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

Model Number	TRF-450
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The event of "capsular contracture" 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: ¿capsular contracture,¿ baker grade unknown, ¿loss of enjoyment of life,¿ ¿significantly increased risk of developing cancer, emotional distress including fear and anxiety of developing cancer, accumulation of foreign and adulterated silicone particles in their bodies, including the resulting inflammation cellular damage, and subcellular damage,¿ ¿physical pain and suffering¿ and ¿rippling.¿.
Event or Problem Description
Patient representative reported patient experienced ¿capsular contracture,¿ baker grade unknown, ¿loss of enjoyment of life,¿ ¿significantly increased risk of developing cancer, emotional distress including fear and anxiety of developing cancer, accumulation of foreign and adulterated silicone particles in their bodies, including the resulting inflammation cellular damage, and subcellular damage,¿ ¿physical pain and suffering¿ and ¿rippling.¿ patient representative also reported patient ¿suffered personal injuries and related damages,¿ ¿high blood pressure¿ and ¿disfigurement;¿ these events are not related to the device.Device was explanted.This record is for the left side.

• 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
• MDR Report Key: 11211048
• Report Number: 9617229-2021-01105
• Device Sequence Number: 11727796
• Product Code: FTR
• UDI-Device Identifier: 10888628008342
• UDI-Public: 10888628008342
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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: 06/03/2020
• Device Model Number: TRF-450
• Device Catalogue Number: TRF-450
• Device Lot Number: 2766669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR