InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 31, 2026 · Event occurred Jun 15, 2026

Report 9617229-2026-14481 · MDR key 50101653

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

68-420

Lot number

1245478

Product problems

Fluid/Blood Leak

Patient

36 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported "deflation". This record is for the left side. Device remains implanted.

Additional Manufacturer Narrative

A review of the Device History Record has been completed. No deviations or non-conformances noted.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: Deflation.