MAUDE Adverse Event Report: Allergan (Costa Rica) Style 115 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	115-435
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "not enough milk production".Healthcare professional later reported "swelling and rupture".This record is for the right side.Device was explanted.Patient received singulair as treatment.
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 23/jan/2012.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.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 ; +1(847)936-6324
• MDR Report Key: 50276341
• Report Number: 9617229-2026-15488
• Device Sequence Number: 10068678
• Product Code: FTR
• UDI-Device Identifier: 10888628002425
• UDI-Public: (01)10888628002425(17)120105
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 01/05/2012
• Device Catalogue Number: 115-435
• Device Lot Number: 1389023
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2007
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 145 LB
• Patient Race: White