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Women can't keep breast implants for life: FDA

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Women can't keep breast implants for life: FDA

Post by COOKIE on 28th June 2011, 1:51 pm

WASHINGTON (Reuters) - Women who get silicone breast implants are likely
to need additional surgery within 10 years to address complications
such as rupturing of the device, U.S. health regulators said on
Wednesday.

The Food and Drug Administration will
work to revise safety labels for silicone breast implants after
reviewing data from several long-term studies, which also showed that the products had a small link to a rare form of cancer.



The agency said the studies overall confirmed
its decision that implants can be used safely, but noted the conclusions
could be limited because some women dropped out.


"The key point is that breast implants are not lifetime devices," said
Jeff Shuren, director of the FDA's Center for Devices and Radiological
Health. "The longer you have the implant, the more likely you are to
have complications."

There were almost 400,000
breast enlargement or reconstruction procedures in the United States in
2010, according to the American Society of Plastic Surgeons. That
includes silicone and saline implants.

Up to 70
percent of all women who received surgery due to disease or trauma, and
up to 40 percent of those getting an enlargement procedure using
silicone, needed another operation within 10 years, post-approval
studies showed.

The FDA approved silicone
gel-filled breast implants sold by Allergan and Johnson & Johnson's
Mentor unit in 2006. It had banned silicone implants for most U.S. women
in 1992 after some complained that the devices leaked and made them
chronically ill.

As a condition of taking the
devices to market, both companies were required to conduct post-approval
studies of 40,000 women for 10 years, as well as extend smaller
pre-approval studies. The FDA considered the companies' results, as well
as reports of negative events and scientific literature.

LOCALIZED COMPLICATIONS

Based on the data, the FDA said most common complications
were localized, such as the hardening of the breast area around the
implant, rupture or deflation of it, and the need for additional
surgeries.

Other local complications include
implant wrinkling, asymmetry, scarring, pain, and infection at the
incision site.

The report also found a small
correlation between implants and anaplastic large-cell lymphoma, a form
of cancer that affects about 3,000 Americans a year.


From 1997 to 2010, there were about 60 cases of ALCL reported for
women worldwide out of about 5 million to 10 million women who had
breast implants, Shuren said.

"If there's a true association between that cancer and implants, it's very, very rare," he said.

The FDA said most long-term studies confirmed initial results, and that most risks of implants were well known.

"Most women reported high levels of satisfaction with
their body image and the shape, feel and size of their implants," the
FDA report said, adding that they should monitor their breasts for the
rest of their lives.

The agency also cautioned that post-approval study data could be limited because of the low response rates.

In the large 10-year studies of 80,000 women, Allergan has
collected preliminary two-year data for 60 percent of participants,
while Mentor has collected three-year data for only 21 percent.


Diane Zuckerman, president of the advocacy group National
Research Center for Women & Families, said the high dropout rates
meant the study was not accurate.

"So many of the
women dropped out before the research was completed that it is
impossible to say what percentage of women need additional surgery or
have health problems five or 10 years after getting breast implants,"
she said.

"This raises questions about FDA's reliance on studies required after a product is approved," she added.

Allergan shares were down 0.9 percent at $82.04 on the New
York Stock Exchange, while Johnson & Johnson dipped 0.2 percent to
$66.36.

(Editing by Michele Gershberg and Lisa Von Ahn)

source HERE

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Re: Women can't keep breast implants for life: FDA

Post by RoxyChick on 28th June 2011, 2:07 pm

Thanks for this Cookie. Good considering the confusion we've had about lifetime warranty recently.

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Re: Women can't keep breast implants for life: FDA

Post by COOKIE on 28th June 2011, 2:08 pm

Yup, I thought so too babe. xx

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Re: Women can't keep breast implants for life: FDA

Post by COOKIE on 28th June 2011, 2:15 pm

Just to add that from all the research I'd done previous to this recent report it all pointed toward most implants only having up to a ten year lifetime anyway, so all this 'lifetime warranty' stuff is purely out there as sales seduction and people are buying into it by the thousands!

Clever! verrrrrry clever indeed.

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Re: Women can't keep breast implants for life: FDA

Post by RoxyChick on 28th June 2011, 2:18 pm

I agree. I understand why they say lifetime, i.e. being so confident in the integrity of their product, but there needs to be more clarification on when they should be replaced.

A few girls have been under the impression that they won't have to change their implants at all.

I've moved this to general surgery section too.

Girls, what do you think about the latest findings?

