Hmm, the article states that they only recmmended the ban be lifted, but that the FDA does not necessarily have to approve the silicone gel implants. I hope they do however. I want a boob job within the next year and would love to have the gels done. *crosses fingers* My poor boobs have gotten alot smaller since I have lost a significant amount of weight recently. Grrr...
For once you have tasted flight you will walk the earth with your eyes turned skyward, for there you have been and there you will long to return.





*Yes, this is just another step in the process. I saw it on the news today too..I was psyched. Woo hoo Mentor! I woner why Inamed didnt get the vote?
*But, 1:10,000 ppl probably might have side effects is still a little unsettling. Then again the severity of the side effects will be different from person to person.
If Mentor perfoms the suggested task asked by the FDA how soon could they be on the market for all?
you live like an ivy vine
you can only survive by clinging onto trees
that's your flaw
put down some roots so you can stand on your own
-Kenpachi





FDA Panel Issues Regrettable Decision on Silicone Gel-Filled Breast Implants
April 13, 2005
"The Food and Drug Administration (FDA) advisory panel's decision is deplorable," said NOW President Kim Gandy. "In light of dramatically insufficient data and overwhelming reports from women who believe they suffered injury and illness from silicone gel-filled breast implants, they favored corporate greed over women's health."
Despite the FDA's request 15 months ago for long-term studies that might indicate safety and effectiveness, the FDA panel approved 7- to- 2, with conditions, a Mentor Corp. application to bring silicone breast implants back onto the general market. These implants were removed from general use in 1992.
The conditions attached to the approval included requirements for more detailed studies relating to rupture and illness as well as training for physicians and independent data monitoring.
"Implant manufacturers and plastic surgeons have utterly failed to monitor and evaluate women with implants over a longer period of time," said Gandy. "The data with regard to health consequences when silicone implants leak or rupture are still lacking."
Most serious problems become manifest at 10 to 12 years after implementation. This means that current studies fall short of providing women with a complete set of data to advise them of the implants full medical risks and options.
Today's action backtracks on the agency's stated intent — to strengthen the scientific basis through longer-term studies and use this information to base their final decision about allowing silicone implants back on the general market.
"Manufacturers had 12 years to conduct detailed studies on reconstruction and other patients who have received silicone gel-filled breast implants in clinical trials, yet this has not happened," said Gandy.
In a 5-to-4 vote Tuesday, the FDA panel rejected a similar application from Inamed Corp. based on reasons of insufficient data. NOW urges FDA interim commissioner Lester Crawford and other top FDA officials - who will review the advisory panel recommendations - to issue their final decision in the best interest of women's health and not corporate profits.
A friend's mom got silicone a long time ago...one of them ruptured. She won a multi-million dollar settlement in the class action against silicone manufacturers about 8 years ago...however, she has a HUGE list of medical problems from having the silicone settling into her joints, etc.
Silicone might feel/look a little better...but I would just be nervous about putting them into my body. I'm going to stick with getting the saline.





That's scary VG! I want to know if co-gels have some sort of side affect when it ruptures. So far there is nothing?
I'm not sure Vyanka...the problem is that they have not been around long enough to view long-term effects of them.



They are silicone vyanka and thats what causes the illnesses. People dont understand that saline can cause the problems as well. Your body still tries to rid itself of the implants no matter what type they are and the tiny pathogens break down the shells. Its a part of having a foreign object in the body and the risk you take. I have seen too many women with silicone with problems to even consider ever getting those.
agreed whole heartedly. i know of someone who had the silicones and same thing. I feel the salines are a good compromise for me although they are firmer. MY CONCERN IS, WILL SALINES BE AN OPTION, or will Ps's go to silicone only ???? we all know silicones are more expensive...meaning more $ for the ps, etc. which leads me to believe they may not offer them. Having just got my breasts done a month ago, i realize they aren't lifelong devices and i'll have to get a redo. I hope saline is an option for me. I'm too chicken sh(t for silicone.Originally Posted by VenusGoddess





I think saline will always be an option. It was my understanding that the silicone implant itself that is more costly...not necessarily the surgeon's fee.
i hope you're right, lsm !




it's the implant that costs more, which does not go to the PS but the the company that makes the implant. Sad thing I had a friend who worked for one of these companies and told me literally the manufacturing cost to make the implants are 10 bucks for saline implants.
I may have many faults, but being wrong ain't one of them.
Bookmarks