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

Model Number	TRM-345
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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/will be requested.No additional information is available at this time.The reason for reoperation is: "concern with the product" and capsular contracture, baker grade iv.
Event or Problem Description
Patient representative reported patient experienced ¿severe emotional distress and lives in daily fear that [the patient] has been exposed to bia-alcl,¿ ¿continues to suffer from mental stress, anxiety, worry, humiliation, fear, concern and other personal ¿ hardship due to the continuous fear of bia alcl,¿ ¿suffered emotional distress, anxiety,¿ ¿loss of quality of life,¿ ¿suffered, or will suffer, painful removal procedures to mitigate the risk of developing bia-alcl, as well as any treatment, therapy, recovery ¿ associated with the removal of the biocell textured breast implants,¿ ¿the potential for the development of bia-alcl, and any condition or symptoms associated with bia-alcl or the prevention of that issue¿ and ¿suffered debilitating physical pain.¿ patient representative also reported patient experienced ¿depression¿ and ¿disability;¿ these events are not related to the device.Healthcare professional later reported a left-side capsular contracture, baker grade iv.This record is for the left side.Device remains implanted.
Event or Problem Description
Healthcare professional additionally reported left side rupture discovered during explant.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to observe since it is not related to the device.Pain: unable to observe since it is not related to the device.Varied injuries-ndr: not applicable as the event is not related to the device.Depression-ndr: not applicable as the event is not related to the device.Anxiety-product/procedure: unable to observe since it is not related to the device.Rupture: no observed rupture on the device.Additional observations: deformation device observed on the device.No further actions are required as the device was implanted.
Event or Problem Description
Patient representative reported patient experienced ¿severe emotional distress and lives in daily fear that [the patient] has been exposed to bia-alcl,¿ ¿continues to suffer from mental stress, anxiety, worry, humiliation, fear, concern and other personal hardship due to the continuous fear of biaalcl,¿ ¿suffered emotional distress, anxiety,¿ ¿loss of quality of life,¿ ¿suffered, or will suffer, painful removal procedures to mitigate the risk of developing bia-alcl, as well as any treatment, therapy, recovery associated with the removal of the biocell textured breast implants,¿ ¿the potential for the development of bia-alcl, and any condition or symptoms associated with bia-alcl or the prevention of that issue¿ and ¿suffered debilitating physical pain.¿ patient representative also reported patient experienced ¿depression¿ and ¿disability;¿ these events are not related to the device.Healthcare professional later reported a left-side capsular contracture, baker grade iv and rupture.This record is for the left side.Device has been explanted.

• 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: 16704073
• Report Number: 9617229-2023-05600
• Device Sequence Number: 5603643
• Product Code: FTR
• UDI-Device Identifier: 10888628008106
• UDI-Public: 10888628008106
• Combination Product (Y/N): N
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2023

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: 01/22/2022
• Device Model Number: TRM-345
• Device Catalogue Number: TRM-345
• Device Lot Number: 3023492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 10/13/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 07/27/2023; 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• 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
• Patient Weight: 58 KG