST EXAMINATION: IMPRESSION: RIGHT LOWER LOBE SEGMENTAL VOLUME LOSS, THE ETIOLOGY OF WHICH IS INDETERMINATE. A DISCRETE MASS IS NOT EVIDENT. NO PULMONARY EMBOLISM IDENTIFIED. (B)(6) 2013, LUNG, LEFT LOWER LOBE, ENDOBRONCHIAL BIOPSY: PREDOMINANTLY AGGREGATES OF DEGENERATIVE EOSINOPHILS. SCANT BENIGN GLANDULAR EPITHELIAL CELLS PRESENT. (B)(6) 2013, BRONCHIAL WASHING, CYTOLOGY: EOSINOPHILIC DEBRIS, SUGGESTIVE OF NUMEROUS DEGENERATING EOSINOPHILS. MALIGNANT CELLS ARE NOT DETECTED. (B)(6) 2015, CHEST 2 VIEW FRONTAL LATERAL: IMPRESSION: UNREMARKABLE CHEST EXAMINATION. (B)(6) 2015, MG-SCREENING DIGITAL MAMMOGRAM AND CAD: IMPRESSION: A NEGATIVE MAMMOGRAM SHOULD NON PERVERT BIOPSY OF A CLINICALLY SUSPICIOUS OR PALPABLE MASS. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ¿UTERINE HAEMORRHAGE¿ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-FEB-2018: PFS AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. AKA NAMES ADDED. LOT NUMBER ADDED. CASE MEDICALLY CONFIRMED. EVENT , ABNORMAL UTERINE BLEEDING WITH MENORRHAGIA, ABNORMAL BLEEDING (VAGINAL), URINARY TRACT INFECTION, INFECTION (OTHER) DESCRIBE: ABDOMINAL WALL CELLULITIS, VAGINAL INFECTION, CANDIDIASIS OF VAGINA, MIGRAINES / HEADACHES, WEIGHT GAIN, ABDOMINAL MASS IN STOMACH, SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST, HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA WERE ADDED. CONCOMITANT, HISTORICAL DRUGS AND TREATMENT DRUGS WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ('ABNORMAL BLEEDING(MENORRHAGIA)'), ABDOMINAL PAIN LOWER ('LOWER QUADRANT PAIN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)'), ABNORMAL UTERINE BLEEDING ('ABNORMAL, UTERINE BLEEDING WITH MENORRHAGIA.'), GENITAL HAEMORRHAGE ('HEAVY AND IRREGULAR BLEEDING') AND CELLULITIS ('INFECTION (OTHER) DESCRIBE: ABDOMINAL WALL CELLULITIS') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628434) INSERTED FOR BIRTH CONTROL. 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". THE PATIENT'S MEDICAL HISTORY INCLUDED LUNG LOBECTOMY IN (B)(6) 2013, TUBAL LIGATION IN 2008, HYSTEROSCOPY IN 2008, CESAREAN SECTION IN 2007, MULTI GRAVIDA, PARITY 2 (TOTAL NUMBER OF LIVE BIRTHS: 2 ((B)(6) 1990, (B)(6) 2007)), RECURRENT ABORTION (7 TERMINATIONS), AMNIOCENTESIS, PNEUMONIA (MEDICATION-2013. PERSISTENT RECURRENT PNEUMONIA, LEFT LOWER LOBE, WITH ATELECTASIS.), AXILLARY ABSCESS, DRAINAGE OF ABSCESS (I&D 2 DAYS), KNEE PAIN (PAIN SCORE: KNEE PAIN (07), SORENESS), BACK PAIN (PAIN SCORE: BACK (5). SORENESS IN BOTH), DYSURIA, VAGINAL ITCHING, TRANSFUSION AND FIBROIDS. NO HISTORY OF DIABETES, CORONARY ARTERY DISEASE (CAD), OR SLEEP APNEA, DRUG USE - NONE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: DEPO PROVERA FROM 2007 TO 2009; FOR AN UNREPORTED INDICATION: NSAID. CONCURRENT CONDITIONS INCLUDED OBESITY, HYPERTENSION, GESTATIONAL DIABETES, VAGINAL YEAST INFECTION, HEAVY PERIODS (VERY HEAVY PERIODS; THERE ARE ,7 DAYS WITH CLOTS), ANEMIA (SUBSEQUENT ,ANEMIA SECONDARY TO MENORRHAGIA), COUGHING, CONGESTION NASAL, FEVER CHILLS, ATELECTASIS (PERSISTENT RECURRENT PNEUMONIA, LEFT LOWER LOBE, WITH ATELECTASIS), HYPERKALEMIA, NONSMOKER, SLEEP APNEA, SEASONAL ALLERGY, SHORTNESS OF BREATH, SEPSIS, ALCOHOL USE AND INSOMNIA. FAMILY HISTORY INCLUDED HYPERTENSION (FATHER AND MOTHER) AND DIABETES MELLITUS (FATHER AND MOTHER). CONCOMITANT PRODUCTS INCLUDED AMLODIPINE BESILATE (NORVASC) SINCE 2008 AND HYDROCHLOROTHIAZIDE SINCE 2008 FOR HYPERTENSION AS WELL AS IBUPROFEN SINCE 2010, IRON, ORAL ANTIDIABETICS SINCE 2007 AND TOPIRAMATE (TOPAMAX). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2009, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2009, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VULVOVAGINAL CANDIDIASIS ("CANDIDIASIS OF VAGINA"), 7 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2010, THE PATIENT EXPERIENCED CELLULITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2011, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABNORMAL UTERINE BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL MASS ("ABDOMINAL MASS IN STOMACH"). THE PATIENT WAS TREATED WITH CIPROFLOXACIN (CIPRO), DOXYCYCLINE, FLUCONAZOLE (DIFLUCAN), KETOROLAC TROMETHAMINE (TORADOL), METRONIDAZOLE (FLAGYL), PHENTERMINE (ADIPEX), PROMETHAZINE, SULFAMETHOXAZOLE;TRIMETHOPRIM (SEPTRA), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY), BLOOD TRANSFUSION AND CALORIE CONTROL AND FOOD DIARY. ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE HEAVY MENSTRUAL BLEEDING, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, ABNORMAL UTERINE BLEEDING, GENITAL HAEMORRHAGE, HEADACHE, URINARY TRACT INFECTION, CELLULITIS, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS, MIGRAINE, WEIGHT INCREASED AND ABDOMINAL MASS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL MASS, ABDOMINAL PAIN LOWER, ABNORMAL UTERINE BLEEDING, CELLULITIS, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE DID NOT CLAIMED THAT ESSURE CAUSED BIRTH DEFECTS. AFTER PLACEMENT, THERE WERE 7 COILS EXTANT CAVITY IN THE RIGHT SIDE AND 13 COILS EXTANT IN THE LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.3 KG/SQM. (B)(6) 2009, KNEE AP/LAT/OBL MIN 3 VIEWS HPN LEFT: IMPRESSION:UNREMARKABLE LEFT KNEE EXAMINATION. (B)(6) 2009, LUMBAR SPINE 2-3 VWS HPN: IMPRESSION: SLIGHT CURVATURE CONVEXED TO THE "LEFT SIDE WITHOUT DEGENERATIVE CHANGES AT THE LUMBOSACRAL JUNCTION. (B)(6) 2012, CHEST 2 VIEWS PA AND LAT HPC: IMPRESSION: INFILTRATE AND WHAT MAY BE SOME PLEURAL REACTIVE CHANGE NOTED AT THE LEFT LUNG BASE CONSISTENT WITH PNEUMONITIS. (B)(6) 2013, CTA CHEST EXAMINATION: IMPRESSION: RIGHT LOWER LOBE SEGMENTAL VOLUME LOSS, THE ETIOLOGY OF WHICH IS INDETERMINATE. A DISCRETE MASS IS NOT EVIDENT. NO PULMONARY EMBOLISM IDENTIFIED. (B)(6) 2013, LUNG, LEFT LOWER LOBE, ENDOBRONCHIAL BIOPSY: PREDOMINANTLY AGGREGATES OF DEGENERATIVE EOSINOPHILS. SCANT BENIGN GLANDULAR EPITHELIAL CELLS PRESENT. (B)(6) 2013, BRONCHIAL WASHING, CYTOLOGY: EOSINOPHILIC DEBRIS, SUGGESTIVE OF NUMEROUS DEGENERATING EOSINOPHILS. MALIGNANT CELLS ARE NOT DETECTED. (B)(6) 2015, CHEST 2 VIEW FRONTAL LATERAL: IMPRESSION: UNREMARKABLE CHEST EXAMINATION. (B)(6) 2015, MG-SCREENING DIGITAL MAMMOGRAM AND CAD: IMPRESSION: A NEGATIVE MAMMOGRAM SHOULD NON PERVERT BIOPSY OF A CLINICALLY SUSPICIOUS OR PALPABLE MASS. