ESSURE
Report
- Report Number
- 2951250-2019-03791
- Event Type
- Injury
- Date Received
- July 12, 2019
- Report Date
- November 19, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY'), UTERINE INFECTION ('UTERINE INFECTION'), SYSTEMIC LUPUS ERYTHEMATOSUS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: LUPUS') AND RHEUMATOID ARTHRITIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: RA,') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, MULTIPAROUS AND ARTHRITIS RHEUMATOID. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED LUPUS SYNDROME, SEIZURES AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN (MOTRIN) SINCE (B)(6) 2012 AND TRAMADOL SINCE (B)(6) 2012. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL), TYPE: UTI,"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL), TYPE: YEAST INFECTION"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY DISORDER"). IN (B)(6) 2012, THE PATIENT EXPERIENCED SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2014, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"). IN (B)(6) 2017, THE PATIENT EXPERIENCED SEIZURE ("SEIZURES"). IN (B)(6) 2018, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), MIGRAINE ("MIGRAINES/HEADACHES"), FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG"), ENDOMETRIOSIS ("ENDOMETRIOSIS,") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, UTERINE INFECTION, SYSTEMIC LUPUS ERYTHEMATOSUS, RHEUMATOID ARTHRITIS, PELVIC PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VULVOVAGINAL MYCOTIC INFECTION, DEPRESSION, ANXIETY, MIGRAINE, FEELING ABNORMAL, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA, ENDOMETRIOSIS, ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, BACK PAIN, ARTHRALGIA, SEIZURE, ABDOMINAL PAIN, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FEELING ABNORMAL, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, RHEUMATOID ARTHRITIS, SEIZURE, SYSTEMIC LUPUS ERYTHEMATOSUS, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATES OF LIVE BIRTHS: (B)(6) 2012 (DISCREPANCY NOTED, REPORTED INSERTION DATE (B)(6) 2012). IF YOU CLAIM UNINTENDED PREGNANCY FOLLOWING ESSURE, PROVIDE: N/A (AS WRITTEN). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-NOV-2019: PFS RECEIVED: REPORTER INFORMATION, MEDICAL HISTORY, CONCOMITANT DRUG WAS ADDED. NEW EVENTS " SEIZURES, ABDOMINAL PAIN, BLADDER OR URINARY PROBLEMS OR CHANGES" WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. 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 PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY'), UTERINE INFECTION ('UTERINE INFECTION'), SYSTEMIC LUPUS ERYTHEMATOSUS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: LUPUS') AND RHEUMATOID ARTHRITIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: RA,') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO CONFIRMATION TEST". IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SYSTEMIC LUPUS ERYTHEMATOSUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), MOOD SWINGS ("MOOD SWING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL), TYPE: UTI,"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL), TYPE: YEAST INFECTION"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), MIGRAINE ("MIGRAINES/HEADACHES"), FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ALOPECIA ("HAIR LOSS"), ENDOMETRIOSIS ("ENDOMETRIOSIS,"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"), BACK PAIN ("LOWER BACK PAIN") AND ARTHRALGIA ("JOINT PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, UTERINE INFECTION, SYSTEMIC LUPUS ERYTHEMATOSUS, RHEUMATOID ARTHRITIS, PELVIC PAIN, MOOD SWINGS, VAGINAL HAEMORRHAGE, MENORRHAGIA, VULVOVAGINAL MYCOTIC INFECTION, DEPRESSION, ANXIETY, MIGRAINE, FEELING ABNORMAL, DYSMENORRHOEA, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA, ENDOMETRIOSIS, ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, BACK PAIN AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FEELING ABNORMAL, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, RHEUMATOID ARTHRITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, URINARY TRACT INFECTION, UTERINE INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-JUL-2019: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION UPDATED. PATIENT DEMOGRAPHIC INFORMATION UPDATED. PRODUCT INDICATION FEMALE STERILIZATION UPDATED. EVENTS: PAIN, HORMONAL CHANGES DESCRIBE: MOOD SWINGS, ABNORMAL BLEEDING VAGINAL, MENORRHAGIA, INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: UTI, INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: YEAST, INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: PELVIC INFLAMMATORY, INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: UTERINE, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, AUTOIMMUNE DISORDER TYPE OF DISORDER: LUPUS, AUTOIMMUNE DISORDER TYPE OF DISORDER:RA, MIGRAINES, HEADACHES, NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN, HAIR LOSS, OTHER INJURY(IES) OR COMPLICATION(S) PLEASE DESCRIBE: ENDOMETRIOSIS, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING, LOWER ABDOMEN PAIN, LOWER BACK PAIN, JOINT PAIN, PLAINTIFF DID NOT UNDERGO CONFIRMATION TEST WERE NEWLY ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S 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 |
|---|---|---|---|---|---|---|---|
| 577391 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | MOTRIN [IBUPROFEN]| TRAMADOL |