Style 168 Saline Filled Breast Implant
Received Jul 31, 2026
Report 9617229-2026-14502 · MDR key 50106118
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
168-390
Lot number
530188
Product problems
- Device Appears to Trigger Rejection
Patient
Female
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported "capsular contracture". Later healthcare professional reported "grade 4 capsular contracture, palpable calcification and a palpable mass consistent with fluid filled cyst". 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 IV, breast mass, calcification.