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SCI/TECH: FDA Considers Easing Restrictions on Silicone Breast Implants

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posted on Apr, 11 2005 @ 10:31 AM
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The U.S. Food and Drug Administration is taking another look at silicone gel breast implants, thirteen years after strictly restricting their availability over health concerns. A three-day conference will be held with manufacturers Inamed and Mentor to review scientific studies of the safety records of the implants. Opponents of lifting the ban feel the silicone implants leak and cause disease and scarring. Proponents of the implants say that the risks are overblown and the implants have a far more natural look and feel than the saline implants now widely available.
 



www.forbes.com
MONDAY, April 11 (HealthDay News) -- The U.S. Food and Drug Administration is once again holding hearings on whether to approve silicone breast implants for women who want aesthetic breast-enhancement surgery.

Starting Monday, the panel that advises the FDA on surgical devices will hear reports from two manufacturers of silicone breast implants as well as presentations from the public about whether to lift the ban currently imposed on the implants, and then decide whether the devices can be sold.

The hearing is the latest in the long and contentious history of the medical devices.


Please visit the link provided for the complete story.


I think the choice should be left up to doctors and patients as to whether they want to take the risk associated with these implants. Many millions have had these implanted prior to the 1992 ban and have suffered no ill effect.

Related News Links:
sfgate.com




posted on Apr, 12 2005 @ 11:31 AM
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I know a woman who had these. She got in a car accident. The seat
belt caused the implants to rupture. The poison went all through her
body ...into her joints and all. She had more health problems after
that ...

It's not worth getting them. The risk is too great. Be happy with
what ever size God made you.



posted on Apr, 12 2005 @ 01:32 PM
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Seems to me that taxpayers should stop funding the FDA. If the medical industry still wants it, let them pay for it. As things stand, we're just paying for lies, bad science and disinformation.



posted on Apr, 12 2005 @ 05:28 PM
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FDA advisory panel narrowly rejected the Inamed implants:



GAITHERSBURG, Md. (Reuters) - A U.S. advisory panel on Tuesday narrowly rejected U.S. sales of Inamed Corp.'s_ silicone gel-filled breast implants by a 5-4 vote.

The U.S. Food and Drug Administration will consider the panel's advice as it decides whether to allow Inamed to widely market silicone breast implants. The FDA banned the devices for most women in 1992 because of concerns leaking silicone could be harmful.

Source: Reuters



posted on Apr, 12 2005 @ 05:32 PM
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This outrageous after all the results on the dangers to women using this Type of implants I can believe that they want to bring them again.

What is more important the health of women or the profits of the silicone makers industry.

No women in her right stay of mind should allow her body to be poison by this type of devices.



posted on Apr, 12 2005 @ 06:18 PM
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This outrageous after all the results on the dangers to women using this Type of implants I can believe that they want to bring them again.

What is more important the health of women or the profits of the silicone makers industry.

No women in her right stay of mind should allow her body to be poison by this type of devices.


There is a place for everything in the world. What about those that get breast cancer and have to have one removed? Shouldn't they be allowed to have implants?


[edit on 4/12/2005 by shots]

[edit on 4/12/2005 by shots]



posted on Apr, 12 2005 @ 06:21 PM
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posted on Apr, 12 2005 @ 06:36 PM
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Shot obviously you are not a women, is other ways to replace breast after a cancer treatment from stomach muscles to rearranging fat, must women with breast removal from cancer can not have implants depending what is the amount of tissue and muscle removed.

I have a friend that has both breast removed do to cancer and she can not have any reconstruction at all because even her breast bone has to be shaved.

Guess what she doesn't care and neither her husband because she is a surviver.

Do a search and you will learn the difference of breast implant to enhance breast when you still have your tissues and muscle intact and what is the breast surgery to restore your breast.

Two different things.

[edit on 12-4-2005 by marg6043]



posted on Apr, 12 2005 @ 08:07 PM
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Originally posted by marg6043
Shot obviously you are not a women, is other ways to replace breast after a cancer treatment from stomach muscles to rearranging fat, must women with breast removal from cancer can not have implants depending what is the amount of tissue and muscle removed.