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ¿UTERINE HAEMORRHAGE¿, ABNORMAL UTERINE BLEEDING WITH MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-AUG-2021: QUALITY SAFETY EVALUATION OF PTC. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ('ABNORMAL BLEEDING(MENORRHAGIA)'), ABDOMINAL PAIN LOWER ('LOWER QUADRANT PAIN'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)'), ABNORMAL UTERINE BLEEDING ('ABNORMAL, UTERINE BLEEDING WITH MENORRHAGIA.'), GENITAL HAEMORRHAGE ('HEAVY AND IRREGULAR BLEEDING') AND CELLULITIS ('INFECTION (OTHER) DESCRIBE: ABDOMINAL WALL CELLULITIS') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628434) INSERTED FOR BIRTH CONTROL. 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". THE PATIENT'S MEDICAL HISTORY INCLUDED LUNG LOBECTOMY IN (B)(6) 2013, TUBAL LIGATION IN 2008, HYSTEROSCOPY IN 2008, CESAREAN SECTION IN 2007, MULTI GRAVIDA, PARITY 2 (TOTAL NUMBER OF LIVE BIRTHS: 2 ((B)(6) 1990, (B)(6) 2007)), RECURRENT ABORTION (7 TERMINATIONS), AMNIOCENTESIS, PNEUMONIA (MEDICATION-2013. PERSISTENT RECURRENT PNEUMONIA, LEFT LOWER LOBE, WITH ATELECTASIS.), AXILLARY ABSCESS, DRAINAGE OF ABSCESS (I&D 2 DAYS), KNEE PAIN (PAIN SCORE: KNEE PAIN (07), SORENESS), BACK PAIN (PAIN SCORE: BACK (5). SORENESS IN BOTH), DYSURIA, VAGINAL ITCHING, TRANSFUSION AND FIBROIDS. NO HISTORY OF DIABETES, CORONARY ARTERY DISEASE (CAD), OR SLEEP APNEA, DRUG USE - NONE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: DEPO PROVERA FROM 2007 TO 2009; FOR AN UNREPORTED INDICATION: NSAID. CONCURRENT CONDITIONS INCLUDED OBESITY, HYPERTENSION, GESTATIONAL DIABETES, VAGINAL YEAST INFECTION, HEAVY PERIODS (VERY HEAVY PERIODS; THERE ARE ,7 DAYS WITH CLOTS), ANEMIA (SUBSEQUENT ,ANEMIA SECONDARY TO MENORRHAGIA), COUGHING, CONGESTION NASAL, FEVER CHILLS, ATELECTASIS (PERSISTENT RECURRENT PNEUMONIA, LEFT LOWER LOBE, WITH ATELECTASIS), HYPERKALEMIA, NONSMOKER, SLEEP APNEA, SEASONAL ALLERGY, SHORTNESS OF BREATH, SEPSIS, ALCOHOL USE AND INSOMNIA. FAMILY HISTORY INCLUDED HYPERTENSION (FATHER AND MOTHER) AND DIABETES MELLITUS (FATHER AND MOTHER). CONCOMITANT PRODUCTS INCLUDED AMLODIPINE BESILATE (NORVASC) SINCE 2008 AND HYDROCHLOROTHIAZIDE SINCE 2008 FOR HYPERTENSION AS WELL AS IBUPROFEN SINCE 2010, IRON, ORAL ANTIDIABETICS SINCE 2007 AND TOPIRAMATE (TOPAMAX). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2009, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2009, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VULVOVAGINAL CANDIDIASIS ("CANDIDIASIS OF VAGINA"), 7 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2010, THE PATIENT EXPERIENCED CELLULITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2011, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABNORMAL UTERINE BLEEDING (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL MASS ("ABDOMINAL MASS IN STOMACH"). THE PATIENT WAS TREATED WITH CIPROFLOXACIN (CIPRO), DOXYCYCLINE, FLUCONAZOLE (DIFLUCAN), KETOROLAC TROMETHAMINE (TORADOL), METRONIDAZOLE (FLAGYL), PHENTERMINE (ADIPEX), PROMETHAZINE, SULFAMETHOXAZOLE;TRIMETHOPRIM (SEPTRA), SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY), BLOOD TRANSFUSION AND CALORIE CONTROL AND FOOD DIARY. ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE HEAVY MENSTRUAL BLEEDING, ABDOMINAL PAIN LOWER, VAGINAL HAEMORRHAGE, ABNORMAL UTERINE BLEEDING, GENITAL HAEMORRHAGE, HEADACHE, URINARY TRACT INFECTION, CELLULITIS, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS, MIGRAINE, WEIGHT INCREASED AND ABDOMINAL MASS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL MASS, ABDOMINAL PAIN LOWER, ABNORMAL UTERINE BLEEDING, CELLULITIS, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE DID NOT CLAIMED THAT ESSURE CAUSED BIRTH DEFECTS. AFTER PLACEMENT, THERE WERE 7 COILS EXTANT CAVITY IN THE RIGHT SIDE AND 13 COILS EXTANT IN THE LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 38.3 KG/SQM. (B)(6) 2009, KNEE AP/LAT/OBL MIN 3 VIEWS HPN LEFT: IMPRESSION:UNREMARKABLE LEFT KNEE EXAMINATION. (B)(6) 2009, LUMBAR SPINE 2-3 VWS HPN: IMPRESSION: SLIGHT CURVATURE CONVEXED TO THE "LEFT SIDE WITHOUT DEGENERATIVE CHANGES AT THE LUMBOSACRAL JUNCTION. (B)(6) 2012, CHEST 2 VIEWS PA AND LAT HPC: IMPRESSION: INFILTRATE AND WHAT MAY BE SOME PLEURAL REACTIVE CHANGE NOTED AT THE LEFT LUNG BASE CONSISTENT WITH PNEUMONITIS. (B)(6) 2013, CTA CHEST EXAMINATION: IMPRESSION: RIGHT LOWER LOBE SEGMENTAL VOLUME LOSS, THE ETIOLOGY OF WHICH IS INDETERMINATE. A DISCRETE MASS IS NOT EVIDENT. NO PULMONARY EMBOLISM IDENTIFIED. (B)(6) 2013, LUNG, LEFT LOWER LOBE, ENDOBRONCHIAL BIOPSY: PREDOMINANTLY AGGREGATES OF DEGENERATIVE EOSINOPHILS. SCANT BENIGN GLANDULAR EPITHELIAL CELLS PRESENT. (B)(6) 2013, BRONCHIAL WASHING, CYTOLOGY: EOSINOPHILIC DEBRIS, SUGGESTIVE OF NUMEROUS DEGENERATING EOSINOPHILS. MALIGNANT CELLS ARE NOT DETECTED. (B)(6) 2015, CHEST 2 VIEW FRONTAL LATERAL: IMPRESSION: UNREMARKABLE CHEST EXAMINATION. (B)(6) 2015, MG-SCREENING DIGITAL MAMMOGRAM AND CAD: IMPRESSION: A NEGATIVE MAMMOGRAM SHOULD NON PERVERT BIOPSY OF A CLINICALLY SUSPICIOUS OR PALPABLE MASS. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ¿UTERINE HAEMORRHAGE¿, ABNORMAL UTERINE BLEEDING WITH MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-AUG-2021: MR RECEIVED : REPORTER INFORMATION ADDED. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("LOWER QUADRANT PAIN") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. IN 2008, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (IN OR AROUND 2011, PATIENT UNDERWENT PELVIC SURGERY). AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 762791 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 628434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IRON| IRON| IRON| IRON| NORVASC| NORVASC| NORVASC| NORVASC| ORAL ANTIDIABETICS| ORAL ANTIDIABETICS| ORAL ANTIDIABETICS| ORAL ANTIDIABETICS| TOPAMAX| TOPAMAX| TOPAMAX| TOPAMAX |