1 Based on worldwide market share. Data as of June 2017.
2 As compared to saline-filled breast implants.
3 Product Dimensions for MemoryGel(TM) and MemoryGel(TM) Xtra Breast Implants Mentor R&D Compression Benchtop Testing - July 2017.
4Most projection based on projection and base width comparisons of the following textured shaped silicone gel breast implants:
1. CPG™ Gel Breast Implants, NATRELLE™ 410 TruForm™
2. Breast Implants, NATRELLE™ 410 TruForm™
3. Breast Implants, NATRELLE™ 510 Dual Gel Anatomical Implants, Silimed BIODESIGN™ Matrix Textured Breast Implants, The Matrix Breast Implants by EUROSILICONE™, NAGOR™ CoGel System® Breast Implants, SEBBIN Naturgel™ Anatomical Breast Implants, CEREPLAS® Anatomical Breasts Implants and POLYTECH SublimeLine®. NATRELLE™ Product Catalogue 11-2008, Silimed Catalogue 2012, EUROSILICONE™ Product Catalogue 2013, NAGOR™ Product Catalogue 2013, SEBBIN Naturgel™ Anatomical Implants Catalog, CEREPLAS® Anatomical Breast Implants, and POLYTECH SublimeLine® Catalogs all accessed 11/4/2014
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Important Safety Information
MENTOR® Breast Implants are indicated for breast augmentation, in women who are at least 18 years old, or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast(s) who have not received adequate treatment for those conditions or who are pregnant or nursing.
There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation is not necessarily a one-time surgery.
The most common complications with MENTOR® MemoryGel™ Breast Implants include re-operation, implant removal, capsular contracture, asymmetry, and breast pain. A lower risk of complication is implant rupture, which is most often silent. The health consequences of a ruptured silicone gel-filled breast implant have not been fully established. Screenings such as mammography, MRI, or ultrasound are recommended after initial implant surgery to assist in detecting implant rupture.
The most common complications with MENTOR® Saline-Filled Implants include re-operation, implant removal, capsular contracture, wrinkling, deflation, asymmetry, and breast pain.
MENTOR® CPX™4 Breast Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures.
These expanders are intended for temporary subcutaneous or submuscular implantation.*
CONTOUR PROFILE™ Tissue Expanders are devices that contain magnetic injection domes and are NOT MRI compatible. Do not use the CONTOUR PROFILE™ Tissue Expander in patients where an MRI may be needed. DO NOT use the CONTOUR PROFILE™ Tissue Expander in patients that have a previously implanted device that could be affected by a magnetic field. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas or where severe surgical reduction of the area has previously been performed.
Your patient needs to be informed and understand the risks and benefits of breast implants, and provided with an opportunity to consult with you prior to deciding on surgery.
For detailed indications, contraindications, warning and precautions associated with the use of all MENTOR® Implantable Devices, please refer to the Product Insert Data Sheet provided with each product, or review the Important Safety Information provided at https://www.jnjmedicaldevices.com/en-EMEA/mentor