MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	TRM-685
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Lymphoma (3263)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient representative reported patient ¿live[s] in fear knowing that their biocell® recalled implants have increased their risk of developing cancer¿ and experienced ¿physical pain and emotional distress.¿ healthcare professional reported rupture.Device has been explanted and replaced.This record is for the left side.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: opening curved on radius, wear abrasion, brown particles in the shell and underweight.A visual and microscopic analysis was performed which identified: opening crease sharp on radius, stress marks and creases fold.Based on the device analysis the final assessment is: an opening crease sharp on radius assessed as fold flaw opening.
Event or Problem Description
Patient representative reported patient ¿live[s] in fear knowing that their biocell® recalled implants have increased their risk of developing cancer¿ and experienced ¿physical pain and emotional distress.¿ healthcare professional reported rupture.Device has been explanted and replaced.This record is for the left side.
Additional Manufacturer Narrative
The event of lymphoma-alcl-suspected is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Patient representative additionally reported "disfigurement", "diagnosed with breast cancer" and diagnosed with bia-alcl.Pathological markers confirming alcl have not been confirmed.Patient representative reported the following event deemed not related to the device: "suffered scarring, loss of quality and enjoyment of life.".

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 12821426
• Report Number: 9617229-2021-57617
• Device Sequence Number: 5760848
• Product Code: FTR
• UDI-Device Identifier: 10888628008205
• UDI-Public: 10888628008205
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: TRM-685
• Device Catalogue Number: TRM-685
• Device Lot Number: 2918334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 07/19/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/15/2021; 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female