Breast augmentation, breast augmentation surgery, breast implant surgery, breast implants, history of silicone implants, silicone breast implants
Basic Questions to be Answered
An overview of the general history of silicone gel filled breast implants from the early 1960s until the present. Where the USFDA stands on silicone implants and which implants are most used around the world. The specific silicone implants that are now available in the US.
The History of Silicone Implants – An International Overview
By ….. , MD
A breast implant - whether saline or silicone gel filled – falls under the category of a “medical device”, which includes devices such as heart valves, contact lenses, artificial joints, etc., and thus requires the approval of the US Food and Drug Administration (USFDA) for sale and use in the United States.
Because of the controversy in the 1980s surrounding the use of silicone in the human body, these medical devices are probably the most tested, studied and researched medical devices in the world, and you owe it to yourself to review the facts before you make your own decision.
The history of silicone implants - from their use prior to a 14-year ban in the US by the FDA to their uninterrupted worldwide use since 1962 when the first silicone envelope filled with silicon gel was used in a breast augmentation procedure – is important for you to review and understand BEFORE you make a choice of breast implant, incision site, and placement.
The United States Food and Drug Administration
The USFDA is a governmental protection agency which analyzes the potential benefits and risks of thousands of products, from drugs and pharmaceuticals to medical devices such as implants, contact lenses, artificial joints, and heart valves. The FDA runs exhaustive clinical trials and safety tests before granting approval for use in the United States. They also determine what potential risk information and safety precautions must be clearly displayed when the product is offered for sale.
The FDA is the highest US consumer protection authority and has a well earned tough reputation worldwide in spite of a few negative high media attention cases (such as the recent Vioxx scandal).
In the early 1980s in the United States a medical controversy arose when some women who presented with symptoms of scleroderma, rheumatoid arthritis, chronic fatigue, hair loss, breast and other cancers began to claim a connection between these various autoimmune and connective tissue diseases and their having undergone breast augmentation using silicone gel implants. Several legal class action suits were brought against implants manufacturers claiming that leaking silicone implants were the cause of a broad range of ailments.
In 1992, in spite of not having any conclusive scientific evidence linking silicone leakage to such ailments, the USFDA revoked their approval to use silicone implants for general cosmetic surgery. Some legal claims were settled out of court and a few cases were won despite any verifying scientific evidence. The controversy received wide media coverage throughout the world.
Silicone implants for reconstructive surgery, implant replacement, the correction of a deformity, or as part of an FDA-sanctioned study, continued to enjoy FDA approval. Allergan and Mentor, the two largest US manufacturers of implants, continued to supply the European and South American markets with silicone implants for use in cosmetic breast augmentation surgery. No foreign licensing authorities saw fit to withdraw approval for use of silicone implants in their countries.
Renewed Approval of Silicone Implants in the US
In November 2006 the US Food and Drug Administration renewed their approval of the use of silicone gel breast implants for cosmetic breast augmentation, lifting their 14-year ban. The FDA approval was eagerly awaited by both plastic surgeons and patient, and the demand for silicone gel implants has in fact skyrocketed since the ruling.
Silicone has rapidly become the preferred choice over saline-filled implants in the US (as it has been right along in Europe and South America). Silicone gel implants had been allowed only for breast cancer reconstructive surgery and approved medical trials in the US, but continued to be used widely in Europe and many other countries around the world for cosmetic breast augmentation.
Throughout the 1990s, silicone gel implants became probably the most exhaustively tested and studied medical devices in US medical history. Independent studies concluded that this type of implant was NOT associated with connective tissue disease or cancer, and NO convincing evidence was found of any link to health problems such as lupus or rheumatoid arthritis. Numerous scientific studies over the years, both in the US and abroad, have shown that silicone gel-filled implants are both safe and effective for breast augmentation and reconstruction.
Pros and Cons
Both saline and silicone implants carry a risk of rupture or slow leakage and capsular contracture. As in all surgery, there is the risk of infection or adverse reactions to anesthetics. The FDA has made it clear that breast implants of either kind may not last a lifetime and may require follow up surgery at some later date.
…have a good safety track record in the US over the past 25-30 years.
…can be inserted through very a small incision, with minimal scaring.
…can be inserted from under the breast, along the areola border, near the belly button or the from under the armpit as it is initially empty and filled once in place.
…may be more likely to ripple or wrinkle than silicone
…rupture or leakage will be immediately obvious and may require a longer incision to remove or repair.
Silicone gel implants…
…have a more natural feel and movement than saline and are more similar to natural breast tissue.
…require a longer incision (and thus a longer scar), usually along the underfold of the breast, as the implant is prefilled.
…are the first choice of almost 90% of breast augmentation candidates in Canada, Europe, South American, and other countries outside the US.
…rupture or leakage may be difficult to detect, but can usually be repaired or replaced through the original incision line.
Making the choice
Taking some time to investigate the various breast augmentation implants available and being guided by your Board Certified plastic surgeon in the choice of implant most suited to your body and goals will ensure you of optimal results with a minimum risk of complication.
Take Home Messages:
Photos of Mentor and Allergan saline and silicone implants, or a chart showing the broad selection.
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Smoking Risks and Side Effects: Short-term vs Long-term Effects
Possibly one of the most unhelpful aspects in the battle to stop smoking is the virtual non-existence of an immediate and measureable negative effect of smoking cigarettes.
If, for instance, every time we inhaled the smoke from a cigarette we experienced a sharp pain, fainted, or turned blue from lack of oxygen, we probably never would have become habitual smokers in the first place. The nicotine in cigarettes would never have had the chance to become additive.
It’s the insidious and cumulative effects of the physically addictive nicotine and the emotionally addictive social aspect of smoking that cause our habitual self-exposure to the full range of carcinogenic and poisonous substances which we all pretty much now agree will cause us long-term negative health consequences.
Why can’t some of us face the clear and scientific evidence of the long-term negative effects?
In some cases, especially among long-term, heavy smokers who try and cannot quit smoking, there may be an element of fatalism in their outlook, in some cases brought on by studies such as the following:
Past Heavy Smoking is Risk Factor for Heart Failure*
Researchers from the University of Alabama at Birmingham found that during 12 years of follow-up, the incidence of heart failure among never-smokers was 20% versus 29% among former smokers who quit smoking 15 or more years ago, but smoked 32 or more pack years - a 44% increase in relative risk over non-smokers.
The findings are based on the Cardiovascular Health Study, funded by the National Heart, Lung, and Blood Institute, which included 5,338 participants with no prevalent heart failure. The analysis focused on 1,297 people who had quit smoking 15 or more years prior and 2,558 people who have never smoked.
Compared with never-smokers, former smokers, who quit 15 or more years earlier but were among the top quarter of smokers in terms of pack years of smoking, also had an increased risk of heart attack and death from all causes. The risk of the former smokers in the remaining three quarters in pack years of smoking was similar to that of never-smokers.
Now, this study could be taken in either of two ways:
(a) it’s too late; I’ve already smoked too long so it won’t make any difference whether I continue smoking or quit; or
(b) it’s not too late to cut back on the number of cigarettes I currently smoke which would move me into the three quarters of former smokers whose risk is no higher after 15 years of smoking than that of never-smokers.
This example illustrates that it is not enough to simply publish the results of clear evidence of long-term effects of cigarette smoking, but that there is a need to interpret results and educate smokers to accept the evidence as it applies to their individual circumstances.
Short-term Positive Effects Could Result in Long-term Positive Effects
The emotional and social aspects of cigarette smoking must be addressed in parallel with the publication of hard, scientific evidence of the risks of the long-term harmful health effects.
Perhaps more studies should be conducted on creating positive short-term results for stopping or cutting back on smoking so that addicted long term smokers could benefit from the long-term positive health benefits.
Such studies - not necessarily scientific - could more aptly fall into the realm of business and monetary incentives, social support methods, and emotional counseling studies.
Some innovative employers have already seen the benefits of rewarding non-smokers rather than shaming or penalizing smokers. Health plans that offer discounts to non-smokers (rather than penalties or refusals to smokers) could be more effective from a psychological standpoint.
