ILLNESS AND CONDITIONS ELSEWHERE IN THE BODY AND BREAST IMPLANTS.

Some women with breast implants have reported problems that have been evaluated but found by most studies not to be associated with the devices. There also have been concerns about possible, but unproven, effects on health. A discussion of these problem reports and health concerns follows.

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 gel may migrate (bleed or sweat) out of the implant into the surrounding tissue. There has been concern that this escaped silicone might cause harmful effects, including connective tissue and related disorders and cancer.

* Connective tissue and related disorders: These disorders of the body's immune, or defense system are related to the connective tissues of the body (connective tissues include mucous, fibrous, fat, cartilage and bone tissues which support body structures and bind body parts together). These illnesses include autoimmune disorders such as lupus, scleroderma and rheumatoid arthritis, as well as disorders such as fibromyalgia and chronic fatigue syndrome. Some women with breast implants have experienced these disorders, as well as a variety of symptoms that could be related to the immune system. These symptoms include 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; and muscle weakness or burning. However, symptoms such as these may be present in persons without connective tissue disease, or without 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 a reduction in symptoms after the implants were removed; in other cases, there was no change in symptoms after the implants were removed.

It is important to understand that individual cases cannot prove or disprove a connection between immune-related disorders and breast implants. Even if a woman with breast implants develops an immune-related disease such as lupus or rheumatoid arthritis, there is no way to tell at this time whether the implants caused her particular disease. This is because these kinds of diseases occur both in people with and without implants. The key question is whether breast implants can increase the risk of developing these conditions. That is, do women with breast implants have a greater chance of getting immune-related disorders than women without implants?

Studies have shown that some women with silicone gel-filled breast implants produced antibodies to their own collagen (a connective tissue protein), but the incidence of these antibodies in the general population is currently unknown.[7,8,9] Further, it is not known whether the presence of these antibodies means an increased risk of actually developing an immune-related disorder. So these antibody studies do not tell us whether there is a link between breast implants and immune-related disorders.

Several other human studies to evaluate women with breast implants have been completed recently, which provide substantial -- but not complete -- information about any possible link between breast implants and immune-related disorders. For example, a study of breast implants and connective tissue diseases, 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.[10] The conclusion was that there was no increased risk of defined connective tissue diseases among the implant recipients. Another study, 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.[11] Still another, the Nurses Health Study, conducted at the Harvard Medical School, included 1183 women with silicone gel-filled, saline, double lumen, polyurethane coated and 56 unknown breast implants.[12] This study found no increase in immune related connective tissue diseases. These studies provide reassurance that the risk of developing a typical or defined connective tissue disease due to a breast implant is not high.

A 1996 study by Hennekens et al., also at the Harvard Medical School, is the largest yet to look at the past experiences of women with breast implants.[13] 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 connective tissue disease 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 connective tissue disease than women without breast implants. The increase in risk applies to all of the connective tissue diseases taken together; when calculated individually, the risk for each of these diseases was not statistically significant. According to the Hennekens study, less than 1 percent of women with breast implants will develop connective tissue diseases associated with the implants.

Taken together, these studies tell us that the vast majority of women will not develop defined immune-related disorders from the implants.

None of the human studies described above can completely resolve the question of whether silicone gel-filled breast implants increase the risk of connective tissue disease or related disorders. First of all, except for the Hennekens study, none of them have been large enough to rule out the possibility that the implants could cause immune-related disorders in a small subset of women who have them. Secondly, since these studies were largely designed to find out whether women with the implants had certain well-defined immune-related diseases, they cannot exclude the possibility that some women with implants might develop other signs and symptoms related to the immune system that do not conform to classic disease descriptions. In other words, these studies do not resolve the question of whether the variety of symptoms some women report might be related to their implants.

* Cancer: At this point there is no scientific evidence that silicone gel-filled breast implants can increase the risk of cancer in women, but we cannot completely rule out this possibility. Average follow-up time of completed studies in women has been too short to fully resolve this question.

* Polyurethane foam-covered implants. About 10 percent of women with breast implants received the 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, which 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.[14] Researchers did find TDA in the urine, but in such tiny amounts that the risk of cancer from the polyurethane foam-coated implants is only about 1 in a million over a woman's lifetime. So it is unlikely that even one 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.

