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January 21, 2004
News this month The Federal Drug Administration (FDA) deferred a decision about lifting an 11-year-old ban on silicone breast implants pending additional information about the product’s safety and failure rate. This decision took place less than three months after the FDA’s own scientific advisors voted 9-6 in favor of lifting the ban. The FDA decided additional studies are needed on the safety of silicone breast implants.
A majority of advisory panel members had agreed with Inamed, the silicone implant manufacturer, that it was unfair to continue to ban the silicone implants when they had not been proven to cause any more problems than saline implants, which have remained on the market. However, after reviewing the recommendation, the FDA determined Inamed needs to do additional studies and provide more information before the agency can determine whether the implants should be available to the public. Specifically, the FDA called for more information about why implants sometimes rupture or leak, what the consequences are of this happening and how women can know if this has happened to them. In addition, the agency would like to know if women with silicone implants should have frequent magnetic resonance imaging (MRI) tests to detect ruptures and if the devices should be removed if they do rupture. “What we are saying is that we think that a lot of information has been developed over the last 10 years that increases our assurance of the safety of silicone implants,” said Dr. David Feigal of the FDA, “but there is additional information that we think is necessary for this product to pass the threshold of what we would consider necessary.” Concerns about potential health risks associated with silicone implants prompted the ban in 1992. Since then, only women who have undergone mastectomies (the removal of the breast due to diseases such as cancer) or who take part in clinical studies can use silicone implants. Saline implants are the alternative. Some users claim that the saline devices are not as natural in appearance or texture. Silicone implants were first introduced in the early 1960s. In the late 1980s and early 1990s, some reports emerged of implant patients with serious complications, including connective tissue and autoimmune diseases such as arthritis and lupus, chronic fatigue syndrome and cancer. The FDA ban and subsequent lawsuits against the four companies that manufactured the gel implants resulted in millions of dollars in settlements to the women. One company, Dow Corning, filed for bankruptcy to pay $3.2 billion to settle the claims against it. Studies…found no evidence that leaked silicone
from gel implants causes systemic disease….
What the research shows In 1999, the IOM issued a report that addressed several areas of major concern. They found that:
 
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 Assessing the relative risks of breast implants None of the studies conducted by scientists has ever showed any causal relationship between silicone breast implants and systemic autoimmune disease. A small percentage of women will develop these serious diseases; some of them will have implants and some will not. At this point, however, we have no reason to believe silicone is the culprit. “The number of women choosing to have breast augmentation has increased by nearly 600 percent since 1992.”
What we do know is there has been a major increase in the number of women choosing to have breast augmentation, up from 32,000 in 1992 to 225,000 in 2002, an increase of nearly 600 percent. The large majority of these women had saline implants, which are currently FDA-approved. They are made of a silicone envelope filled with a sterile saline solution, instead of silicone, which is a gel-like substance. The remaining women who had silicone implants include a small percentage of patients who met the strict protocol established by the FDA. These include women seeking breast reconstruction or revision of an existing silicone breast implant and women who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast or a medical condition causing a severe breast abnormality. This group of women has been followed very closely If you have a choice There are pros and cons of both saline and silicone implants, and each woman needs to consider these differences in consultation with her surgeon. “I would urge women…to research prospective surgeons carefully and
to make sure they are thoroughly briefed on all the associated benefits and risks.”
Leaks and ruptures The leak rates for saline and silicone implants are about the same, but silicone implant ruptures are harder to detect. When saline implants rupture, they undergo rapid deflation and the results are seen almost immediately. When silicone implants rupture, the breast often looks and feels the same because the silicone gel may leak into surrounding areas of the breast without a visible difference. Saline is quickly absorbed by the body with no complications. Silicone leaks are generally contained within the protective capsule, or scar wall, the body naturally produces to isolate any implant or foreign object. It is quite rare for silicone to leak out beyond this natural body barrier, but when it does happen, it usually needs to be surgically removed. Natural appearance and feel If the implant is inserted above the chest muscle, just under the skin, as you would do with a breast reconstruction, silicone implants usually do look more natural. If the implant is being inserted under the muscle, the texture of the implant is not as apparent and is not a major factor. Incision size Hardened breasts Additional surgery brings risks associated with any surgery—pain, risk of infection and the dangers of anesthesia. Although definitive studies are limited, there is evidence to suggest saline implants are less likely to result in contracture than silicone implants. Other considerations for those considering implants There are some issues related to mammography for cancer screening. A skilled technician can be expected to successfully screen 85 to 90 percent of a breast that has an implant. Generally if a patient has a strong family history of breast cancer, I would counsel them carefully to consider this small risk of missing a tumor because of imaging challenges. Breast implant surgery carries risks, as does any surgery. I would urge women who are considering an implant to research prospective surgeons carefully and to make sure they are thoroughly briefed on all the associated benefits and risks. Dr. Pan is an associate with Plastic & Reconstructive Surgery Associates and an attending plastic surgeon at Yale-New Haven Hospital. |
