MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Style 120 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	120-340
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069); Lymphoma (3263)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial medwatch: (b)(4).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 seroma-late 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: seroma-late and rupture.These are known potential adverse events addressed in the product labeling.Medwatch follow-up: (b)(4).Additional, changed, and/or corrected data: a2, b5, g1, g2.A review of the device history record has been completed.No deviations or non-conformance's noted.The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: seroma-late, lymphoma, capsular contracture baker grade iv, rupture.
Event or Problem Description
Patient reported "leak", "one implant is leaking or has fluid around it", "extraordinarily exhausted and have had significant mastalgia".Later patient reported "hodgkin¿s lymphoma that textured implants caused" which is not device related.Later, patient reported "exchange from textured to smooth due to the patients¿ concern of the product", and "rupture and seroma".Later patient reported "implant exchange due to the patient's concern with the product plus on the left side pain, seroma, capsular contracture baker grade iv, and a rupture" with ct scan.This record is for the left side.Device remain implanted.
Event or Problem Description
Patient reported "leak", "one implant is leaking or has fluid around it", "extraordinarily exhausted and have had significant mastalgia".Later patient reported "hodgkin¿s lymphoma that textured implants caused".Later, patient reported "exchange from textured to smooth due to the patients¿ concern of the product", "rupture" and "seroma".Later patient reported "pain", "seroma", "capsular contracture baker grade iv", and "rupture".Patient later reported "rupture and free silicone", "breast implant illness", "arthritis", "emotional stability", "was sick", "couldn't remember words", "it was like having the flu every day", "joints hurt", and "moods were all over the place".This record is for the left side.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h.6.

• 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 ; +1(847)936-6324
• MDR Report Key: 23325339
• Report Number: 9617229-2025-17820
• Device Sequence Number: 18795649
• Product Code: FTR
• 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: 2007
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 12/08/2011
• Device Catalogue Number: 120-340
• Device Lot Number: 1376348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2007
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Weight: 145 LB
• Patient Race: White