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Important Safety Information for Europe & the Middle East

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© Johnson & Johnson and its affiliates, 2024 
CA_MNT_BRST_388736

MENTOR™ MemoryGel™ Breast Implants and MENTOR™ Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel™ Implants, and 18 years old for Saline Implants) or for breast reconstruction. MENTOR™ MemoryGel™ SILTEX™ BECKER™ Expander/Breast Implants are indicated 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 who are currently pregnant or nursing.

Breast implants are not lifetime devices and breast implantation may not be a one-time surgery.

The most common complications for breast augmentation and reconstruction with MemoryGel™ Implants include any reoperation, capsular contracture, breast pain, and implant removal with or without replacement, and ptosis. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel 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.

The most common complications for MemoryGel™ SILTEX™ BECKER™ Expander/Breast Implants are consistent with types of complications associated with other gel filled breast implant studies.

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

For MemoryGel™ Implants, patients should receive a copy of Important Information for Augmentation Patients about MENTOR™ MemoryGel™ Breast Implants or Important Information for Reconstruction Patients about MENTOR™ MemoryGel™ Breast Implants. For MemoryGel™ BECKER™ Expander/Breast Implants, patients should receive a copy of Important Information for Reconstruction Patients About MENTOR™ MemoryGel™ BECKER™ Expander/Breast Implants. For MENTOR™ Saline-filled Implants, patients should receive a copy of Saline-Filled Breast Implants: Making an Informed Decision.

Your need to read and understand the information regarding the risks and benefits of breast implants, with an opportunity to consult with a plastic surgeon prior to deciding on surgery.

The CONTOUR PROFILE™ (CPX4™) Breast Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures.

The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. Do not use the CONTOUR PROFILE™ (CPX4™) Breast 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, warnings, and precautions associated with the use of all MENTOR™ Implantable Devices, which include MENTOR™ Saline-filled Implants, MemoryGel™ Implants, MemoryGel™ BECKER™ Expander/Breast Implants, and CONTOUR PROFILE™ (CPX4™) Breast Tissue Expander, please refer to the Product Insert Data Sheet provided with each product or visit https://www.jnjmedicaldevices.com/en-CA/mentor

 

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