inforMED
InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 31, 2026

Report 9617229-2026-14487 · MDR key 50102491

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Catalog number

68HP-400

Product problems

  • Device Appears to Trigger Rejection

Patient

Female

  • Capsular Contracture

Narrative

Description of Event or Problem

Healthcare professional reported through National Breast Implant Registry "Capsular Contracture Baker Grade III" against the left side record. The 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.