Wednesday, February 14, 2007

Silicone Breast Enhancement

Well, it's official. The FDA has finally lifted their almost 14 year ban on silicone breast Enhancement which had resulted after overwhelming health complaints from women who had this implant device.

Now, the FDA is backing the return of the infamously more natural feeling and looking breast Enhancement, and two lucky manufacturers seem to have the corner on the market right now.

A company called Inamed is currently one the sole producers of this supposedly newer and safer implant device for women who get breast Enhancement, with the original manufacturer, Dow Corning, now a defunct company after being inundated with litigation over the silicone Enhancement, having to file bankruptcy. The other manufacturer to gain FDA approval to start almost immediately marketing their implant was Mentor Corp.

So why now has the FDA decided to lift this ban with only a few restrictions on the silicone Enhancement? Well, although they have met with a lot of resistance from consumer advocacy groups who say the device is nowhere near proven to again be safe, the FDA has agreed to pretty much widely offer the silicone option again.

The only restrictions will be that the person opting for silicone over saline must be at least 22 years of age, which is when experts agree the breast has fully matured on a woman, and there are no restrictions at all if the surgery in reconstructive in nature.

Reconstructive breast implant surgery may be due to a cancer that resulted in removal or partial removal of a breast, or other circumstances where the breasts are seriously deformed or maimed.

Many analysts believe that this new, almost carte blanche approval of the silicone breast Enhancement will lead to the eventual takeover of saline Enhancement, the only currently approved breast Enhancement on the market.

They believe this to be true because many women have actually requested to have the silicone Enhancement, and most women want a more natural feel to their breast Enhancement and look than the saline breast implant can currently offer in their eyes.

The silicone offers a more natural look because it is a gel-like substance which actually mimics the look of real breast tissue fairly well, and "moves" more like a real breast than saline does.
They also are reported to drop more naturally and lay more naturally than a saline implant does. Not only that, but women with silicone breast Enhancement report that both they and their partners think the silicone implant feels natural.

But at what cost? Many silicone-implanted women complained of health issues and complications, and there was an alarmingly high rupture rate on these implants, which led to lawsuits and FDA complaints, and ultimately led to the 14 year ban.

The interesting part here though is that years of research were conducted to see if silicone breast implants had any medical correlation to the reported health issues, which ranged from lupus and cancer, to autoimmune diseases and other complications that could not even be pinpointed.

The benefit that silicone has over saline is only cosmetic in nature. Saline is a completely inert substance which does no harm if the implant ruptures, and this is why it has been the only implant used, while silicone itself has never been proven to be 100% safe when introduced into the blood stream.

The FDA has made statements saying the research studies and tests show that the two new implants approved for sale have been shown to be reasonably safe, at least enough for approval, and that there have been no alarming findings that the implant is prone to rupture the silicone fluid into the blood stream.

Although they have been reintroduced for sale, the FDA does tag a warning on them reminding women that they are not lifetime devices, and will need to be removed and replaced, requiring another surgery about once every ten years.

This is actually true for any type of implant though. They also have required manufacturers to sponsor ongoing studies of women with the implants, to further cement the fact that they are safe, over the long haul.