PFM Medical TiLOOP Bra Notice D'utilisation page 13

Warnings
The packaging is to be carefully examined before use in order to ensure that it is intact. Do not
use the product if the packaging should be damaged, soaked or accidentally opened or should
you have doubts regarding the sterility or should the use by date have expired.
Carefully inspect the mesh implant before use in order to ensure that it is intact. Do not use
a damaged mesh implant. Damage is deemed to have been caused if the function of the mesh
can no longer be warranted. Ensure that the mesh implant is not accidentally damaged during
surgery. A conscious cutting of the mesh implant to size using a pair of scissors or a scalpel is
permitted. When cutting the mesh implant to size, ensure that there is an adequate clearance
from the seam so that it cannot be damaged. Avoid an irreversible overstretching of the mesh
material. Do not use an irreversibly deformed mesh implant.
Each product is packed separately and is supplied EO-sterilised and pyrogen-free. It is only to
be used once. Do not reuse, reprocess or resterilise. A reuse, reprocessing or resterilisation
of disposable products can result in a reduced performance or a loss of their functionality. A
reuse of disposable products can result in exposure to pathogens such as viruses, bacteria,
fungi or prions.
It is to be taken into account in connection with all events that result in a change to the breast
volume (e.g. growth phase, weight changes, pregnancies) that the mesh implant only has a
restricted degree of elasticity.
Precautions
• The physician should be experienced with the surgical procedures and techniques. The physician
is responsible for the implantation.
• It is to be ensured that the mesh implant is positioned without any creases if possible.
Contraindications
• Do not use in patients with an intolerance and / or allergy / allergies in connection with the
product.
• Do not use in infected, contaminated or inflamed areas.
Recommended implantation procedure
General
The TiLOOP® breast mesh implant can be used in various forms of oncological and plastic-aesthetic
mamma surgery. The following surgical techniques are possible:
• Reconstruction after ablation mammae (modified radical mastectomy, skin sparing mastectomy
and nipple-areola-complex sparing subcutaneous mastectomy)
• Operations for tightening, elevating and lifting
MK-E000689_10 / 2022-01-28
English
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