Эндопротезы молочной железы c принадлежностями: принадлежности к имплантатам молочной железы:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Mentor Medical Systems B.V., НИДЕРЛАНДЫ

класс:

изделия медицинского назначения

Производитель:

Mentor Medical Systems B.V.

Дата Авторизация:

2021-03-16

Характеристики продукта

GEL BREAST IMPLANTS
JUNE 2021, 156001-04
LAB100069598v7
DESCRIPTION
MENTOR® Gel Breast Implants are silicone elastomer mammary devices.
The gel-filled shell is constructed of successive cross-linked layers
of silicone elastomer, which give the prosthesis its elasticity
and integrity.
Mentor offers Gel Breast Implants with two types of shell surfaces:
SILTEX™ and smooth surfaced. The SILTEX™ shell is textured to
provide a disruptive surface for collagen interface. All MENTOR®
Gel Breast Implants contain silicone gel which is cohesive. Mentor
offers Gel Breast Implants with a variety of cohesivity levels of the
filling material. The devices are available in a round shape with
different projections and in several contour shapes with different
heights and projections. The volume indicated on the product label is
the fill volume of the gel.
INDICATIONS
This prosthesis may be used in the case of one or more of the
following indications:
•
Cosmetic augmentation. The European Parliament “recommends that
implants in women under 18 years of age should be authorized only on
medical grounds.”
•
Immediate or delayed breast reconstruction following mastectomy.
•
Reconstruction due to cancer treatments other than mastectomy.
•
Revision due to complications or other undesirable results of a
previous surgery for mastectomy or cancer treatments other than
mastectomy.
•
Post-Trauma defined as total or partial removal of the breast(s)
through surgery (for any reason) or as a result of the trauma itself.
•
Congenital deformities: Pectus Excavatum defined as congenital concave
chest-wall deformity with abnormalities of the sternum and anterior
ribs; Pectus Carinatum defined as congenital
convex chest-wall deformity with abnormalities of the sternum and
anterior ribs; and severe asymmetry defined as congenital or acquired
substantial discrepancy in breast sizes such as to
represent a significant physical deformity (e.g., Poland’s
syndrome).
•
Severe ptosis defined as requiring a specific reconstruction procedu