ESSURE
Report
- Report Number
- 2951250-2017-07078
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- June 4, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ANXIETY, DEPRESSION, MENORRHAGIA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED: NEW EVENTS: VAGINAL HAEMORRHAGE, MENORRHAGIA, REPORTER, PATIENT DEMOGRAPHIC INFORMATION ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') AND TOOTH DISORDER ('DENTAL PROBLEMS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 771092) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), URTICARIA ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HIVES/RASHES"), ALOPECIA AREATA ("RASHES OR SKIN CONDITIONS DISORDER: ALOPECIA AREATA"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES / HEADACHES"), TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ARTHRALGIA ("JOINT PAIN"), PAIN IN EXTREMITY ("HAND PAIN /LEG PAIN"), BACK PAIN ("BACK PAIN"), NECK PAIN ("NECK PAIN"), HYPOVITAMINOSIS ("VITAMIN DEFICIENCIES") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROOT CANAL AND TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ANXIETY, DEPRESSION, MENORRHAGIA, VAGINAL HAEMORRHAGE, URTICARIA, ALOPECIA AREATA, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, FATIGUE, ALOPECIA, PAIN IN EXTREMITY, BACK PAIN AND NECK PAIN OUTCOME WAS UNKNOWN AND THE MIGRAINE, DYSMENORRHOEA, WEIGHT INCREASED, ARTHRALGIA, HYPOVITAMINOSIS AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ALOPECIA AREATA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HYPOVITAMINOSIS, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-2020: PFS RECEIVED- NEW EVENT ABNORMAL BLEEDING (GENERAL), ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HIVES/RASHES, AUTOIMMUNE DISORDER TYPE OF DISORDER: ALOPECIA AREATA, BLADDER OR URINARY PROBLEMSOR CHANGES, MIGRAINES / HEADACHES, RASHES OR SKIN CONDITIONSTYPE: URTICARIA, DENTAL PROBLEMS,DYSMENORRHEA (CRAMPING), DYSPAREUNIA, FATIGUE, HAIR LOSS, WEIGHT GAIN, JOINT PAIN, HAND PAIN /LEG PAIN, BACK PAIN, NECK PAIN, VITAMIN DEFICIENCIES, BLOATING WERE ADDED.EVENT OUTCOME OF JOINT PAIN, VITAMIN DEFICIENCIES, MIGRAINES, PAINFUL PERIODS/ CRAMPING, RASHES/HIVES, BLOATING/WEIGHT GAIN WERE UPDATED.SERIOUSNESS CRITERIA (MEDICALLY SIGNIFICANT) OF EVENT GENITAL HEMORRHAGE WAS REMOVED. LOT NUMBER WAS RECEIVED. 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 PELVIC PAIN ('PAIN') AND TOOTH DISORDER ('DENTAL PROBLEMS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 771092) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), URTICARIA ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HIVES/RASHES"), ALOPECIA AREATA ("RASHES OR SKIN CONDITIONS DISORDER: ALOPECIA AREATA"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES / HEADACHES"), TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ARTHRALGIA ("JOINT PAIN"), PAIN IN EXTREMITY ("HAND PAIN /LEG PAIN"), BACK PAIN ("BACK PAIN"), NECK PAIN ("NECK PAIN"), HYPOVITAMINOSIS ("VITAMIN DEFICIENCIES") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROOT CANAL AND TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ANXIETY, DEPRESSION, MENORRHAGIA, VAGINAL HAEMORRHAGE, URTICARIA, ALOPECIA AREATA, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, FATIGUE, ALOPECIA, PAIN IN EXTREMITY, BACK PAIN AND NECK PAIN OUTCOME WAS UNKNOWN AND THE MIGRAINE, DYSMENORRHOEA, WEIGHT INCREASED, ARTHRALGIA, HYPOVITAMINOSIS AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ALOPECIA AREATA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HYPOVITAMINOSIS, MENORRHAGIA, MIGRAINE, NECK PAIN, PAIN IN EXTREMITY, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBER:771092, MANUFACTURE DATE: 2010-08, EXPIRATION DATE: 2013-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE AND PELVIC PAIN 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 |
|---|---|---|---|---|---|---|---|
| 835105 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 771092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |