MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 15 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	15-616
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.The reason for reoperation is rupture.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported left side possible rupture.Additional events of "pain and hardness" and "droopy" stating that it may be due to the implanting physician "not removing enough tissue." device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a4, b5, d6b, h6.
Event or Problem Description
The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ rupture: observed three openings assessed as surgical damage.¿ pain: unable to observe as it is not related to the manufacturing process.¿ visibility/palpability: unable to observe as it is not related to the manufacturing process.No other observations observed, no further actions are required.Additional, changed, and/or corrected data: b5, d9, h3, h6.
Event or Problem Description
Healthcare professional reported left side possible rupture.Additional events of "pain and hardness" and "droopy" stating that it may be due to the implanting physician "not removing enough tissue." healthcare professional later reported "smaller implant on the patient's left." device has been explanted and replaced with non-abbvie device.

• Brand Name: STYLE 15 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; suite 100; irvine, CA 92612 ; 8479366324
• MDR Report Key: 8595339
• Report Number: 9617229-2019-04685
• Device Sequence Number: 2293633
• Product Code: FTR
• UDI-Device Identifier: 10888628001541
• UDI-Public: 10888628001541
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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: 10/11/2019
• Device Catalogue Number: 15-616
• Device Lot Number: 2670652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 01/03/2025; 03/20/2025
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 01/22/2025; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2014
• 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: 57 KG