InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 28, 2026 · Event occurred Jul 2, 2026

Report 9617229-2026-14288 · MDR key 50060697

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

68HP-400

Lot number

3582980

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 right side. Device was explanted.

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