NYT/AP: Health Advisers Recommend Lifting Breast Implant Ban (turnaround)

[DeepModem Mom]

Health Advisers Recommend Lifting Breast Implant Ban
By THE ASSOCIATED PRESS

Published: April 13, 2005


WASHINGTON -- In a surprising turnaround, federal health advisers Wednesday recommended allowing silicone-gel breast implants to return to the U.S. market after a 13-year ban on most uses of the devices -- but only under strict conditions that will limit how easily women can get them.

Mentor Corp. persuaded 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, Inamed Corp., failed to satisfy lingering concerns about how often the implants break apart and leak inside women's bodies.

FDA's advisers said Wednesday that Mentor had performed more convincing research that the implants only rarely break in the first few years after they're inserted -- about 1.4 percent over three years -- and showed some evidence that they may last as long as 10 years....


http://www.nytimes.com/2005/04/13/health/13wire-implant.html?hp&ex=1113451200&en=38a40f5b0c0d935f&ei=5094&partner=homepage

[MADem]

1. Why do I get a funny feeling about this?

It's almost like, well, it is 'only' a female, so what if they aren't safe, totally, as long as they look and feel good.

I understand the need for women with cancer who need reconstruction and so on, but you know the bulk of the customers won't be those poor women. It will be women who for reasons of vanity want them, and will believe that they 'must' be safe, else they would not be approved.

Why can't they come up with something better to help the women with cancer? If they took the money they spent on lawyers to ram this through and applied it to research, maybe they could develop a safer alternative.

How many women here are interested in getting cut open every ten years to replace their chests, since the things fail about every ten years?

The whole business seems fishy to me. Someone has to be on the take in a big way...

[ananda]

2. a bunch of balloony

Someone's on the take all right.

An implant -might- last from 3 to 10 years? Then what?

Safe my eye...

Sue

[Pithlet]

5. That "as long as ten years"

Do most women who have them plan on going in to have them removed before then, or do they even think that far ahead? It's hard for me to understand why anyone would want to surgically implant anything into their body purely for appearance, unless one is disfigured, no matter how safe they say it is. It has to come out at some point. I can understand wanting to improve appearance. If I could wave a magic wand, there are a few things I would change. A nip and tuck is even understandable. But, actually adding foreign substances? I wouldn't do it.

[MADem]

6. Speaking of foreign substances

...one of the things that I find disgusting is the "fat lip" look that is obtained not from that collagen, but from that special stuff they use that is essentially "essence of dead people." Apparently, it doesn't wear off as fast as collagen...but ugh. Having the chomped up chunks of a dead guy injected into your body is just...so soylent green!

When you give your body to science, you could end up on a starlet's lips...how incredibly bizarre!

[Pithlet]

7. It isn't terribly attractive, either.

I call it worm lips. Artificially puffed up lips almost never look good.

[MADem]

16. They look like victims of abuse, IMHO

You expect to see some fellow in a wifebeater tee shirt, like a bit player from COPS, lurking behind them, ready to smack them in the mouth yet again. And when you add the rigid bosoms that couldn't move on a trampoline workout, it just seems so fake and cartoonish.

There's something to be said for letting nature take its course. There's wisdom and beauty in real faces that have seen a bit of life.

[Pithlet]

20. I agree.

Although, I'm 32, so I guess it's easy for me to say. I just don't think the plastic, stretched tight, permanent look of surprise is all that much better. When people first start out and have very light surgery, just a little work around the eyes, it looks nice. But, they don't always stop there, and it starts looking scary. It's a shame that getting old has to be so stigmatized. It's something we all hope we'll do, after all.

I have full lips, and I do an impersonation of someone with puffy lips whenever we see someone like that on tv that cracks my husband up. It's got to be a Hollywood thing, because I don't see that often in real life. It's just so silly looking. I think if cosmetic surgeons told people that an implanted cucumber sticking out of the forhead looks sexy, we'd see Hollywood stars with them in a matter of months.

[MADem]

21. And it isn't just women either

It's easy to take the cheap shot at say, Joan Rivers, who looks like skeletor after a day at Elizabeth Arden, but Michael Douglas, Ahhh-nuld, and a host of men have been nipped and tucked as well, many badly.

You look close at some of those cleft chins, and you realize they've been yanked up so tight, it's the vestiges of their belly button!!!!!!

[progressivebydesign]

9. How vain have women become??

Bad enuff they're shooting botulism in their faces regularly. Hello? I'm 45, even with surgery I won't look 20, I'll just look like a scary version of myself. I'm thinking Gloria Swanson in Sunset Blvd.

[Horse with no Name]

27. I thought Meg Ryan was beautiful until she had this done

Now she looks like she ran into the back of a car, mouth first.
Totally disgusting.

[NC_Nurse]

3. Women who have reconstruction after mastectomy

can get them now. There is a long-term study they can join.

This is purely for $$$$ to get back into the "augmentation" market again.

Don't do it ladies! It ain't worth it. I've met MANY women who've had problems with rupture, scar tissue, and they look like shit when you age too.

Just sayin' ....

[Lars39]

4. Reconstruction is being HEAVILY pushed.

Even TRAM. :scared: I wouldn't have that one done for love or money!

[OzarkDem]

14. Reconstruction isn't pushed

but its very, very important to women who've lost their breast(s). After all they go through, most breast cancer survivors have a desire to do all they can to feel like a whole person again. They deserve safe alternatives and most plastic surgeons very compassionately try to find safe, natural alternatives for them.

I'd be very surprised if many surgeons who specialize in post-mastectomy reconstruction would push silicone implants. The surgery to repair the damage after they rupture is very difficult and they don't like putting patients through it. If a patient insists, they'll probably honor their wishes, but they'll fully inform them of all the risks. Maybe I'm spoiled, but my plastic surgeon was very good in that respect.

[DeepModem Mom]

15. Demgirl, thank you so much for your informed posts....

here, and elsewhere on DU.

[Lars39]

17. That hasn't been my experience.

The assumption is that every woman is going to have reconstruction.

[MADem]

19. I want to make it very clear that I think that is a reasonable

...and totally validated justification for the procedure. A woman should be able to have this available to get back to where they were before they had to go through a living hell. It's bad enough dealing with the disease, the treatment, and so on, and I agree that safe reconstructive surgery is absolutely needed.

I just find it a bit foolish when people will assume the risk and cheerfully go under the knife simply for a slightly (or much larger) prow.

I'm glad you had a good doc, and hope you are doing well.

[OzarkDem]

22. Agree

Breast surgery is no walk in the park and considering the downside of the synthetic implants, I can't understand anyone doing it just for a bigger rack.

I'm ok, 6 yr survivor after bilateral mastectomy, w/ 1 saline implant which is doing ok. Other implant failed due to irradiated skin and staph infection problems.

[MADem]

23. You have my best wishes

That certainly couldn't have been an easy road for you.

[OzarkDem]

12. Not if, but when

Even if new silicone implants are more durable, they still have a limited life and will eventually rupture anyway. Any breast implant will eventually rupture or leak.

Silicone is a problem because of what it leaks - a substance that doesn't break down in the body and is difficult to remove surgically from surrounding tissue. Its a mess.

OTOH, saline is preferred because its absorbed naturally by the body, or tram flap, using their own body fat.

I've also talked to some breast cancer survivors who have opted for the "jelly" transplants, given what they've been through.

[progressivebydesign]

8. $$$$$$$$$$$ Corporate Donors $$$$$$$$$$$$

That should answer any questions.

Really. I worked for a company that manufactured breast implants in one of their other divisions. I typed up many of the reports about the adverse health effects of implanted silicone devices. They also had a non-cosmetic device that was a silicone implant. Though I loved the people there, and was paid well, I quit upon realizing that they were implanting pigs and dogs with multiple silicone implants to test them, and then killing the animals shortly after for autopsy. Silicone is unsafe... they knew it, too.

$$$$$$$$$ talks.

[Trillo]

10. Got the word from 'On High' as in 'from Above'...

...sounds like money talks.

[Robeson]

11. Corporate America on the march......

....and always keeping our best interest in mind. I'm sure there is absolutely no profit motive to this at all...

:sarcasm:

[MetaTrope]

13. Let's see them apply the same safety standards to psychedelic drugs...

:hippie:

[Kimber Scott]

18. Boy, these are going to be hot sellers. I can't wait to run out and get a

pair!

Not.

[leesa]

24. Surprising? I don't know why...the check cleared, obviously

Just like the FDA putting Celebrex back on the market when the companie's stocks dropped. The FDA is fully corrupt.

[delhurgo]

25. I'm glad to hear this.

They shouldn't have been taken off the market in the first place. There was never any scientific proof that breast implants caused the conditions they were said to; it was all some women having medical problems (much of it imagined) looking to find something to place blame on, and the FDA knew it - but the political pressure was too great. And alot of it was about lawyers looking to make easy money off of lawsuits.

The other factor involved was a political agenda of feminists thinking its male dominated society pressuring women into being sex objects. Whether thats true or not is irrelevant; it should be up to women themselves to decide what to do with their bodies, no matter whether its for just wanting to being more attractive or for reconstruction - both are about body image anyhow. As long as they have the best information available about possible side effects, they should get to "choose". If theres a chance of breaking in 10 years, they should be told that and let them decide.

[leesa]

26. Are you one of their salespersons? There IS evidence linking

problems with silicon leakage, but they don't want to lose the enormous income fake breasts generate so they aren't gonna say a word. The breast clinic I work with finds that when women have them removed, symptoms disappear...but it's all in their heads, right? Just like Gulf war syndrome is all in their heads, right?