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Re: Women can't keep breast implants for life: FDA

Post by sequinssparkle on 28th June 2011, 2:26 pm

Thankyou,this has been interesting to read. I think we all knew that we will have to get our implants changed ten yearly ...however the fact that we get all Oooh lifetime guarantee on implNts it confuses most if us to think they cN stay in for our lifetime.

Thanx x
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Re: Women can't keep breast implants for life: FDA

Post by lindsaylouise on 28th June 2011, 2:39 pm

I just read that all the way through, very interesting... and its cleared a lot of things up, I for one thought, maybe i could keep my implants in for ever if i wanted, as my po said shes known people have them in for up to 25 year!!... funny tho as she was only about 30 (ish) lol...

It just goes to show no matter what implant you get at the extra cost, they will all need to be done in about 10 years!

Hope mine have no complications up until this point..

Thanks again for that xx
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Re: Women can't keep breast implants for life: FDA

Post by kezza85 on 28th June 2011, 2:45 pm

After reading that Im pleased I made the choice NOT to spend x amount extra on an implant with a "lifetime"guarentee xxxx
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Re: Women can't keep breast implants for life: FDA

Post by misf1 on 28th June 2011, 3:08 pm

I always think of it like the lifetime warrantee they put on car paint. After a certain amount of miles it's worthless and they aren't going to spray the car with new paint if the paint gets damaged with age. I never trust life time warrantees.
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Re: Women can't keep breast implants for life: FDA

Post by RoxyChick on 28th June 2011, 3:30 pm

From what I understand, the lifetime guarantee is never meant to actually be used. It's more like a 'we think this product is so great we guarantee it for life!' kinda thing, which confuses people.

Everyone going into surgery should be aware that at about 10 years PO they'll need a revision. Possibly an uplift if the original implants were large, but definitely an implant change.

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Re: Women can't keep breast implants for life: FDA

Post by lindsaylouise on 28th June 2011, 3:52 pm

Also i think and always have thought, no matter what the person is trying to sale, as soon as they say life time guarantee it means its not and its just there way of making you try and buy it!

im actually looking forward to my next boob job now xx
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Re: Women can't keep breast implants for life: FDA

Post by COOKIE on 28th June 2011, 3:56 pm

[You must be registered and logged in to see this link.] wrote:I agree. I understand why they say lifetime, i.e. being so confident in the integrity of their product, but there needs to be more clarification on when they should be replaced.

A few girls have been under the impression that they won't have to change their implants at all

I think this probably the exact reason why the 'lifetime warrantee' is tagged to the product, it sells to the supplier and in turn is a great sales addition to push the product forward to the consumer, some very cleverly disguising the implant warranty as their own too, now that's naughty! But as they actually say in small print the facts of their own guarantee there would be nothing anyone could do later to claim on it years on if they thought they could, so girls, READ YOUR AFTERCARE VERY CAREFULLY!

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Re: Women can't keep breast implants for life: FDA

Post by COOKIE on 28th June 2011, 4:00 pm

[You must be registered and logged in to see this link.] wrote:I've moved this to general surgery section too.


Maybe we could keep this thread as a sticky Roxy as there is so much confusion over implant warranties and what they actually mean in addition to the actual aftercare offered by clinics/surgeons?

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Re: Women can't keep breast implants for life: FDA

Post by lindsaylouise on 28th June 2011, 4:03 pm

Its quite worrying all the things that can actually go wrong with them, cc, rupture, deflate, if any of this actually happened would they re do the op for free within the first 3 years? thats with transform... i think ive actually been really silly, and rushed straight in and not even thought about any of this stuff... the po wasnt very honest, i asked her if they needed changing, and her answer was, people have them in for 25 years, unless something goes wrong then you should be fine! bla bla bla...

xx
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Re: Women can't keep breast implants for life: FDA

Post by COOKIE on 28th June 2011, 4:22 pm

[You must be registered and logged in to see this link.] wrote:Its quite worrying all the things that can actually go wrong with them, cc, rupture, deflate, if any of this actually happened would they re do the op for free within the first 3 years? thats with transform... i think ive actually been really silly, and rushed straight in and not even thought about any of this stuff... the po wasnt very honest, i asked her if they needed changing, and her answer was, people have them in for 25 years, unless something goes wrong then you should be fine! bla bla bla...

xx

Yes, the patient co-ordinators can get a little carried away, but then, they aren't medically trained in any way, they are sales women and are there to sell a product so they're gonna use every trick in the book to do that, afterall, that's what they're employed to do!

