MENTOR® Important Safety Information

MENTOR® Important Safety Information

At Mentor, we are committed to ensuring every woman has a full understanding of both benefits and risks before deciding to undergo surgery for breast implants. The important safety information you and your patients should discuss prior to surgery is available below.

Important Safety Information: MENTOR® MemoryGel® 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 those women with active infection anywhere in their body, those with existing cancer or pre-cancer of their breast(s), those who have not received adequate treatment for these conditions or those 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. Your patient needs to be informed and understand the risks and benefits of breast implants, and she should be provided with an opportunity to consult with you prior to deciding on surgery.
 
For detailed indications, contraindications, warnings and precautions associated with the use of all MENTOR® Implantable Devices, please refer to the Product Insert Data Sheet provided with each product.
 
The most common complications for breast augmentation with MemoryGel® Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. The most common complications with CPG® Implants for breast augmentation include reoperation for any reason, 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.
 
^Many key complications including capsular contracture, reoperation, implant removal.

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