INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-04798
- Event Type
- Injury
- Date Received
- January 15, 2025
- Report Date
- March 17, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191607469
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. INFLAMMATION/IRRITATION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. PAIN: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AUTOIMMUNE/CONNECTIVE TISSUE DISORDERS - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. PAIN - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. VARIED INJURIES - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. GRANULOMA: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. PRURITUS: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. EDEMA: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. CALCIFICATION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ANXIETY - PRODUCT/ PROCEDURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. SKIN RASH/DERMATITIS - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. LYMPHADENOPATHY: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ALLERGIC REACTION/HYPERSENSITIVITY - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. DYSPNEA - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. BRUISING - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NEUROLOGICAL SYMPTOMS - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. SENSATION INCREASE/DECREASE - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. MYALGIA - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. HEADACHE - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. DIZZINESS - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ANAPHYLACTIC REACTION - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ALLERGIC REACTION/HYPERSENSITIVITY - DELAYED: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. INFECTION (UNKNOWN ONSET) - NDR: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, B6, E1, H6.
CONTINUED H.6. HEALTH EFFECT - IMPACT CODE: F2201. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF LYMPHADENOPATHY IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 AND LYMPHADENOPATHY.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5.
PATIENT REPORTED RIGHT SIDE "RECALLED", ¿CHRONIC INFLAMMATORY REACTION¿, ¿CHRONICALLY ELEVATED INFLAMMATORY MARKERS¿, ¿SILICONE AND SILICONE MATERIALS LEAKING FROM YOUR DEVICE INTO MY BODY¿, ¿BREAST PAIN¿, "CHEST PAIN", ¿BREAST SWELLING¿, ¿SKIN ITCHING¿, ¿ITCHING RASHES ON BREAST SKIN¿, AND "SWOLLEN LYMPH NODES¿. PATIENT ALSO REPORTED THE FOLLOWING, WHICH ARE ALL NOT DEVICE-RELATED: ¿DEBILITATING FATIGUE¿, ¿BRAIN FOG, MEMORY LOSS, COGNITION PROBLEMS¿, ¿HAIR LOSS¿, ¿INSOMNIA AND POOR SLEEP¿, ¿SEVERE DRY EYES¿, ¿DECLINE IN VISION, FLOATERS, EARLY BILATERAL CATARACTS, OCULAR HYPERTENSION¿, ¿FLUCTUATIONS IN BLOOD PRESSURE¿, ¿THROAT CLEARING, COUGH, DIFFICULTY SWALLOWING, REFLUX, NIGHT SWEATS, HEAT INTOLERANCE, INABILITY TO SWEAT¿, ¿TINNITUS¿, ¿FOOD INTOLERANCES¿, ¿HEART PALPITATIONS¿, ¿COLD AND DISCOLOURED HANDS AND FEET¿, ¿MUSCLE PAIN AND WEAKNESS¿, ¿JOINT PAIN¿, ¿EASY BRUISING¿, ¿DYSAUTONOMIA¿, ¿AUTONOMIC DYSFUNCTION¿, ¿VERTIGO¿, ¿HEADACHES, MIGRAINES, OCULAR MIGRAINES¿, ¿PERSISTENT VIRAL INFECTIONS: SHINGLES, CYTOMEGALOVIRUS, EBV¿, ¿SHORTNESS OF BREATH¿, ¿ALLERGIES¿, ¿ANAPHYLAXIS REACTIONS¿, AND ¿NUMBNESS AND TINGLING IN LIMBS¿. PATIENT LATER REPORTED GRANULOMA AND CALCIFICATION. DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED RIGHT SIDE "RECALLED", ¿CHRONIC INFLAMMATORY REACTION¿, ¿CHRONICALLY ELEVATED INFLAMMATORY MARKERS¿, ¿SILICONE AND SILICONE MATERIALS LEAKING FROM YOUR DEVICE INTO MY BODY¿, ¿BREAST PAIN¿, "CHEST PAIN", ¿BREAST SWELLING¿, ¿SKIN ITCHING¿, ¿ITCHING RASHES ON BREAST SKIN¿, AND "SWOLLEN LYMPH NODES¿. PATIENT ALSO REPORTED THE FOLLOWING, WHICH ARE ALL NOT DEVICE-RELATED: ¿DEBILITATING FATIGUE¿, ¿BRAIN FOG, MEMORY LOSS, COGNITION PROBLEMS¿, ¿HAIR LOSS¿, ¿INSOMNIA AND POOR SLEEP¿, ¿SEVERE DRY EYES¿, ¿DECLINE IN VISION, FLOATERS, EARLY BILATERAL CATARACTS, OCULAR HYPERTENSION¿, ¿FLUCTUATIONS IN BLOOD PRESSURE¿, ¿THROAT CLEARING, COUGH, DIFFICULTY SWALLOWING, REFLUX, NIGHT SWEATS, HEAT INTOLERANCE, INABILITY TO SWEAT¿, ¿TINNITUS¿, ¿FOOD INTOLERANCES¿, ¿HEART PALPITATIONS¿, ¿COLD AND DISCOLOURED HANDS AND FEET¿, ¿MUSCLE PAIN AND WEAKNESS¿, ¿JOINT PAIN¿, ¿EASY BRUISING¿, ¿DYSAUTONOMIA¿, ¿AUTONOMIC DYSFUNCTION¿, ¿VERTIGO¿, ¿HEADACHES, MIGRAINES, OCULAR MIGRAINES¿, ¿PERSISTENT VIRAL INFECTIONS: SHINGLES, CYTOMEGALOVIRUS, EBV¿, ¿SHORTNESS OF BREATH¿, ¿ALLERGIES¿, ¿ANAPHYLAXIS REACTIONS¿, AND ¿NUMBNESS AND TINGLING IN LIMBS¿. PATIENT LATER REPORTED GRANULOMA AND CALCIFICATION. DEVICE HAS BEEN EXPLANTED.
