Instructions For Use - PFM Medical TiLOOP MPX Instrucciones De Uso

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Instructions for use

TiLOOP® Bra MPX
Description
The TiLOOP® Bra MPX mesh implant is a large-pored, non-absorbable prosthetic mesh made of monofilament polypropylene and
coated with a titanium-containing layer. The mesh implants are available in customised forms and sizes. TiLOOP® Bra MPX was
developed for reconstructive and aesthetic plastic breast surgery following the universally recognised surgical methods.
These Instructions for Use are also valid for other TiLOOP® Bra MPX product variants.
Indication
TiLOOP® Bra MPX is intended for the support, reinforcement and bridging of body's own tissue in reconstructive and aesthetic plastic
breast surgery.
Mode of action
TiLOOP® Bra MPX is intended for the support, reinforcement and bridging of body's own tissue and is designed for mammary gland
reduction surgeries in particular. The mesh structure serves as a matrix for the ingrowing of stromal cells, resulting in the apposition
of a thin fibrous layer of tissue. The cells of the tissue grow through the pores of the mesh. The mesh implant is hence completely
encased by the body's own tissue.
Similar to all titanised mesh implants for breast surgery, a limitation of radiological diagnostic methods (X-ray, CT, MRI and ultrasonic
examinations) by the synthetic material and its titanium-containing layer of coating is not known.
8 MK-A001068_02 / 2016-11-02