Date: Sat, 17 Nov 2001 04:16:09 EST

Some women with breast implants have reported health problems that they believe are related to their implants, but most studies of these illnesses have failed to show an association with breast implants. There also have been concerns about possible, but unproven, effects on health.

Most of the health concerns about breast implants are related to silicone gel. Even if a silicone gel-filled breast implant does not rupture, small amounts of the silicone fluid or oil may bleed out of the implant and migrate into the surrounding tissue. There has been concern that this escaped silicone fluid or oil might cause harmful effects, including connective tissue disease and related disorders and/or cancer.

Connective Tissue Diseases (CTDs) and Related Disorders The body's immune system is the network of cells that protect against infectious diseases. Antibodies are one type of substance the body produces to fight off infectious agents. CTDs and related disorders of the body's immune system are related to the connective tissues of the body, which include fibrous tissues, cartilage, and bone that support body structures and bind body parts together. Some CTDs are autoimmune diseases that occur when a woman's immune system attacks her own cells as if they were foreign.

lupus

rheumatoid arthritis

polymyositis

dermatomyositis

progressive systemic sclerosis or scleroderma

fibromyalgia

chronic fatigue syndrome

Some women with breast implants have experienced the diseases and/or disorders listed above, as well as a variety of signs and symptoms that could be related to the immune system. However, this is not considered a defined disorder.

pain and swelling of joints

tightness

redness or swelling of the skin

swollen glands or lymph nodes

unusual or unexplained fatigue

swelling of the hands and feet

excessive hair loss

memory problems

headaches

muscle weakness or burning

Signs and symptoms such as these may be present in women without CTD or related disorders or without breast implants. Individual cases alone cannot scientifically prove or disprove a connection between CTDs and related disorders and breast implants.

Some doctors and women have thought that these signs and symptoms are part of a new disease which is related to silicone and have called the disease "human adjuvant disease," "silicone related syndrome," "atypical disease," or other names. The IOM report stated "The diagnosis of this condition could depend on the presence of a number of symptoms that are nonspecific and common in the general population. Thus, there does not appear to be even suggestive evidence of a novel [new] syndrome in women with breast implants." So, it is unclear at this time whether the signs and symptoms experienced by these women are related to their implants. In some cases, women have reported fewer symptoms after the implants were removed. In other cases, there was no change in signs and symptoms after the implants were removed.

Studies have shown that some women with silicone gel-filled breast implants produced antibodies to their own collagen (a connective tissue protein), but we do not know how often these antibodies occur in the general population, and there are no data that show these antibodies cause CTDs and related disorders.(12)(13)(14) There are reports of women with implants who have other autoantibodies. However, the presence of these antibodies does not mean that a woman has an increased risk of actually developing a CTD or related disorder.

Several other studies of women with breast implants have been completed recently. These studies provide substantial, but not complete information, about the lack of a possible association between breast implants and CTDs. For example:

A study by Gabriel et al. of breast implants and CTDs, conducted at the Mayo Clinic, compared the medical records of 749 women with breast implants in Olmsted County, Minnesota, with a similar group of women from the same area who did not have implants.(15) The researchers concluded that there was no increased risk of defined CTD and related disorders among the women with breast implants.

A study by Englert et al., conducted in Australia, found no increase in scleroderma, a connective tissue disease whose possible connection to breast implants had been the source of some concern.(16)

A study by Sanchez-Guerrero, conducted at the Harvard Medical School, included 1183 women with silicone gel-filled, saline, double lumen, polyurethane coated and 56 unknown breast implants.(17) This study found no increase in CTDs.

A 1996 study by Hennekens et al., also conducted at the Harvard Medical School, is the largest study to look at the past experiences of women with breast implants.(18) Almost 400,000 women (nearly 11,000 with breast implants) completed questionnaires for the study. The study showed a small but statistically significant increase in the risk of all CTDs reported by women with breast implants. The study indicated that over a 10-year-period, women with breast implants were 1.24 times more likely to report having a CTD or related disorder than women without breast implants. The increase in risk applies to all of the CTDs and related disorders taken together. When calculated individually, however, the risk for each of these diseases was not statistically significant. According to this study, having breast implants did not increase the risk of getting any one of these CTDs and related disorders when they are considered individually. When considered together, these studies indicate that the risk of developing a typical or defined CTD or related disorder due to having a breast implant is low.

