InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 30, 2026 · Event occurred Jun 23, 2026

Report 9617229-2026-14359 · MDR key 50085121

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Product code (FWM)

Model (68HP-550)

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

68HP-550

Lot number

3677627

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. The device remains implanted.

Additional Manufacturer Narrative

A review of the Device History Record has been initiated. If any new, changed or corrected information is noted, a supplemental MedWatch will be submitted.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.