InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 27, 2026 · Event occurred Jun 26, 2026

Report 9617229-2026-13967 · MDR key 50000616

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

68-330

Lot number

3674805

Product problems

Fluid/Blood Leak

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Patient reported "deflation". This record is for the right side. Device was explanted.

Additional Manufacturer Narrative

This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.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.