ESSURE
Report
- Report Number
- 2951250-2020-12500
- Event Type
- Injury
- Date Received
- July 29, 2020
- Report Date
- August 25, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION'), DEVICE DISLOCATION ('IUD WAS OUT OF POSITION, IN LOWER UTERINE SEGMENT'), GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND HEMIPARAESTHESIA ('TINGLING ON LEFT SIDE OF MY FACE') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626978) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MIRENA INTRAUTERINE DELIVERY SYSTEM FOR HEAVY PERIODS. THE PATIENT'S MEDICAL HISTORY INCLUDED TENSION HEADACHE, CAESAREAN SECTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED OBESITY, ANXIETY, OVARIAN CYST, PANIC ATTACK, SCIATICA, FOLLICULITIS, VIRAL SYNDROME, SINUSITIS, FLANK PAIN, OVARIAN TORSION (RIGHT OVARIAN CYSTS), MENSES IRREGULAR, PAIN IN HIP, ANEMIA, VAGINAL CANDIDIASIS, CHEST PAIN, ROTATOR CUFF TENDINITIS (LEFT), COSTOCHONDRITIS, INSOMNIA, ACUTE STRESS DISORDER, PLANTAR FASCIITIS (RIGHT/LEFT), WEIGHT LOSS, OVARIAN CYST RUPTURED (RIGHT), ALCOHOL USE, ITCHING, COUGH, CHEST PAIN, PAIN IN HIP, LEG PAIN, PANIC DISORDER, GERD, INSOMNIA, WEAKNESS, SHORTNESS OF BREATH, PAIN, CHILLS, GENERAL BODY PAIN, DIARRHEA, CONJUNCTIVITIS, LIGHT HEADEDNESS, NECK PAIN, BREAST TENDERNESS, NAUSEA, JOINT PAIN, DYSPNEA AND VAGINAL IRRITATION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;NORETHISTERONE ACETATE (MICROGESTIN), IRON, NAPROXEN SINCE 2011, SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE 2015 AND SUMATRIPTAN (IMITREX) SINCE 2019. ON AN UNKNOWN DATE, THE PATIENT HAD MIRENA 52 MG INSERTED (INTRA-UTERINE), RELEASING PRODUCT AT 20 G PER DAY, CONTINUOUSLY. ON (B)(6) 2009, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 64 DAYS BEFORE INSERTION OF ESSURE. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2009, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL BLEEDING ("ABNORMAL BLEEDING (VAGINAL)"), HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2009, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN/ PELVIS PAIN"). IN (B)(6) 2009, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DYSMENORRHOEA ("MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"), BACK PAIN ("BACK PAIN/ LOWER BACK PAIN") AND PAIN IN EXTREMITY ("PAIN LEGS AND HANDS/ PAIN ARM/ PAIN THUMB"). IN (B)(6) 2009, THE PATIENT EXPERIENCED TEMPERATURE INTOLERANCE ("COLD INTOLERANCE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY/WORSENED ANXIETY"). IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN/ PAIN") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS/WEIGHT GAIN APPROX. 30 LBS TOTAL/ LOSS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY INFECTION"). ON (B)(6) 2020, THE PATIENT EXPERIENCED THE SECOND EPISODE OF DYSMENORRHOEA ("VERY PAINFUL MENSTRUAL CRAMPS WITH MIRENA / CRAMPING"). IN (B)(6) 2020, THE PATIENT EXPERIENCED SPOTTING VAGINAL ("SPOTTING ONE WEEK AFTER INSERTION OF MIRENA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("PAIN IN LEFT LOWER SIDE ABDOMEN"), ABDOMINAL DISTENSION ("BLOAT"), PAIN ("BODY ACHES"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), DENTAL CARIES ("TOOTH DECAY"), OVARIAN CYST ("OVARIAN CYSTS/ CYST IN HER OVARY"), SCIATICA ("SCIATICA"), ADNEXA UTERI CYST ("TUBULAR CYSTIC STRUCTURE IN THE LEFT ADNEXA"), ORGASM ABNORMAL ("CHANGE IN ORGASMS"), STRESS ("STRESS"), INSOMNIA ("INSOMNIA"), MUSCULOSKELETAL PAIN ("BUTTOCK PAIN IN LEFT SIDE"), ARTHRALGIA ("KNEE PAIN/ PAIN WRIST"), CYST ("CYST"), HOT FLUSH ("HOT FLESH"), CHEST PAIN ("CHEST PAIN"), TIREDNESS ("TIRED"), HEMIPARAESTHESIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MUSCULAR WEAKNESS ("LOOSING STRENGTH OF LEFT ARM") AND BREAST PAIN ("BREST PAIN"). THE PATIENT WAS TREATED WITH IBUPROFEN. ESSURE