Warnings And Precautions - PFM Medical TiLOOP MPX Instrucciones De Uso

Application
In case of oncological indications for surgery, the mesh implant may be used for the following basic surgical procedures: reconstruc-
tion after ablation mammae (modified radical mastectomy, skin sparing mastectomy and nipple-areola-complex sparing subcutane-
ous mastectomy) and reduction mammaplasty or other forms of mammary gland reduction surgery (such as those following a partial
resection); as well as for the following aesthetic plastic breast surgeries: mastopexy (form changing breast surgery in the surface
area of the skin for elevation, lifting as well as for tightening), symmetrisation surgery and reduction mammaplasty, if using tissue
supporting, strengthening and bridging material is indicated.
Preparation:
When choosing the size of the mesh, ensure that a dimensionally stable yet a soft mesh implant layer covers the breast implant,
expander or the corpus mammae, which is disconnected from the subcutaneous tissue and needs to be fixated, as much as possible.
A necessary custom fitting of the mesh can be performed by using a pair of scissors or a scalpel.
The placement of the mesh implant must be performed with the desired tension respective to the aim of mesh implant positioning.
Please make sure that the implant is inserted as wrinkle-free as possible. When choosing and using the surgical suture material,
surgeons should observe current medical standards.
Recommended implant procedure:
For mastopexy, symmetrising surgery and reduction mammaplasty, the function of the TiLOOP® Bra MPX mesh implant is to cover
the corpus mammae that has been partially or fully disconnected from the subcutaneous tissue and its fixation. For this purpose, the
TiLOOP® Bra MPX mesh implant is placed over the part of the corpus mammae that needs to be covered, so that the incision of the
mesh is facing in cranial direction. After the cranial surgical suture fixation of both mesh wings, the medial, lateral and caudal attach-
ment of the mesh implant follows. For fixating the mesh implant it is recommended to use monofilament surgical suture material
and place the sutures in such a way that dislocation of the mesh implant as well as of the corpus mammae section that needs to be
fixated is prevented. The circular cut-out in the mesh provides free space for the nipple-areola complex.
Recommendations for post-operative care:
• A s it is universally recommended for reconstructive and aesthetic plastic breast surgery, the breast must be supported (supportive
bra, possibly with a Stuttgart-belt).
• Heavy lifting, physical activities and exercise should be avoided for 4-6 weeks.

Warnings and precautions

Only doctors who are familiar with the correspondingly recognised surgical techniques and methods should use
TiLOOP® Bra MPX.
Every product is individually packaged in primary and secondary packaging and is supplied EtO sterilised and
pyrogen-free. It is only intended for single use and should not be reused, reprocessed or resterilised. Reusing,
reprocessing or resterilising single-use products can lead to diminished performance or loss of functionality.
Check to see if the packaging is still intact before use. If the packaging is damaged, opened or damp, do not use
the mesh implant on any account. Do not use the mesh implant if there is any doubt to its sterility or the use-by date has expired. The inner packaging must only be opened before the insertion of the mesh implant and must
solely be handled with sterile gloves and sterile instruments.
Reusing single-use products can lead to exposure to pathogens such as viruses, bacteria, fungi or prions.
For treating contaminated or infected wounds, the recognised surgical procedures should be observed.
Please note that in case of a change to the volume of the breast (e.g. period of growth, weight changes, pregnancies),
the mesh implant only has a limited stretchability.
MK-A001068_02 / 2016-11-02
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