ESSURE
Report
- Report Number
- 2951250-2019-07798
- Event Type
- Injury
- Date Received
- September 23, 2019
- Date of Event
- December 1, 2014
- Report Date
- February 27, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('LEFT ESSURE COIL IN PIECES/ ESSURE METALLIC COIL AND ATTACHED SMOOTH MUSCLE FRAGMENTS'), EMBEDDED DEVICE ('LEFT ESSURE COIL EMBEDDED IN CORNUA AND PROXIMAL LEFT TUBE'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MIGRATED TO ABDOMEN ON RIGHT/ ESSURE COIL IN ABDOMEN/ MIGRATED TO ABDOMEN ON RIGHT') AND PELVIC PAIN ('PELVIC PAIN/CHRONIC PELVIC PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C03090) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LEFT OCCLUSION ONLY/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S),". THE PATIENT'S MEDICAL HISTORY INCLUDED HEART MURMUR, DIFFICULTY SLEEPING, SHORTNESS OF BREATH, HIVES AND ITCHING. CONCURRENT CONDITIONS INCLUDED RASH, ALLERGIC REACTION TO ANALGESICS (CODEINE, FENTANYL, MORPHINE, TRAMADOL), DRUG ALLERGY, PAP SMEAR, PYELONEPHRITIS, CHEST PAIN, ASTHMA AND CHOLELITHIASIS. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, ALPRAZOLAM (ALPROZOLAM) FROM 2015 TO 2016, ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;COLECALCIFEROL;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;VITAMIN B12 NOS;ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA), DEXAMETHASONE, GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), HYDROMORPHONE, IBUPROFEN SINCE 2010, IPRATROPIUM BROMIDE;SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL), KETOROLAC, LIDOCAINE, LISDEXAMFETAMINE MESILATE (VYVANSE), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2014 TO (B)(6) 2019, NEOSTIGMINE, NITROFURANTOIN, ONDANSETRON, PARACETAMOL (ACETAMINOPHEN) SINCE 2010, PROPOFOL, RANITIDINE FROM 2010 TO 2014, ROCURONIUM, SALBUTAMOL SULFATE (PROAIR HFA), SERTRALINE SINCE 2018 AND ZOLPIDEM SINCE 2018. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING ( MENORRHAGIA),"), FATIGUE ("FATIGUE"), POLLAKIURIA ("BLADDER /URINARY: UNSPECIFIED/ BLADDER /URINARY PROVBLEMS CHANGES :- INCREASED FREQUENCY"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), PAPILLOMA VIRAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: LOW GRADE CHANGES AND POSITIVE FOR HIGH RISK HUMAN PAPILLOMA VIRUS") AND BIPOLAR DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: BIPOLAR DISORDER"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES"), HEADACHE ("HEADACHES") AND ABDOMINAL PAIN UPPER ("RIGHT UPPER QUADRANT PAIN"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2019, THE PATIENT EXPERIENCED DECREASED APPETITE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DECREASE IN APPETITE") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("ALLERGY") AND BLADDER DISORDER ("BLADDER /URINARY: UNSPECIFIED"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC REMOVAL OF MIGRATED RIGHT ESSURE COIL SURGICAL REMOVAL OF). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE DISLOCATION, PAPILLOMA VIRAL INFECTION AND DECREASED APPETITE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, FATIGUE, MIGRAINE, HEADACHE, HYPERSENSITIVITY, BLADDER DISORDER, POLLAKIURIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, BIPOLAR DISORDER, ABDOMINAL PAIN UPPER AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, BACK PAIN, BIPOLAR DISORDER, BLADDER DISORDER, DECREASED APPETITE, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, POLLAKIURIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: INSERTION DATE: (B)(6) 2014 (DISCREPANCY). SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS"DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, MIGRAINE, HEADACHES". DATE OF INSERTION: (B)(6) 2014, (B)(6) 2018. DATE OF REMOVAL: (B)(6) 2015, (B)(6) 2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: (UNSPECIFIED). RESULT: LEFT OCCLUSION ONLY. