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

Model Number	FF-410425
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In response to fda report number: mw5103692.(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified: weight to the spec, opening, brown particles on the surface of the shell.A microscopic analysis was performed which identify a striated edge opening.Based on the device analysis the final assessment is: a striated edge opening on anterior side assessed as surgical damage.The events of lymphoma - alcl - suspected and seroma - late are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: "560ml of late seroma fluid was tested and came back positive for alcl; cytological evaluation demonstrated an atypical cd30-postive t-cell population.Large atypical cells are cd3 positive, cd30 positive, and alk negative.".
Event or Problem Description
Healthcare professional initially reported "patient noted increased swelling of their right breast" and a right side "later seroma fluid as well as bilateral exchange from textured to smooth due to concern with the product".Healthcare professional later reported via regulatory agency "anaplastic large cell lymphoma after breast augmentation with natrelle textured silicone implants.Right breast positive for alcl related to breast implant." it was further noted that the patient ¿had a pet scan and ultrasound done.¿ per ultrasound guided aspiration, cytological evaluation demonstrated an atypical cd30-postive t-cell population.Large atypical cells are cd3 positive, cd30 positive, and alk negative.Indication for the procedure was as follows: "large right breast peri-implant fluid collection.Large volume aspiration performed for patient conform and to evaluate for breast implant associated anaplastic large cell lymphoma.560 ml of light yellow thin fluid was aspirated." affected side is right.The device has been explanted and replaced.

• 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: 12682506
• Report Number: 9617229-2021-49942
• Device Sequence Number: 6233279
• Product Code: FTR
• UDI-Device Identifier: 10888628002685
• UDI-Public: 10888628002685
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: 01/10/2020
• Device Model Number: FF-410425
• Device Catalogue Number: FF-410425
• Device Lot Number: 2704858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2011068-7/2/19-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 90