Addressing the social and emotional factors which are an integral part of cigarette smoking is becoming more essential if we as a free society are to continue to decrease smoking without infringing on individual rights.
*American Heart Association Meeting Report – “Past heavy smoking is risk factor for heart failure”, Abstract 17788, Chicago, November 15, 2010, http://www.newsroom.heart.org/index.php?s=43&item=1146 .
Pretty Easy Web Design
A professional copywriter’s point of view
I love to talk about web design. I have just enough technical knowledge to appreciate the ghastly difficulty of getting a web design “right”. And just enough credulity (or is it starry-eyed ignorance?) to still get a huge charge out of the sites that work and to beet up with frustration over the ones that don’t.
I’ll never learn to just be cool when it comes to web design.
As a copywriter and Internet researcher I have the pleasure of cruising and using many web sites every working day. I mean, first I have to Google, Ask, beg, burrow and borrow to find relevant sites. Then I book ‘em and sort them and put them in my lineup. And then I knock ‘em over, one by one. And, because in my business time is money, I move fast.
Each new site is like a walnut waiting for me to crack it open and dig out the meat. I can honestly admit that I open every single site every day with joyful anticipation.
Of course most of the time I’m sorely disappointed. Not with the information, mind you; I always get the ‘meat’ eventually; but with the website design.
What is a good web design?
A good website design is one that delivers the message without being noticed.
The trouble with most web designs is that they are too egotistical. “Look at me, look at me!” they shout, forgetting that at least 99% of the time their job is supposed to be murmuring in a hushed tone, “Take this.” “Look at this.” “Here’s some more.” What else can I get you?” Like a good waiter in a top drawer restaurant. When you leave him a generous tip at the end of a perfectly served meal it’s because he performed his job invisibly…not because he wore a red bowtie, coughed in your soup, made loud mouth noises or threw the dishes around.
Vincent Flanders (that author/web designer fellow that coined the phrase, “mystery meat navigation”) has a great analogy; he says don’t confuse web design with good sex (or something like that). Anyway, good sex requires foreplay. Good web site design doesn’t. When you go into a site you want the payoff up front, the answer before you ask the question, the punch line without the whole shaggy dog story.
That’s life today on the Internet. You want what you want when you want it!
The good, the ugly, and the bad…
Now, I don’t mean to imply that web design shouldn’t be beautiful, or colorful, or have plenty of the bells, buttons and whistles that are so dear to every web designer’s heart. I also love a fully packed site.
I’ll give you an example. This one’s pretty esoteric; you may have to love fishing to really appreciate it. I came across it while I was researching for a piece on game fishing: www.kuuloakai.com
If I didn’t lose you altogether to that site (and you’re now on your way to Hawaii…), I’ll be surprised.
Anyway, my point is, everything on that site works quickly and efficiently and offers up tons of fishing information, both practical (where and how to book, what to bring, how much, etc.) as well as frivolous (like the fun fish encyclopedia – click “The Quarry” in the left column). If something flashes, it’s because it takes you where the fish are.
It’s attractive. It’s easy. It’s fast and it’s accessible.
Even when a web site is not overtly selling a product or a service it’s still selling something. If you don’t leave the site with that ‘something’ then it wasn’t a good web design. Even if that ‘something’ was finding out that the product or service was not what you were looking for, the web design was a success because it delivered up the goods for your inspection quickly and easily.
Then there’s the frustrating and the sad…
The most frustrating web site is the one that’s packed with the information you need urgently, but the font is microscopic against a dark background, you need to open lots of hidden doors to see what turn out to be obvious headings, there are a bunch of distracting flashing images that don’t contribute any information, and - the worst crime of all - it’s slow.
The saddest web sites are the ones that are fast, work great, have clean fonts, good background, fast buttons, efficient layout…but the ‘something’ the site is selling is not worthy of the design. It’s enough to make the poor web designer cry.
Of course there are lots of amazing websites; you recognize one as soon as you enter.
But the best sites of all are the sites that are both pretty and easy.
Pretty. Easy. Got it?
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