11-07-2010, 12:41
Regarding silicon breast implants
May 22 2007 at 11:57 AM Tiffany (no login)
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Women who are excited that silicon implants are back on the market be warned. A former employee of implant manufacturer Mentor claims he was part of a group asked to fix leaky silicone breast implants that were up for review at the FDA, stirring up more questions about the already-controversial falsies.
First, some history. In 1992 the FDA placed an indefinite moratorium on the silicon implants, citing a lack of long-term safety data about oily discharge that oozed into women’s bloodstreams. For years, most women were left with saline — silicone’s safer, but less realistic, counterpart.
More than a decade later, two corporations (Mentor and Inamed) came back to the FDA, making their case that thanks to technological advances, implant-leakage is now both minor and benign. T FDA believed them and issued approvals to both manufacturers.
But around the time the approvals were confirmed, the former Mentor employee wrote to the FDA, asserting that he was told to create a "low-bleed patch" for "sizers" — the implant models women wear externally as try-outs. The patch would stem that worrisome oily leakage, which one assumes is not a big Mentor selling point. Trouble is, if the company believed it needed patches for sizers, wouldn’t it be safe to assume that patches might also be needed for the real things, when implanted in the body?
These recent allegations beg the questions constantly raised by women’s-health activists such as Diana Zuckerman, president of the Washington, DC–based Center for Women and Families, who has spent years researching and testifying against silicon breast implants. She asks: "If this patch is bleeding silicon, how much silicon is it, and how much is that going to amount to over several years? And most importantly, how is that going to affect women’s health?"
In a statement — released after questioning the former employee’s character, and accusing him of stealing from the company — the corporation claims that "the sizers are not the same as Mentor implants, and are not for implant purposes."
Apparently, this isn’t enough to warrant additional FDA investigation. An agency spokesman wrote in an e-mail that "we believe we have received adequate data to support the approvals."
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Black Sheep
(no login) Re: Regarding silicon breast implants July 4 2007, 5:10 AM
Not to be picky, but it's 'silicone'. Silicon and silicone are two different substances.
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Jennelle
(Login Jenneelle)
EVE MEMBERS Re: Regarding silicon breast implants September 11 2007, 10:45 AM
That's true, but it's not a big difference. Silicon is a chemical element, silicones are plastics and other materials made from silicon.
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Black Sheep
(no login) Re: Regarding silicon breast implants October 25 2007, 11:16 AM
I thought all breast implants had to be saline now, which is just a salt solution isn't it?
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Woolly Sheep
(no login) Re: Regarding silicon breast implants October 25 2007, 6:21 PM
You are way out of date. Silicone breast implants have been allowed again for more than a year.
May 22 2007 at 11:57 AM Tiffany (no login)
--------------------------------------------------------------------------------
Women who are excited that silicon implants are back on the market be warned. A former employee of implant manufacturer Mentor claims he was part of a group asked to fix leaky silicone breast implants that were up for review at the FDA, stirring up more questions about the already-controversial falsies.
First, some history. In 1992 the FDA placed an indefinite moratorium on the silicon implants, citing a lack of long-term safety data about oily discharge that oozed into women’s bloodstreams. For years, most women were left with saline — silicone’s safer, but less realistic, counterpart.
More than a decade later, two corporations (Mentor and Inamed) came back to the FDA, making their case that thanks to technological advances, implant-leakage is now both minor and benign. T FDA believed them and issued approvals to both manufacturers.
But around the time the approvals were confirmed, the former Mentor employee wrote to the FDA, asserting that he was told to create a "low-bleed patch" for "sizers" — the implant models women wear externally as try-outs. The patch would stem that worrisome oily leakage, which one assumes is not a big Mentor selling point. Trouble is, if the company believed it needed patches for sizers, wouldn’t it be safe to assume that patches might also be needed for the real things, when implanted in the body?
These recent allegations beg the questions constantly raised by women’s-health activists such as Diana Zuckerman, president of the Washington, DC–based Center for Women and Families, who has spent years researching and testifying against silicon breast implants. She asks: "If this patch is bleeding silicon, how much silicon is it, and how much is that going to amount to over several years? And most importantly, how is that going to affect women’s health?"
In a statement — released after questioning the former employee’s character, and accusing him of stealing from the company — the corporation claims that "the sizers are not the same as Mentor implants, and are not for implant purposes."
Apparently, this isn’t enough to warrant additional FDA investigation. An agency spokesman wrote in an e-mail that "we believe we have received adequate data to support the approvals."
Edit Message Delete Message Lock Thread Respond to this message
Author Reply
Black Sheep
(no login) Re: Regarding silicon breast implants July 4 2007, 5:10 AM
Not to be picky, but it's 'silicone'. Silicon and silicone are two different substances.
Edit Message Delete Message
Jennelle
(Login Jenneelle)
EVE MEMBERS Re: Regarding silicon breast implants September 11 2007, 10:45 AM
That's true, but it's not a big difference. Silicon is a chemical element, silicones are plastics and other materials made from silicon.
Edit Message Delete Message
Black Sheep
(no login) Re: Regarding silicon breast implants October 25 2007, 11:16 AM
I thought all breast implants had to be saline now, which is just a salt solution isn't it?
Edit Message Delete Message
Woolly Sheep
(no login) Re: Regarding silicon breast implants October 25 2007, 6:21 PM
You are way out of date. Silicone breast implants have been allowed again for more than a year.