None of the studies described above can completely resolve the question of whether silicone gel-filled breast implants increase the risk of CTDs and related disorders. Without a group of women without implants who are of similar age, health, and social status and followed for a long time (such as 10-20 years), a relationship between implants and these diseases cannot conclusively be made. Also, except for the Hennekens study, none of the studies has been large enough to rule out the possibility that the implants could cause CTD or a related disorder in a small subset of women who have them. Because these studies were largely designed to find out whether women with the implants had certain well-defined CTDs and related disorders, they also cannot exclude the possibility that some women with implants might develop other signs and symptoms related to the immune system that are not a defined CTD. In other words, these studies do not resolve the question of whether the variety of signs and symptoms some women report might be related to their implants.

The IOM report indicates that breast cancer is no more common in women with implants than those without implants.(19)

At this time, there is no scientific evidence that silicone gel- filled breast implants can increase the risk of other cancers in women, but this possibility cannot be completely ruled out because the studies to evaluate the risk of other cancers have not been done.

About 10% of women with breast implants received the polyurethane foam-coated type until they were taken off the market in 1991 because of concerns that the coating might increase the risk of breast cancer. This coating released small quantities of the chemical called TDA (2,4-toluenediamine) that has been shown to cause cancer in animals. Because of this concern, the manufacturer of the coated implants, Bristol-Myers Squibb Company, analyzed the urine of women with these devices for TDA.(20) Researchers found TDA in the urine but in such tiny amounts that the risk of cancer from the polyurethane foam-coated implants is only about l in a million over a woman's lifetime. Therefore, it is unlikely that even 1 of the estimated 110,000 women who got the polyurethane foam-covered implants will get cancer as a result of exposure to the TDA. This study supports FDA's recommendation that women with polyurethane foam- covered breast implants should not have them removed based solely on concerns about cancer from TDA.

Concerns have also been raised about whether the TDA from the polyurethane-coated implants could increase the risk of cancer to a nursing infant. FDA required the manufacturer to analyze mother's milk for TDA, but the manufacturer was unable to get enough lactating women with these implants to conduct a valid study.

Women of childbearing age who want to breast feed should be aware of the negative impact of breast implants on breast feeding.

One concern is the ability to successfully breast feed after breast implantation. Some women who undergo breast augmentation can successfully breast feed and some cannot. Women who undergo a mastectomy will be unable to breast feed on the affected side due to loss of breast tissue and glands that produce milk.

One study by Hurst reports that up to 64% of 42 women with implants were unable to breast feed compared to 7% of 42 women without implants.(21) This is the highest reported range in the literature. While there have been no definitive studies regarding this issue, having an implant may significantly affect your ability to breast feed.

It is not known if a small amount of silicone may pass from the silicone shell of an implant into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. Although there are no current methods for detecting silicone levels in breast milk, a study by Semple et al. measuring silicon (one component in silicone) levels showed the same levels in breast milk from women with silicone gel-filled implants when compared to breast milk from women without implants.(22)

Concerns have been raised about the potential damaging effects on children born of mothers with implants. The IOM report said that the information is insufficient or flawed to draw definite conclusions about this issue.(23) In other words, it is not known what effect breast implants may have on a fetus and the nursing infant.

There is some concern, but little information, about possible risks from the silicone material of the shell from the saline-filled and silicone gel-filled breast implants.

Another concern relates specifically to saline-filled breast implants. Questions have been raised about the potential for the saline to become contaminated (not sterile) with fungus or bacteria and to be released into the woman's body if her implant deflates or ruptures or if the valve leaks. However, saline-filled implants are now generally filled from a bag and tubing rather than from an open bowl, which should reduce the risk of this complication. Also, the manufacturers have advised doctors against adding any antibacterial, antiseptic, or cleansing agent to the saline as it may decrease the strength of the implant shell.