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2020: PFS& MR RECEIVED: - NEW REPORTER INFORMATION WAS ADDED. LOT NO WAS ADDED. NEW EVENT ADDED DEVICE BREAKAGE, EMBEDDED DEVICE, DEVICE DISLOCATION, GENITAL BLEEDING, VAGINAL BLEEDING, PAPILLOMA VIRAL INFECTION, BIPOLAR DISORDER, DECREASE IN APPETITE, RIGHT UPPER QUADRANT PAIN, LOWER ABDOMINAL PAIN. SEVERITY ADDED AND EVENT OUTCOME ADDED. MEDICAL HISTORY AND CONCOMITANT DRUGS, LAB TEST UPDATED. BLADDER DISORDER DELETED AND URINARY DISORDER UPDATED POLLAKIURIA. 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 DEVICE BREAKAGE ('LEFT ESSURE COIL IN PIECES/ ESSURE METALLIC COIL AND ATTACHED SMOOTH MUSCLE FRAGMENTS'), EMBEDDED DEVICE ('LEFT ESSURE COIL EMBEDDED IN CORNUA AND PROXIMAL LEFT TUBE'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MIGRATED TO ABDOMEN ON RIGHT/ ESSURE COIL IN ABDOMEN/ MIGRATED TO ABDOMEN ON RIGHT') AND PELVIC PAIN ('PELVIC PAIN/CHRONIC PELVIC PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C03090) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LEFT OCCLUSION ONLY/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED HEART MURMUR, DIFFICULTY SLEEPING, SHORTNESS OF BREATH, HIVES AND ITCHING. CONCURRENT CONDITIONS INCLUDED RASH, ALLERGIC REACTION TO ANALGESICS (CODEINE, FENTANYL, MORPHINE, TRAMADOL), DRUG ALLERGY, PAP SMEAR ABNORMAL, PYELONEPHRITIS, CHEST PAIN, ASTHMA AND CHOLELITHIASIS. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, ALPRAZOLAM (ALPROZOLAM) FROM 2015 TO 2016, ASCORBIC ACID;BETACAROTENE; CALCIUM CARBONATE; COLECALCIFEROL; DOCOSAHEXAENOIC ACID; FERROUS FUMARATE; FOLIC ACID;NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; VITAMIN B12 NOS; ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA), DEXAMETHASONE, GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE), HYDROCODONE BITARTRATE; PARACETAMOL (VICODIN), HYDROMORPHONE, IBUPROFEN SINCE 2010, IPRATROPIUM BROMIDE; SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL), KETOROLAC, LIDOCAINE, LISDEXAMFETAMINE MESILATE (VYVANSE), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2014 TO (B)(6) 2019, NEOSTIGMINE, NITROFURANTOIN, ONDANSETRON, PARACETAMOL (ACETAMINOPHEN) SINCE 2010, PROPOFOL, RANITIDINE FROM 2010 TO 2014, ROCURONIUM, SALBUTAMOL SULFATE (PROAIR HFA), SERTRALINE SINCE 2018 AND ZOLPIDEM SINCE 2018. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) OF 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING ( MENORRHAGIA),, FATIGUE ("FATIGUE"), POLLAKIURIA ("BLADDER /URINARY: UNSPECIFIED/ BLADDER /URINARY PROVBLEMS CHANGES : INCREASED FREQUENCY"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL), PAPILLOMA VIRAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: LOW GRADE CHANGES AND POSITIVE FOR HIGH RISK HUMAN PAPILLOMA VIRUS") AND BIPOLAR DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: BIPOLAR DISORDER"). IN (B)(6) OF 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES"), HEADACHE ("HEADACHES") AND ABDOMINAL PAIN UPPER ("RIGHT UPPER QUADRANT PAIN"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) OF 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2019, THE PATIENT EXPERIENCED DECREASED APPETITE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DECREASE IN APPETITE") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("ALLERGY") AND BLADDER DISORDER ("BLADDER /URINARY: UNSPECIFIED"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC REMOVAL OF MIGRATED RIGHT ESSURE COIL SURGICAL REMOVAL OF). