Style 468 Saline Filled Breast Implant
Received Jul 27, 2026 · Event occurred Jul 7, 2026
Report 9617229-2026-14038 · MDR key 50015280
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
468-495
Lot number
1559519
Product problems
- Fluid/Blood Leak
- Device Appears to Trigger Rejection
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported "deflation and textured to smooth", later healthcare professional reported "contracture". This record is for the right side. Device was explanted.
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 Unknown and Deflation. This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.