Perform ™ is an injectable long-term filler suitable for the correction of congenita! and acquired soft tissue deficits of the face and the body.
Perform™ is suitable to integrate and/or enhance the adipose tissue of the subcutaneous layer. lt can be used in plastic and reconstructive surgery to correct different soft tissue defects such as:
– Cheek’s hypovolumetry- Chin’s hypoplasia- Non surgical rhinoplasty- Facial lipoatrophy- Buttock’s atrophy- Calves hypoplasia – Congenita! atrophy – Pectus excavatum – Poland Syndrome – Parry-Romberg Syndrome – Deep scars- Post- traumatic reconstruction.
BiologicaL safety and efficacy
The safety and efficacy of Perform ™ have bee n demonstrated throughout the years in a number of properly conducted clinica! trials, whose results have been published in the literature. These trials and additional laboratory tests have also proven that Perform ™ is highly biocompatible,non toxic and non sensiting.
Perform ™ is a synthetic macromolecular hydrogel containing 96% of non-pyrogenic water and 4% of crosslinked polyalkylimide (amide-imide alkyl type) polymeric chains. These chains are linked together and form a dense three-dimensional structure that retains water.
The hydrogel constituing Perform ™ has biomimetic properties that result in a very natural effect. This is because of the high water content, which ensures an excellent softness, and the visco-elastic, mechanical properties that mimic very well the consistency of the fat
human soft tissue. Once injected, Perform ™ maintains the same consistency as the surrounding tissue without visible or palpable artificial appearance.
Medical device CE marked, according to DDM 93/42/EEC, manufactured by EUmaterials Srl.
Can Perform ™ be considered a permanent or a degradable implant?
Perform ™ is a polymeric hydrogel. Ali hydrogels, once injected in the human body, are subjected to degradation by the action of hydrolytic enzymes, mechanical wear, temperature changes and/or oxidation. Following the injection of Perform ™, the formation of a thin collagen capsule may occur in about 6 weeks. This capsule surrounds the gel completely and isolates it from the nearby tissues for a long time.
Perform ™ can be considered an innovative concept of “prosthesis”: the hydrogel itself is not permanent but the implant, if appropriately injected, may last for severa! years.
Can Perform ™ be removed?
Perform ™ may be included completely in a very thin collagen capsule, after the implantation, if made according to the correct injection technique.
This “capsule” can be completely removed with an appropriate procedure, as suggested by the manufacturer in the Guidelines.
The total re m ovai ofthe implant cannot be guaranteed in the case of altered physiological condition such as local inflammation or infection.
Can Perform ™ migrate?
Perform ™is a cohesive gel and cannot migrate through the vessels and towards other tissues.
Cases of implant moving to adjacent areas of the tissue have bee n reported in the literature and in postmarketing surveillance studies. This effect, termed “dislocation”, may happen because of improper injection technique, injection of an excessive quantity of product, or excessive mechanical stimulation of the anatomica! application area. Chronic systemic toxicity studies have never shown the presence of fragments of Perform ™ away from the injection site, or of any side effect caused by them.