Style 68 Saline Filled Breast Implant
Received Jul 27, 2026
Report 9617229-2026-14166 · MDR key 50040264
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68-240
Lot number
3596422
Product problems
- Device Appears to Trigger Rejection
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported of the right side device: sagging of the breast, waterfall deformity, Baker grade III capsular contracture, and "implant gradually moving up on her chest wall". The device remains implanted.
Additional Manufacturer Narrative
This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.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.