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE DISLOCATION, PAPILLOMA VIRAL INFECTION AND DECREASED APPETITE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, FATIGUE, MIGRAINE, HEADACHE, HYPERSENSITIVITY, BLADDER DISORDER, POLLAKIURIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, BIPOLAR DISORDER, ABDOMINAL PAIN UPPER AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, BACK PAIN, BIPOLAR DISORDER, BLADDER DISORDER, DECREASED APPETITE, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, POLLAKIURIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS"DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, MIGRAINE, HEADACHES". DATE OF INSERTION: (B)(6) 2014, (B)(6) 2018. (DISCREPANCY). DATE OF REMOVAL: (B)(6) 2015, (B)(6) 2019, (B)(6) 2019. (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: (UNSPECIFIED). RESULT: LEFT OCCLUSION ONLY. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 DEVICE BREAKAGE ('LEFT ESSURE COIL IN PIECES/ ESSURE METALLIC COIL AND ATTACHED SMOOTH MUSCLE FRAGMENTS'), EMBEDDED DEVICE ('LEFT ESSURE COIL EMBEDDED IN CORNUA AND PROXIMAL LEFT TUBE'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: MIGRATED TO ABDOMEN ON RIGHT/ ESSURE COIL IN ABDOMEN/ MIGRATED TO ABDOMEN ON RIGHT') AND PELVIC PAIN ('PELVIC PAIN/CHRONIC PELVIC PAIN') IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C03090) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LEFT OCCLUSION ONLY/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S)". THE PATIENT'S MEDICAL HISTORY INCLUDED HEART MURMUR, DIFFICULTY SLEEPING, SHORTNESS OF BREATH, HIVES AND ITCHING. CONCURRENT CONDITIONS INCLUDED RASH, ALLERGIC REACTION TO ANALGESICS (CODEINE, FENTANYL, MORPHINE, TRAMADOL), DRUG ALLERGY, PAP SMEAR ABNORMAL, PYELONEPHRITIS, CHEST PAIN, ASTHMA AND CHOLELITHIASIS. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, ALPRAZOLAM (ALPROZOLAM) FROM 2015 TO 2016, ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;COLECALCIFEROL;DOCOSAHEXAENOIC ACID;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;VITAMIN B12 NOS;ZINC OXIDE (PRENATAL MULTIVITAMIN + DHA), DEXAMETHASONE, GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE), HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), HYDROMORPHONE, IBUPROFEN SINCE 2010, IPRATROPIUM BROMIDE;SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL), KETOROLAC, LIDOCAINE, LISDEXAMFETAMINE MESILATE (VYVANSE), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM(B)(6) 2014 TO (B)(6) 2019, NEOSTIGMINE, NITROFURANTOIN, ONDANSETRON, PARACETAMOL (ACETAMINOPHEN) SINCE 2010, PROPOFOL, RANITIDINE FROM 2010 TO 2014, ROCURONIUM, SALBUTAMOL SULFATE (PROAIR HFA), SERTRALINE SINCE 2018 AND ZOLPIDEM SINCE 2018. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING ( MENORRHAGIA),"), FATIGUE ("FATIGUE"), POLLAKIURIA ("BLADDER /URINARY: UNSPECIFIED/ BLADDER /URINARY PROVBLEMS CHANGES :- INCREASED FREQUENCY"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), PAPILLOMA VIRAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: LOW GRADE CHANGES AND POSITIVE FOR HIGH RISK HUMAN PAPILLOMA VIRUS") AND BIPOLAR DISORDER ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: BIPOLAR DISORDER"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES"), HEADACHE ("HEADACHES") AND ABDOMINAL PAIN UPPER ("RIGHT UPPER QUADRANT PAIN"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 7 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2019, THE PATIENT EXPERIENCED DECREASED APPETITE ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DECREASE IN APPETITE") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("ALLERGY"), BLADDER DISORDER ("BLADDER /URINARY: UNSPECIFIED") AND PERINATAL DEPRESSION ("POSTPARTUM DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) - LAPAROSCOPIC REMOVAL OF MIGRATED RIGHT ESSURE COIL SURGICAL REMOVAL OF). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE DISLOCATION, PAPILLOMA VIRAL INFECTION, DECREASED APPETITE AND PERINATAL DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, FATIGUE, MIGRAINE, HEADACHE, HYPERSENSITIVITY, BLADDER DISORDER, POLLAKIURIA, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, BIPOLAR DISORDER, ABDOMINAL PAIN UPPER AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, BACK PAIN, BIPOLAR DISORDER, BLADDER DISORDER, DECREASED APPETITE, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PAPILLOMA VIRAL INFECTION, PELVIC PAIN, PERINATAL DEPRESSION, POLLAKIURIA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS"DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, MIGRAINE, HEADACHES". DATE OF INSERTION: (B)(6) 2014, (B)(6) 2018. (DISCREPANCY). DATE OF REMOVAL: (B)(6) 2015, (B)(6) 2019, (B)(6) 2019. (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: (UNSPECIFIED). RESULT: LEFT OCCLUSION ONLY. UNILATERAL OCCLUSION (LEFT TUBE OCCLUDED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA RECEIVED NEW EVENTS: POSTPARTUM DEPRESSION. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LEFT OCCLUSION ONLY". ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), HYPERSENSITIVITY ("ALLERGY"), BLADDER DISORDER ("BLADDER/URINARY: UNSPECIFIED") AND URINARY TRACT DISORDER ("BLADDER/URINARY: UNSPECIFIED"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERGONE SURGERY TO REMOVE THE DEVICE ON (B)(6) 2019). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, FATIGUE, MIGRAINE, HEADACHE, HYPERSENSITIVITY, BLADDER DISORDER AND URINARY TRACT DISORDER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: INSERTION DATE: 08SEP2014 (DISCREPANCY). SHE HAD RECEIVED TREATMENT FOR FOLLOWING EVENTS "DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, MIGRAINE, HEADACHES". DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON AN UNKNOWN DATE: (UNSPECIFIED). RESULT: LEFT OCCLUSION ONLY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: CORRECT CCC ADDED AND DPC CODE UPDATED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 899732 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C03090 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | ACETAMINOPHEN.| ACETAMINOPHEN.| ACETAMINOPHEN.| ALPRAZOLAM.| ALPRAZOLAM.| ALPRAZOLAM.| ALPROZOLAM.| ALPROZOLAM.| ALPROZOLAM.| DEPO PROVERA.| DEPO PROVERA.| DEPO PROVERA.| DEXAMETHASONE.| DEXAMETHASONE.| DEXAMETHASONE.| GLYCOPYRROLATE [GLYCOPYRRONIUM BROMIDE].| GLYCOPYRROLATE [GLYCOPYRRONIUM BROMIDE].| GLYCOPYRROLATE [GLYCOPYRRONIUM BROMIDE].| HYDROMORPHONE.| HYDROMORPHONE.| HYDROMORPHONE.| IBUPROFEN.| IBUPROFEN.| IBUPROFEN.| IPRATROPIUM/ALBUTEROL.| IPRATROPIUM/ALBUTEROL.| IPRATROPIUM/ALBUTEROL.| KETOROLAC.| KETOROLAC.| KETOROLAC.| LIDOCAINE.| LIDOCAINE.| LIDOCAINE.| NEOSTIGMINE.| NEOSTIGMINE.| NEOSTIGMINE.| NITROFURANTOIN.| NITROFURANTOIN.| NITROFURANTOIN.| ONDANSETRON.| ONDANSETRON.| ONDANSETRON.| PRENATAL MULTIVITAMIN + DHA.| PRENATAL MULTIVITAMIN + DHA.| PRENATAL MULTIVITAMIN + DHA.| PROAIR HFA.| PROAIR HFA.| PROAIR HFA.| PROPOFOL.| PROPOFOL.| PROPOFOL.| RANITIDINE.| RANITIDINE.| RANITIDINE.| ROCURONIUM.| ROCURONIUM.| ROCURONIUM.| SERTRALINE.| SERTRALINE.| SERTRALINE.| VICODIN.| VICODIN.| VICODIN.| VYVANSE.| VYVANSE.| VYVANSE.| ZOLPIDEM.| ZOLPIDEM.| ZOLPIDEM. |