After 14 years of intense research and scrutiny, Silicone Breast Implants are approved by the Food and Drug Administration (FDA). They are now available to anyone over the age of 22.
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Silicone Implant |
In 1992, silicone breast implants were taken off of the U.S. market over concerns that they may increase the chances of disease such as Rheumatoid Arthritis, Lupus and Chronic Fatigue Syndrome among others. Since then, numerous major studies have shown that there is no increased risk of disease and that the implants are safe.
"Silicone breast implants were never taken off the market in Europe and have demonstrated that they are safe." says Dr. Cruise, board certified plastic surgeon. "Still, I believe the FDA did the right thing back in 1992. Whenever there is a safety concern the first thing we should do is take the product off the market and perform in depth research so that no one is harmed." This is exactly what happened as silicone breast implants became the most researched and scrutinized medical device in the U.S.
The studies on silicone implants will continue even as they are available to the public and the data accumulated over the past 14 years will continue to be evaluated. "Silicone implants are wonderful when used in the right person. The approval allows me to offer my patients a choice between silicone and saline," says Dr. Cruise. "Many of my patients come to me wondering which implants are best for them."
To help patients understand better which implants to choose, Dr. Cruise developed a list of questions each woman considering implants should read.
FAQ-SILICONE BREAST IMPLANTS
Why where silicone breast implants taken off the market in 1992?
At the time there were concerns about an increased risk of auto-immune and connective tissue diseases from the silicone.
Why were silicone breast implants recently approved?
Over the past 14 years numerous studies have shown silicone to be safe. There appears to be no increased risk of disease. In addition, similar studies in Europe where the implants were never taken off the market show it to be safe as well. With all this information, the FDA gave silicone breast implants its approval. Studies will continue.
Is there anyone who can not get silicone breast implants?
The FDA's only restriction is that the woman must be 22 years of age or older.
What are the Advantages of Silicone over Saline?
Silicone has two significant advantages:
- It feels more like breast tissue. The gel-like feel is more natural than the fluid-like feel of saline.
- Silicone gel is less likely to ripple than saline.
What are the Advantages of Saline over Silicone?
Saline has several advantages over silicone:
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Saline Implant |
Sixty per cent of the human body is made of saline. Therefore, if there is a rupture the saline just gets flushed out of the body. With silicone, the gel remains and is much harder to remove it completely.
- The incision to put silicone implants in is a little longer than that of saline. This is because saline implants go into the breast empty and then are inflated, silicone implants, on the other hand, go into the body already filled.
- Cost. Silicone implants cost more.
Do silicone or saline implants increase the risk of cancer?
No, there doesn't appear to be any increased risk with either silicone or saline implants.
Do silicone implants affect mammography screening?
Both silicone and saline implants make mammography screening slightly less effective. There is very little difference between silicone and saline. Both implants require special mammography views to be done in order to better see around the implant.
Who benefits most from silicone implants compared to saline implants?
The women who benefit the most from the improved feel and decreased rippling of silicone implants are women with little natural breast tissue. These women do not have much tissue to cover the implant, therefore, the feel of the implant becomes very important.
Is this the end of saline implants?
No, many women will continue to feel more comfortable with saline implants over silicone. Saline implants have been used almost exclusively over the past 14 years and have done very well. They remain a good option. This is especially true for women who have a fair amount of natural breast tissue. In these women the difference in feel becomes much less significant. Silicone implant approval simply means that women have a choice.
 What are the long term consideration with silicone implants?
Neither silicone or saline implants are meant to last a life time. Anyone considering breast augmentation should anticipate the need to have at least one more surgery on their breast. This may be because of implant exchange, change in size, breast lift, etc. The main difference is that saline implants do NOT HAVE to be replaced unless there is a problem. Silicone implants, on the other hand, should be replaced every 10-15 years even if there is no problem.
Why do silicone implants need to be replaced every 10-15 years?
The reason is because a small rupture in a silicone implant may not change the breast shape. The silicone may get out of the implant shell but it will remain in the capsule that forms around the implant. This exposes the body directly to the gel. This has not been shown to be a problem but implant removal/exchange is still highly suggested.
If a woman already has saline implants and wants to exchange them, when is a good time?
There is no "ideal" time. Simply, it is when the woman wants to have it done. Indications to exchange include the desire to have a more natural feel and if there is significant rippling with the current saline implant.
Is silicone a better choice for women who also need a lift?
Possibly. Often women who are interested in breast lifting have given birth, lost weight or have aged. Commonly these will lead to loss of breast tissue in the upper part of the breasts. Silicone implants allow for this to be filled out with a more natural appearance than saline in these patients. Of further consideration is the fact that silicone gel is heavier than saline. Therefore large implants should be discouraged, or sagging may reoccur.
Plastic Surgery Societies Applaud the FDA’s Decision to Approve Silicone Breast Implants
The American Society for Aesthetic Plastic Surgery and The American Society of Plastic Surgeons, the two largest plastic surgery membership organizations, applaud the FDA’s decision today to approve (manufacturer’s) silicone breast implants and return these devices to the U.S. market. This decision comes 14 years after the FDA restricted access to the silicone implants because of safety concerns.
“This is a great day for American women and the plastic surgeons who care for them,” said Roxanne Guy, MD, ASPS president. “Silicone breast implants have been scrutinized more than any medical device, and we applaud the FDA for making its well thought-out decision and allowing American women to make informed choices about their health care.”
Today’s FDA decision follows a lengthy process in which the agency sent “approvable with conditions” letters to the two silicone breast implant manufacturers in the second half of 2005. The approvable letter stipulated a number of conditions that the manufacturers needed to satisfy in order to receive FDA final approval to market and sell silicone breast implants in the United States. These letters came after an FDA advisory panel hearing in April 2005, in which the panel heard more than 20 hours of data presentations from the manufacturers and public comment.
Approved with Conditions
FDA approved the silicone gel-filled breast implants with a number of conditions, including requiring each company to:
- Conduct a large postapproval study;
- Continue its core study through 10 years;
- Conduct a focus group study of the patient labeling;
- Continue laboratory studies to further characterize types of device failure; and
- Track each implant in the event, for example, that health professionals and patients need to be notified of updated product information.
Approximately 300,000 women chose breast augmentation in 2005, according to ASAPS and ASPS statistics. Nearly 58,000 women had breast reconstruction in 2005, according to ASPS. Both breast augmentation and reconstruction have been proven in numerous studies to have psychological and physical benefits for women who choose these procedures.
The ASPS and ASAPS will continue to offer their assistance to the manufacturers for the conditions set forth by the FDA related to physician and patient education. One comprehensive example of this assistance is a joint Web site, breastimplantsafety.org, which offers objective and science based information regarding saline and silicone breast implants.
The American Society for Aesthetic Plastic Surgery (ASAPS) is the leading organization of board-certified plastic surgeons specializing in cosmetic plastic surgery. ASAPS active-member plastic surgeons are certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. www.surgery.org .
The American Society of Plastic Surgeons is the largest organization of board-certified plastic surgeons in the world. With more than 6,000 members, the Society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises more than 90 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the Society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada. www.plasticsurgery.org
Breast Augmentation Information Resource for Southern California including Orange County, Newport Beach, Los Angeles, San Diego, and Beverly Hills.
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