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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).
Additional Resources and References
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