* Pregnancy and Breast-feeding: At this time it is not known whether a mother's breast implants can have an effect on the fetus. It is also not known what effect implants have on lactation, and whether or not there is a difference in the rate of implant rupture, breast pain, migration of the implant, or mastitis in women who are pregnant or lactating.[15]

It is not known whether the small amount of silicone that bleeds from silicone gel-filled breast implants or from the silicone envelope encasing the saline-filled implants can find its way into breast milk and, if this were to occur, whether it could affect the nursing infant. There is one inconclusive report that describes eight children breast fed by women with silicone breast implants.[16] These children experienced abdominal pain and swallowing problems. However, it is not known if the problems of these children are related to their mother's breast implants. Further study is needed.

At least some women with breast augmentation are able to nurse their babies. A woman who has had a mastectomy is unable to breast-feed on the affected side due to loss of breast tissue and glands that produce milk.

A woman with breast implants who has questions about risks while pregnant or breastfeeding should consult her doctor. A woman who suspects that an adverse event experienced by her child may be related to her breast implants should report this information to her doctor. Suspected serious adverse events should be reported to FDA's MedWatch program.

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 company was unable to get enough lactating women with these implants to conduct a valid study. It is reassuring to note, however, that a study of the cancer risk to women with polyurethane-coated implants found that risk to be negligible.[17] A woman who has these implants and is concerned about nursing her infant should consult with her doctor.

* Saline implants. There is some concern, but little information, about possible risks from the silicone rubber material of the envelope. Questions have been raised about the potential for the saline to become contaminated with fungus or bacteria. If so, these organisms might be released into the woman's body if her implant deflated. However, surgeons are advised against adding any antibacterial, antiseptic, or cleansing agent to the saline as it may compromise the strength of the envelope.

[7] Wolf LE, Lappe M, Peterson RD, et al. Human immune response to polydimethylsiloxane (silicone): screening studies in a breast implant population. FASEB J 1994;7:1265-1268.

[8] Tueber SE, Rowley MJ, et al. Anti-collagen antibodies are found in women with silicone breast implants. J Autoimmunity 1993;6:357-377.

[9] Rowley MJ Cook AD, et al. Antibodies to collagen: comparative epitope mapping in women with silicone breast implants, system lupus erythematosus and rheumatoid arthritis. J Autoimmunity 1994; 7:775-789

[10] Gabriel SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Mellon LJ. Risk of connective-tissue diseases and other disorders after breast implantation. N Engl J Med 1994; 330:1697-1702

[11] Englert HJ, Brooks P. Scleroderma and augmentation mammoplasty--a casual relationship? Aust NZ J ME 1994;24:74-80.

[12] Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunder DJ, Speizer FE, Liang MH. Silicone breast implants and the risk of connective-tissue diseases and symptoms. New Engl J Med 1995;322:1666-1670.

[13] Hennekens CH, Lee I-M, Cook NR, Hebert PR, Karlson EW, LaMotte F, Manson JE, Buring JE. Self-reported breast implants and connective-tissue diseases in female health professionals. JAMA 1996;275:616-621.

[14] Hester TR Jr, Ford NF, Gale PJ, Hammett JL, Raymond RH, Turnbull D, Frankos VH, Cohen MB. Measurement of 2,4,toluenediamine in the urine and serum samples from women with Meme or Replicon breast implants. Plast Reconstr Surg, 1997;100:1291-1298.

[15] Grant S, Edelman DA. Pregnancy, lactation and the use of silicone breast implants. Advances in Contraception, 1994;(10)187-193.

[16] Levine JJ and Ilowite NT. Sclerodermalike esophageal disease in children breast-fed by mothers with silicone breast implants. JAMA 1994:271:213-216.

[17] Hester TR Jr, Ford NF, Gale PJ, Hammett JL, Raymond R, Turnbull D, Frankos VH, Cohen MB. Measurement of 2,4,toluenediamine in the urine and serum samples from women with Meme or Replicon breast implants. Plast Reconstr Surg, 1997;100:1291-1298.