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

Model Number	TRX-800
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930)
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 events of capsular contracture and infection (unknown onset) are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: "removal of implants due to fear of alcl, to reduce risk of alcl, and due to symptoms consistent with alcl and fear of alcl including: mental anguish and fear of alcl, increased risk of alcl, evaluation for alcl,¿ ¿suffers from serious emotional distress including anguish, fright, horror, nervousness, grief, anxiety, and worry of bia-alcl,¿ ¿aggravation of underlying conditions including but not limited to anxiety,¿ ¿contracture,¿ baker grade unknown, ¿tissue damage,¿ ¿pain,¿ ¿swelling¿ and ¿rashes.¿.
Event or Problem Description
Patient representative reported patient underwent ¿removal of implants due to fear of alcl, to reduce risk of alcl, and due to symptoms consistent with alcl and fear of alcl including: mental anguish and fear of alcl, increased risk of alcl, evaluation for alcl,¿ ¿suffers from serious emotional distress including anguish, fright, horror, nervousness, grief, anxiety, and worry of bia-alcl,¿ ¿aggravation of underlying conditions including but not limited to anxiety,¿ ¿contracture,¿ baker grade unknown, ¿tissue damage,¿ ¿pain,¿ ¿swelling¿ and ¿rashes.¿ patient representative also reported patient ¿suffered personal injuries and related damages,¿ ¿other physical and emotional manifestations that are severe and ongoing¿ ¿disfigurement,¿ ¿aggravation of underlying conditions including but not limited to gerd¿ ¿chronic insomnia,¿ ¿panic disorder,¿ ¿weight loss and gain, irritable bowel, chronic gi upset/reflux, diarrhea on an ongoing basis,¿ ¿post-operative complications including infection,¿ ¿aggravation of underlying conditions including but not limited to depression,¿ ¿vomiting on an ongoing basis¿ and ¿nausea on an ongoing basis;¿ 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: 11418046
• Report Number: 9617229-2021-04163
• Device Sequence Number: 3853400
• Product Code: FTR
• UDI-Device Identifier: 10888628008632
• UDI-Public: 10888628008632
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/04/2021

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: 02/28/2021
• Device Model Number: TRX-800
• Device Catalogue Number: TRX-800
• Device Lot Number: 2895742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/04/2021
• 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