ESSURE
Report
- Report Number
- 2951250-2019-11256
- Event Type
- Injury
- Date Received
- November 7, 2019
- Date of Event
- April 1, 2012
- Report Date
- June 11, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE/MALPOSITION ESSURE COILS'), EMBEDDED DEVICE ('A SIGNIFICANT AMOUNT OF COILS JUST UNDER THE SEROSA'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND HEAVY MENSTRUAL BLEEDING ('MENORRHAGIA/ EXCESSIVE VAGIAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871972, 869761) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA UNTIL (B)(6) 2010. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, UTERINE FIBROIDS AND UTERUS ENLARGED. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("PAIN LOWER BACK"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), ALLERGY TO METALS ("NICKEL ALLERGY"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION ¿ BLOATING, SWELLING OF STOMACH"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), ALOPECIA ("HAIR LOSS"), CYSTITIS ("INFECTION BLADDER"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND MIGRAINE ("MIGRAINES/HEADACHE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("PAIN ABDOMEN") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND YSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, ALLERGY TO METALS, VAGINAL DISCHARGE, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS, URINARY TRACT INFECTION, MIGRAINE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE BACK PAIN, ABDOMINAL DISTENSION, VAGINAL INFECTION AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 146 LBS. DATE OF INSERTION: (B)(6) 2011 (AS PER PIF )DISCREPANCY NOTED REMOVAL DETAILS: THERE APPEARED TO BE AT LEAST 3 COILS PRESENT AS WELL AS THE INSERT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. BILATERAL FALLOPIAN TUBES ARE SUCCESSFULLY OCCLUDED WITH ESSURE IMPLANTS.. LOT NUMBER: 869761 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06 . LOT NUMBER: 871972 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION, ABDOMINAL DISTENSION, ABDOMINAL PAIN QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUN-2021: MR RECEIVED. REPORTER INFORMATION ADDED. RCC UPDATED. NEW EVENT ADDED- EMBEDDED DEVICE. 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 DISLOCATION ('MIGRATION OF ESSURE DEVICE/MALPOSITION ESSURE COILS'), EMBEDDED DEVICE ('A SIGNIFICANT AMOUNT OF COILS JUST UNDER THE SEROSA'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND HEAVY MENSTRUAL BLEEDING ('MENORRHAGIA/ EXCESSIVE VAGIAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871972, 869761) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA UNTIL (B)(6) 2010. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, UTERINE FIBROIDS AND UTERUS ENLARGED. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("PAIN LOWER BACK"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), ALLERGY TO METALS ("NICKEL ALLERGY"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION ¿ BLOATING, SWELLING OF STOMACH"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), ALOPECIA ("HAIR LOSS"), CYSTITIS ("INFECTION BLADDER"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND MIGRAINE ("MIGRAINES/HEADACHE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("PAIN ABDOMEN") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND YSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, ALLERGY TO METALS, VAGINAL DISCHARGE, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS, URINARY TRACT INFECTION, MIGRAINE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE BACK PAIN, ABDOMINAL DISTENSION, VAGINAL INFECTION AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 146 LBS. DATE OF INSERTION: (B)(6) 2011 (AS PER PIF )DISCREPANCY NOTED REMOVAL DETAILS: THERE APPEARED TO BE AT LEAST 3 COILS PRESENT AS WELL AS THE INSERT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. BILATERAL FALLOPIAN TUBES ARE SUCCESSFULLY OCCLUDED WITH ESSURE IMPLANTS.. LOT NUMBER: 869761 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06; LOT NUMBER: 871972 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION, ABDOMINAL DISTENSION, ABDOMINAL PAIN. 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 11-JUN-2021: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT) 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 DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871972, 869761) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA UNTIL DECEMBER 2010. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, UTERINE FIBROIDS AND UTERUS ENLARGED. IN DECEMBER 2011, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2012, THE PATIENT EXPERIENCED BACK PAIN ("PAIN LOWER BACK"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION ¿ BLOATING, SWELLING OF STOMACH"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), ALOPECIA ("HAIR LOSS"), CYSTITIS ("INFECTION BLADDER"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND MIGRAINE ("MIGRAINES/HEADACHE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("PAIN ABDOMEN") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL DISCHARGE, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS, URINARY TRACT INFECTION, MIGRAINE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE BACK PAIN, ABDOMINAL DISTENSION, VAGINAL INFECTION AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, MIGRAINE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 146 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.4 KG/SQM. HYSTEROSALPINGOGRAM - ON 14-MAR-2012: TOTAL BILATERAL OCCLUSION. BILATERAL FALLOPIAN TUBES ARE SUCCESSFULLY OCCLUDED WITH ESSURE IMPLANTS.. LOT NUMBER: 869761 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06 . LOT NUMBER: 871972 MANUFACTURE DATE: 2011-06 EXPIRATION DATE: 2014-06 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-NOV-2019: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 DISLOCATION ('MIGRATION OF ESSURE DEVICE'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)') AND MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871972, 869761) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA UNTIL (B)(6) 2010. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, UTERINE FIBROIDS AND UTERUS ENLARGED. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("PAIN LOWER BACK"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), ALLERGY TO METALS ("NICKEL ALLERGY"), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION ¿ BLOATING, SWELLING OF STOMACH"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), ALOPECIA ("HAIR LOSS"), CYSTITIS ("INFECTION BLADDER"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND MIGRAINE ("MIGRAINES/HEADACHE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("PAIN ABDOMEN") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, ALLERGY TO METALS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL DISCHARGE, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, CYSTITIS, URINARY TRACT INFECTION, MIGRAINE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE BACK PAIN, ABDOMINAL DISTENSION, VAGINAL INFECTION AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, MIGRAINE, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.4 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. BILATERAL FALLOPIAN TUBES ARE SUCCESSFULLY OCCLUDED WITH ESSURE IMPLANTS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2019: PLAINTIFF FACT SHEET: CASE BECOMES INCIDENT. PREVIOUSLY REPORTED EVENT ¿INJURY TO HERSELF¿ REPLACED BY NEW SPECIFIC EVENTS: MIGRATION OF ESSURE DEVICE, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), BLADDER OR URINARY PROBLEMS OR CHANGES, URINARY PROBLEMS OR CHANGES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION ¿ BLOATING, SWELLING OF STOMACH, HAIR LOSS, INFECTION BLADDER, URINARY TRACT INFECTION, VAGINAL INFECTION, MIGRAINES/HEADACHE, NICKEL ALLERGY, WEIGHT GAIN, VAGINAL DISCHARGE, PAIN LOWER BACK AND PAIN ABDOMEN WERE ADDED. LOT NUMBER, INDICATION, ESSURE INSERTION AND REMOVAL DATE WERE ADDED. PATIENT DATE OF BIRTH, HEIGHT AND WEIGHT WERE ADDED. NEW REPORTER, MEDICAL HISTORY AND LAB DATA WERE 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1084949 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 871972, 869761 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R |