MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	68HP-280
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/12/2014
Type of Reportable Event	Serious Injury
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 unknown, deflation.A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Patient reported "firm and looks abnormal due to capsular contracture".Later healthcare professional reported "deflation".This record is for left side.Device was explanted and replaced.
Additional Manufacturer Narrative
Clarification to b5 description of event: the initial medwatch was submitted due to a report that the patient had devices explanted on (b)(6) 2025.Healthcare professional later clarified that the explanted devices were not manufactured by allergan/abbvie.The last known information regarding the patient/device in this record is the patient's report of capsular contracture and the device remaining implanted.Because it was confirmed that the patient had a different set of devices explanted, it is also confirmed that the device in this record was explanted on an unknown date.However, the adverse event reported by the healthcare professional does not relate to the device in this record.Clarification to d6b explant date: it is known that the devices have been explanted.However, it is unknown when explant surgery was performed.The (b)(6) 2025 surgery date reported in the initial medwatch does not pertain to the device in this record.Correction to h6 adverse event problem from the initial medwatch: un-reporting a050401 fluid leak.It has been confirmed that the event of deflation does not pertain to the device in this record.
Event or Problem Description
Patient reported via bifs "firm and looks abnormal due to capsular contracture".This record is for left side.Device was explanted and replaced.

• 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 ; 8479366324
• MDR Report Key: 23190836
• Report Number: 9617229-2025-16667
• Device Sequence Number: 13038787
• Product Code: FWM
• UDI-Device Identifier: 10888628000384
• UDI-Public: 10888628000384
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2011
• Device Catalogue Number: 68HP-280
• Device Lot Number: 1403093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2007
• 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: 54 YR
• Patient Sex: Female