Editor's note:
On October 16, 2003 an advisory panel to t FDA Hears Testimony About Safety of Silicone Breast Implants (dateline October 15, 2003) | Breast Health News | Imaginis - The Women's Health & Wellness Resource Network

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FDA Hears Testimony About Safety of Silicone Breast Implants (dateline October 15, 2003)

Editor's note:
On October 16, 2003 an advisory panel to the U.S. Food and Drug Administration voted to allow silicone breast implants back on the U.S. market, with certain provisions. These include patient and physician education about silicone implants, procedures for monitoring implants, etc. The FDA usually follows the recommendation of its advisory panel.

The U.S. Food and Drug Administration (FDA) announced that it is holding a hearing to discuss the possible medical risks of silicone gel filled breast implants. 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, several studies have failed to confirm that silicone breast implants are the cause of these disorders. The FDA’s decision to hear evidence for and against silicone breast implants has sparked debate from experts and women on both sides of the issue.

Over a decade ago, the FDA imposed a ban on the general use of silicone gel-filled breast implants. Currently, silicone implants may only be used in closely monitored medical trials until they are determined safe for widespread use. Questions concerning the safety of silicone implants arose after manufacturing defects and implant misuse led to silicone leakage and rupturing in many patients. When silicone gel is free in breast tissue, it may move to nearby tissues or to the lymph nodes. Some medical experts attribute silicone leakage to immune-related disorders and other sicknesses. Many women who experienced silicone leakage reported:

  • breast pain
  • fatigue
  • myalgias (muscle pain)
  • arthralgias (joint pain)
  • hair loss
  • memory loss

There is much controversy surrounding silicone breast implants. Many medical experts doubt silicone implants cause any significant medical disease.

Several studies have failed to establish a link between silicone gel filled breast implants and a variety of diseases, including many types of cancer. For example, in recent studies by the National Cancer Institute, researchers found all cancers, circulatory and digestive system diseases, endocrine, nutritional, metabolic and immune diseases, and cirrhosis of the liver occurred less often in women who had implant surgery, compared to the general population. In addition, when women with breast implants were compared to women who had other cosmetic surgeries, the researchers found that the rates for several other cancers (including mouth, stomach, large intestine, breast, cervix, uterus, ovary, bladder, thyroid, connective tissue, and immune system cancers) were also lower among the women with implants.

However, the researchers did find an increased risk for suicides, brain cancer, respiratory cancers, pneumonia, and emphysema among the women who had silicone breast implants. According to the NCI, the higher suicide rates of the implant patients correlate with characteristics described among implant patients in previous reports, including marital difficulties, depression, emotional disorders, and low self-esteem.

In a 2001 study published in the Archives of Internal Medicine, 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. MGUS, monoclonal gammopathy of undetermined significance, is an immune-related disorder. Based on the study results, Dr. Karlson and her colleagues concluded that there is "little evidence to support a substantial increased risk of MGUS in women exposed to breast implants."

While the FDA will evaluate the medical consequences of silicone breast implants, there is little debate that many women experience side effects from breast implants. These can include:

  • Capsular contracture (hardening of scar tissue around the implant)
  • Calcium deposits in the breast tissue around the implant (usually non-cancerous but occasionally have to be surgically removed to assure they do not indicate cancer)
  • Infection around the implant
  • Hematoma or seroma (blood or fluid trapped in the wound)
  • Delay in healing
  • Shifting of implant (further surgery may be necessary)
  • Temporary or permanent changes in the feeling of the nipple or breast (some women report areas of increased or decreased sensitivity or numbness near the incision)

Breast implants may also deflate or rupture from injury to the breast or through normal wear over time. Saline implants tend to deflate quickly, and surgery is usually done immediately to remove or replace the implant. Approximately 50% of saline implants need some type of modification or replacement after five or 10 years. Breast implants also make mammography more difficult to perform and may obscure breast abnormalities from detection on a mammogram. For this reason, several special mammography views are usually taken. 

The National Cancer Institute estimates that approximately 1.5 million to 2 million American women have undergone implant surgery since 1962, when implants were first introduced on the market. According to Inamed Corporation, a maker of silicone implants, 225,000 women chose to undergo surgical breast enhancement in 2002. Approximately 80% of women get implants for cosmetic reasons while 20% get implants to reconstruct their breasts after breast cancer surgery (mastectomy).

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