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FDA approves silicone implants (no innuendo,.... really)


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HighHeat
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PostPosted: 04/14/05 - 08:16    Post subject: FDA approves silicone implants (no innuendo,.... really)
I never realized that implants were so short lived. Do women really have to undergo some kind of periodic maintenance or replacement with them every few years?

I'm admittedly ignorant about the health concerns associated with silicone vs saline. Is allowing silicone implants really a significant risk over saline?

Anyone have any thoughts on this one way or the other?


Quote:
A federal health panel radically reversed course yesterday and lifted a 13-year ban on silicone breast implants that many women claim wreaked havoc with their health and their lives.

"There'll be more people besides me that look the way I am,'' said Rosemary Toppi of Revere, who first had implants in 1984 after having cysts removed from her breasts and now has scars and skin grafts in the implants' place. ``Believe me.''

Toppi, 46, said her first implants ruptured after a year, then another set broke and had to be removed. Her body rejected a third set six years ago.

"Now I have nothing,'' she said. "My husband hasn't seen me fully (naked) in years. When it's bedtime, you have a shirt on and the lights off. I can't wear a bathing suit or short sleeves.''

But yesterday Mentor Corp. convinced advisers to the Food and Drug Administration that its newer silicone implants are reasonably safe and more durable than older versions. The 7-2 vote came just one day after a rival manufacturer failed to allay lingering concerns about how often the implants break apart and leak inside women's bodies.

FDA advisers said Mentor had provided more convincing evidence that the implants rarely break in the first few years after they're inserted, and some data showing they may last as long as 10 years.

But the advisers emphasized that sales should resume only if Mentor meets strict conditions, such as forcing patients to sign consent forms; only selling the implants to doctors who complete special training to avoid ruptures; and documenting how often implants break within 10 years. The advisers also recommended patients get MRIs to find undetected ruptures.

Toppi doubts the new, more stringent rules will work.

She said her health has steadily declined over the past two decades, which she blames on the amount of silicone still in her body. As she has gotten weaker, her husband has shouldered the burden of raising their children, now 16 and 20.

In addition to the physical and psychological scars, she said doctors have told her the silicone that remains in her body will someday kill her.

"It's just going to get in the wrong place, in my blood system,'' she said.

"So I know it's going to get me.''


http://news.bostonherald.com/national/view.bg?articleid=78407
BobM59
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PostPosted: 04/14/05 - 08:21    Post subject:
I don't understand the advantage of silicone over saline in any way. Silicone is a much more foreign substance to the body.

That said, it doesn't matter to me, and isn't any of my business. I think there should be a rigid process in the US. Force surgeons to provide all the dangers and risks associated with a cosmetic procedure, and make the prospective patient sign a waiver citing that he/she understands the risks involved. Then let people do whatever the hell they want to themselves, and endure the risks they undertake in the name of vanity.
RangerG
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PostPosted: 04/14/05 - 09:04    Post subject:
BobM59 wrote:
IThen let people do whatever the hell they want to themselves, and endure the risks they undertake in the name of vanity.


Yea, you can tell that worked out well for Mr. M Jackson... I wonder how much makup he wears to court every day to hide that major CF....

Of course only his cellmates will know for sure... Wink
HighHeat
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PostPosted: 04/14/05 - 09:06    Post subject:
BobM59 wrote:
Then let people do whatever the hell they want to themselves, and endure the risks they undertake in the name of vanity.


Is having implants because you had a mastectomy considered vain?


just sayin'...
BobM59
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PostPosted: 04/14/05 - 10:25    Post subject:
HighHeat wrote:


Is having implants because you had a mastectomy considered vain?


just sayin'...


No, but choosing to take silicone over saline (why?) may be.
j1miller
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PostPosted: 04/14/05 - 10:26    Post subject:
I don't know.

i just don't know.
JACKED UP
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PostPosted: 04/14/05 - 10:33    Post subject:
My friend had saline implants put in last year she's 23. She was told 5-10 years and she would need to have them redone. I thought is was like forever. dunno
Pug
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PostPosted: 04/14/05 - 12:01    Post subject:
Random: I first read this as "FDR Approves Implants".
Astara
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PostPosted: 04/15/05 - 03:20    Post subject:
I don't know what all the studies say, but I do personally know three women who've had silicone implants who are now suffering with or did have breast cancer.


~Astara~
brie k
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PostPosted: 04/15/05 - 06:15    Post subject:
After watching Breast Men, the movie about the boob job pioneers, I'm really hesitant to think that silicone will ever be safe. I do however know several ladies who are participating in an FDA clinical trial (had to have problems with their saline implants to get in this trial--yipes!) and they appear to be ok so far. The one benefit of the Mentor trial is that these women get all their checkups for free (for a great deal of time, like 5+years), and I think that if something were to go wrong, they wouldn't pay for surgery.

Personally, I'd rather have my salines changed out every 10 years if necessary. I don't care what Mentor says. Saline leaking into your body is just bad and all kinds of scary. But having someone slice me open and stick little saline-filled water balloons under my muscle, that's not scary at all. I know, I'm a dork.

Don't get me wrong, I'd love it if mine looked or felt more real. Until I'm a topless dancer or porn star though, saline is my filler of choice.
rolling rock
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PostPosted: 04/15/05 - 06:26    Post subject:
it's incredible to me that they reapprove this gunk for use in a woman's body. have you ever seen video of a surgery to remove a failed silicone implant? it's like pulling a mass of stringy bubble gum out of a chest cavity. looks healthy to me.

i'm taking my teeny tinys to the box with me.....
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