BREAST AUGMENTATION - Models who utilize breast implants

Photos of models with breast implants

The Latest News about Breast Implantation

Despite more than a decade of controversy over their safety, breast implants are more popular than ever among women who want to build upon what they were born with, or who want to restore what disease has taken away. Whatever the reason, opting for breast implants is a personal decision that should be made only after a woman fully understands and accepts all of the potential risks

Some people see an enormous benefit to receiving implants and they're willing to accept the known risks. They say that using breast implants to rebuild the breast (reconstruction), or change its size and shape (augmentation), significantly improves the quality of life for many women. Advocates of breast implants might also say that a woman's decision for surgery should be considered valid as long as she weighs the risks against the benefits of the procedure.

While every surgical procedure has potential risks, such as infection, bleeding, and scarring, there are risks that are specific to breast implants. Learning about them is key to being properly informed about the procedure.

According to the American Society of Plastic Surgeons (ASPS), there were nearly 255,000 breast enhancement implant surgeries in 2003, nearly twice the number done in 1998. Another 68,000 women received breast implants for reconstruction following mastectomy due to cancer or other disease. But also in 2003, 45,000 augmentation patients and 17,000 reconstruction patients had their breast implants removed. The medical community and others, including the Food and Drug Administration, would like to better understand why.
Breast implants are designed for augmentation, a cosmetic procedure; reconstruction; and replacement of existing implants, called revision. There are two primary types: saline-filled and silicone gel-filled. Depending on the type of implant, the shell is either pre-filled with a fixed volume of solution or filled through a valve during the surgery to the desired size. Some allow for adjustments of the filler volume after surgery. Breast implants vary in shape, size, and shell texture.

Breast implants were first marketed in the early 1960s, before the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act required a reasonable assurance of safety and effectiveness to be shown for certain medical devices. The 1976 law gave the FDA authority over such devices, but breast implants were "grandfathered" into the regulatory scheme, meaning that manufacturers were not required to provide the agency with scientific evidence of product safety unless questions arose about the safety and effectiveness of these already-marketed devices. Silicone was initially assumed by manufacturers to be biologically inactive and, therefore, to have no harmful effects. But over the years, questions did arise about the effects of silicone on the body. In 1991, the FDA published a regulation that required manufacturers of silicone gel-filled breast implants to submit premarket approval applications (PMAs). This requirement meant that the FDA needed to agree that the manufacturer has presented data showing a reasonable assurance of safety and effectiveness ill order for the devices to remain on the market.

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