Important Safety Information

MEMORY GEL® Breast Implants and MENTOR® Saline-Filled Breast Implants (including SILTEX SPECTRUM®) are indicated for breast augmentation in women (at least 18 years old) or for breast reconstruction.

The MENTOR® Sterile Resterilisable Gel Breast Implant Sizer (Gel Sizer) is indicated for temporary intraoperative insertion as a tool to assist the surgeon in determining the shape and size in permanent breast implant selection. The MENTOR® Saline Breast Implant Sizer (Sizer) is only indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.

Breast implant surgery should not be performed in women with active infection anywhere in their body with existing cancer or precancer of their breast who have not received adequate treatment for those conditions or are pregnant or nursing.

Breast implants are not lifetime devices and breast implantation is not necessarily a one-time surgery. The most common complications with the MEMORY GEL® Breast Implants include reoperation, explantation, change in nipple/breast sensation, capsular contracture, asymmetry, and breast pain. A lower risk of complication is rupture. 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 Breast Implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain, altered nipple sensation and deflation.

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.

CONTOUR PROFILE™ Tissue Expanders and Smooth Round Tissue Expanders with Remote Dome are used for breast reconstruction following mastectomy. These expanders are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. The use of these tissue expanders is contraindicated in patients who have active infection anywhere in the body, existing malignant or premalignant breast cancer without adequate treatment.

Do not use the CONTOUR PROFILE™ Tissue Expanders in patients who have implanted devices such as pacemakers, drug infusion devices, artificial sensing devices, etc. that would be affected by a magnetic field. Do not use the CONTOUR PROFILE™ Tissue Expander in patients where an MRI may be needed. 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.

Complications associated with CONTOUR PROFILE™ Tissue Expanders and Smooth Round Tissue Expanders include reoperation, capsule contracture, complications of tissue expansion, deflation/rupture/leakage and extrusion of the tissue expander.

For detailed indications, contraindications, warning, precautions and complications associated with the use of all Mentor® Implantable Devices, which include BECKER™ Expander Breast implants, SILTEX SPECTRUM® Post-Operatively Adjustable Saline Implants, Mentor® Saline-Filled Breast Implants, MEMORY GEL® Breast Implants and Tissue Expanders, please refer to the Product Insert Data Sheet provided with each product.

For detailed indications, contraindications, warning and precautions associated with the use of FLEX HD® and FLEX HD® Pliable please refer to the Product Insert Data Sheet provided with each product.

Mentor® SILTEX® BECKER™ EXPANDER/BREAST IMPLANTS Product Insert Data Sheet
Mentor® CPX™4 and CPX™4 with Suture Tabs Breast Tissue Expanders Product Insert Data Sheet
Mentor® GEL BREAST IMPLANTS Product Insert Data Sheet
Mentor® STERILE RESTERILIZABLE GEL BREAST IMPLANT SIZER Product Insert Data Sheet