Silicone implants

Over the years, several concerns have arisen regarding the safety of the silicone gel-filled implants, and in 1992, these implants were taken off the market by the US Food and Drug Administration. Canada's parallel body, the Health Protection Branch, soon followed with a similar ruling. The concerns were regarding the possible relationship of various diseases to the breast implants: a possible increased risk of cancer, a possible link to immune-related diseases, and leakage of the implants. These concerns were largely put to rest in a consensus report delivered to the FDA in June 1999.

Breast cancer

We know that breast cancer occurs in about 1 out of every 9 women in North America today. Some women with breast implants, therefore, are bound to develop breast cancer. However, several studies have monitored many thousands of patients for long periods. From these studies it seems quite clear that implants do not increase the risk of a woman developing breast cancer, nor do they significantly affect treatment, when cancer is found.

Implants do make mammograms somewhat less accurate, although saline-filled implants are better in this respect than the gel-filled ones were, especially when placed under the muscle.

Immune-related diseases

Rheumatoid arthritis is the most common of the so-called "connective tissue diseases." In these diseases, the body's immune system "mistakenly" reacts to certain parts of the body, causing symptoms. In arthritis, the symptoms occur mainly in the joints, but other body systems may also be involved.

In a small number of patients with breast implants, symptoms of allergic or immune illness have been seen, such as rheumatoid arthritis, scleroderma or other diseases. The incidense of scleroderma is much lower than rheumatoid arthritis. The total incidense of all these illnesses is about 2%. Scleroderma is a disease that results in hardening and thickening of the skin and other organs due to growth of fibrous tissue. Since approximately 2% of all women develop these symptoms, it is not surprising that some patients with implants will develop such symptoms. However, it is important to realize that these symptoms are not caused by the implants.

Leakage of implants

Careful study has shown that gel-filled implants leak much earlier and at a much higher rate than was previously thought. Depending on the manufacturer, implants used between approximately 1972 and 1987 may develop small or major leaks as early as 4 or 5 years after surgery. The main reason the implants were taken off the market by the US Food and Drug Administration was that Dow Corning, a manufacturer, withheld information and misinformed plastic surgeons regarding the true risk of leakage.

On the other hand, the presence of a leak does not seem to cause illness, nor does it seem to cause very significant amounts of silicone to circulate elsewhere in the body.

It is difficult to detect whether a gel-filled implant is leaking. From the information now available, it seems that the best course for a patient with older implants (especially pre-1987) is to have them removed and replaced with saline (salt and water) implants.

Although saline implants are now being used research continues in the attempt to find the ideal implant. To try to make rippling (of saline) less of a problem and to make mammograms more accurate, soy oil-filled implants have been tried. These concerns are discredited, and other alternate fill substances are being developed.

Benjamin Gelfant, MD, 
in association with the MediResource Clinical Team