MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Style 68 Saline Filled Breast Implant; prosthesis, breast, inflatable, internal, saline

Catalog Number	68HP-200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: deflation.
Event or Problem Description
Healthcare professional reported "deflation".This record is for the left side.The device remains implanted.
Event or Problem Description
Healthcare professional later reported "asymmetry as well as visible rippling", "appear to be a defect in the shell near the seal" and "implant was removed intact".This record is for the left side.The device was explanted.Un-reporting deflation.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.The event of "visibility/palpability" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: visibility/palpability.Clarification to h11.: ¿this report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.¿.

• 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: 25363654
• Report Number: 9617229-2026-10247
• Device Sequence Number: 13223354
• Product Code: FWM
• UDI-Device Identifier: 10888628000360
• UDI-Public: (01)10888628000360(17)070613
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 06/13/2007
• Device Catalogue Number: 68HP-200
• Device Lot Number: 563814
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 09/03/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/22/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2003
• 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