The breast consists of milk ducts and glands, surrounded by fatty tissue that provides its shape and feel. Situated beneath the breast is the pectoralis major muscle or chest muscle. Factors such as pregnancy (when milk glands are temporarily enlarged), rapid weight loss, and the effects of gravity as you age combine to stretch the skin, which may cause the breast to droop or sag.

A breast implant is a sac (implant shell) of silicone elastomer (rubber), which is surgically implanted under your chest tissues. Implants may be filled with either saline or silicone gel.
 
MemoryGelTM silicone breast implants you've been hearing about have actually been trusted and in use for almost 20 years – sometimes they are referred to as "gummy bear implant" style due to their cohesiveness.
 
This is because MemoryGelTM silicone breast implants feature a cohesive, gelatin-like silicone substance that acts as a solid rather than a liquid. It holds together uniformly while still retaining the natural give of breast tissue.
 
MemoryGelTM silicone breast implants feel more like natural breast tissue.
 
Over a million women all over the world have them. And now, after almost two decades of research with surgeons and patients, MemoryGelTM breast implants, exclusively from Mentor, are now available in the U.S.
 
MemoryGelTM 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.
 
The saline breast implant is inflated with a saline (salt-water) solution through a valve. Saline is much like the fluid that makes up most of the human body. There are two types/families of implants filled with saline — one referred to as Saline-Filled and the other referred to as SpectrumTM implants. The Saline-Filled family of implants has a self-sealing valve located on the front (anterior) of the implant that is used for filling the device. The SpectrumTM family has a valve on the back (posterior) of the implant that allows saline to be added after surgery (postoperative adjustability). Mentor's Spectrum implant is a saline-filled breast implant that lets your physician adjust the size of your breasts after your surgery. In a simple office procedure, your physician can change your implant size by either adding or removing saline for up to six months after your surgery.

Silicone is derived from silicon, a semi-metallic or metal-like element that in nature combines with oxygen to form silicon dioxide, or silica. Beach sand, crystals, and quartz are silica. Silica is the most common substance on earth. Heating silica with carbon at a high temperature can produce silicon. Further processing can convert the silicon into a long chemical chain, or polymer, called silicone - which can be a liquid, a gel, or a rubbery substance. Various silicones are used in lubricants and oils, as well as in silicone rubber. Silicone can be found in many common household items, such as polishes, suntan and hand lotion, antiperspirants, soaps, processed foods, waterproof coatings, and chewing gum.

Special studies have been done and have determined that much higher levels of silicone have been found in cows’ milk and commercially available infant formula than are found in the breast milk of women with implants. 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.”

Mentor does not use latex in any of its implantable devices. These include tissue expanders, saline volume sizers, saline-filled breast implants or silicone gel-filled breast implants. Latex gloves are not allowed on the floor of the production process. Both are powder-free. At no time during manufacturing process is latex or talc-containing material utilized. (Natural latex contains proteins which may cause allergic reaction in some individuals).

Breast implants are not considered lifetime devices. You will likely undergo implant removal with or without replacement over the course of your life. Whether or not you are undergoing augmentation, be aware that breast implantation may not be a one-time surgery. You are likely to need additional surgery and doctor visits over the course of your life.
 
Many of the changes to your breast following implantation are irreversible (cannot be undone). Problems such as deflation, capsular contracture, infection, and shifting can require removal of the implants. Many women decide to have the implants replaced, but some women do not. If you later choose to have your implant(s) removed, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast.
 
Deposits of calcium can be seen on mammograms and can be mistaken for possible cancer, resulting in additional surgery to biopsy and/or removal of the implant to distinguish them from cancer.

Breast implants come in a variety of shapes, surface textures, and sizes. The implants are available with a textured or smooth surface shells. Mentor breast implants come in either round or contoured shapes. Mentor's Spectrum implant is an adjustable saline-filled breast implant that lets your physician adjust the size of your breasts after your breast augmentation surgery. In a simple office procedure, your physician can change your implant size by either adding or removing saline for up to six months after your surgery.

Saline breast implants are to be used for females for the following indication: Breast Augmentation — This procedure is done to increase the size and proportion of a woman's breasts. A woman must be at least 18 years old for breast augmentation.
 
Breast implant surgery should not be performed in:

• Women with active infection anywhere in their body.
• Women with existing cancer or pre-cancer of their breast whohave not received adequate treatment for those conditions.
• Women who are currently pregnant or nursing

Mentor MemoryGel Silicone Gel-Filled Breast Implants are indicated for females for the following uses (procedures):
 
Breast augmentation for women at least 22 years old.
Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. 
 
Breast reconstruction.
Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. (A separate patient brochure is available for and should be read for breast reconstruction.) 
 
Breast implant surgery should not be performed in:

• Women with active infection anywhere in their body.
• Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.
• Women who are currently pregnant or nursing.

If you are currently pregnant or breast-feeding or have an active infection anywhere in your body. If you have an existing malignant or pre-malignant breast cancer for which you have not yet received adequate treatment.

• Accept your breasts as they are.
• Wear a padded bra or external prostheses

Upon request, you will be provided with a copy of the Directions for Use (package insert). You can request a copy from your surgeon or from Mentor. For more detailed information on the preclinical and clinical studies conducted by Mentor, you are referred to the Summary of Safety and Effectiveness Data for this product at: http://www.fda.gov. You will be given a device identification card with the style and serial number of your breast implant(s).
 
Mentor Corporation
1-800-Mentor-8
 
Institute of Medicine Report on the Safety of Silicone Implants
 
Food and Drug Administration
1-888-INFO-FDA or 301-827-3990s