MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 120 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	120-400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
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: rupture.
Event or Problem Description
Patient reported "i just read about the textured silicone being recalled", "larger breast", "burning" ,"pain" and "chronic fatigue, muscle aches, brain fog, autoimmune disease" not device related.Later patient reported "possible rupture" and "exchange of textured device due to patient's concern with product".Later, healthcare professional reported "possible silicone rupture" and "implant exchange from textured to smooth due to the patients concerns with the product".Later, patient confirmed "rupture".This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h.6.
Event or Problem Description
Patient reported "i just read about the textured silicone being recalled", "larger breast", "burning" ,"pain" and "chronic fatigue, muscle aches, brain fog, autoimmune disease" not device related.Later patient reported "possible rupture" and "exchange of textured device due to patient's concern with product".Later, healthcare professional reported "possible silicone rupture" and "implant exchange from textured to smooth due to the patients concerns with the product".Later, patient confirmed "rupture".Later, healthcare professional reported "double capsule", "free silicone" and "the silicone that was spilled was noted to be whitish in color and perhaps a mix of silicone and seroma".Later, healthcare professional reported "hole-non specific".This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h.6.
Event or Problem Description
Patient reported "i just read about the textured silicone being recalled", "larger breast", "burning" ,"pain" and "chronic fatigue, muscle aches, brain fog, autoimmune disease" not device related.Later patient reported "possible rupture" and "exchange of textured device due to patient's concern with product".Later, healthcare professional reported "possible silicone rupture" and "implant exchange from textured to smooth due to the patients concerns with the product".Later, patient confirmed "rupture".Later, healthcare professional reported "double capsule", "free silicone" and "the silicone that was spilled was noted to be whitish in color and perhaps a mix of silicone and seroma".Later, healthcare professional reported "hole-non specific".This record is for the right side.Device was explanted.

• Brand Name: STYLE 120 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 24200028
• Report Number: 9617229-2026-01789
• Device Sequence Number: 18555178
• Product Code: FTR
• UDI-Device Identifier: 10888628002555
• UDI-Public: 10888628002555
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 120-400
• Device Lot Number: 2603467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 03/06/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/06/2026; 03/30/2026
• Date Device Manufactured: 05/28/2014
• 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
• Patient Weight: 61 KG