InjuryFWM

Style 168 Saline Filled Breast Implant

Received Jul 30, 2026 · Event occurred Jun 30, 2026

Report 9617229-2026-14383 · MDR key 50087013

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

168-270

Lot number

2-513558

Product problems

Fluid/Blood Leak

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare Professional reported "deflation". This record is for the left side. Device was explanted and replaced.

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.