ESSURE
Report
- Report Number
- 2951250-2019-08475
- Event Type
- Injury
- Date Received
- September 26, 2019
- Report Date
- March 30, 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BREAKAGE/ EXPULSION- BREAKAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PELVIC PAIN FEMALE/ CHRONIC"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS- BLADDER PROBLEMS"), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND NERVOUS SYSTEM DISORDER ("NUERO CONDIT/PROBLEM") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),OOPHORECTOMY (BILATERAL},OTHER). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, FATIGUE, HEADACHE, NAUSEA, NERVOUS SYSTEM DISORDER AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DEVICE BREAKAGE, DYSPAREUNIA, FATIGUE, HEADACHE, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2013, 2014 RECEIVED TREATMENT FOR: DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC/ ABDOMINAL, BACK PAIN, BREAKAGE, DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: RESULT- BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-SEP-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. NO LOT NUMBER 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BREAKAGE/ EXPULSION- BREAKAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MICRONOR. CONCOMITANT PRODUCTS INCLUDED ETONOGESTREL (NEXPLANON) AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN FEMALE/ CHRONIC"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS- BLADDER PROBLEMS"), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), NERVOUS SYSTEM DISORDER ("NUERO CONDIT/PROBLEM") AND MIGRAINE ("MIGRAINES / HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),OOPHORECTOMY (BILATERAL},OTHER, SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, ABDOMINAL DISTENSION, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, FATIGUE, HEADACHE, NAUSEA, NERVOUS SYSTEM DISORDER, WEIGHT INCREASED AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2013, 2014, (B)(6) 2014 RECEIVED TREATMENT FOR: DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC/ ABDOMINAL, BACK PAIN, BREAKAGE, DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: RESULT- BILATERAL OCCLUSION; ON (B)(6) 2014: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: RESULT- NOT PROVIDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED. REPORTER INFORMATION, CONCOMITANT DRUGS, LAB DATA ADDED. EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), MIGRAINES / HEADACHES, DYSMENORRHEA (CRAMPING), GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE (' BREAKAGE') AND EMBEDDED DEVICE ('EMBEDDED WITHIN IN BILATERAL CORNUA AND BILATERAL PROXIMAL FALLOPIAN TUBE ARE SYMMETRIC SILVER COATED METALLIC COILED WIRE CONSIST WITH THE ESSURE COIL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BRONCHIAL LEIOMYOMA, ADENOMYOSIS, PARATUBAL CYST, HYPERKERATOSIS, MULTI GRAVIDA, GRAND MULTIPARITY AND SPONTANEOUS ABORTION (2 SPONTANEOUS ABORTIONS). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MICRONOR. CONCOMITANT PRODUCTS INCLUDED ETONOGESTREL (NEXPLANON) AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. 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), PELVIC PAIN ("PELVIC PAIN FEMALE/ CHRONIC"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS- BLADDER PROBLEMS"), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), NERVOUS SYSTEM DISORDER ("NUERO CONDIT/PROBLEM") AND MIGRAINE ("MIGRAINES / HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),OOPHORECTOMY (BILATERAL},OTHER, SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, EMBEDDED DEVICE, PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, ABDOMINAL DISTENSION, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, FATIGUE, HEADACHE, NAUSEA, NERVOUS SYSTEM DISORDER, WEIGHT INCREASED AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2013, 2014, (B)(6) 2014. RECEIVED TREATMENT FOR: DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC/ ABDOMINAL, BACK PAIN, BREAKAGE, ESSURE WAS PLACED WITH 5 TRAILING COILS REMAINING AND SUBSEQUENTLY RIGHT ESSURE PLACED WITH 5 TRAILING COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: RESULT- BILATERAL OCCLUSION; ON (B)(6) 2014: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: RESULT- NOT PROVIDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAR-2020: MR RECEIVED REPORTER'S INFORMATION WERE ADDED. EVENT: EMBEDDED WITHIN IN BILATERAL CORNUA AND BILATERAL PROXIMAL FALLOPIAN TUBE ARE SYMMETRIC SILVER COATED METALLIC COILED WIRE CONSIST WITH THE ESSURE COIL WERE ADDED. FU 5 AND 6 PROCESSED TOGETHER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BREAKAGE/ EXPULSION- BREAKAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PELVIC PAIN FEMALE/ CHRONIC"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), BLADDER DISORDER ("BLADDER/URINARY PROBLEMS- BLADDER PROBLEMS"), FATIGUE ("FATIGUE"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND NERVOUS SYSTEM DISORDER ("NEURO CONDIT/PROBLEM") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),OOPHORECTOMY (BILATERAL},OTHER). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, PSYCHOLOGICAL TRAUMA, BLADDER DISORDER, FATIGUE, HEADACHE, NAUSEA, NERVOUS SYSTEM DISORDER AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, DEVICE BREAKAGE, DYSPAREUNIA, FATIGUE, HEADACHE, NAUSEA, NERVOUS SYSTEM DISORDER, PELVIC PAIN, PSYCHOLOGICAL TRAUMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2013, 2014 RECEIVED TREATMENT FOR: DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC/ ABDOMINAL, BACK PAIN, BREAKAGE, DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST(S) CONDUCTED, SPECIFY: RESULT- BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PFS RECEIVED. EVENT INJURY WAS UPDATED AND NEW EVENTS: DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),PELVIC/ ABDOMINAL, BACK PAIN, BREAKAGE/ EXPULSION- BREAKAGE, PSYCH INJURY, BLADDER/URINARY PROBLEMS- BLADDER PROBLEMS, OTHER INJURIES/SYMPTOMS- FATIGUE, HEADACHES, NAUSEA, NEUROLOGICAL CONDIT/PROBLEM ,WEIGHT GAIN WERE ADDED. PLAINTIFFS INFORMATION AND LAB DATA ADDED. NO LOT NUMBER 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 |
|---|---|---|---|---|---|---|---|
| 918952 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | DEPO PROVERA| DEPO PROVERA| NEXPLANON| NEXPLANON |