InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 31, 2026 · Event occurred Jul 7, 2026

Report 9617229-2026-14453 · MDR key 50099289

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

68HP-240

Lot number

3141980

Product problems

Fluid/Blood Leak

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported a deflation. This record is for the right side. The 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. The reason for reoperation: Deflation.