What’s the Story on Silicone Gel Breast Implants?

What’s the Story on Silicone Gel Breast Implants?

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In November, 2006, the FDA issued its approval of silicone gel implants after a 14-year period of limited use. They had been restricted to reconstructive use and banned for cosmetic use. Why was that?

Breast implants were first on the market in 1962. From then until the early 1990s, they were becoming popular as cosmetic surgery in general was catching on. Most procedures used silicone gel implants rather than saline implants, as most people thought they had a more natural look and feel.

Not everyone approved of breast augmentation, seeing it as pandering to males. Some women came forward with complaints that their silicone gel implants had ruptured and leaked the gel into their bodies. The claim was that this had caused cancer and autoimmune or connective tissue diseases such as lupus.

There was a loud flurry of media allegations. Accusations flew back and forth and lawyers saw an opportunity for class action suits. Eventually in January, 1992, the FDA decided to put an end to it by declaring a moratorium on cosmetic use pending further safety studies. They kept them available for women recovering from breast cancer, or from injury that required breast reconstruction.

National Cancer Institute Study

In the ensuing 14 years, many safety studies were done across the country, differing in size and duration. The National Cancer Institute did a large study starting in 1992. They studied 13,500 women for an average time of 13 years. Unlike some other studies, this one included each woman’s medical history and lifestyle, and compared the women’s health risks to both those of the general population and those of other plastic surgery patients.

This study took into account many variables missing in other studies, and because of the highly-charged political atmosphere surrounding breast implants, objectivity was a high priority. They kept a website where results were posted as they became available. They found it was more meaningful to compare the implant patients with other plastic surgery patients rather than with the general population because there were more similarities.


To cut the long story short, this study found that women with implants:

• Had no higher risk of breast cancer

• Had no higher risk of any cancer except brain and respiratory cancers and of these, only the respiratory cancers had a statistically significant increase.

• Had no increased risk of death, except again from brain and respiratory cancers, and also from suicide. Again, only the respiratory cancers reached statistical significance.

• Had no increased risk of connective tissue disorders

The study also found a curious tendency for implant patients to die in motor vehicle accidents. They theorized that some of those accidents were not really accidental, and some involved drug or alcohol use. They also thought that the increased mortality risk regardless of cause was not related to silicone but to factors common among women who have breast implants.

It is certainly true that many people who seek cosmetic surgery tend to have a self-esteem problem, with unrealistic expectations for what an improved body shape will do for them. Although most cosmetic surgeons try to correct false expectations before they do any surgery, and urge people to have their procedures for their own sakes, rather than to please anyone else, some women probably still have implants based on false hopes.

What is silicone?

It is a mix of silicon (without an “e”) and oxygen, hydrogen, and carbon. Silicon (without an “e”) is the second most common element on the planet, after oxygen. It is found everywhere in rocks, sand, and crystals.

There are a variety of silicones (with the “e”). They can have a liquid, gel, or rubbery consistency. Silicones are part of other implants such as artificial joints and facial implants. It is also used in artificial heart valves, many catheters, dentistry, and ophthalmology; in tissue expanders, cosmetic treatments for wrinkles and scars, in penile prostheses, and the list goes on much longer. In addition, it is in common household products such as dish detergent, hand lotions, and hairsprays.

The new silicone gel implants

Mentor and Inamed are the two companies whose implants are now FDA-approved, and both kinds of a 3-layer shell around the gel. They come pre-filled and sealed. In the very unlikely event that the shell ruptured, the gel would not leak out, because it is a new, stickier gel that adheres to itself.

When the FDA announced its approval of these new implants, cosmetic surgeons nationwide rejoiced, and women rushed to ask about them and compare them to silicone implants. Again, they have become the preferred type of breast implant.

If you would like to know more about them, you can contact a qualified cosmetic surgeon such as Dr. Bellin at Renaissance Plastic Surgery in Indianapolis.



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