MENTOR^® Silicone Breast Implants have been successfully used and trusted for over 20 years by millions of women worldwide. Why? Our implants feel more like natural breast tissue without compromising reliability or safety. Mentor currently has seven silicone gel breast implant clinical studies in progress. Over 200,000 women have participated in Mentor’s studies in order to provide a significant body of clinical evidence demonstrating the safety and effectiveness of silicone-filled breast implants. As we have to date, Mentor will remain committed to providing objective, clinical information about breast implant safety.

MENTOR^® MemoryGel® Breast Implants are FDA approved for breast reconstruction and augmentation. The Institute of Medicine concluded that: “There is no evidence that silicone implants are responsible for any major diseases of the whole body. Women are exposed to silicone constantly in their daily lives.”

Silicone Used Today, Versus Silicone Of The Past

Silicone gel-filled breast implants have undergone changes over time to meet increasingly sophisticated consumer expectations. The first silicone breast implants used thick shells and contained firm gel. The second generation of implants (introduced in the late 1970’s) had thinner shells and used less firm gel to address concerns of patients and surgeons who believed that implants were too firm, palpable, and visible.

In the mid 1980’s, concerns related to rupture rates of the second generation thinner-shelled implants led manufacturers to introduce a third generation of implants. The shell and gel of these implants are thicker but still soft. These third generation silicone gel-filled breast implants are typically referred to as cohesive gel implants.

Today these third generation silicone gel filled breast implants are typically referred to as cohesive gel implants. Mentor’s products have kept pace with the ever-evolving expectations of surgeons and women who desire a safe, soft gel to retain the natural feel that resembles actual breast tissues.

Silicone Exposure

The amount of silicone material released from MENTOR^® Breast Implants is extremely minimal. It is less than is absorbed from daily consumer products containing silicone. (For example, silicone can be found in many common consumer items, such as suntan and hand lotion, antiperspirants, soaps, processed foods, waterproof coatings, and chewing gum.)

The amount of silicone material released is:

• Equal to approximately 1/1000th the weight of the head of a straight pin
• More than a million fold below established safety limits, based on the results of studies presented to the FDA
• More than a hundred-fold below absorbed daily exposures to the same materials from commonly used consumer products, such as antiperspirants, skin care lotions, and hair care products