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 Codes	Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	09/24/2020
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 requested.No additional information is available at this time.Reason for reoperation: capsular contracture, baker grade iv.
Event or Problem Description
Healthcare professional reported right side capsular contracture, baker grade unknown.Additionally, healthcare professional reported capsular contracture, baker grade iv.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.
Event or Problem Description
Patient representative reported right side "painful removal procedures as well as treatment, therapy, recovery, and expense associated with the removal of the biocell textured breast 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, increased risk of alcl, evaluation for alcl, explant, reconstruction, seromas, physical pain, scarring and disfigurement.Plaintiff experienced breast pain, severe pain from right shoulder/neck to right hand, tightness in right breast, thick scarring near right under armpit and bilateral breasts, capsular contracture in right breast, excruciating pain in joints, muscular twitching in right breast and shoulder, chronic ear infections/sinus infections/swollen lymph nodes in throat and neck, ringing in ears, chronic bloating and stomach discomfort, chronic and debilitating headaches, cognitive dysfunction and memory loss, stuttering, chronic fatigue, rashes on breasts, bruising and skin irritation, indentations to chest, skin irritations and redness on shoulders and chest, asymmetry, extreme hardening of breasts, seromas, double encapsulations, limited physical mobility, difficulty in daily activities such as showering, sitting, ambulating, working, and exercising, and diagnosis of idiopathic intracranial hypertension.Additionally, plaintiff suffered aggravation of underlying conditions including emotional distress and anxiety, as well as loss of quality of life and depression; and other physical and emotional manifestations that are severe and ongoing.".The 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 10837198
• Report Number: 9617229-2020-18530
• Device Sequence Number: 3501562
• Product Code: FTR
• UDI-Device Identifier: 10888628008342
• UDI-Public: 10888628008342
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2022

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: 02/12/2021
• Device Model Number: TRF-450
• Device Catalogue Number: TRF-450
• Device Lot Number: 2880870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 07/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2016
• 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 Age: 29 YR
• Patient Sex: Female