Nchi: Belarusi
Lugha: Kirusi
Chanzo: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Mentor Medical Systems B.V., НИДЕРЛАНДЫ
изделия медицинского назначения
Mentor Medical Systems B.V.
2021-03-16
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 Soma hati kamili