Rejuvenation
Silicone gel breast implants
Specialist in silicone gel breast implants, breast augmentation, and breast implant exchange for Northern Virginia, West Virginia, Maryland, & Washington DC
Return to our Virginia breast augmentation overview.
Silicone gel breast implants are approved by the FDA
There has been a considerable amount of ‘bad press’ and concern about the uncertainty of the safety of silicone gel filled breast implants. The majority of these problems or controversy began with litigation efforts by attorneys filing lawsuits in the 1990’s on behalf of women who alleged that their breast implants compromised their immune systems and caused them to develop auto-immune diseases. These litigations and irresponsible, inflammatory news reports prompted the breast implant manufacturers and the FDA to withdraw the silicone gel breast implants from the US markets until scientific proof could be presented to the safety of these commonly used breast devices throughout the world. The silicone gel breast implants have not been removed from the worldwide market. On November 17, 2006 the FDA announced that it was satisfied that the data supports the safety of silicone gel breast implants. The FDA has now allowed the use of silicone gel breast implants in US for women desiring breast augmentation and breast reconstruction.
Current use of silicone gel breast implants
The FDA has lifted it's ban of silicone gel breast implants, as of November 2006. Silicone gel breast implants will now be available to women who are:
1) at least 22 years of age
2) request primary or initial breast augmentation using silicone gel breast implants
3) request a breast reconstruction, which includes primary reconstruction to replace breast tissue.
The FDA is still following silicone gel breast implants and has required that a 10 year study be conducted on women receiving silicone gel breast implants. This study is to continue research on leaks and safety.
Dr. Michael J. Brown has been involved with the previous investigative studies on silicone gel breast implants and has many years of experience utilizing silicone gel breast implants for breast augmentation surgery. He continues to use silicone gel breast implants and has done so since the early 1990's.
To learn more about the history of breast implants and silicone gel breast implants click here.
Silicone gel breast implants benefits
The silicone gel breast implants have a superior and more natural feel in most cases. In some women saline breast implant rippling or wrinkling can be severe. Silicone gel breast implants tend to lessen this appearance and improve the feel of the breast mounds. So in very thin women these breast implants can be especially useful.Silicone gel breast implants limitations
Silicone gel breast devices are prefilled and volume can not be adjusted. So breast asymmetries may be more difficult to correct, or at least more involved. A second limitation also involves them being prefilled, and therefore the larger breast implants require larger incisions than the saline filled breast implants (filled after placement). Patients should also be aware that the life expectancy of silicone gel breast implants is not the same as saline filled breast implants. Silicone breast implants should be replaced after 10 years.
Silicone gel breast implants and immune system diseases and unknown risks
Some women with silicone gel breast implants have reported symptoms similar to those of known diseases of the immune system, such as systemic lupus erythematosis, rheumatoid arthritis, scleroderma, and other arthritis-like conditions. To date, there is no scientific evidence that women with either silicone gel-filled or saline-filled breast implants have an increased risk of these diseases, but the possibility cannot be excluded. If a causal relationship is established, the theoretical risk of immune and unknown disorders may be low. The effects of breast implants in individuals with pre-existing connective-tissue disorders is unknown.
Unlike silicone gel-filled breast implants, the saline-filled breast implants contain salt water. Any risk related to silicone gel would not be associated with saline-filled breast implants. However, gel-filled and saline-filled breast implants devices have a silicone rubber envelope or outer shell. Theoretically, an increased risk of autoimmune disease is possible even from saline filled breast implants. Reliable medical laboratory tests to determine antibodies to silicone do not exist. It has not been proved that there is a relationship between silicone antibodies and disease in women with breast implants. Currently, there is insufficient evidence to state that there is a health benefit from removing either breast implant(s) and scar-tissue capsule(s) or that removal will alter autoimmune disease or prevent its potential occurrence.
In very few women who have breast implants, a variety of other symptoms and conditions have been reported, suggestive of an auto-immune multiple-sclerosis-like syndrome. Additional complaints involve the musculoskeletal, skin, nervous, and immune systems. The relationship of breast implants to these conditions has been hypothesized, although not scientifically proven. Because such disease states are rare, they are difficult to research.
Current studies have only looked for the symptoms of known autoimmune diseases, rather than the variety of symptoms that women report experiencing. Some of the reported symptoms include:
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Cancers
Reports by the Institute of Medicine indicate that breast cancer is no more common in women with silicone gel breast implants than those without silicone gel breast implants. While not definite, cancer rates have been reported to be slightly higher for certain types of cancers. Cancers rates that have been higher in more than one study are lung and vulva. More information on cancer and breast implants is available at the National Cancer Institute website.
Neurological symptoms/diseases
Difficulties with vision, sensation, muscle strength, walking, balance, thinking or remembering things are some of the neurological signs various women with silicone gel breast implants have reported after breast augmentation with silicone gel breast implants. Several studies have indicated that women with silicone-gel breast implants are not at an increased risk of being hospitalized with neurological disease compared to women without silicone gel breast implants. The Institute of Medicine found no basis to assume that women with silicone gel breast implants were more likely to suffer from neurological diseases or symptoms.
Silicone sensitivity
Currently, there are no FDA-approved tests to identify silicone in the body or to determine whether or not a woman's immune system is susceptible to any component of silicone gel breast implants. Finding silicon or silicone in the body fluids does not necessarily prove a person is sensitive to these substances or at risk for any particular disease. Silicon is one of the most abundant elements on the earth. Some researchers continue to search for a test that can identify antibodies due to silicone in blood; however, the proven accuracy and usefulness of the test has not been determined.
Tests with reliable, validated techniques to detect the spreading of silicone from breast implants in the body have shown either no distribution or a presence of minute amounts at distant sites following the rupture of silicon gel breast implants or after deliberate injection of the gel.
Platinum
Platinum is a metal that has been used in the manufacturing of certain breast implants. Recent scientific reports have found that small amounts of platinum leaks from these breast implants into the surrounding tissue. Because certain chemical forms of platinum may cause allergic reactions, there are concerns that platinum leaks from these breast implants may be harmful. FDA scientists reviewed the currently available studies on breast implants and platinum leaks and did not find evidence that this causes illness in women with breast implants.
Silicone implant bleed
A concern directly related to silicone gel breast implants is the bleeding of small amounts of the silicone fluid or oil, through the shell, into the surrounding breast tissue. This leak of silicone fluid could cause complications. There is currently not enough information to conclude the severity of the health risks from silicone gel leaks or how to measure the amount of gel bleed that could cause health risks.
The chances of developing a connective tissue disease or related disorder caused by having a breast implant, studies have indicated, is low. However, these studies have not resolved the question of whether or not silicone gel breast implants could possibly increase the risk of connective tissue disease or related disorders.
Read more about silicone gel breast implant safety and current studies.
To learn more about breast augmentation surgery, click to review more of an overview of breast augmentation. To learn about breast anatomy and breast implant positioning you may want to start here.
To see the steps of breast augmentation using 3-D illustrations, visit the breast implant surgery page. For more information click on the icon above or to see the actual breast augmentation surgery be performed on a live person, visit one of Dr. Brown's breast specific web sites.
Prior to any surgical procedure, it is imperative that you have read and understand the consent forms required for a plastic surgical procedure.
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