I have a friend that has both breast removed do to cancer and she can not have any reconstruction at all because even her breast bone has to be shaved.

Guess what she doesn't care and neither her husband because she is a surviver.

Do a search and you will learn the difference of breast implant to enhance breast when you still have your tissues and muscle intact and what is the breast surgery to restore your breast.

Two different things.

[edit on 12-4-2005 by marg6043]


A few reasons why some women decide FOR reconstruction with breast implants:

1. to restore body image following mastectomy surgery for breast cancer

2. to replace an external breast form (prosthesis)

3. to avoid being constantly reminded of their breast cancer diagnosis

4. to avoid embarrassment in public dressing areas

5.to help create a look that makes them feel more comfortable with or without clothes

BTW I never said they were the same. What I stated was everything has a place nothing more nothing less.

And I do not have to ask a friend about it and get the information second hand as you claim is your source. No doubt probably as good as your last source was which we both know was proven wrong.


[edit on 4/12/2005 by shots]



posted on Apr, 12 2005 @ 08:36 PM
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Sorry my friend I just found out that another friend is going treatment for breast cancer.

I just found out a few hours ago.

You know shots when a women reach my age we are more aware of what is going on around us when it comes with this type of women problems like breast, cervical, ovarian and uterine cancer.

I already went through major surgery because I was diagnosed with a tumor that could have been cancer.

I am glad that after my surgery the results were negative, we all women have to take risk and live with the results.

Yes silicon implants are more popular on young women trying to enhance their looks than on women that are going through reconstruction after breast cancer.

These type of implants are dangerous and should never be allowed again in the market.

Its plenty of data and victims of what they can do to the body.



posted on Apr, 13 2005 @ 07:26 AM
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Originally posted by marg6043
These type of implants are dangerous and should never be allowed again in the market.

Its plenty of data and victims of what they can do to the body.


Oh wake up and come out the dark ages marg. What you are saying is no longer true.

1. Today's silicone implants no longer leak even if the shell gets ruptured.

2. The Institute Of Medicine, which is a branch of government, showed silicone implants does not cause cancer or auto-immune diseases or other problems, nor does it affect pregnant mothers, or does it pass through the milk to the infants. So the implants have been shown to be safe.

3. It's a new implant. The implant no longer leaks. It's cohesive. It's almost semi-solid."





[edit on 4/13/2005 by shots]



posted on Apr, 13 2005 @ 09:58 AM
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Yes, are other alternatives for plastic surgery to enhance appearance non related to after cancer reconstruction.

The targeted majority of women are not the cancer patients but the healthy younger women that want to look better.

Reconstruction for a cancer patient is more complicated due to the nature of the surgery the possibility of treatment after the breast removal, and also if the cancer comes back.

So believe it the targeting here is not the lady that has to undergo breast removal but the healthy women.

For cometic purposes you have the
Saline implants, The shell silicone rubber, and the silicone.

For cancer reconstruction you have the, above and the body tissue reconstruction.

If a women have muscle and tissue removed the doctor cannot just put an implant and the lady be happy, is a process, first the tissue has to be expanded and if muscle is available and was not damage during surgery implants can be used.

If no enough muscle is there, the surgery is more complicated, a flap of muscle is taken from the back.



This muscle however, usually only covers the upper ½ of the implant and to achieve a complete coverage, the latissimus muscle (latissimus flap) is often brought around from the back (again requiring sacrifice of a large functional muscle from the back). The incision required for latissimus transfer is placed across the back and is typically visible in swimwear, low cut evening gowns, etc. Implants are prosthetic devices and are subject to wear and tear. Most patients require re-operation at some point to address problems with their implants including leakage, overt deflation, infection, extrusion through the skin, capsular contracture (becoming hard), pain, and/or desire for size alteration.


That is why the target is healthy younger women.



in 2002 a total of 59,292 women had breast implants removed, 15,785 of which were reconstruction patients. If you have had radiation therapy as a part of your treatment or radiation is likely for you following mastectomy, breast implants are often regarded as a poor choice. Radiation treatments make the breasts much more prone to harden after implant placement. As a result, most recommend reconstruction with your own body’s tissue after radiation.


The other most common reconstruction for cancer patients that have no much tissue left and muscle are.

Your Own Body’s Tissue (“Flaps”)
• TRAM Flap (Transverse Rectus Abdominus Myocutaneous)
• DIEP (Deep Inferior Epigastric Perforator)
• GAP (Gluteal Artery Perforator)
My point again the marketers of silicone implants wants healthy women. That is why women that have to go through a breast removal due to cancer prefer the removable alternative prosthesis than going through more painful surgical procedures.

This is a link to the above sirguries.

breastcenter.com...



posted on Apr, 13 2005 @ 10:25 AM
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Originally posted by marg6043
Yes, are other alternatives for plastic surgery to enhance appearance non related to after cancer reconstruction.

The targeted majority of women are not the cancer patients but the healthy younger women that want to look better.

Reconstruction for a cancer patient is more complicated due to the nature of the surgery the possibility of treatment after the breast removal, and also if the cancer comes back.

Snip the blah blah stuff


First I am not talking about the young chicks, I am talking about only those who have had a breast removed because they got cancer.

Now with that said, obviously you are no aware that the law allows implants to be used for patients that want it, are you?


I do not know what is so hard to understand about that?

Also they were banned over 13 years ago and many many improvements have been made and contrary to what you might think they are now safer then they were. Perhaps not perfect, but then nothing is life is perfect is it?

If everyone had the same thought process as some have, I guess we should take all cars, planes and trains off the road because they can kill right? NOT!!!!!





posted on Apr, 13 2005 @ 05:11 PM
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The FDA advisory panel recommended that Mentor's silicone implants be allowed on the market, after rejecting Inamed's implant design yesterday:



WASHINGTON -- In a surprising turnaround, federal health advisers today recommended allowing silicone-gel breast implants to return to the U.S. market after a 13-year near-ban -- 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 failed to satisfy lingering concerns about how often the implants break apart and leak inside women's bodies.

Today, FDA's advisers said Mentor had performed more convincing research that the implants only rarely break in the first few years after they're inserted, and some data that they may last as long as 10 years.

Source: Baltimore Sun



posted on Apr, 13 2005 @ 06:05 PM
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Thanks for the update dj that update confirms what I was trying to tell marg, perhaps now she will believe me, since it says they are safer.



posted on Apr, 13 2005 @ 06:19 PM
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Originally posted by shots
Thanks for the update dj that update confirms what I was trying to tell marg, perhaps now she will believe me, since it says they are safer.


I am trying to figure out Shots what is your malfuntion. If you read the post I did, you see the difference on women that have breast implants for fun, and women that have reconstruction after breast cancer.

Marketers of breast implants like silicon is targeting the healthy younger women that wants breast for fun and enhanment.

Two different things and silicone is the last choice for a cancer patient. I think you have a problem with conprehending , maybe is my lack of english grammar or maybe my posts are hard to read



posted on Apr, 13 2005 @ 08:13 PM
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Originally posted by marg6043

Originally posted by shots
Thanks for the update dj that update confirms what I was trying to tell marg, perhaps now she will believe me, since it says they are safer.


I am trying to figure out Shots what is your malfuntion. If you read the post I did, you see the difference on women that have breast implants for fun, and women that have reconstruction after breast cancer.



No malfunction here you can be sure of that. I made myself very clear from the start I was only talking about those that wanted them after cancer surgery.

I started out with

There is a place for everything in the world. What about those that get breast cancer and have to have one removed? Shouldn't they be allowed to have implants?


Then stated later

First I am not talking about the
young chicks, I am talking about only those who have had a breast removed because they got cancer.


Kindly note in both I was very specific by stating cancer, yet for some odd reason you could not get my point why is that?





posted on Apr, 13 2005 @ 08:19 PM
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I don't know shots I really like you.....you know, I guess we can not click right sometimes.

Sorry if I misread your post, I am having some major headache now. But I guess we see the implant thing in two different point of view.



posted on Apr, 13 2005 @ 08:20 PM
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..........sorry LOL ....thought that the post said ....
eating restrictions on silicone ....
ok, I know, im not mad yet......

So I guess..
ok
helen...



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