MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	FX-410280
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis: visual analysis of the returned device identified; fold creases, wear abrasion, brown particles in shell, deformation, weight within specification.After autoclave cycle was identified: cloudy gel.Based on the device analysis the final assessment is: - no issues found related with the manufacturing process.A review of the device history record has been completed.No deviations or non-conformances noted.The event of seroma 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: seroma, pain, depression, anxiety-product/procedure.
Event or Problem Description
Patient reported right side exchange from textured to smooth due to concern with the product.Patient's representative later reported patient underwent 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.Additionally, patient 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.Patient has not been diagnosed with bia-alcl.Device has been explanted.
Additional Manufacturer Narrative
Visual analysis identified: - depression: unable to observe as it is a medical event that is not related to the device.- pain: unable to observe as it is a medical event that is not related to the device.- seroma-late: unable to observe as it is a medical event that is not related to the device.- anxiety-product/procedure: unable to observe as it is a medical event that is not related to the device.
Event or Problem Description
Patient reported right side exchange from textured to smooth due to concern with the product.Patient representative later reported plaintiff underwent right side "fear of alcl" "mental anguish" ¿seromas¿, ¿physical pain,¿ "loss of quality of life," ¿anxiety", and "depression." unknown treatment and therapies were noted.Device has been explanted.

• Brand Name: STYLE 410 COHESIVE 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: 16718135
• Report Number: 9617229-2023-06040
• Device Sequence Number: 20642281
• Product Code: FTR
• UDI-Device Identifier: 10888628002951
• UDI-Public: 10888628002951
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 01/20/2022
• Device Model Number: FX-410280
• Device Catalogue Number: FX-410280
• Device Lot Number: 3023283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2017
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 54 KG