InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 31, 2026 · Event occurred Jul 8, 2026

Report 9617229-2026-14462 · MDR key 50100140

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

68-420

Lot number

1400516

Product problems

Fluid/Blood Leak

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported "deflation" and implant date is after the expiry date. This record is for the left side. The device was explanted.

Additional Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time.A review of the Device History Record has been completed. No deviations or non-conformances noted.Reason for reoperation: Deflation.