ESSURE
Report
- Report Number
- 2951250-2017-07965
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- January 1, 2010
- Report Date
- August 26, 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
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("HEAVY BLEEDING / BLEEDING") IN A 48-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 "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: IUD AND ORTHO EVRA PATCH. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, FIBROMYALGIA AND BACK STRAIN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/SHARP STICKING PAIN/PELVIC PAIN/PELVIC STABBING PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN FEBRUARY 2012, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL PROBLEMS TOOTH ACHE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2013, THE PATIENT UNDERWENT TRANSFUSION ("BLOOD OR HEART DISORDER/CONDITION - TYPE: BLOOD TRANSFUSION"). ON (B)(6) 2013, 3 YEARS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED EPISTAXIS ("NOSE BLEEDING"), CHEST PAIN ("CHEST PAIN") AND HYPERTENSION ("BLOOD PRESSURE WAS 120/165"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("EXTREME DEBILITATING MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/BIG BLOOD CLOTHS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS: WEIGHT GAIN"), ABDOMINAL PAIN LOWER ("CRAMPS"), BLADDER PAIN ("BLADDER PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), NON-CONSUMMATION ("NOT SEXUALLY ACTIVE"), ALOPECIA ("HAIR LOSS") AND NERVOUS SYSTEM DISORDER ("NERVE SENSES WERE OUT OF CONTROL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), BILATERAL SALPINGECTOMY, OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MIGRAINE, ANXIETY, DEPRESSION, WEIGHT INCREASED, BACK PAIN AND NON-CONSUMMATION HAD NOT RESOLVED, THE HORMONE LEVEL ABNORMAL, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, HEADACHE, TOOTHACHE, PELVIC PAIN, ABDOMINAL PAIN, TRANSFUSION, EPISTAXIS, CHEST PAIN, HYPERTENSION, BLADDER PAIN, ALOPECIA AND NERVOUS SYSTEM DISORDER OUTCOME WAS UNKNOWN AND THE VAGINAL HAEMORRHAGE, DYSPAREUNIA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, BLADDER PAIN, CHEST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EPISTAXIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERTENSION, MENORRHAGIA, MIGRAINE, NERVOUS SYSTEM DISORDER, NON-CONSUMMATION, PELVIC PAIN, TOOTHACHE, TRANSFUSION, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE, OCCASIONS FOR SYMPTOMS OF EXTREME, DEBILITATING MENSTRUAL PAIN, HEAVY BLEEDING , AND MIGRAINES AMONG OTHER COMPLICATIONS.SHE REQUIRED TO UNDERGO A PARTIAL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICES ON OR ABOUT (B)(6) 2013. SHE WAS SUBSEQUENTLY REQUIRED TO UNDERGO A FULL HYSTERECTOMY ON OR ABOUT (B)(6) 2013. BECAUSE OF THE REQUIREMENT TO UNDERGO A HYSTERECTOMY/BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES, SHE HAD BEEN LEFT WITH SERIOUS INJURIES. CURRENT WEIGHT: 230 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.4 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-NOV-2018: PFS RECEIVED: REPORTERS ADDED. DEMOGRAPHIC CONDITIONS ADDED. INSERTION DATE UPDATED. EVENTS: HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL), APAREUNIA, BLADDER OR URINARY PROBLEMS, HEADACHES, TOOTH ACHE, DYSPAREUNIA, FATIGUE, WEIGHT GAIN, CRAMPS, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, BLOOD TRANSFUSION, HYPERTENSION, CHEST PAIN, NOSE BLEEDING, STOMACH PAIN, BLADDER PAIN, HAIR LOSS, NOT SEXUALLY ACTIVE, NERVES SYSTEM DISORDER WERE ADDED. EVENT ONSET DATE AND OUTCOME WERE UPDATED. CONCOMITANT AND HISTORICAL DRUGS WERE ADDED. CONCOMITANT CONDITIONS ADDED. REPORTER CAUSALITY COMMENTS 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 GENITAL HAEMORRHAGE ('HEAVY BLEEDING / BLEEDING') IN A 48-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 "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE FIBROIDS AND MENORRHAGIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: IUD AND ORTHO EVRA PATCH. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, FIBROMYALGIA AND BACK STRAIN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/SHARP STICKING PAIN/PELVIC PAIN/PELVIC STABBING PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN 2010, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/BIG BLOOD CLOTHS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL PROBLEMS TOOTH ACHE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2013, THE PATIENT UNDERWENT TRANSFUSION ("BLOOD OR HEART DISORDER/CONDITION - TYPE: BLOOD TRANSFUSION") AND EXPERIENCED ANAEMIA ("ANEMIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED EPISTAXIS ("NOSE BLEEDING"), CHEST PAIN ("CHEST PAIN") AND HYPERTENSION ("BLOOD PRESSURE WAS 120/165/ HIGH BLOOD PRESSURE"), 3 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("EXTREME DEBILITATING MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN LOWER ("CRAMPS"), THE FIRST EPISODE OF BLADDER PAIN ("BLADDER PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), NON-CONSUMMATION ("NOT SEXUALLY ACTIVE"), ALOPECIA ("HAIR LOSS"), PERIPHERAL SENSORY NEUROPATHY ("NERVE SENSES WERE OUT OF CONTROL"), MICTURITION URGENCY ("BLADDER URGENCY") AND THE SECOND EPISODE OF BLADDER PAIN ("BLADDER PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), BILATERAL SALPINGECTOMY, OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MIGRAINE, ANXIETY, DEPRESSION, WEIGHT INCREASED, BACK PAIN AND NON-CONSUMMATION HAD NOT RESOLVED, THE HORMONE LEVEL ABNORMAL, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, HEADACHE, TOOTHACHE, PELVIC PAIN, ABDOMINAL PAIN, TRANSFUSION, EPISTAXIS, CHEST PAIN, HYPERTENSION, PERIPHERAL SENSORY NEUROPATHY, ANAEMIA, MICTURITION URGENCY AND THE LAST EPISODE OF BLADDER PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, DYSPAREUNIA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, ANAEMIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CHEST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EPISTAXIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERTENSION, MENORRHAGIA, MICTURITION URGENCY, MIGRAINE, NON-CONSUMMATION, PELVIC PAIN, PERIPHERAL SENSORY NEUROPATHY, TOOTHACHE, TRANSFUSION, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF BLADDER PAIN AND THE SECOND EPISODE OF BLADDER PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE, OCCASIONS FOR SYMPTOMS OF EXTREME, DEBILITATING MENSTRUAL PAIN, HEAVY BLEEDING , AND MIGRAINES AMONG OTHER COMPLICATIONS. SHE REQUIRED TO UNDERGO A PARTIAL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICES ON OR ABOUT (B)(6) 2013. SHE WAS SUBSEQUENTLY REQUIRED TO UNDERGO A FULL HYSTERECTOMY ON OR ABOUT (B)(6) 2013. BECAUSE OF THE REQUIREMENT TO UNDERGO A HYSTERECTOMY/BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES, SHE HAD BEEN LEFT WITH SERIOUS INJURIES. CURRENT WEIGHT: 230 LBS. THE INTRODUCER WAS RETRACTED AND APPROXIMATELY 2 COILS WERE VISUALIZED. ATTENTION WAS THEN TURNED TO THE LEFT OSTIA WHERE A SIMILAR PROCEDURE WAS PERFORMED. UPON RETRACTION OF THE INTRODUCER, 3 COILS WERE VISUALIZED. 3 COILS WERE VISUALIZED. DISCREPANCY NOTED IN DATE OF REMOVAL (B)(6) 2013. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.4 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-AUG-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS 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 GENITAL HAEMORRHAGE ('HEAVY BLEEDING / BLEEDING'). IN A 48-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, "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED: UTERINE FIBROIDS AND MENORRHAGIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: IUD AND ORTHO EVRA PATCH. CONCURRENT CONDITIONS INCLUDED: OVERWEIGHT, FIBROMYALGIA AND BACK STRAIN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/SHARP STICKING PAIN/PELVIC PAIN/PELVIC STABBING PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN 2010, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/BIG BLOOD CLOTHS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL PROBLEMS TOOTH