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

Model Number	MX-410550
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of silicone migration 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: silicone migration.
Event or Problem Description
Legal representative reported 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, past and future medical expenses, physical pain and suffering from explantation" agaist natrelle 133 plus tissue expander and natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants style mx.Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Legal representative reported "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, past and future medical expenses, physical pain and suffering from explantation" against natrelle 133 plus tissue expander and natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants style mx.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: 14992871
• Report Number: 9617229-2022-11563
• Device Sequence Number: 1880893
• Product Code: FTR
• UDI-Device Identifier: 10888628003774
• UDI-Public: 10888628003774
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 09/19/2020
• Device Model Number: MX-410550
• Device Catalogue Number: MX-410550
• Device Lot Number: 2813856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2015
• 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