PAL 7020 Console

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs is a temporary implantable device used for breast reconstruction after mastectomy, correction of underdeveloped breast, scar revision, and tissue defect procedures. It works by incremental filling with saline solution to stretch surrounding tissue and is intended for subcutaneous or submuscular implantation for no longer than six months.

The proposed device features a redesigned internally-attached injection port with a plastic needle guard and smaller magnet for improved MR compatibility (MR Conditional), new sheeting-based self-sealing bufferzone technology with updated geometry, thinner three-layer smooth silicone shell, updated design control technology components, and additional suture tabs at 1:30, 4:30, 7:30, and 10:30 positions in addition to the predicate's 3, 6, 9 o'clock tabs.

ASTM F1441-03 (Standard Specification for Soft-Tissue Expanders) for mechanical testing including valve functionality, joint bond strength, tensile/elongation properties, shell tension set, needle stop penetration, and injection site leakage. ISO 10993-1 for biocompatibility assessment. MR safety testing for induced force, torque, and heating; CT and radiation therapy compatibility testing.

The device uses identical technological principles as the predicate (saline-filled silicone shell with integrated injection port and magnetic locator), maintains the same indications for use and patient-contacting materials, and all mechanical performance testing met acceptance criteria equivalent to the predicate. Design refinements (thinner shell, improved bufferzone, smaller magnet, additional suture tabs) represent minor modifications that enhance functionality without changing the fundamental operating principle; biocompatibility testing confirmed no change in safety profile compared to the predicate device.