Style 168 Saline Filled Breast Implant
Received Jul 30, 2026
Report 9617229-2026-14381 · MDR key 50086808
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
168-360
Lot number
531405
Product problems
- Device Appears to Trigger Rejection
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported "capsular contracture." Later healthcare professional reported "grade 3 capsular contracture, palpable calcification and a palpable mass consistent with fluid filled cyst." This record is for the left 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. The reason for reoperation: Capsular Contracture Baker grade III.