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FDA allows silicone breast implants back on market
POSTED: 10:41 a.m. EST, November 20, 2006

WASHINGTON (CNN) -- The FDA is allowing silicone breast implants to be sold again, 14 years after they were removed from the market by the same agency over questions of safety.

The approved silicone implants are made by two companies, Inamed Aesthetics, now a part of Allergan, and Mentor.

The FDA says these implants are approved "for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older."

Daniel Shultz, director of the FDA's Center for Devices and Radiological Health, told reporters that younger women's breasts continue to develop through their teens and early 20s, and the agency wanted to make sure breast development was completed before women had devices implanted. (Watch FDA spokeswoman explain rationale -- 1:26)

In 1992, then-FDA Commissioner Dr. David Kessler took silicone breast implants off the market, citing concerns over their safety, including how often they ruptured in a woman's body and whether leaking silicone could lead to diseases as some women claimed.

After the ban, the implants were available only to women in clinical trials who needed them after surgery, especially after breast cancer. At that point, lawsuits over the products drove one of the manufacturers, Dow Corning, into bankruptcy.

Since then, most studies have failed to link the implants to serious or chronic diseases such as cancer and lupus, but questions remained over how often the implants rupture and what happens if the silicone enters the body.

In a meeting before an FDA advisory committee in April 2005, Inamed said its implants have a 14 percent likelihood of rupturing over a 10-year period. Mentor conducted a three-year study and said the rupture rate at that point was negligible.

To help answer questions on long-term safety, the FDA is requiring Inamed and Mentor each to study 40,000 women for 10 years to assess potential health problems.

The consumer advocacy group Public Citizen, which has long opposed silicone implants, criticized the decision and called it "a terrible reminder of the double standard for women versus men" and noted that the FDA has not approved silicone gel testicular implants because of inadequate testing.

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i have silicone implants. i got them almost two years ago; since i had already had had breast surgery (a lift--three kids, you know), i qualified for silicone rather than having to get saline. i like them alot (duh), but what did kinda suck is that one of the implants exploded when the surgeon was putting it in. silicone implants are already "filled" when they are inserted, rather than saline implants, which can be inserted empty then filled up. since it takes alot of "wrestling" to fit a 425cc implant [as mine are ] into a relatively small incision, they tend to rupture more easily during the surgery. so the guy had to dig out all the silicone, and the additional "manhandling" left me completely black and blue from neck to knees for months. plus, i'll probably die from some horrible disease from whatever silicone got left in there. but who cares? at least i'll die with nice tits.

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Jeff, we have another new series over here!

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i have silicone implants. i got them almost two years ago; since i had already had had breast surgery (a lift--three kids, you know), i qualified for silicone rather than having to get saline. i like them alot (duh), but what did kinda suck is that one of the implants exploded when the surgeon was putting it in. silicone implants are already "filled" when they are inserted, rather than saline implants, which can be inserted empty then filled up. since it takes alot of "wrestling" to fit a 425cc implant [as mine are ] into a relatively small incision, they tend to rupture more easily during the surgery. so the guy had to dig out all the silicone, and the additional "manhandling" left me completely black and blue from neck to knees for months. plus, i'll probably die from some horrible disease from whatever silicone got left in there. but who cares? at least i'll die with nice tits.

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Jeff, we have another new series over here!

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Exploding Titties!!

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Good to know, but will they also approve string implants?

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if i remember correctly from back in my lurking days, christianxxx is a fan of chix with string implants. personally, i find it rather disturbing, but then again i actually paid money to have someone stuff me like a turkey with a known disease- causing agent, so what the fuck do i know?

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... at least i'll die with nice tits.

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... at least i'll die with nice tits.

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And as a bonus, you're tits will live on for all eternity, unchanged, like twin monuments!

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Even with saline implants, the bag is made of silicone. They should've had silicone implants back on the market years ago just like Canada.

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I prefer the saline over-the-muscle kind of implant. As long as girls have something nice, I'm happy to allow them another choice.

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i've been told that over the muscle looks great for a short while, then tends to sag more quickly than an under=the-muscle job. they heal more quickly, ergo strippers often get this type of implant i.e., less time off work, etc. but, to each her own. and nice titties are nice titties, of course!

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Wow loopnode! Well at first I thought that they were to large however they are so beautiful! Well I would like to know what breasts feel like! Well maybe I like big breasts because my real mother is large and I am used to it.

Furthermore I would like to say that when I was a little bit sober before that GONZOGIRL reminded me of THREESOMEBOD0Y and especially about CHRISTIAN. Well christian is nice however well nevermind.

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i've been told that over the muscle looks great for a short while, then tends to sag more quickly than an under=the-muscle job.

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i've been told that over the muscle looks great for a short while, then tends to sag more quickly than an under=the-muscle job.

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They should have some sag on them, don't you think? Appearances will vary based on several factors, but a good boob job can become great when they sag down and look like a mature, natural rack. My opinion of course, I am a breast man through and through.

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