ACHE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN APRIL 2013, THE PATIENT UNDERWENT TRANSFUSION ("BLOOD OR HEART DISORDER/CONDITION, TYPE: BLOOD TRANSFUSION") AND EXPERIENCED ANAEMIA ("ANEMIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED EPISTAXIS ("NOSE BLEEDING"), CHEST PAIN ("CHEST PAIN") AND HYPERTENSION ("BLOOD PRESSURE WAS 120/165/HIGH BLOOD PRESSURE"), (B)(6) YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("EXTREME DEBILITATING MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN LOWER ("CRAMPS"). THE FIRST EPISODE OF BLADDER PAIN ("BLADDER PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), NON-CONSUMMATION ("NOT SEXUALLY ACTIVE"), ALOPECIA ("HAIR LOSS"), PERIPHERAL SENSORY NEUROPATHY ("NERVE SENSES WERE OUT OF CONTROL"), MICTURITION URGENCY ("BLADDER URGENCY"). AND THE SECOND EPISODE OF BLADDER PAIN ("BLADDER PAIN"). AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). AND WEIGHT INCREASED ("WEIGHT GAIN/LOSS: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), BILATERAL SALPINGECTOMY, OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MIGRAINE, ANXIETY, DEPRESSION, WEIGHT INCREASED, BACK PAIN AND NON-CONSUMMATION HAD NOT RESOLVED. THE HORMONE LEVEL ABNORMAL, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, HEADACHE, TOOTHACHE, PELVIC PAIN, ABDOMINAL PAIN, TRANSFUSION, EPISTAXIS, CHEST PAIN, HYPERTENSION, PERIPHERAL SENSORY NEUROPATHY, ANAEMIA, MICTURITION URGENCY AND THE LAST EPISODE OF BLADDER PAIN OUTCOME WAS UNKNOWN. THE VAGINAL HAEMORRHAGE, DYSPAREUNIA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED. AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, ANAEMIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CHEST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EPISTAXIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERTENSION, MENORRHAGIA, MICTURITION URGENCY, MIGRAINE, NON-CONSUMMATION, PELVIC PAIN, PERIPHERAL SENSORY NEUROPATHY, TOOTHACHE, TRANSFUSION, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF BLADDER PAIN AND THE SECOND EPISODE OF BLADDER PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE, OCCASIONS FOR SYMPTOMS OF EXTREME DEBILITATING MENSTRUAL PAIN, HEAVY BLEEDING , AND MIGRAINES AMONG OTHER COMPLICATIONS. SHE REQUIRED TO UNDERGO A PARTIAL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICES ON OR ABOUT (B)(6) 2013. SHE WAS SUBSEQUENTLY, REQUIRED TO UNDERGO A FULL HYSTERECTOMY ON OR ABOUT (B)(6) 2013. BECAUSE OF THE REQUIREMENT TO UNDERGO A HYSTERECTOMY/BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES, SHE HAD BEEN LEFT WITH SERIOUS INJURIES. CURRENT WEIGHT: 230 LBS. THE INTRODUCER WAS RETRACTED. AND APPROXIMATELY 2 COILS WERE VISUALIZED. ATTENTION WAS THEN TURNED TO THE LEFT OSTIA, WHERE A SIMILAR PROCEDURE WAS PERFORMED. UPON RETRACTION OF THE INTRODUCER, 3 COILS WERE VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS: INDEX WAS 26.4 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020, REPORTER, PATIENT DEMOGRAPHICS WERE ADDED. ADDED EVENTS: ANEMIA, BLADDER URGENCY, BLADDER PAIN. UPDATED OUTCOME OF EVENT ALOPECIA AS RECOVERING. ON (B)(6) 2020, MEDICAL RECORDS RECEIVED: MEDICAL HISTORY, REPORTER INFORMATION WERE 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 GENITAL HAEMORRHAGE ('HEAVY BLEEDING / BLEEDING') IN A 48-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 "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: IUD AND ORTHO EVRA PATCH. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, FIBROMYALGIA AND BACK STRAIN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/SHARP STICKING PAIN/PELVIC PAIN/PELVIC STABBING PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN 2010, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)/BIG BLOOD CLOTHS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED TOOTHACHE ("DENTAL PROBLEMS TOOTH ACHE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2013, THE PATIENT UNDERWENT TRANSFUSION ("BLOOD OR HEART DISORDER/CONDITION - TYPE: BLOOD TRANSFUSION") AND EXPERIENCED ANAEMIA ("ANEMIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED EPISTAXIS ("NOSE BLEEDING"), CHEST PAIN ("CHEST PAIN") AND HYPERTENSION ("BLOOD PRESSURE WAS 120/165/ HIGH BLOOD PRESSURE"), 3 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("EXTREME DEBILITATING MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN LOWER ("CRAMPS"), THE FIRST EPISODE OF BLADDER PAIN ("BLADDER PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), NON-CONSUMMATION ("NOT SEXUALLY ACTIVE"), ALOPECIA ("HAIR LOSS"), PERIPHERAL SENSORY NEUROPATHY ("NERVE SENSES WERE OUT OF CONTROL"), MICTURITION URGENCY ("BLADDER URGENCY") AND THE SECOND EPISODE OF BLADDER PAIN ("BLADDER PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL), BILATERAL SALPINGECTOMY, OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MIGRAINE, ANXIETY, DEPRESSION, WEIGHT INCREASED, BACK PAIN AND NON-CONSUMMATION HAD NOT RESOLVED, THE HORMONE LEVEL ABNORMAL, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, HEADACHE, TOOTHACHE, PELVIC PAIN, ABDOMINAL PAIN, TRANSFUSION, EPISTAXIS, CHEST PAIN, HYPERTENSION, PERIPHERAL SENSORY NEUROPATHY, ANAEMIA, MICTURITION URGENCY AND THE LAST EPISODE OF BLADDER PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, DYSPAREUNIA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED AND THE ALOPECIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN UPPER, ALOPECIA, ANAEMIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CHEST PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EPISTAXIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERTENSION, MENORRHAGIA, MICTURITION URGENCY, MIGRAINE, NON-CONSUMMATION, PELVIC PAIN, PERIPHERAL SENSORY NEUROPATHY, TOOTHACHE, TRANSFUSION, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF BLADDER PAIN AND THE SECOND EPISODE OF BLADDER PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE, OCCASIONS FOR SYMPTOMS OF EXTREME, DEBILITATING MENSTRUAL PAIN, HEAVY BLEEDING , AND MIGRAINES AMONG OTHER COMPLICATIONS.SHE REQUIRED TO UNDERGO A PARTIAL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICES ON OR ABOUT (B)(6) 2013. SHE WAS SUBSEQUENTLY REQUIRED TO UNDERGO A FULL HYSTERECTOMY ON OR ABOUT (B)(6) 2013. BECAUSE OF THE REQUIREMENT TO UNDERGO A HYSTERECTOMY/BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES, SHE HAD BEEN LEFT WITH SERIOUS INJURIES. CURRENT WEIGHT: 230 LBS. THE INTRODUCER WAS RETRACTED AND APPROXIMATELY 2 COILS WERE VISUALIZED. ATTENTION WAS THEN TURNED TO THE LEFT OSTIA WHERE A SIMILAR PROCEDURE WAS PERFORMED. UPON RETRACTION OF THE INTRODUCER, 3 COILS WERE VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.4 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: REPORTER, PATIENT DEMOGRAPHICS WERE ADDED. ADDED EVENTS ANEMIA, BLADDER URGENCY, BLADDER PAIN. UPDATED OUTCOME OF EVENT ALOPECIA AS RECOVERING. 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 GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("EXTREME DEBILITATING MENSTRUAL PAIN"), MIGRAINE ("MIGRAINES"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT WAS TREATED WITH SURGERY (UNDERGO A PARTIAL HYSTERECTOMY AND FULL HYSTERECTOMY TO REMOVE THE ESSURE DEVICES). ESSURE WAS REMOVED IN (B)(6) 2013. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA, MIGRAINE, ANXIETY AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT ON MULTIPLE, OCCASIONS FOR SYMPTOMS OF EXTREME, DEBILITATING MENSTRUAL PAIN, HEAVY BLEEDING , AND MIGRAINES AMONG OTHER COMPLICATIONS. SHE REQUIRED TO UNDERGO A PARTIAL HYSTERECTOMY AND REMOVAL OF THE ESSURE DEVICES ON OR ABOUT (B)(6) 2013. SHE WAS SUBSEQUENTLY REQUIRED TO UNDERGO A FULL HYSTERECTOMY ON OR ABOUT (B)(6) 2013. BECAUSE OF THE REQUIREMENT TO UNDERGO A HYSTERECTOMY/BILATERAL SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES, SHE HAD BEEN LEFT WITH SERIOUS INJURIES. 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 |
|---|---|---|---|---|---|---|---|
| 836114 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other| R |