MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	20-750
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Lymphoma (3263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacturer report number 2024601-2014-00312.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of "lymphoma" is a physiological complication and analysis of the device generally does not assist abbvie 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: "lymphoma, non-hodgkin's"; rupture.
Event or Problem Description
Patient reported, via breast implant follow-up study (bifs), having been diagnosed with "non-hodgkins lymphoma".Side unspecified, this file is for the right side.No indication of treatment or surgical reoperation.Later healthcare professional reported "ruptured".Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.6., h.6.
Event or Problem Description
Patient reported, via breast implant follow-up study (bifs), having been diagnosed with "non-hodgkins lymphoma".Side unspecified, this file is for the right side.No indication of treatment or surgical reoperation.Later healthcare professional reported "ruptured".Device was explanted.

• Brand Name: STYLE 20 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: 24405371
• Report Number: 9617229-2026-03361
• Device Sequence Number: 18618186
• Product Code: FTR
• UDI-Device Identifier: 10888628001794
• UDI-Public: 10888628001794
• 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: 2008
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Study,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 02/14/2013
• Device Catalogue Number: 20-750
• Device Lot Number: 1571059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 03/25/2008
• 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 Race: White