Style 468 Saline Filled Breast Implant
Received Jul 27, 2026
Report 9617229-2026-14027 · MDR key 50013686
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
468-350
Lot number
2-525383
Product problems
- Device Appears to Trigger Rejection
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported "Grade III Capsule". This record is for the left side. Device remains implanted.
Additional Manufacturer Narrative
A review of the Device History Record has been completed. No deviations or non-conformances noted.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.This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.