08 December 2008

FDA rules against silicone

Are silicone implants safe or not? The Food and Drug Administration in the US doesn't seem to think so as the organisation recently declined to approve of their use.

More information is needed on the long-term safety of silicone implants before their use can be approved, according to a letter sent in the first week of January by the FDA to silicone implant manufacturer Inamed Corp.

So how safe are silicone implants? Should you consider it?

"Silicone is extremely safe for use in breast augmentations and the scare in the US, which led to the banning of silicone implants in that country, was based on nothing more than urban legend," according to Professor Don Hudson, Head of the Department of reconstructive surgery at UCT medical school.

Stories about women whose silicone breasts burst on transatlantic flights, or who have silicone leaking from their eyes have done the rounds for many years. Do silicone breast implants hold some real health risks for women? And have the silicone implants improved since the 60s, when ruptures were common? Heath24 investigated.

FDA retracts recommended lift of ban
In 2003, a recommendation was made by an advisory panel of the US Food and Drug Administration (FDA) to lift the ban on silicone breast implants. But in January 2004, the FDA decided not to follow these recommendations and cited leakage and rupture problems as the reason for deciding against the use of silicone implants.

The original recommended banning lift in 2003 came after the FDA banned the implants in 1991 after several women reported health problems following the rupture of implants. The recommendation was all the more surprising in the light of the findings of an FDA study in the year 2000, which found a silicone implant rupture rate as high as 55 percent, with up to 69 percent of women likely to experience a rupture in at least one breast.

Both Prof. Don Hudson and Dr Jenny Edge, general surgeon from Cape Town, contest these findings.

Europe and SA used silicone throughout
"Silicone has been in constant use throughout in both South Africa and European countries – with no ill effects. Only the US banned silicone implants for breast augmentation, leaving American women with no choice but to use uncomfortable saline implants. But oddly enough, women who were having reconstructive surgery after mastectomies were still allowed to have silicone implants," according to Prof. Hudson.

"Ruptures or leaks are extremely uncommon," according to both Dr Edge and Prof. Hudson. "And, in the unlikely case of a leak occurring, the implant can merely be replaced with very little fuss."

A recent study by a group of Danish researchers used magnetic resonance imaging (MRI) to study implant rupture rates in 300 women over a period of three years, and according to them, the rupture rate is as low as 15 – 17 percent.

Rupture rate 'very low'
Some plastic surgeons, like Dr Barry Zide of New York University, believes the rupture rate is even lower. He also objects to the use of the term 'rupture', as he says the term is used incorrectly to refer to what are essentially small and very slow leaks. He stresses that even if silicone leaves the implant, there is no direct evidence that this can have an ill effect on a woman's health. Prof. Hudson agrees.

But Diana Zuckerman, executive director of the American National Center for Policy Research for women and families, disagrees with both the Danish study and Dr Zide. She says that the studies on which these findings were based, studied women only over a three-year period, which is insufficient. A ten-year period would give a more accurate indication of rupture rates.

Autoimmune diseases and silicone link?
She also disagreed with the contention that ruptured and leaking implants caused no other health problems. She quotes a study by the FDA itself in which it was found that there was a significant increase in the incidence of fibromyalgia and several autoimmune diseases among the women whose implants had ruptured.

Once again, Dr Edge contests these findings.

"Autoimmune diseases are very common in the very age group who may be having breast implants. Unless thousands of women were studied over a significant period of time, it would be very difficult to reach any real conclusions. This is always the case where researchers try and draw parallels between two common conditions or diseases commonly found in a particular demographic group."

Silicone gel-filled breast implants were first used in the US in the 1960s, but in 1976, devices such as implants were placed under FDA regulation. And shortly afterwards, the urban legends started doing the rounds.

Silicone implants drastically improved
"The quality of silicone implants has improved drastically in the last twenty years. They cannot really be compared with implants which were used in the 60s and 70s," according to Prof. Hudson.

All synthetic breast implants are surrounded by a firm silicone shell. The saline implants are filled with salt water and are definitely more prone to ruptures. They are also prone to wrinkling and look and feel less natural than other implants.

So is it safe to have silicone gel implants?

"Definitely yes," Prof. Hudson says. "The silicone scare was completely unnecessary. In fact, we all have some silicone in our bodies, because it is found on the tip of every injection needle. So every time you have an injection, a bit of silicone finds its way into your body. If it were truly dangerous to your health, people like Type 1 diabetics, who inject themselves every day, would not last long."

(Susan Erasmus, Health24)


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