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FDA Breast Implant Consumer Handbook - 2004

DISEASES

Some women with breast implants have reported health problems that they believe are related to their implants, but most studies of these diseases 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 the body reacting to a foreign material, such as silicone gel. These diseases are discussed below.

Connective Tissue Diseases (CTDs) and Related Disorders

These are a group of diseases and disorders related to the immune system and to the connective tissue of the body (e.g., muscle, tendon, bone, etc.) that supports body structures and binds body parts together. 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.

The cause of CTDs is unknown. Some CTDs have autoimmune characteristics in that a woman's immune system attacks her own cells as if they were foreign.

CTDs with autoimmune characteristics include:

• lupus
• rheumatoid arthritis
• polymyositis
• dermatomyositis
• progressive systemic sclerosis or scleroderma.

CTDs without autoimmune characteristics include:

• fibromyalgia
• chronic fatigue syndrome.

Some women with breast implants have experienced the diseases or disorders listed above, as well as a variety of signs and symptoms that could be related to the immune system or to the connective tissues of the body. However, these signs and symptoms are not considered a defined disease or disorder. These signs and 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
• muscle weakness or burning.

Signs and symptoms, such as those bulleted above, may be present in women without CTD or related disorders or in women 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 report³⁷ 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 or not 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. ^38,39,40There are reports of women with implants who have a variety of autoantibodies. (Autoantibodies are antibodies that your body makes that accidentally target your own tissues.) However, the presence of these autoantibodies does not mean that a woman has an increased risk of actually developing a CTD or related disorder.

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. However, these studies have not been large enough to resolve the question of whether or not breast implants slightly increase the risk of CTDs or related disorders. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made.

There have been reports of women with fibromyalgia following breast implants, and a preliminary study conducted by FDA⁴¹ found an association between self-reported fibromyalgia and extracapsular rupture diagnosed by MRI. However, this association has not been repeated in a similar study based on a large group of Danish women⁴² and the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants.

Cancers

The IOM report⁴³ indicates that breast cancer is no more common in women with breast implants than those without breast implants. While not conclusive, cancer rates have been reported to be slightly higher for some types of cancers. Cancers rates that have been higher in more than one study are lung and vulva. Because these cancers may be related to other factors that were not examined in these studies (such as smoking) these studies are not conclusive.

More information on cancer and breast implants is available at the National Cancer Institute website at:

• http://www.nci.nih.gov/newscenter/silicone-othercancers
• http://www.nci.nih.gov/newscenter/silicone-mortality
• http://www.nci.nih.gov/newscenter/siliconebreast.

Neurological Symptoms/Diseases

Some women with breast implants have reported that they have neurological symptoms (such as difficulties with vision, sensation, muscle strength, walking, balance, thinking or remembering things) or diseases (such as multiple sclerosis) related to their implants. Several studies have indicated that women with implants are not at an increased risk of being hospitalized with neurological disease compared to other women. The IOM report⁴⁴ found no basis for thinking that women with implants were more likely to have neurological diseases or symptoms.

Since the IOM report, Winther, et al.⁴⁵ published additional follow-up of the Danish group of 1,653 women with cosmetic breast implant surgery at private clinics in Denmark compared to a comparison group of 1,736 women who underwent other types of cosmetic procedures. No increased risks for neurological disorders were found in the breast implant patients. However, it should be noted that these studies are limited in that rare disorders cannot be addressed.

³⁷Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM Report}. Also available through IOM website at www.iom.edu.
³⁸Wolf 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.
³⁹Tueber SE, Rowley MJ, et al. Anti-collagen antibodies are found in women with silicone breast implants. J Autoimmunity 1993;6:357-377.
⁴⁰Rowley 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.
⁴¹Brown, et al. Assn of SBI rupture and BI. Clin Rheumatol. 2002; 4(4);293-298.
⁴²Holmich, et al. Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants. Plast Recon Surg. 2003; 111(2):723-732.
⁴³Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM Report}. Also available through IOM website at www.iom.edu.
⁴⁴Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM Report}. Also available through IOM website at www.iom.edu.
⁴⁵Winther, JF, et al. Neurological disease among women with silicone breast implants in Denmark. Acta Neurol Scand 2001; 103:93-96.

Updated June 8, 2004