ESSURE
Report
- Report Number
- 2951250-2017-10065
- Event Type
- Injury
- Date Received
- December 6, 2017
- Report Date
- August 16, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MORBID OBESITY, CHRONIC PAIN, MIGRAINE, HEADACHE, DEGENERATIVE DISC DISEASE, ALLERGIC RHINITIS, HEADACHE, AGORAPHOBIA, STRESS INCONTINENCE, PLANTAR FASCIAL FIBROMATOSIS, OSTEOARTHROSIS, FIBROMYALGIA, BIPOLAR DISORDER, CHRONIC PAIN, CARPAL TUNNEL SYNDROME, CESAREAN SECTION, PREGNANCY IN MARCH 2013 AND UNSPECIFIED ABORTION ON (B)(6) 2014. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: INDOCIN. CONCURRENT CONDITIONS INCLUDED BLACK STOOLS, SORE THROAT, FEVER, GENERAL BODY PAIN, RESPIRATORY TRACT CONGESTION, COUGH, EAR PAIN, SUBLUXATION, NUMBNESS, NECK PAIN, PARESTHESIA, STROKE, CHILLS, MENSTRUAL DISORDER, OCCIPITAL NEURALGIA, KNEE PAIN, CHEST TIGHTNESS, PALPITATIONS, CERVICAL PAIN, EYE PAIN, APHTHOUS STOMATITIS, SPINAL OSTEOARTHRITIS, SPASMODIC TORTICOLLIS, MOOD SWINGS, CONSTIPATION, LIBIDO DECREASED, EYE IRRITATION, EYE REDNESS, BURNING EYES, VAGINAL CYST, UNSPECIFIED ABORTION, PANIC DISORDER, MENOMETRORRHAGIA, INTRAMURAL LEIOMYOMA OF UTERUS AND OSTEOARTHROSIS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION IMAGING - ORDERS AND RESULTS XR CERVICAL SPINE 4 OR 5 VIEWS FINDINGS: THERE IS VISUALIZATION TO C7 ON THE LATERAL RADIOGRAPH. THERE IS NORMAL VERTEBRAL BODY ALIGNMENT THERE IS MILD MULTILEVEL DEGENERATIVE DISK DISEASE WITH ANTERIOR OSTEOPHYTES AND CALCIFICATION AT THE ANTERIOR LONGITUDINAL LIGAMENT PREVERTEBRAL SOFT TISSUES ARE OTHERWISE UNREMARKABLE. NO DEFINITE ACUTE FRACTURE DEFORMITY. NO SIGNIFICANT BONY NEURAL FORAMINAL STENOSIS DEMONSTRATED ON THE OBLIQUE IMAGES. ATLANTOAXIAL ARTICULATION IS SYMMETRIC. THE ODONTOID IS GROSSLY INTACT. IMPRESSION: MILD CERVICAL SPONDYLOSIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS VAGINAL BLEEDING, MENORRHAGIA, DYSMENORRHEA, PREGNANCY & SPONTANEOUS ABORTION ARE ADDED. LOT NUMBER ADDED. LAB DATA UPDATED. CONCOMITANT & HISTORICAL CONDITIONS & DRUGS ARE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. INCIDENT: AT THE TIME OF REPORTING, 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810890) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MORBID OBESITY, CHRONIC PAIN, MIGRAINE, HEADACHE, DEGENERATIVE DISC DISEASE, ALLERGIC RHINITIS, HEADACHE, AGORAPHOBIA, STRESS INCONTINENCE, PLANTAR FASCIAL FIBROMATOSIS, OSTEOARTHROSIS, FIBROMYALGIA, BIPOLAR DISORDER, CHRONIC PAIN, CARPAL TUNNEL SYNDROME, CESAREAN SECTION, PREGNANCY IN MARCH 2013 AND UNSPECIFIED ABORTION ON (B)(6) 2014. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: INDOCIN. CONCURRENT CONDITIONS INCLUDED STOOL TARRY, SORE THROAT, FEVER, GENERAL BODY PAIN, RESPIRATORY TRACT CONGESTION, COUGH, EAR PAIN, SUBLUXATION PATELLOFEMORAL JOINT, NUMBNESS, NECK PAIN, PARESTHESIA HAND, STROKE, CHILLS, CHRONIC PAROXYSMAL HEMICRANIA, OCCIPITAL NEURALGIA, KNEE PAIN, CHEST TIGHTNESS, PALPITATIONS, NECK PAIN, EYE PAIN, APHTHOUS STOMATITIS, SPINAL OSTEOARTHRITIS, SPASMODIC TORTICOLLIS, MOOD SWINGS, CONSTIPATION, LIBIDO DECREASED, EYE IRRITATION, EYE REDNESS, BURNING EYES, VAGINAL CYST, UNSPECIFIED ABORTION, PANIC DISORDER, MENOMETRORRHAGIA, INTRAMURAL LEIOMYOMA OF UTERUS AND OSTEOARTHROSIS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 5-AUG-2011: TOTAL BILATERAL OCCLUSION IMAGING - ORDERS AND RESULTS XR CERVICAL SPINE 4 OR 5 VIEWS FINDINGS: THERE IS VISUALIZATION TO C7 ON THE LATERAL RADIOGRAPH. THERE IS NORMAL VERTEBRAL BODY ALIGNMENT THERE IS MILD MULTILEVEL DEGENERATIVE DISK DISEASE WITH ANTERIOR OSTEOPHYTES AND CALCIFICATION AT THE ANTERIOR LONGITUDINAL LIGAMENT PREVERTEBRAL SOFT TISSUES ARE OTHERWISE UNREMARKABLE. NO DEFINITE ACUTE FRACTURE DEFORMITY. NO SIGNIFICANT BONY NEURAL FORAMINAL STENOSIS DEMONSTRATED ON THE OBLIQUE IMAGES. ATLANTOAXIAL ARTICULATION IS SYMMETRIC. THE ODONTOID IS GROSSLY INTACT. IMPRESSION: MILD CERVICAL SPONDYLOSIS . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT: AT THE TIME OF REPORTING, 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") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED 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 |
|---|---|---|---|---|---|---|---|
| 866406 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |