FDA now admits breast implants only last 10 years

[Arnold]

FDA now admits breast implants only last 10 years and have to be removed in all women
by J. D. Heyes

(NaturalNews) Reversing earlier statements that breast implants are completely safe and never have to be replaced, the Food and Drug Administration now says many women who have implants must have them removed or replaced within a decade.

According to the agency, new research data from a long-term study found that the implants should be examined every 10 years because they were at risk of rupturing, and that some are linked to a rare form of cancer.

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

The agency says there were some 400,000 breast enhancement or reconstruction surgeries in the U.S. alone last year, making it the number one cosmetic surgery procedure in the country. Breast implant and augmentation surgery is followed in popularity by nose reshaping, eyelid surgery, liposuction and abdominoplasty (tummy tucks).

The FDA banned silicone gel-filled implants in 1992 after some women complained they leaked and caused some chronic illnesses. The health regulatory agency approved silicone implants made by Allergen and Johnson & Johnson's Mentor division for use again in November 2006.

Then, the agency said it approved the silicone-filled implants only "after rigorous scientific review" that the agency said took years.

"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products," Daniel Schultz, M.D., director of the agency's Center for Devices and Radiological Health. The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."

Now, however, the agency is singing a different tune.

Implants "are not lifetime devices," adding that "the more likely she is to experience complications," with one in five women who have implants "will need them removed within 10 years of implantation."

 

[sassy69]

Damn... I'm one year out of compliance.

 

[awhites1]

not that the breast implants only last 10 years, just the women who get them level of desirability expires after 10 years.

 

[sassy69]

not that the breast implants only last 10 years, just the women who get them level of desirability expires after 10 years.

So if you get a re-boob, does that mean you start a new 10 yr warranty on desirability too?

 

[awhites1]

So if you get a re-boob, does that mean you start a new 10 yr warranty on desirability too?

only if you go bigger.

 

[sassy69]

only if you go bigger.

Go big or go home!

 

[Muscle_Girl]

Well, this is just logical. How can you expect that plastic in the body can be good for you? Breasts are the way they are for a reason, nature. You screw with nature and nature screws with you.

 

[Ravager]

Sounds like a scam to get you to spend another $5k every 10 years to me.

Just like frozen food expires............. scam.

 

[Muscle_Girl]

Just like frozen food expires............. scam.

Lol, I should run down to the basement and take a picture of the freezer. My roommate is one of those people that loves to spend money, and I am sure if I looked at some of the packages, some would be years old. The meat and fish in their packages certainly don't look healthy enough to eat. You couldn't pay me to eat it! Frozen food does expire, just not in the way you would expect regular decay to occur.

 

[Arnold]

Sounds like a scam to get you to spend another $5k every 10 years to me.

Just like frozen food expires............. scam.

no its true, plastic surgeons say the same thing, Gena's is on her second set now.

 

[sassy69]

I asked exactly this question back in 2000. They literally said they didn't have any complete information on how long they lasted. I've seen some people need a reboob (usually due to capsular contracture) and a PL'er friend recently had a blowout on one side while benching w/ a shirt. So I think they can generally take a pretty good impact, but its hard to know what general wear & tear-driven shelf life is. I am assuming they know more than 11 years ago, but I'm at 11 yrs with zero issues. I stick w/ incline presses and very little flat bench and of course, I avoid impact to the area, as you would w/ any $5-10K investment.

 

[Nightowl]

Thanks for the 411. Nice to know!

 

[ParadiseCup]

So if you get a re-boob, does that mean you start a new 10 yr warranty on desirability too?

only if you go bigger.

Go big or go home!

lol !!

 

[LAM]

my gf's Dr told her that 3 years ago after she had hers done. a lot of cosmetic surgery needs maintenance down the road, that stuff is an investment not just a one shot deal.

 

[Arnold]

another variable to add here is saline vs. silicone implants, Gena had saline the first time around, the second set she has now are silicone.

 

[Nightowl]

I was told the Saline was with complications back long ago, but the softness was what made it the winner down the road now. Silicone was to last longer and was considered harder in feel...since this post is in reference toward the time frame, can someone elaborate their experience with silicone and add any such results between the two with the matter of time?
* I heard more complications with Saline, with holes and such and with replacing necessary.

 

[Arnold]

I was told the Saline was with complications back long ago, but the softness was what made it the winner down the road now. Silicone was to last longer and was considered harder in feel...since this post is in reference toward the time frame, can someone elaborate their experience with silicone and add any such results between the two with the matter of time?
* I heard more complications with Saline, with holes and such and with replacing necessary.

silicone is the way to go IMO, saline is like a water balloon in your chest.

 

[sassy69]

another variable to add here is saline vs. silicone implants, Gena had saline the first time around, the second set she has now are silicone.

Very good point - back circa 2000, the only real option was saline, and all the way thru 2005/2006 silicone was really only by special request.

Doing a quick google on 'statistics on breast implant rupture", http://www.breastimplantinfo.org/recon/implantfacts.html posted this note which includes statistics on ruptures. It was interesting to find that statistics, at least amongst reconstruction patients (they just say statistics are lower amongst augmentation patients):

What are the known risks?

Reports of complications among women with implants have been published in medical journals and discussed at public FDA meetings. There are a number of short-term and long-term risks that any woman thinking about getting breast implants or about removing or replacing older implants needs to be aware of.

"Local complications" refer to problems that occur in the breast area that are obviously related to the breast implants or the surgery. Common complications include infection and other surgical risks, chronic breast pain, breast or nipple numbness, capsular contracture, breakage and leakage, necrosis (skin death), the need for additional surgery, and "cosmetic" problems (such as dissatisfaction with how the breast looks with the implant).

Studies of saline breast implants and silicone gel breast implants conducted by implant manufacturers have shown that within the first three years, approximately three out of four reconstruction (breast cancer) patients and almost half of first-time augmentation patients experienced at least one local complication – such as pain, infection, hardening, or the need for additional surgery.3

For example, among reconstruction patients:

46% of women with silicone gel implants and 21% with saline implants underwent at least one re-operation within three years;
25% of silicone patients and 8% of saline patients had implants removed; and
6% of silicone patients and 16% of saline patients experienced breast pain.4, 5
Complication rates were lower, but still substantial, for augmentation patients. The FDA has a consumer handbook with descriptions of common complications as well as photographs, available to consumers here.

 

[Arnold]

and as far as looking natural and feeling real, silicone wins hands down.

 

[sassy69]

and as far as looking natural and feeling real, silicone wins hands down.

Come on! Don't you like the sloshing while you're going at it? Sort of like "the motion of the ocean" sort of thing?

LOL (I"m kidding )

The weirdest part w/ saline is chest contractions for a side chest pose or doing incline press. But until I find another $8K laying around, or a sugar daddy, I'll be working w/ what I've got.