Instructions For Use - PFM Medical TiLOOP Bra Notice D'utilisation

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Instructions for use

TiLOOP® Bra
Description
The sterile mesh implants comprise a large-pored non-absorbable prosthetic knitted fabric made using a
monofilament polypropylene thread with a titanium containing coating. The mesh implants are availa-
ble in various grammages with defined shapes and dimensions. The TiLOOP® breast mesh implants
have been developed for use in the most diverse indications and all implantation techniques that ha-
ve been applied to date in the field of reconstructive and plastic-aesthetic mamma surgery. The mesh
implants are designed in keeping with the requirements of the respective area of use in terms of their
tensile strength and strain characteristics.
Intended use
The TiLOOP® breast mesh implants are intended for the support, reinforcement and bridging of
body's own tissue.
Indication
TiLOOP® Bra is intended for the support, reinforcement and bridging of body's own tissue in reconst-
ructive and plastic-aesthetic breast surgery.
Mode of action
The mesh structure serves as matrix for the ingrowing of stromal cells. Thereby, the adsorption of a
thin fibrous tissue layer appears whose cells grow through the pores of the mesh fabric. By this ef-
fect, the mesh implant is completely enclosed by body's own tissue. Experimental investigations have
shown that the implant remains soft and flexible.
The titanium containing coating of the plastic does not have an effect on radiological diagnosis proce-
dures (X-ray, CT, MRI and sonographic examinations).
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