MAUDE Adverse Event Report: Allergan (Costa Rica) Style 68 Saline Filled Breast Implant; prosthesis, breast, inflatable, internal, saline

Catalog Number	68HP-350
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "scar tissue contracture, painful beaker iii/iv encapsulation, "hardening of the supralateral axillary region and thickening of the pectoralis mayor muscle with painful breast deformity", "double-bubble breast deformity", "decreased size" and "upper pole fullness".This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
The event of "capsular contracture" 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: capsular contracture, baker grade iii/iv.

• Brand Name: Style 68 Saline Filled Breast Implant
• Common Device Name: prosthesis, breast, inflatable, internal, saline
• 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: 50101242
• Report Number: 9617229-2026-14475
• Device Sequence Number: 5279068
• Product Code: FWM
• UDI-Device Identifier: 10888628000407
• UDI-Public: (01)10888628000407(17)100515
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2010
• Device Catalogue Number: 68HP-350
• Device Lot Number: 1288639
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2006
• 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