AND MIRENA TREATMENTS WERE NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, MENORRHAGIA, THE LAST EPISODE OF DYSMENORRHOEA, DYSPAREUNIA, VAGINAL BLEEDING, SPOTTING VAGINAL, BACK PAIN, ABDOMINAL DISTENSION, PAIN, HEADACHE, MIGRAINE, IRON DEFICIENCY ANAEMIA, DENTAL CARIES, FATIGUE, DEPRESSION, WEIGHT FLUCTUATION, URINARY TRACT INFECTION, OVARIAN CYST, PAIN IN EXTREMITY, ANXIETY, SCIATICA, ADNEXA UTERI CYST, TEMPERATURE INTOLERANCE, ALOPECIA, ORGASM ABNORMAL, STRESS, INSOMNIA, MUSCULOSKELETAL PAIN, ARTHRALGIA, CYST, HOT FLUSH, CHEST PAIN, TIREDNESS, HEMIPARAESTHESIA, MUSCULAR WEAKNESS AND BREAST PAIN OUTCOME WAS UNKNOWN AND THE DEVICE DISLOCATION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI CYST, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BREAST PAIN, CHEST PAIN, CYST, DENTAL CARIES, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEMIPARAESTHESIA, HOT FLUSH, INSOMNIA, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MIGRAINE, MUSCULAR WEAKNESS, MUSCULOSKELETAL PAIN, ORGASM ABNORMAL, OVARIAN CYST, PAIN, PAIN IN EXTREMITY, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, SCIATICA, STRESS, TEMPERATURE INTOLERANCE, URINARY TRACT INFECTION, VAGINAL BLEEDING, WEIGHT FLUCTUATION, THE FIRST EPISODE OF DYSMENORRHOEA, SPOTTING VAGINAL, TIREDNESS AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADNEXA UTERI CYST, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BREAST PAIN, CHEST PAIN, CYST, DENTAL CARIES, DEPRESSION, DEVICE DISLOCATION, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEMIPARAESTHESIA, HOT FLUSH, INSOMNIA, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MIGRAINE, MUSCULAR WEAKNESS, MUSCULOSKELETAL PAIN, ORGASM ABNORMAL, OVARIAN CYST, PAIN, PAIN IN EXTREMITY, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, SCIATICA, STRESS, TEMPERATURE INTOLERANCE, URINARY TRACT INFECTION, VAGINAL BLEEDING, WEIGHT FLUCTUATION, THE FIRST EPISODE OF DYSMENORRHOEA AND TIREDNESS WITH MIRENA. THE REPORTER CONSIDERED SPOTTING VAGINAL AND THE SECOND EPISODE OF DYSMENORRHOEA TO BE RELATED TO MIRENA. THE REPORTER COMMENTED: FIRST MIRENA WAS INSERTED ON (B)(6) 2007 FOR BIRTH CONTROL AND FOUND TO BE DISLOCATED IN LOWER UTERINE SEGMENT IN (B)(6) 2009. IT WAS REMOVED ON (B)(6) 2009 (DATE OF ESSURE INSERTION). SECOND MIRENA WAS INSERTED ON (B)(6) 2020 TO CONTROL HEAVY PERIODS. PER MR: INSERTION DETAILS OF ESSURE: RIGHT: 2 COILS LEFT: 0 COILS (POSSIBLY 0.5 CM DOWN TUBE). SHE HAD NOT UNDERGONE ESSURE (OR ANY PART OF THE DEVICE) REMOVAL, WAS NOW INTERESTED IN A HYSTERECTOMY FOR ONGOING MENOMETRORRHAGIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.2 KG/SQM. BIOPSY ENDOMETRIUM - ON (B)(6) 2020: NORMAL. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: FALLOPIAN TUBES WERE FULLY OCCLUDED. ULTRASOUND PELVIS - ON (B)(6) 2010: RIGHT OVARIAN CYSTS (TORSION); ON (B)(6) 2020: UTERUS ANTEVERTED IN MIDLINE, ENDOMETRIAL STRIPE THICKENED, 2 UTERINE FIBROIDS VISUALIZED, LARGEST 2.6X2.1X1.8 CM, POSTERIOR, INTRAMURAL, ENDOMETRIAL CYSTS SEEN; SIMPLE OVARIAN CYST IN RIGHT OVARY, LEFT OVARY NORMAL; ON (B)(6) 2020: MIRENA IN SITU; ON (B)(6) 2017: PREVIOUS OVARIAN CYST, THEN RESOLUTION; ESSURE COILS SEEN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: ABDOMINAL PAIN, BACK PAIN, DYSMENORRHEA, MENORRHAGIA, FATIGUE, URINARY TRACT INFECTION, MENORRHAGIA, VAGINAL BLEEDING AND OVARIAN CYST, MIGRAINE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-AUG-2020: QUALITY SAFETY EVALUATION OF PTC. (PRODUCT TECHNICAL COMPLAINT). FU6, FU7, FU8 AND FU9 PROCESSED TOGETHER. ON 4-AUG-2020: MEDICAL RECORDS WAS RECEIVED. REPORTER INFORMATION AND PATIENT'S MEDICAL HISTORY WERE ADDED. FURTHERMORE, THE CONCOMITANT MEDICATION IUD NOS WAS UPDATED TO MIRENA, AND CONSIDERED AS CO-SUSPECT DRUG, IBUPROFEN CONSIDERED AS TREATMENT MEDICATION AND THE EVENTS ¿SPOTTING VAGINAL¿ AND ¿DYSMENORRHOEA¿ WERE ADDED. THE EVENT DEVICE DISLOCATION OCCURRED DURING THE USE OF FIRST MIRENA, BEFORE INSERTION OF ESSURE. FU6, FU7, FU8 AND FU9 WERE PROCESSED TOGETHER. ON 11-AUG-2020: PLAINTIFF FACT SHEET WAS RECEIVED. EVENT ADDED FROM PFS- PELVIC PAIN, TUBULAR CYSTIC STRUCTURE IN THE LEFT ADNEXA, BLOAT, COLD INTOLERANCE, HAIR LOSS, CHANGE IN ORGASMS, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), ANEMIA, STRESS, INSOMNIA. REPORTER INFORMATION. EVENTS ONSET DATE WERE ADDED. FU6, FU7, FU8 AND FU9 PROCESSED TOGETHER. ON 12-AUG-2020: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED. EVENT ADDED- DEVICE DISLOCATION. REPORTER INFORMATION, MEDICAL HISTORY WERE ADDED. FU6, FU7, FU8 AND FU9 PROCESSED TOGETHER. ON 13-AUG-2020: PLAINTIFF FACT SHEET WAS RECEIVED. NO NEW INFORMATION WAS ADDED. FU6, FU7, FU8 AND FU9 PROCESSED TOGETHER. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 INFLAMMATORY DISEASE ('PELVIC INFLAMMATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626978) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GERD, TENSION HEADACHE, CAESAREAN SECTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED OBESITY, UNSPECIFIED, ANXIETY, OVARIAN CYST, PANIC ATTACK, SCIATICA, FOLLICULITIS, VIRAL SYNDROME, SINUSITIS, FLANK PAIN, OVARIAN TORSION (RIGHT OVARIAN CYSTS), IRREGULAR MENSTRUATION, PAIN IN HIP, ANEMIA, VAGINAL CANDIDIASIS, CHEST PAIN, ROTATOR CUFF TENDINITIS (LEFT), COSTOCHONDRITIS, INSOMNIA, ACUTE STRESS DISORDER, PLANTAR FASCIITIS (RIGHT/LEFT), WEIGHT LOSS, OVARIAN CYST RUPTURED (RIGHT) AND ALCOHOL USE. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) FOR CONTRACEPTION. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN/PAIN"), BACK PAIN ("BACK PAIN/LOWER BACK PAIN"), WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS/WEIGHT GAIN APPROX. 30 LBS TOTAL/LOSS") AND PAIN IN EXTREMITY ("PAIN LEGS AND HANDS"). IN 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), FATIGUE ("FATIGUE"), URINARY TRACT INFECTION ("URINARY INFECTION") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), DYSMENORRHOEA ("MENSTRUAL PAIN"), DENTAL CARIES ("TOOTH DECAY"), DEPRESSION ("DEPRESSION"), OVARIAN CYST ("OVARIAN CYSTS IN THE RIGHT OVARY"), ANXIETY ("ANXIETY") AND SCIATICA ("SCIATICA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, MIGRAINE, DENTAL CARIES, FATIGUE, DEPRESSION, WEIGHT FLUCTUATION, URINARY TRACT INFECTION, MENORRHAGIA, VAGINAL HAEMORRHAGE, OVARIAN CYST, HEADACHE, PAIN IN EXTREMITY, WEIGHT INCREASED, ANXIETY AND SCIATICA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DENTAL CARIES, DEPRESSION, DYSMENORRHOEA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, OVARIAN CYST, PAIN IN EXTREMITY, PELVIC INFLAMMATORY DISEASE, SCIATICA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER MR: INSERTION DETAILS: RIGHT: 2 COILS LEFT: 0 COILS (POSSIBLY 0.5 CM DOWN TUBE). SHE HAD NOT UNDERGONE ESSURE (OR ANY PART OF THE DEVICE) REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: FALLOPIAN TUBES WERE FULLY OCCLUDED. ULTRASOUND PELVIS - ON (B)(6) 2010: RESULTS: RIGHT OVARIAN CYSTS (TORSION). ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: ABDOMINAL PAIN, BACK PAIN, DYSMENORRHEA, MENORRHAGIA, FATIGUE, URINARY TRACT INFECTION, MENORRHAGIA, VAGINAL BLEEDING AND OVARIAN CYST." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JUL-2020: PFS RECEIVED: EVENTS ADDED: PELVIC INFLAMMATION, ANXIETY, SCIATICA. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801043 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 626978 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | IMITREX [SUMATRIPTAN]| IRON| IUD NOS| MICROGESTIN| NAPROXEN| ZOLOFT| IUD NOS |