Style 68 Saline Filled Breast Implant
Received Jul 31, 2026 · Event occurred Jun 23, 2026
Report 9617229-2026-14475 · MDR key 50101242
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68HP-350
Product problems
- Device Appears to Trigger Rejection
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported "scar tissue contracture, painful Beaker III/IV encapsulation, "hardening of the supralateral axillary region and thickening of the pectoralis mayor muscle with painful breast deformity", "double-bubble breast deformity", "decreased size" and "upper pole fullness". This record is for the right side. Device was explanted.
Additional Manufacturer Narrative
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/IV.