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Safety Information

MemoryGel Breast Implants

MemoryGel Breast Implants are indicated for breast augmentation in women at least 22 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 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 MemoryGel Breast Implants include reoperation, 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. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture.

Patients should receive a copy of Important Information for Augmentation Patients about MENTOR® MemoryGel Silicone Gel-Filled Breast Implants or Important Information for Reconstruction Patients about MENTOR® MemoryGel Silicone Gel-Filled Breast Implants. Your patient needs to read and understand the information regarding the risks and benefits of breast implants, with an opportunity to consult with you prior to deciding on surgery.

For detailed indications, contraindications, warning and precautions associated with the use of MemoryGel Breast Implants please refer to the Product Insert Data Sheet provided with each product, or online at www.mentorwwllc.com/global-ca/.

MENTOR® SPECTRUM and Saline-Filled Breast Implants

MENTOR® Saline-filled Breast Implants are indicated for breast augmentation in women 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 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 Saline-filled breast implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain and deflation.

Patients should receive a copy of Saline-Filled Breast Implants, Making an Informed Decision. Your patient needs to read and understand the information regarding the risks and benefits of breast implants, with an opportunity to consult with you prior to deciding on surgery.

For detailed indications, contraindications, warning and precautions associated with the use of Saline-filled breast implants please refer to the Product Insert Data Sheet provided with each product, or online at http://www.mentorwwllc.com/global-ca/.

Important Safety Information for Tissue Expanders:

CONTOUR PROFILE Tissue Expanders are used for breast reconstruction following mastectomy. This expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. Do no 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.

For detailed indications, contraindications, warning and precautions associated with the use of Tissue Expanders, please refer to the Product Insert Data Sheet provided with each product, or online at www.mentorwwllc.com/global-ca/.

CONTOUR PROFILE Tissue Expander With BufferZone Patch Area

Smooth Tissue Expander