INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-04568
- Event Type
- Injury
- Date Received
- March 27, 2023
- Date of Event
- July 6, 2022
- Report Date
- September 19, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191607674
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PHOTO DEVICE EVALUATION: "VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. PAIN, DELAYED HEALING, SKIN RASH/DERMATITIS: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AUTOIMMUNE/CONNECTIVE TISSUE DISORDERS-NDR, VARIED INJURIES-NDR, MALAISE-NDR, OTHER-MEDICAL-NDR, EDEMA-NDR, INFECTION (UNKNOWN ONSET)-NDR, RESPIRATORY DISORDER-NDR, PAIN-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED." THE EVENT OF "WOUND HEALING DISORDERS" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. REASON FOR REOPERATION: "WOUND HEALING DISORDERS".
HEALTH EFFECT: F2203. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. ADDITIONAL OBSERVATIONS: RED PARTICLES ON THE SURFACE OF THE SHELL. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. IT CANNOT BE DETERMINED WHICH DEVICE IS FOR THE LEFT OR RIGHT SIDE PER THE PHOTOS PROVIDED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE.
PATIENT REPORTED LEFT SIDE RUPTURE DIAGNOSED BY ULTRASOUND. PATIENT REPRESENTATIVE REPORTED PATIENT ¿SUFFERED FROM PAINFUL WOUND HEALING DISORDERS OVER A LONG PERIOD OF TIME AND HAD TO REPEATEDLY SEEK TREATMENT FOR WOUND CARE OVER [EXTENDED PERIOD]," "PAINFUL¿, ¿PAIN IN THE BACK AND SHOULDERS," AND "ATOPIC DERMATITIS¿, ¿PAINFUL INFLAMED ACNE IN THE DÉCOLLETÉ AND ON THE FACE." PATIENT REPRESENTATIVE ALSO REPORTED ¿MASSIVE SLEEP DISORDERS¿, ¿DEPRESSIVE MOODS¿, ¿REDUCED LIBIDO¿, ¿HASHIMOTO AUTOIMMUNE DISEASE¿, ¿THYROID DYSFUNCTION¿, ¿EXTREME HAIR LOSS¿, ¿EXTREME LACK OF CONCENTRATION AND FORGETFULNESS¿, ¿SENSITIVITY TO NOISE UP TO BRIEF HEARING DISORDERS IN BOTH EARS¿, ¿NOTICEABLE VEINS IN THE CHEST VISIBLE ON THE OUTSIDE¿, ¿EXTREME LISTLESSNESS¿, ¿FREQUENT FATIGUE, ¿ANXIETY AND PANIC ATTACKS WITH HEART PALPITATIONS¿, ¿PALE SKIN AND SEVERE DARK CIRCLES UNDER THE EYES¿, ¿SWELLING OF THE FACE AND HANDS/LEGS/FEET¿, ¿POOR CONCENTRATION AND MEMORY LAPSES¿, ¿ASTHMA¿, ¿SHORTNESS OF BREATH¿, ¿FEELINGS OF SUFFOCATION¿, ¿RESTLESSNESS¿, ¿INDIGESTION (CONSIDERABLE) ASSOCIATED WITH EXTREME ABDOMINAL PAIN¿, ¿HERPES SIMPLEX VIRUS¿, ¿SYMPTOMS OF BREAST IMPLANT ILLNESS (BII)¿, ¿HAD A "STRANGE FEELING" [¿] AND WAS DIAGNOSED WITH "ABNORMALITIES" DURING AN ULTRASOUND¿ WHICH WERE DETERMINED TO BE NOT DEVICE-RELATED.
PHYSICIAN REPORTED LEFT SIDE RUPTURE DIAGNOSED BY ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555875 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2683448 | 05060191607674 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Required Intervention |