MENTOR^® MemoryGel™ and MENTOR^® Saline-filled Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR^® MemoryGel® Implants and at least 18 years old for MENTOR^® Saline Implants - 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
• Who are currently pregnant or nursing

Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.

There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation is likely not a one-time surgery. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.

The most common complications with MENTOR^® MemoryGel® Breast Implants include reoperation, capsular contracture, asymmetry, and breast pain. A lower risk of complication is implant rupture, which is most often silent (meaning neither you nor your doctor will know you have a rupture). MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture.

The most common complications with MENTOR^® Saline-filled Breast Implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain and deflation.

Detailed information regarding the risks and benefits associated with MENTOR^® Breast Implants is provided in two brochures, Important Information for Augmentation Patients about MENTOR^® MemoryGel® Silicone Gel-Filled Breast Implants or MENTOR^® Saline-Filled Breast Implants, Making an Informed Decision available from your surgeon or on line at www.mentorwwllc.com. It is important that you read and understand these brochures when considering MENTOR^® Breast Implants.

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 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 place 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.

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 MENTOR^® Saline-filled breast implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain and deflation.

Patients should receive a copy of MENTOR^® 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 MENTOR^® Saline-filled breast implants please refer to the Product Insert Data Sheet provided with each product, or online at www.MentorCorp.com.

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.MentorCorp.com.