The U.S. Department of Health and Human Services states:

“For some years controversy has existed over silicone implants used for breast augmentation or replacement after mastectomy. Adverse effects from their use have been widely reported in the popular press, with conflicting information often appearing in the medical literature. This controversy and the attendant publicity led the Food and Drug Administration (FDA) first to ban any use of these implants and then to permit limited use, mainly as replacement after mastectomy.

“Silicone is used not only in breast implants but also in implants located literally throughout every part of the body. It has been used: toconstruct heart valves and other cardiovascular prostheses; to fashion catheters which are used for purposes ranging from drug delivery to cardiac monitoring; in dentistry; in the gastrointestinal tract; as a facilitator for nerve regeneration; in ophthalmology; in the ear, nose, throat, and respiratory tract; as a prosthesis or ingredient in prostheses for many parts of the skeletal system; as a tissue expander; as a cosmetic agent for treatment of scars and wrinkles; in the urogenital tract, including penile prostheses; and in many other applications.”

To access the Breast Implants Patients Surveys 2003: http://www.surgery.org/download/implantsurvey.pdf

Breast Implants: Now

Currently, almost all women in the U.S. undergoing breast augmentation receive saline-filled implants. Approximately 10% of women undergoing breast procedures receive silicone gel-filled implants, but this is permitted only for breast reconstruction, implant replacement, and severe breast ptosis (sagging). In October 2003, the FDA reviewed new data on silicone gel-filled implants that was derived from ongoing clinical studies and was submitted by implant manufacturers with the hope of winning FDA approval for reintroduction of silicone gel-filled breast implants for general use in breast reconstruction and augmentation. The FDA’s advisory panel recommended reintroduction of silicone gel implants for general use with conditions. The FDA usually follows the recommendations of its advisory panels, but has not yet ruled on the safety and efficacy of silicone gel.

Silicone gel remains a potentially popular implant choice primarily because it produces a natural-feeling breast and is particularly effective for women with minimal breast tissue. Recently, a new formulation of silicone gel, which is thicker than previous gels and retains its shape even in the event of a tear or rupture of the implant shell, has been developed and is undergoing clinical trials. Called “cohesive silicone gel,” this new filler innovation has already been used extensively outside the United States, and eventual FDA approval is anticipated.

The use of sustained mechanical force to induce tissue growth in the breasts has been touted as a method to achieve modest enlargement of the breasts. While some physicians have reported promising results with this technique, others claim widespread failure to achieve satisfactory results with consequent patient disappointment.

What Does the Future Hold?

Some researchers say that new tissue engineering technology using stem cells derived from liposuctioned fat may someday be used to “grow” breast tissue. Or breast enlargement may be achieved through manipulation of hormones or other chemical or biological substances.

These and other innovations are likely to provide increased options for breast augmentation in the 21st Century. In the meantime, women seeking breast enlargement have a variety of choices, and most breast augmentation patients will achieve a high level of satisfaction with the current methods and devices. Surveys consistently show that the overwhelming majority of women who undergo breast augmentation say they would make the same decision again.

The information provided is for general education about breast augmentation, saline and silicone breast implants cosmetic surgery procedures.