Re: is FDA approving silicone again? was that the outcome of hearings?

[Guest guest]

,

The recent meeting regarding silicone gel implants was a hearing which resulted in the FDA Advisory panel making a recommendation to approve silicone gel breast implants for general market use. It is only a recommendation at this point, and the FDA has yet to formally approve silicone gel breast implants again. I think they will be making a final decision sometime in the near future.

It was disheartening to hear this news of the recommendation to approve. However, since then, the Chairman of the Advisory panel, Dr Whalen (who only had the capacity to vote in case of a tie) has written a letter the the FDA Commissioner recommending that this misguided vote be put aside and not acted upon. It was a great letter, and a copy is posted on our group. Hopefully, with enough pressure the FDA will come to its senses and realize that the panel acted in haste. The biggest issue is that the FDA has absolutely no authority to enforce the conditions that were agreed to at the Advisory panel hearing. This means that in order to be prudent, the FDA should delay their approval until all these conditions are met FIRST. The chances of any of the conditions being met at a future date after approval are nil, without any way to enforce them. What reason would motivate the manufacturers to fulfill any of the conditions anyway? Once implants are approved there is nothing left to work toward, so why bother? I can only pray that the FDA comes to its senses and sees what is going on. Don't give up yet....it isn't over till it's over. Keep praying.

Take care.

Patty

----- Original Message -----

From: michelle king

Sent: Saturday, November 22, 2003 6:13 PM

Subject: is FDA approving silicone again? was that the outcome of hearings?

My Mom told me they are putting silicone back on the market. How awful. There shoots my social security case. Isn't there anyone who stands in our corner, saying silicone poisons? This is ludicrist. i read the hearing, a large majority of it and basically the federal government is putting blinders on. There must be some heavy payoff. Well pharmaseticals and medical etc. own so much share into big business. Its like tryng to fight a damn oil company. All we were asking for was to get longer case studies that none had been done and if the implants were approved before the studies would be done then these silicone companies wouldn't do the studies. From what I read almost 4 to 1 women complained of haiving complications with these implants. The women who want them are the cancer survivors who say they want a choice saline or silicone and because many of them are speaking up, I guess they win. their prob ably paid by these large companies. Why, Why on God's Green Earth, or How can these manufacturers, doctors ignore the obvious. Why is this happening to us? Implants must bring in a pretty penny is all I can say. God Bless Everyone, and everyone who has commented on my posts lately thank you so much and God Bless,