MEDICAL STAFF REPORTED RIGHT SIDE "SYSTEMIC ANTINFLAMMATORY HEALTH CONDITIONS AND CONNECTIVE TISSUE COMPLICATIONS (NOT DEVICE RELATED), CHRONIC LOW GRADE INFLAMMATION AND ALLERGIES, RECURRENT HEART INFLAMMATIONS, INTERMITTENT SHARP PAINS IN RIGHT BREAST AND RASHES." PATIENT LATER REPORTED SWOLLEN LYMPH NODES, BREAST SWELLING, SHARP BREAST PAIN AND INFLAMMATORY REACTION TO SILICONE MATERIALS AND LEAKING OR SHEDDING SILICONE MATERIALS FROM TEXTURED IMPLANT VIA HISTOLOGY REPORT. THE REPORTED EVENTS OF SHORTNESS OF BREATH, PERSISTENT VIRAL INFECTIONS: SHINGLES, CYTOMEGALOVIRUS, EBV, HEADACHES, MIGRAINES, OCULAR MIGRAINES, ITCHING RASHES ON BREAST SKIN, DEBILITATING FATIGUE, MUSCLE PAIN AND WEAKNESS, JOINT PAIN, NUMBNESS AND TINGLING IN LIMBS, AND COLD AND DISCOLOURED HANDS AND FEET ARE NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED RIGHT SIDE "RECALLED", ¿CHRONIC INFLAMMATORY REACTION¿, ¿CHRONICALLY ELEVATED INFLAMMATORY MARKERS¿, ¿SILICONE AND SILICONE MATERIALS LEAKING FROM YOUR DEVICE INTO MY BODY¿, ¿BREAST PAIN¿, "CHEST PAIN", ¿BREAST SWELLING¿, ¿SKIN ITCHING¿, ¿ITCHING RASHES ON BREAST SKIN¿, AND "SWOLLEN LYMPH NODES¿. PATIENT ALSO REPORTED THE FOLLOWING, WHICH ARE ALL NOT DEVICE-RELATED: ¿DEBILITATING FATIGUE¿, ¿BRAIN FOG, MEMORY LOSS, COGNITION PROBLEMS¿, ¿HAIR LOSS¿, ¿INSOMNIA AND POOR SLEEP¿, ¿SEVERE DRY EYES¿, ¿DECLINE IN VISION, FLOATERS, EARLY BILATERAL CATARACTS, OCULAR HYPERTENSION¿, ¿FLUCTUATIONS IN BLOOD PRESSURE¿, ¿THROAT CLEARING, COUGH, DIFFICULTY SWALLOWING, REFLUX, NIGHT SWEATS, HEAT INTOLERANCE, INABILITY TO SWEAT¿, ¿TINNITUS¿, ¿FOOD INTOLERANCES¿, ¿HEART PALPITATIONS¿, ¿COLD AND DISCOLOURED HANDS AND FEET¿, ¿MUSCLE PAIN AND WEAKNESS¿, ¿JOINT PAIN¿, ¿EASY BRUISING¿, ¿DYSAUTONOMIA¿, ¿AUTONOMIC DYSFUNCTION¿, ¿VERTIGO¿, ¿HEADACHES, MIGRAINES, OCULAR MIGRAINES¿, ¿PERSISTENT VIRAL INFECTIONS: SHINGLES, CYTOMEGALOVIRUS, EBV¿, ¿SHORTNESS OF BREATH¿, ¿ALLERGIES¿, ¿ANAPHYLAXIS REACTIONS¿, AND ¿NUMBNESS AND TINGLING IN LIMBS¿. DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1584013 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2803004 | 05060191607469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |