The Safety of Silicone

INAMED® Silicone-Filled Breast Implants are FDA approved.
With the recent approval of silicone gel-filled breast implants for breast augmentation and breast reconstruction, physicians and patients can be assured of the safety of silicone. This confirmation is based on extensive preclinical testing, four years of data on 715 women from Allergan's Core Clinical Study and a European study that evaluated implant rupture prevalence rates beyond 10 years. In addition, countless published, peer-reviewed studies and research support the safety of silicone gel-filled breast implants.

Silicone gel-filled breast implants are arguably the most studied medical devices and decades of research have evaluated their safety and effectiveness.

The Allergan Core Clinical Study
Allergan's Core Clinical Study is an ongoing 10-year study of 940 women who had breast augmentation, reconstruction or revision of a previous surgery between 1999 and 2000. Safety and effectiveness is evaluated through patient follow-up at zero to four weeks, six months, 12 months, 24 months, and annually through 10 years. Safety is assessed by complications, such as implant rupture, capsular contracture and re-operation. Benefit (effectiveness) is assessed by patient satisfaction and measures of body image/esteem and self-esteem.

The result: The FDA has evaluated Allergan's Core Clinical Study data at four years and determined that INAMED® Silicone-Filled Breast Implants are safe and effective for use in breast augmentation and breast reconstruction.

Studies show silicone gel-filled breast implants are safe, but that doesn't make them right for everybody.
Silicone gel-filled breast implants are not lifetime devices. It is possible at some point in your lifetime that the implant(s) would need to be removed or replaced. To ensure that you achieve your optimal results safely, patients should be aware that you should not have breast implant surgery if you:

Have existing malignant or pre-malignant cancer of the breast and have not been successfully treated
Have an active infection anywhere in the body
Are currently pregnant or nursing

Breast Implant Information
Mentor has been making breast implants for more than 30 years. We are recognized as the international leader in the category. Our rich history is filled with industry firsts, innovative product designs, and ground-breaing research. While other breast implant manufacturers have come and gone, Mentor has consistently produced high-quality breast implants under unwavering, strict standards of design and testing. Because of this, we have achieved a tremendous level of respect in the medical community.

Introducing MemoryGel™ Breast Implants
Mentor MemoryGel™ breast implants are now FDA approved for breast augmentation in the United States!

These MemoryGel™ implants you've been hearing about have actually been trusted and in use for almost 20 years. In fact, a million women all over the world have them. MemoryGel™ implants feel more like natural breast tissue. After almost two decades of research with surgeons and patients, MemoryGel™ breast implants, exclusively from Mentor, are available now available in the U.S.

As illustrated by this photo of a MemoryGel™ breast implant cut in half, MemoryGel™ implants feature a cohesive, gelatin-like substance that acts as a solid rather than a liquid. It holds together uniformly while still retaining the natural give of breast tissue.

MemoryGel™ breast implants are available in a variety of profiles (which refers to the amount of forward projection off the chest wall, in relation to the base width of the implant), This allows your doctor to achieve a better match between desired breast projection and your individual body frame. Ask your plastic surgeon for greater detail on selecting the right breast implant for you.

Breast Implant Styles
If you decide to have breast augmentation, you also will need to decide what kind of breast implant will help you and your plastic surgeon achieve the result you want. Both MemoryGel™ and saline breast implants are available in a variety of shapes and sizes. Prior to your breast enlargement surgery, you and your doctor will discuss the implant size, shape, and surface that are most appropriate for you.

Breast Implant Defined
A breast implant is a sac (implant shell) of silicone, a rubber-like substance filled with silicone gel or saline, which is surgically implanted under your chest tissue.

Mentor offers breast implants in a variety of sizes and shapes to accommodate various body types. Our range of MemoryGel™ breast implants and round saline breast implants include High Profile, Moderate Plus Profile, and Moderate Profile – each offering a different level of projection (profile) for an individual woman's preference and body type. In fact, Mentor was the first to offer the High Profile Breast Implant – offering greater projection, particularly designed for women with a narrower chest wall.

Breast Implant Size
For many women, deciding what breast size they want can be the most difficult part about choosing breast augmentation. Generally, the larger you want your cup size to be, the larger the breast implant your surgeon will consider using. Your plastic surgeon will evaluate your existing breast tissue to determine if you have enough tissue to accommodate the desired size of breast implant.

If you desire a breast implant that is too large for your tissue, the implant's edges may be visible through your skin after your operation or the implant may be more easily felt. By choosing a breast implant that is too large for your tissue, you may increase the risk of having surgical complications. Also, breast implants that are excessive in size may increase the effects of gravity on your body, which may cause your breasts to prematurely droop or sag.

Smooth & Textured Breast Implant Surfaces
Breast implant shells have a smooth or textured surface. As a natural reaction to any device placed in the body, scar tissue will form around the breast implant surface, creating a capsule. In some women, the capsule can tighten and squeeze the implant. This occurrence is called capsular contracture.

Textured breast implants were designed to reduce the chance of capsular contracture. Some information in the literature on small numbers of patients suggests that surface texturing reduces the chance of severe capsular contracture, but clinical information from studies of a large number of women with Mentor implants shows no difference in the likelihood of developing capsular contracture with textured implants compared to smooth-surfaced implants.