ESSURE
Report
- Report Number
- 2951250-2018-04839
- Event Type
- Injury
- Date Received
- November 28, 2018
- Date of Event
- June 14, 2015
- Report Date
- November 29, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE DEVICE : RIGHT HIP") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821674- INV,840016-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY, FLUID RETENTION AND NUMBNESS. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM FROM (B)(6) 2012 TO (B)(6) 2016 FOR ANXIETY AS WELL AS ESTRADIOL FROM (B)(6) 2014 TO (B)(6) 2014, ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) SINCE 2004 TO (B)(6) 2013, GABAPENTIN (GAPENTIN) SINCE 2009 TO (B)(6) 2013, PHENTERMINE SINCE SEPTEMBER 2013, PROGESTERONE FROM JANUARY 2017 TO JUNE 2018 AND THYROTROPHIN (THYROID STIMULATING HORMONE) FROM (B)(6) 2014 TO (B)(6) 2014. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTIONS : TYPE: UTI"), PERIPHERAL SWELLING ("HORMONAL CHANGES DESCRIBE:SWELLING HANDS AND FEET"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), ANXIETY DISORDER ("ANXIETY DISORDER"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND OEDEMA PERIPHERAL ("LOWER EXTREMITY EDEMA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, 1 YEAR 8 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL ISSUES"), BACK PAIN ("LOWER BACK RIGHT SIDE PAIN"), ARTHRALGIA ("RIGHT SIDE HIP PAIN") AND ANXIETY ("ANXIETY"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENSTRUAL DISORDER, URINARY TRACT INFECTION, WEIGHT INCREASED, PERIPHERAL SWELLING, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, ANXIETY DISORDER, MIGRAINE, HEADACHE, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, BACK PAIN, ARTHRALGIA, OEDEMA PERIPHERAL AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, OEDEMA PERIPHERAL, PERIPHERAL SWELLING, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 268 LBS. FOUR COILS WERE VISUALIZED ON THE LEFT AND THREE COILS ON THE RIGHT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN VAGINA - ON (B)(6) 2015: RESULTS: ESSURE COILS TAKEN OUT SINCE IT MIGRATED TO MY HIP MIGRATION OF ESSURE DEVICE.. LOT NUMBERS REPORT {821674,840016} ARE NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: UPDATE OF INFORMATION (BATCH IS NOT VALID) 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 DEVICE DISLOCATION ("MIGRATION OF THE DEVICE: RIGHT HIP") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 821674, 840016) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY, FLUID RETENTION AND NUMBNESS. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM FROM (B)(6) 2012 TO (B)(6) 2016 FOR ANXIETY AS WELL AS ESTRADIOL FROM (B)(6) 2014 TO (B)(6) 2014, ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) SINCE 2004 TO (B)(6) 2013, GABAPENTIN ("GAPENTIN") SINCE 2009 TO (B)(6) 2013, PHENTERMINE SINCE (B)(6) 2013, PROGESTERONE FROM (B)(6) 2017 TO (B)(6) 2018 AND THYROTROPHIN (THYROID STIMULATING HORMONE) FROM (B)(6) 2014 TO (B)(6) 2014. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTIONS: TYPE: UTI"), PERIPHERAL SWELLING ("HORMONAL CHANGES DESCRIBE:SWELLING HANDS AND FEET"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), ANXIETY DISORDER ("ANXIETY DISORDER"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND OEDEMA PERIPHERAL ("HORMONAL CHANGES DESCRIBE: LOWER EXTREMITY EDEMA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, 1 YEAR 8 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL ISSUES"), BACK PAIN ("LOWER BACK RIGHT SIDE PAIN"), ARTHRALGIA ("RIGHT SIDE HIP PAIN") AND ANXIETY ("ANXIETY"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENSTRUAL DISORDER, URINARY TRACT INFECTION, WEIGHT INCREASED, PERIPHERAL SWELLING, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, ANXIETY DISORDER, MIGRAINE, HEADACHE, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, BACK PAIN, ARTHRALGIA, OEDEMA PERIPHERAL AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, ANXIETY DISORDER, ARTHRALGIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, FATIGUE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, OEDEMA PERIPHERAL, PERIPHERAL SWELLING, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6). FOUR COILS WERE VISUALIZED ON THE LEFT AND THREE COILS ON THE RIGHT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN VAGINA - ON (B)(6) 2015: RESULTS: ESSURE COILS TAKEN OUT SINCE IT MIGRATED TO MY HIP. MIGRATION OF ESSURE DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-NOV-2018: PLAINTIFF FACT SHEET WAS RECEIVED. EVENTS ADDED FROM PFS- LOWER EXTREMITY EDEMA, ANXIETY. REPORTER INFORMATION, CONCOMITANT DRUG, LAB DATA WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 952308 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 821674- INV,840016-INV | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other | 1) NUVARING.| 1) NUVARING.| 2) ALPRAZOLAM (ALPRAZOLAM).| 2) ALPRAZOLAM (ALPRAZOLAM).| 3) PHENTERMINE (PHENTERMINE).| 3) PHENTERMINE (PHENTERMINE).| 4) GAPENTIN (GABAPENTIN).| 4) GAPENTIN (GABAPENTIN).| 5) PROGESTERONE.| 5) PROGESTERONE.| 6) ESTRADIOL.| 6) ESTRADIOL.| 7) THYROID STIMULATING HORMONE.| 7) THYROID STIMULATING HORMONE.| "GAPENTIN" (GABAPENTIN)| ALPRAZOLAM (ALPRAZOLAM)| ESTRADIOL| NUVARING| PHENTERMINE (PHENTERMINE)| PROGESTERONE| THYROID STIMULATING HORMONE |