MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-222
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/08/2025
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, fever, pain-ndr.
Event or Problem Description
Patient reported "groin pain and pelvic pain", "fever and breast size are clearly different", "the size got bigger and bigger" and "rupture".The event "groin pain and pelvic pain" is not device related.This record is for the left side.The device was explanted and will be returned.The patient was prescribed medication and antibiotics.
Additional Manufacturer Narrative
Device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ rupture: not observed through visual inspection.¿ fever: unable to observe through visual inspection as it is a physiological phenomenon.¿ pain: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (deformation.) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Patient reported "groin pain and pelvic pain", "fever and breast size are clearly different", "the size got bigger and bigger" and "rupture".The event "groin pain and pelvic pain" is not device related.This record is for the left side.The device was explanted and will be returned.The patient was prescribed medication and antibiotics.
Event or Problem Description
Patient reported "groin pain and pelvic pain", "fever and breast size are clearly different", "the size got bigger and bigger" and "rupture".The event "groin pain and pelvic pain" is not device related.Later, healthcare professional reported "implant rupture", "increase in breast size", "sensation of heat and fever", "suspected diagnosis of bia-alcl", "signs of implant rupture along with a large amount of fluid (peri-implant effusion) around the implant", "thickening and enhancement of the capsule surrounding the implant" and "hypertrophy and pain".Later, healthcare professional reported "diagnosed cd30 as negative, although a few cells were cd30 positive" and confirmed "patient was ultimately not diagnosed with bia-alcl".This record is for the left side.The device was explanted.The patient was prescribed medication and antibiotics.
Additional Manufacturer Narrative
Reason for reoperation: rupture.

• Brand Name: STYLE 115 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: 23667719
• Report Number: 9617229-2025-20595
• Device Sequence Number: 21078385
• Product Code: FTR
• UDI-Device Identifier: 10888628002340
• UDI-Public: (01)10888628002340(10)2760460(11)150615(17)200515
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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: 05/15/2020
• Device Catalogue Number: 115-222
• Device Lot Number: 2760460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 01/26/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 01/16/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2015
• 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: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian