FDA ends 14-year virtual ban on silicone-gel breast implants

[Roon]

FDA ends 14-year virtual ban on silicone-gel breast implants
Breaking on http://www.msnbc.msn.com/

[dipsydoodle]

1. I recall some rather large ones

being listed on ebay a while back. Can't imagine of what possible use a second hand pair of silicone implants could be to anyone other than fake jelly fish for an aquarium.

[MGKrebs]

2. So, after 14 years they become safe again?

:wtf: :shrug:

[tammywammy]

3. I remember reading about this a few years ago

Basically, the studies they've done since the ban don't link silicone implants to the various diseases people said they caused.


I think women should have the choice between the saline & silicone.

[PaDUer]

12. They didn't do studies

on women..they did studies on Dow's false studies..I've got the copies that Dow hid in Scandinavia that proves they KNEW they were lethal back in the 70's.

[JoFerret]

30. An even better choice

would be to choose neither.

[tammywammy]

35. I don't necessarily agree

As of now I wouldn't get breast implants.

But who knows, later in life I may get breast cancer, have a mastectomy and want breast implants.

[Solo_in_MD]

4. Some of the concern may have been overdone

[Xithras]

5. No, they were never all that dangerous in the first place.

A lot of the arguments against them were later found to be based on unfounded hysteria. The actual failure rates for silicone breast implants weren't found to be any higher than the rates for any other medical device approved to be implanted within the body. Many of the most well known complaints against them, including skin hardening and muscle problems, were found to be related more to rejection than to the silicone in particular, and are just as prevalent in saline implants as in silicone implants. Again, the silicone implants proved to me no more dangerous than anything else approved for internal use.

There is a risk anytime you insert a foreign object into the body, and breast implants are no exception. What happened in the early 1990's was media driven hysteria wherein a handful of women who had experienced rejection issues were held up as examples of the implants failure.

Silicone leakage was a real issue, but modern designs are more durable and the newest use a gel form of silicone that is incapable of leaking.

[LiberalHeart]

10. Handful of women? Hardly.

Hundreds of thousands of women have suffered a group of symptoms, not knowing there were others going through the same thing they were, and not knowing doctors weren't telling the truth when they said implants are safe.

The studies, largely funded by the manufacturers who worked with research folks at medical facilities/universities, looked for a link between known diseases and implants. That was a faulty approach because the women knew they were sick, but they weren't saying they had known diseases, and they begged researchers to look at the galaxy of symptoms assocated with the implants and to find ways to help those who were suffering. Any research that set out to prove, for example, that implants cause MS were doomed. Researchers knew what wasn't there and then searched for it anyway. That was a total disservice to women and produced so-called medical studies that people with a vested interest could point to when lying to the public.

After a double mastectomy, I got saline-filled implants (silicone shell with texturizing). I was very ill within 8 weeks. It was like having a bad case of the flu every damn day of my life -- it went on for years. Medical tests showed no problems. Lucikly I had an enlightened doctor who kept looking for the cause. He called my plastic surgeon and asked if the illness could be related to the implants. The surgeon said nope, no way, no women were complaining of the symptoms I had. Years went by (about three, I think) and then all hell broke loose about implants and I found huge numbers of women who were experiencing precisely what I was.

My doctor submitted paperwork to my insurance company, requesting explant surgery for me. It was denied. I decided to pay for it myself but then couldn't get any doctor to agree to do the surgery. They called it vandalism (to my body), said the implants don't make people sick, and on and on like that. I tried every surgeon in my area and they all said no. Finally I found one at Cleveland Clinic and had a surgery date set -- but then a lawyer said he'd fight for free for me to get the surgery voa my insurance plan, and to have it done at a local hospital by a local surgeon so I wouldn't have to be away from home when recovering.

The insurance company continued to say no, calling it -- get this -- "cosmetic" surgery. The lawyer finally won the coverage for me by pointing out that my insurance policy covered reconstructive surgery and what I wanted was to have my post-mastectomy chest reconstructed so I'd be post-mastectomy flat again. Once the insurance company agreed to provide the coverage, surgeons in my area were willing to do the surgery. I interviewed them to find the one who would do it the right way -- removing not just the implants, but the capsule that forms around them. Only one would agree to that lengthy, difficult surgery.

I had the capsule sent to the hospital's pathologist to see what was in it -- and just as I had suspected, there were pieces of that texturizing material (silicone, like the envelope itself) that had drifted from the implant and set up an inflammatory response in my body as my body tried to fight off the foreign body. So it's not just the gooey silicone leakage that's a problem, and it's not just the hardening around it, and it's not just the immediate area fighting the foreign material. The response for me was systemic and horribly debilitating. I lost my ability to concentrate, to work, to remember things. And I hurt all over my entire body, sometimes in my muscles, sometimes in my joints, sometimes both -- and the surface of my skin became very tender, like it was bruised. Also an area where I'd once had a broken bone became a focal point of sometimes extreme pain. I was told by my doctor at Cleveland Clinic this was common for women who had implants -- the response to the silicone caused previously injured body parts to become painful.

I began to feel better within a month of having the implants removed. Not a lot, but some. And the improvement continued month after month for a year or more. Eventually I was back to my old self again.

I personally know several others who've had experiences a great deal like mine.

I think women need to get over their breasts. It's not worth risking your health to go this route.

I believe this return of silicone will attract a lot of women to the surgery -- ones who didn't get it before because of the less natural look and feel of saline implants. And I predict we'll see more sad stories as women suffer the consequences of the sometimes wayward behavior of the implants once they're in the body, the problems associated with leakage, the pain of hardening, and the illnesses that many are unwilling to admit are very real and very devastating.

And if you've had mastectomies, having the implants removed is not a simple thing. You end up with a chest that's far worse looking than a post-mastectomy chest. It's concave, like inverted cereal bowls on your chest. Tops/shirts that follow the form of the body dip inward where the implants were.

Women who risk getting these types of problems over something as silly as filling out a sweater are making a huge mistake. The FDA is putting them at risk with this foolhardy move.

[PaDUer]

18. You're one of the lucky women

who feels somewhat better :-) The women were lied to, as I'm sure they told you also that they were safe and would last a lifetime, right? I'm sure you know women who haven't gotten better and have to depend on meds for the rest of their lives because of MS, strokes, lupus, reynauds, sjogrens, myasthenia gravis, demyelinating neurapathy, vasculitis, and other health diseases. You notice they don't discuss all the women who've died already, do they? I can write a book on this issue and the quality (?) of life these people now have, for what's left of it.

[all.of.me]

21. Wow, that is quite a story.

I am so glad things worked out for you, but I am sorry you went through it. Thanks for telling us.

I love that you say, 'Get over your breasts.' The 'perfect' body that society has created for us via the media is a crock of shit.

A friend of mine had a mastectomy, and to me she is the most beautiful when she comes over on a casual morning for coffee or something without her prosthesis. What a statement!

I hope this does not push more women into plastic surgery again, esp with all the reality (or far removed from reality!) shows about it.

[AngryAmish]

28. The "perfect body" was not created by the media

It is hard wired into all males in the world. A certain breast-waist-hip ratio is considered attractive by all males. Don't blame the media, blame DNA.

[smirkymonkey]

29. Oh - so women should endanger their health so that "all males"

will find them attractive? The media has created the image of the anorexic stick woman with huge (usually artificial) breasts - that is hardly "hard wired" into all males.

[SemperEadem]

36. No, and no one has said that

It is the practice of giving the media what it wants that has made this such an issue. If young women would say "no" to boob jobs and starving their bodies in order to make money in the media, then this wouldn't be an issue. But there are always going to be women out there who will take the money and lose the weight, get the boob job because John and Joan Q. Public considers a woman with curves and meat on her bones to be fat.

The fault lies with the public because they buy that stuff--they watch Entertainment Tonight; they buy fashion magazines; they have negative comments to make if a woman has either aged or put on weight--and it's acceptable to be catty, no matter what the sex of the person bearing claws.

[primavera]

42. Then how do you explain...

... diverse "ideal" body types across different cultures and periods of history? For example, by today's standards, the ideal woman of the 19th century would be considered grotesquely obese. What receives our brank of approval today, by the standards of a different era, would be considered emaciated. Likewise, the ideal female form for other cultures will vary from what our culture prefers. How can this be if it's all genetically hardwired as you suggest?