With Transform, if you had a problem that is 'listed' in there policy then they 'should' honour that and you 'should' get a free re-op, however be prepared with these larger companies as the 'free' can suddenly turn into you having to pay a part payment for one reason or another, it's not always the case but it has been known so be prepared, it happened to me as well as other women here, I now keep a boobie fund in the event of my having to need a re-op anytime soon, that might sound daft, but last year after only 3 years and still within my aftercare I had to fork out a further £3500 for my re-op and it was a definate struggle to find the money quickly as I had a rupture and needed to have the implant removed ASAP. xx

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Re: Women can't keep breast implants for life: FDA

Post by kezza85 on 28th June 2011, 4:26 pm

My PC was actually very honest when I asked about the natural implants she said there was little point she also told me they would more than likely need to be replaced in 10-15 years maybe a little longer depending on the implant and myself but she said they would need to be replaced at some point. x Maybe I was just lucky? x
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Re: Women can't keep breast implants for life: FDA

Post by Little jen on 28th June 2011, 4:49 pm

The lifetime guarantee is 25 years with the Allergan naturelles, I would have opted for the CUI implants with 10 years aftercare but only paid £100 more for the naturelles, so I was chuffed.
I think u have to have an open mind and accept that something can go wrong and extra cost can be incurred no matter what implants you have so Cookie i will take your advice and start a new boob fund, just in case.

Great tip hun, Thank u.

xx
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Re: Women can't keep breast implants for life: FDA

Post by COOKIE on 28th June 2011, 4:51 pm

[You must be registered and logged in to see this link.] wrote:Cookie i will take your advice and start a new boob fund, just in case.

Great tip hun, Thank u.

xx

No probs babe, it took a big bite on the bum for me to start one, so if you're able, it's something I'd advise all women who've had breast augmentation to do. xx

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Re: Women can't keep breast implants for life: FDA

Post by Little jen on 28th June 2011, 4:53 pm

Well spare change in a sealed tin will soon add up, I know i'll be buying one.

x
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Re: Women can't keep breast implants for life: FDA

Post by stokesy88 on 28th June 2011, 4:58 pm

I haven't had my BA yet but my surgeon has also told me I will need a re-op in about 10 years and will probably end up having a couple of ops in my lifetime. Glad to see there are some honest people! A very interesting read though! Xx
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Re: Women can't keep breast implants for life: FDA

Post by RoxyChick on 28th June 2011, 5:01 pm

[You must be registered and logged in to see this link.] wrote:
[You must be registered and logged in to see this link.] wrote:I've moved this to general surgery section too.


Maybe we could keep this thread as a sticky Roxy as there is so much confusion over implant warranties and what they actually mean in addition to the actual aftercare offered by clinics/surgeons?

Good idea. Can you also copy the article and post it in [You must be registered and logged in to see this link.] too? Thanks lovely!

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Re: Women can't keep breast implants for life: FDA

Post by kezmac on 28th June 2011, 5:10 pm

My PS told me about 10 years, and also mentioned about MRI scans if I suspect anything wrong in the future. I think its like anything cosmetic, it doesnt last forever x
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Re: Women can't keep breast implants for life: FDA

Post by DL on 28th June 2011, 6:16 pm

yes must admit my surgeon also told me they only last about 10years xx
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Re: Women can't keep breast implants for life: FDA

Post by ariaangie on 28th June 2011, 6:51 pm

saw my surgeon for the first time yesterday and he said about 10 years too, maybe longer if I am lucky/they aren't affected by having children at some point! (I'm guessing it's likely they will be!)

He also mentioned the 'rare cancer' research that was posted at the beginning, which I guess was nice and honest of him.

Anyone know whether the Mybreast aftercare is worth it's weight??

xx
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Re: Women can't keep breast implants for life: FDA

Post by COOKIE on 28th June 2011, 8:07 pm

[You must be registered and logged in to see this link.] wrote:
[You must be registered and logged in to see this link.] wrote:
[You must be registered and logged in to see this link.] wrote:I've moved this to general surgery section too.


Maybe we could keep this thread as a sticky Roxy as there is so much confusion over implant warranties and what they actually mean in addition to the actual aftercare offered by clinics/surgeons?

Good idea. Can you also copy the article and post it in [You must be registered and logged in to see this link.] too? Thanks lovely!

Yeah, no problem hun. xx

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First BA 2006 460CCs CUIs. Ruptured 2009
Revision with full capsulectomy & uplift 410CCs CUIs 2009
Scar Revision with Lollipop Lift 2011
Scar revision resulting in heamatoma 2012
Capsular Contracture & Seroma 2014


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