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

Model Number	FM-410310
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2019
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.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: "rippling" and "rubber looking." patient representative reported "disfigurement", "along with increased risk of alcl, fear due to risk of alcl, and any condition or symptoms associated with alcl" and "mental pain and suffering, mental anguish, emotional distress, and other physical and emotional manifestations that are severe and ongoing", "because of the accumulation of foreign and adulterated silicone particles in breast tissue, lymph nodes, and throughout her body", "resulting in inflammation, cellular, and subcellular damage", "pain", and "itching.".
Event or Problem Description
Patient reported a right side "rippling" and "rubber looking." patient representative reported "disfigurement", "along with increased risk of alcl, fear due to risk of alcl, and any condition or symptoms associated with alcl" and "mental pain and suffering, mental anguish, emotional distress, and other physical and emotional manifestations that are severe and ongoing", "because of the accumulation of foreign and adulterated silicone particles in breast tissue, lymph nodes, and throughout her body", "resulting in inflammation, cellular, and subcellular damage", "pain", and "itching." patient representative additionally reported "painful removal procedures", "scarring", "diagnostics and explant, reconstruction, hospitalization, additional care, as well as other treatment, therapy, recovery, and expense associated with the removal of the biocell textured breast implants, the monitoring for or prevention of the disease", "and other past and future economic and non-economic damages such as medical care costs, lost wages, lost wage earning capacity"; these events are not device related.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
• MDR Report Key: 12346291
• Report Number: 9617229-2021-50254
• Device Sequence Number: 14735195
• Product Code: FTR
• UDI-Device Identifier: 10888628002845
• UDI-Public: 10888628002845
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: 10/27/2019
• Device Model Number: FM-410310
• Device Catalogue Number: FM-410310
• Device Lot Number: 2679199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/19/2021
• 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
• Patient Age: 60 YR