INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2022-18545
- Event Type
- Injury
- Date Received
- October 12, 2022
- Date of Event
- February 2, 2022
- Report Date
- May 4, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191606592
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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.
DEVICE PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. PAIN-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. OTHER-MEDICAL-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. VARIED INJURIES-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. MALAISE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. DYSPNEA-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. DIZZINESS-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. HEADACHE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. SKIN RASH/DERMATITIS-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. SILICONE MIGRATION: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED.
DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED AN OPENING THE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. PAIN-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. OTHER-MEDICAL-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. VARIED INJURIES-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. MALAISE-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. DYSPNEA-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. DIZZINESS-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. HEADACHE-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. SKIN-RASH/DERMATITIS-NDR: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. SILICONE MIGRATION: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG THROUGH THE PHOTOS PROVIDED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, H6.
PATIENT REPORTED RUPTURE DIAGNOSED BY ULTRASOUND AND MRI AND BREAST IMPLANTS ILLNESS (BII).SEE ATTACHED. SYMPTOMS EXPERIENCED "FAINTING, HEART PALPITATIONS, PANIC ATTACKS, PULSE FLUCTUATIONS, DYSPHAGIA, HIGH BLOOD PRESSURE, LOW BLOOD PRESSURE, HEADACHES, MUSCLE ACHES, TENSION, GASTROINTESTINAL COMPLAINTS,SHORTNESS OF BREATH, CHEST TIGHTNESS AND PAIN, ASTHMA, LUMP IN THROAT, DIARRHOEA, LYMPH NODE SWELLING, EXTREME HAIR LOSS, EXTREME SWEATING, BODY ODOUR, PUFFY EYES, RASH ALL OVER THE BODY, JELLY-LIKE COUGHING UP, FATIGUE, GENERAL WEAKNESS, DROWSINESS, LOSS OF STRENGTH, RINGING IN THE EARS, FORGETFULNESS, DRY MOUTH, DIFFICULTY CONCENTRATING, TINGLING IN THE ARMS, DEAFNESS, IMPAIRED VISION." THE DEVICE HAS BEEN EXPLANTED. THIS RECORD RELATES TO THE LEFT SIDE.
PATIENT REPORTED LEFT RUPTURE AND LYMPH NODE (AXILLARY SILICONOMA). PATIENT ALSO REPORTED "BREAST IMPLANT ILLNESS, FAINTING, HEART PALPITATIONS, PANIC ATTACKS, PULSE FLUCTUATIONS, DYSPHAGIA, HIGH BLOOD PRESSURE, LOW BLOOD PRESSURE, HEADACHES, MUSCLE ACHES, TENSION, GASTROINTESTINAL COMPLAINTS, SHORTNESS OF BREATH, CHEST TIGHTNESS AND PAIN, ASTHMA, LUMP IN THROAT, DIARRHEA, EXTREME HAIR LOSS, EXTREME SWEATING, BODY ODOUR, PUFFY EYES, RASH ALL OVER THE BODY, JELLY-LIKE COUGHING UP, FATIGUE, GENERAL WEAKNESS, DROWSINESS, LOSS OF STRENGTH, RINGING IN THE EARS, FORGETFULNESS, DRY MOUTH, DIFFICULTY CONCENTRATING, TINGLING IN THE ARMS, DEAFNESS, IMPAIRED VISION" ALL NON DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.
.PATIENT REPORTED RUPTURE, "LYMPH NODES (AXILLARY SILICONOMA)" AND BREAST IMPLANTS ILLNESS (BII) INCLUDING THE FOLLOWING SYMPTOMS "FAINTING, HEART PALPITATIONS, PANIC ATTACKS, PULSE FLUCTUATIONS, DYSPHAGIA, HIGH BLOOD PRESSURE, LOW BLOOD PRESSURE, HEADACHES, MUSCLE ACHES, TENSION, GASTROINTESTINAL COMPLAINTS, SHORTNESS OF BREATH, CHEST TIGHTNESS AND PAIN, ASTHMA, LUMP IN THROAT, DIARRHOEA, LYMPH NODE SWELLING, EXTREME HAIR LOSS, EXTREME SWEATING, BODY ODOUR, PUFFY EYES, RASH ALL OVER THE BODY, JELLY-LIKE COUGHING UP, FATIGUE, GENERAL WEAKNESS, DROWSINESS, LOSS OF STRENGTH, RINGING IN THE EARS, FORGETFULNESS, DRY MOUTH, DIFFICULTY CONCENTRATING, TINGLING IN THE ARMS, DEAFNESS, IMPAIRED VISION." ULTRASOUND, CT AND MRI SCANS PERFORMED. THE DEVICE HAS BEEN EXPLANTED. THIS RECORD RELATES TO THE LEFT SIDE.
PATIENT REPORTED LEFT RUPTURE AND LYMPH NODE (AXILLARY SILICONOMA). PATIENT ALSO REPORTED "BREAST IMPLANT ILLNESS, FAINTING, HEART PALPITATIONS, PANIC ATTACKS, PULSE FLUCTUATIONS, DYSPHAGIA, HIGH BLOOD PRESSURE, LOW BLOOD PRESSURE, HEADACHES, MUSCLE ACHES, TENSION, GASTROINTESTINAL COMPLAINTS, SHORTNESS OF BREATH, CHEST TIGHTNESS AND PAIN, ASTHMA, LUMP IN THROAT, DIARRHEA, EXTREME HAIR LOSS, EXTREME SWEATING, BODY ODOUR, PUFFY EYES, RASH ALL OVER THE BODY, JELLY-LIKE COUGHING UP, FATIGUE, GENERAL WEAKNESS, DROWSINESS, LOSS OF STRENGTH, RINGING IN THE EARS, FORGETFULNESS, DRY MOUTH, DIFFICULTY CONCENTRATING, TINGLING IN THE ARMS, DEAFNESS, IMPAIRED VISION" ALL NON DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2445404 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2536962 | 05060191606592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Required Intervention |