[Le Taz Hot]

23. THIS is why women need to talk with other women.

I swear it's the only way to get accurate information. And its why it's so important that women such as yourself relate your experiences. Not that it compares to the severity of what you had to go through but I had something similar happen with the whole menopause thing. Doctors telling me I was exaggerating my symptoms. :mad: I finally started consulting other women who had been through it and found out my symptoms were pretty common and, consequently, found the best course of action.

[Evergreen Emerald]

24. Thank you for sharing your story

I wondered also why they were suddenly deemed safe. Perhaps they think that our in American's short-attention-spanned minds, we have forgotten. It does seem that some people have indeed forgotten.

What, as a society, are our priorities?

[JoFerret]

31. Flat is beautiful

.

[lostnfound]

33. Thanks for sharing all that. Worth reading.

How horrible..

[NotGivingUp]

37. wow...what an ordeal you have been through. i am so glad

you finally won your case and that your insurance company had to pay for everything to be made right. the nerve of them to say they weren't going to cover cuz it was COSMETIC??? UNBELIEVABLE!!! glad you are feeling better today and that all is well. i really wish that women would smarten up. i can't believe how many are undergoing breast augmentation each and every year...300,000 just in the united states. ladies, please, think enough of yourselves NOT to do this. you are not here in this world to be a pair of large breasts. don't fall for this mutilation that is being advocated by those greedy bastards that keep making tons of money off of making women feel like they are inadequate.

[PaDUer]

17. Disagree

Would you like to see medical reports and biopsy reports? I guess you've never been to a seminar to see all these women who are affected, and don't forget about the men who have penile implants because they've got the same illnesses..plus, there's many people out there who don't realize what's happening to them and are attributing to being sick from aging..There's certain tests that have to be done to prove these illnesses...Some women who've had them removed felt somewhat better after explantation, but, there's many who worsened, and there's many lying 6 ft deep now..Dow's trying to wait it out because they KNOW these women are dying so they can get out from under from paying these people..They're no more bankrupt than bushies..who, btw, owns some stock in Baxter, another manufacturer of the implants. They blasted all over the media that their products didn't cause any harm to influence the general public that these women were insane, and don't forget the plastic surgeons need to make a living! Ask some plastic surgeons if their wives, daughters, and whoever have the implants--bet not!

[Odin2005]

26. The whole thing was overblown by tort lawyers by what I've heard

[Morgana LaFey]

40. Yes, there were people and interests who wanted you to think that

Unfortunately, they weren't the people on the side of the affected women, now, were they?

It amazes me that of all people, DUers can still be so naive about such things as the lies corporations will tell them to get over on all of us and get by with their crimes.

[MGKrebs]

6. I love it when I learn something new.

Thanks.
And thanks to DU, for being here.

[Bitwit1234]

7. Stupid

With all the problems this has caused any woman who gets one of these just has to be absolutely crazy..

[Crim_n al]

8. Any woman who gets one of these is not only crazy, she's lopsided.

:evilgrin:

[krispos42]

9. LMAO :-) Oh, that's a good one! n/t

[LiberalHeart]

11. In one of fantasies of something that'd be fun to do ---

I've thought about going to a plastic surgeon, telling the doc I want just one implant because I can't afford to have both sides done. Thought it be fun to see the response.

[krispos42]

32. Uniboob? lmao n/t

[Heidi]

13. Kick.

:kick:

[kskiska]

14. WP: FDA Ends Ban on Silicone Implants

Safety Concerns Led to '92 Moratorium

Saturday, November 18, 2006; A01

The Food and Drug Administration ended its 14-year ban on the cosmetic use of silicone breast implants yesterday, despite lingering safety concerns from some health advocates.

The FDA is requiring that manufacturers tell women that the implants "are not lifetime devices" and that most will need at least one additional surgery to remove or replace any implants they receive. The agency is requiring the makers, Mentor Corp. and Allergan Inc., to conduct an extensive study of at least 40,000 implant recipients over the next decade and provide their findings to the government.

More than 264,000 women had breast implants last year with saltwater-filled devices, whose availability was never limited. Medical experts predict that yesterday's approval will increase that number because silicone-gel implants, which are considered more natural and appealing, will prove popular. The FDA is allowing the devices for breast augmentation for women who are least 22 years old and for all breast-reconstruction patients.

Silicone implants were first marketed more than 30 years ago, but a moratorium was placed on them in 1992 after many women who had received them reported pain, deformity and serious illness caused when the implants ruptured or leaked. At the time, the FDA concluded there was "inadequate information to demonstrate that breast implants were safe and effective." A major implant manufacturer, Dow Corning Corp., was pushed into bankruptcy because of lawsuits stemming from the problematic devices.

more…
http://www.washingtonpost.com/wp-dyn/content/article/2006/11/17/AR2006111701246.html

[valerief]

15. I wish we could ban big boobs in the White House. nt

[PaDUer]

16. Am not surprised..

The FDA has turned their heads the other way and should be held also liable for what they've done to all the men, women, and vets who've been stricken w/ autoimmune diseases and how many have died..We have Dow to thank for this since they've contributed big bucks to the honchos in DC, and Dow built Mayo clinic a nice new lab to deny the truth about silicone. Plus, let's not forget the plastic surgeons who are making cash on these lethal things, and the saline implants still have silicone shells that still bleeds into your bodies and can't ever be removed. I can talk on this issue forever becuase Dow has lied and is far from bankrupt and is still trying to get away from paying the people for what they've done to them. The truth is, the money doesn't mean a thing when you don't have your health, and how many families lives have been destroyed due to this also..There's plenty of sites that show pix of the women who've died and are dying every day from their greed. As they say, big bucks talk! And, guess WHO owns stock in Baxter, another manufacturer of these implants..

-edit-
BTW, Dow's never done a study or tests on any female who's sick..they only looked at their own studies and lie to the public..There's lots more to the truth about these implants and how these manufacturers ran doctors and scientists out of their businesses for telling the truth about the toxic chemicals in peoples bodies...Just like the scientists that "suicided", ya right.

The vets who've been fighting these wars also have autoimmune diseases just like the people who have been exposed to silicone, including men's penile implants and silicone jaws.

More info and action alert--
http://www.now.org/press/11-06/11-17.html

FDA Approval of Dangerous Implants During Lame Duck Session
Follows FDA Pattern of Favoring Money and Politics Over Science

Unfortunately, the FDA has not required manufacturers to study the impact of silicone implants on breast milk, breastfeeding, or the health of offspring born to women with implants. At NOW, we have heard from many women who believe that their silicone breast implants have adversely affected their children's health. In the coming weeks, NOW will be reviewing more than 1,000 questionnaires filled out by mothers with implants who detail the deformities and illnesses found in their children.

[bleedingheart]

27. I don't believe that they are safe either.

I think that because consumers, Dow and physicians are clamoring for them...they are ignoring the health risks of women.

Wait until about another 10 years and a bunch of young women end up sick again...then we will have the FDA running to ban them again.

This stuff just pisses me off.

Why can't people be happy with being natural?

[MGD]

19. Now if they could just develop a safe penile enlargement procedure. eom

[robcon]

20. They were never unsafe.

This was just anti-science running amok, IMO.

[Morgana LaFey]

41. You're entitled to your own opinion

You're NOT entitled to your own facts. In this instance, your "opinion" on this is based on pure fantasy, not the actual facts.

[poofer]

22. Fake breasts

Fake relationship!

[Strathos]

25. Why not just be natural?

I understand for reconstruction, but I'll never understand cosmetic breast enhancement.

[tabasco]

34. I wish women would not chop up their bodies like this!

Implants are a turn-off for so many reasons.

Vanity, lack of self-respect, medical hazards, scars.

It might not be fair but I consider women who do this very stupid.

I also consider enhanced breasts very unattractive because they are almost always obvious and un-natural in appearance.

PLEASE STOP IT!

[NotGivingUp]

38. Well said! Ladies...stop being fools and respect yourselves.

[HockeyMom]

39. I was a 32B at the time all this happened before

It NEVER occurred to me to ever get any kind of a breast implant. How I felt back then, and still do, is that if somebody doesn't like my breasts, or my body, that is THEIR problem, not mine.

It is what is inside that counts, not whether you are a 32B or size 24.