Women with silicone gel or saline filled New Study Finds No Link Between Breast Implants and Immune-Related Disorder (dateline April 3, 2001) | Breast Health News | Imaginis - The Women's Health & Wellness Resource Network

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New Study Finds No Link Between Breast Implants and Immune-Related Disorder (dateline April 3, 2001)

Women with silicone gel or saline filled breast implants do not need to worry about an immune-related disorder known as MGUS (monoclonal gammopathy of undetermined significance), according to a new study from Harvard Medical School. While most cases of MGUS do not warrant concern, approximately 20% of patients with MGUS eventually develop more serious conditions, including certain forms of cancer (such as multiple myeloma). The general use of silicone gel-filled breast implants was banned in the United States in 1992 after women reported immune-related disorders and other sicknesses. However, this latest study provides more data to show that silicone breast implants may not cause significant medical conditions.

To conduct the study, lead researcher Dr. Elizabeth W. Karlson and her colleagues from Harvard Medical sampled blood from 288 women who had breast implants and used medical records of another 288 women who did not have breast implants to determine if there was a link between implants and MGUS. The researchers found a total of nine cases of MGUS, five among the women with breast implants and four among the women without implants. Therefore, the researchers conclude that there is "little evidence to support a substantial increased risk of MGUS in women exposed to breast implants."

MGUS occurs when the body’s plasma cells produce an abnormal protein in the blood. The condition is not usually associated with any symptoms but can be diagnosed with a specific blood test called serum protein electrophoresis. Approximately 80% of patients with MGUS do not need any treatment. However, because 20% of patients with MGUS may eventually develop more serious conditions, including multiple myeloma (a cancer of the plasma cells), the Mayo Clinic suggests that patients with MGUS be monitored with blood tests every year to determine if there is an increase in the amount of abnormal protein in the blood.

The Harvard study is the latest to show that silicone breast implants do not cause serious health conditions. In 1999, a 13-member panel of national scientific experts also found that breast implants do not cause cancer or other autoimmune disorders. The report, which was published in the Journal of the National Cancer Institute, involved an analysis of over 3,000 publications and personal testimonies from more than 60 women.

The U.S. Food and Drug Administration (FDA) banned the general use of silicone gel filled breast implants in 1992 after implant manufacturers were unable to provide evidence that silicone implants were safe and effective. The ban also came after several women with silicone implants complained of immune-related disorders and symptoms such as breast pain, fatigue, and muscle or joint pain. However, after careful evaluation, the FDA concluded that silicone breast implants should still be available for women who need breast reconstruction or revision of an existing breast implant.

Currently, saline (salt water) filled breast implants are the only type of implant available for general use in the United States. In May 2000, the FDA made a formal review of saline breast implants and approved the continued use of saline implants made by two companies, Mentor Corporation and McGhan Medical Corporation. However, the FDA noted that breast implants can be associated with a high rate of side effects and therefore requires plastic surgeons to give patients an FDA-published booklet on breast implants and discuss possible complications before implant surgery.

The risks of breast implants:

  • Over 20% of patients who have implants placed for cosmetic reasons need additional surgery within three years due to infection or painful scar tissue.
  • Nearly 40% of patients who have implants placed after breast cancer surgery need additional implant surgery within three years.
  • Up to 73% of patients in one study experienced at least one side effect of implants (such as pain, implant leakage, or hardening of scar tissue).
  • Patients who have implants removed due to complications may experience breast skin dimpling or puckering if new implants are not placed.
Muscle flap reconstruction is another option for breast cancer patients after mastectomy  (surgical breast removal). This involves using the patient’s own tissue (from the abdomen, back or other body area) to reconstruct the breast. For breast cancer patients who do not choose reconstruction with implants or muscle tissues, a variety of breast prostheses and mastectomy bras are available. Many health insurance companies will cover the cost of breast reconstruction or the purchase of prostheses/mastectomy bras after breast cancer surgery.

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