An updated look at the safety and efficacy of breast implants

The first documented report of breast-augmentation surgery dates to the late 19th century: Fatty tissue was transplanted to the breast from another area of a woman’s body to repair damage caused by the loss of tissue from the removal of a noncancerous tumor.

By the early 1900s, breast enlargement was performed by injecting liquefied paraffin wax into the breast. Paraffin and olive oil, when combined, created an injectable liquid that eventually formed hard masses inside the breast—as a result, this technique was abandoned.

In Japan in the 1950s, liquid silicone was injected to enlarge women’s breasts, and this method soon found its way to the United States. Before silicone gel was developed, breast implants were carved from hard polyurethane blocks. The first silicone-gel implants, developed in the 1960s, were teardrop-shaped bags with polyester patches on their backs to affix them to the chest wall.1

All implants used today have a solid silicone shell that is filled with salt water or silicone gel. Other fillers, such as peanut oil, soybean oil, and liquid silicone, have been tried without success.

Concerns about the use of silicone-gel-based implants began to surface in the United States and Canada in the 1980s, then spread to Europe in the 1990s. In 1992, spurred by concerns that silicone gel leaking into the body might harm the immune system, the US Food and Drug Administration (FDA) declared a moratorium on using silicone gel in the United States.

Intensive Study

Silicone breast implants have been studied more intensively over the past 2decades than any other medical device or material, and no link between them and breast cancer, connective-tissue disease, or joint problems has been found. Also, scientists have found no conclusive evidence that silicone causes systemic diseases such as lupus or breast cancer. As a result, both major breast-implant manufacturers have received “approvable” letters from the FDA, indicating that silicone-gel-filled implants will be available for general use within the year.

The chief advantage of silicone gel as an implant filler is that the implant feels more natural—and more like a human breast—than a saline implant. It has a fleshy consistency and “squeezability” like real tissue.

The chief disadvantage of silicone is that if the implant ruptures, the gel leaks into the surrounding pocket. It is usually contained within the scar capsule that forms naturally around the implant, but sometimes it migrates out of the capsule and into the breast tissue, causing small clumps of scar tissue, or granulomas, to form. The effects of a ruptured silicone implant are localized to the breast. Silicone is not known to migrate to other parts of the body.

The newest silicone-gel implant models are made from more viscous and cohesive gels that are designed to minimize the silicone migration that has been associated with conventional gel implants. The implants that were popular in the 1970s, however, had a more liquidlike gel and thinner shells, and were more prone to rupture and gel migration than the products available today.

In fact, a totally cohesive gel implant that completely prevents migration is being developed and evaluated. Even if this implant’s outside shell breaks down, the gel will not leak because it has a molecular structure that is more like a solid than a liquid.

The gel is firmer than conventional gels, and will perhaps strike a balance between implant feel and safety. With the new cohesive-gel implants, ruptures should be less likely and the gel should be more contained if they do occur, but some risk still exists.

Consequences of Ruptures

When a saline implant ruptures, the breast’s volume gradually diminishes over several days or even a few weeks. The body absorbs the salt water as though it had been ingested, and the rupture is harmless.

In contrast, gel-implant ruptures may be silent and no change in the breast’s appearance or feel is noticeable. For this reason, it will be recommended that women with gel implants receive long-term follow-up care. They will be encouraged to undergo diagnostic testing such as magnetic resonance imaging (MRI) every 5 to 10years to assess the integrity of the gel implant. Women who choose silicone-gel im-plants must be made fully aware of this recommendation so that they can weigh the benefits and risks of these types of implants.

As of this writing, only women in selected clinical trials for saline-implant failure or for restorative work—including reconstruction for mastectomy, congenital deformities, and severe ptosis—have the option of receiving silicone-gel implants. When these restrictions are lifted, each patient and physician will be allowed to weigh the advantages and disadvantages of each material in each individual case.

Choice of Implant

A physician may recommend one material over the other for his or her patient. For example, saline implants may cause a rippling effect in thin-skinned women with relatively little breast tissue. For them, gel-filled im­plants have fewer visibility problems. When a woman has had a suboptimal experience with either type of implant, it may also be appropriate for her to switch to the other implant.

An additional factor to consider is that with silicone implants, there is still a slight risk that thick scar tissue will form around the implant and cause a capsular contracture. This can happen in both types of implants, but it occurs more frequently in gel implants.

Physicians may have different medical reasons for preferring one type of implant over another, but at this time, the choices are limited to women who fall within the scope of the clinical trials. Each case must be assessed in terms of patient need.

Patients and physicians should be able to freely discuss the risks and benefits of each type of implant, from its feel and appearance to the additional expense of periodic breast MRIs to check for gel-implant ruptures. Plastic surgeons must support the patient’s right to make an informed decision, and be committed as active participants in the ongoing monitoring of all implants. PSP

Allen D. Rosen, MD, FACS, is a board-certified plastic surgeon and the founding partner and medical director of The Plastic Surgery Group in Montclair, NJ. He serves as an assistant clinical professor in the Department of Plastic Surgery at the University of Medicine and Dentistry of New Jersey in Newark.

Valerie J. Ablaza, MD, FACS, is a board-certified plastic surgeon and a partner and the corporate vice president of The Plastic Surgery Group. She is affiliated with St Barnabas Medical Center (Livingston, NJ), Mountainside Hospital (Montclair), and Passaic Beth Israel Hospital (Passaic). Both authors can be reached at (973) 233-1933 or via their Web site,

This article was adapted from the authors’ book, Beauty in Balance: A Common Sense Approach to Cosmetic Surgery and Treatments. New York, NY:; 2006.


1. Historical information is from Haiken E. Venus Envy. Baltimore, Md: Johns Hopkins University Press; 1999.