MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs

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 saline filling to stretch surrounding tissue and is intended for subcutaneous or submuscular implantation for no longer than six months.

The proposed device features a thinner three-layer silicone shell, an internally-attached injection port with plastic needle guard and silicone backing, a smaller magnet for improved MR compatibility, new sheeting-based self-sealing bufferzone technology, updated design control technology components, and additional suture tabs at 1:30, 4:30, 7:30, and 10:30 positions (vs. predicate tabs only at 3, 6, 9 o'clock). The patient-contacting surface and expansion principle remain identical to the predicate.

ASTM F1441-03 Standard Specification for Soft-Tissue Expanders was used for mechanical testing including valve functionality, leakage, joint bond strength, tensile/elongation properties, shell tension set, needle stop penetration, and injection site leakage. ISO 10993-1 was applied for biocompatibility assessment. MR safety testing included induced force, induced torque, and induced heating evaluations.

The proposed device uses the identical expansion principle and intended use as the predicate (saline-filled silicone expander for temporary breast reconstruction). All patient-contacting materials are identical to the predicate, and biocompatibility testing showed no change in safety profile. All mechanical performance testing met predefined acceptance criteria. Design changes (thinner shell, smaller magnet, improved bufferzone, additional suture tabs) are material refinements that enhance function and compatibility without altering the fundamental operating principle. Additional suture tabs provide surgeon options for device stability but do not change the core mechanism.