Re: CNN: Silicone breast implants may soon be back

[Guest guest]

It's awful to say this, but it seems inevitable for Silicone to come back (and Salines will stay legal), so we have to find a bright side.

While God knows I'd hate to see anyone get sick, it is equally inevitable that more women WILL... So maybe at least the good will be that they will be able to identify the symptoms sooner (thanks to our lovely founders of boards like this, and many women who suffer before them), and hopefully more treatment centers will open up with more affordable explant and detoxing.

What a blow...

[Guest guest]

Brigite . . . and everyone else . . . It was a financial firm that released this info . .. IMHO, hoping to profit on a rise in stocks. . . The manufacturer's and plastic surgeons are always making these press releases too. . . Just trying to get their names in the news and drum up more business! Don't count on implants being back on the market until the FDA actually approves them! . . . We've still got a lot of fight left in us! Rogene KissofSadness@... wrote: It's awful to say this, but it seems inevitable for Silicone to come back (and Salines will stay legal), so we have to find a bright side. While God knows I'd hate to see anyone get sick, it is equally inevitable that more women WILL... So maybe at least the good will be that they will be able to identify the symptoms sooner (thanks to our lovely founders of boards like this, and many women who suffer before them), and hopefully more treatment centers will open up with more affordable explant and detoxing. What a blow...

[Guest guest]

I've been thinking about printing up some business cards...they are free on www.Vistaprint.com (go to free business cards link, and you will just pay for shipping), and using these to hand out to anyone I think is in need of the contact info for the group, or just to tack up on corkboards that are around town. Is anyone else interested in doing this too? I don't want to necessarily include phone numbers for local contact, although that is certainly an option, but my main thrust is to get women to come and look around for information regarding the dangers associated with implants on the Internet. If we can get business cards printed up and shared in communities all over this country, maybe we can get the word out even better. We have got to be prepared to do something....if silicone gel get approved and they come back on the market in droves, then

more and more women are going to be getting sick and doctors are going to be even more embedded into the cement of "Implant safety" and telling them it's not the implants. We can't stay silent, but rather, we will need to become even more vocal. We are going to have to shout loudly, not just shout. I took a look the other day at what was offered on vistaprint for free, and thought the blue spider web one was good (that is symbolic, I thought!) I'll probably fill out the lines like this: Breast Implants? (Company name) Are they safe? (Message) Find out more (Full name) At our informative website! (Job Title) We are women like you (Address line 1) who will share our experiences, (line 2) answer your

questions, (line 3) help you through any difficulties, (phone/other) Give you answers you won't find anywhere else (Fax/other) / (Web/other) Any other ideas anyone? Is there anyone who will join me in this effort? I could even order a whole bunch of them and send them out to whoever is interested in sharing them in your community. Let me know. PattyIlena Rose <colibrimama@...> wrote: Note from Ilena: I can hear the BI Industry licking their chops in anticipation. Interesting note ... at the bottom of this article was a link to "doubts" the industry put on the platinum issue ... but nothing about the almost useless 'studies' done by the manufacturers which only included a small percentage of the women they were supposted to be studying. Here's that link ... http://www.nj.com/printer/printer.ssf?/base/news-8/11554444054100.xml & coll=1 Mentor was faulted by members of an FDA advisory panel and healthgroups last year for losing track of patients enrolled between 1992and 2002 in its Adjunct Study, with the company able to follow up on only about 19 percent of the women three years after surgery, and about 11 percent at five years. ~~~~~~~~~~~~~~~ http://money.cnn.com/2006/08/16/news/companies/silicone/ Silicone breast implants may soon be back Allergan and Mentor are both poised to profit if the FDA does lift its 14-year ban. By , CNNMoney.com staff writer August 16 2006: 2:51 PM EDT NEW YORK (CNNMoney.com) -- For the first time since 1992 - the year Bill Clinton was elected, Gotti was convicted, and Los Angeles spiraled into riots - silicone breast implants may once again be available in America. Allergan (up $1.42 to $113.27, Charts ), which owns breast implant maker Inamed, and rival implant maker Mentor Corp., ( Charts ) are both trying to get silicone implants back on the U.S. market. They've each filed applications with the Food and Drug Administration for new, improved implants, and now they're waiting to see if the agency will lift its 14-year silicone ban. There seems to be little doubt that the FDA will ultimately approve the silicone-filled implants, which could double the $350 million U.S. market for implants, currently dominated by saline. The question is exactly when, and how. The FDA banned silicone implants for most women back in 1992, because of growing concerns about ruptured shells and leaking gel. Since that time, only women requiring post-mastectomy reconstructive surgery have been permitted to use silicone-filled implants in the U.S. Women who want implants for cosmetic purposes have had to be content with the less-popular saline-filled implants, or willing to jet off to the thriving silicone markets in Europe and South America. Allergan and Mentor, both based in California, currently sell silicone implants to overseas markets, but the international arena only accounts for about a quarter of the companies' implant sales. Both Allergan and Mentor received "approvable" letters last year from the FDA, a step in the regulatory process that is generally seen as a move towards final approval in the U.S. Since then, analysts and insiders have been trying to guess when the agency will make its final decision, and

there are bold signals that approval could come this year. "I think it's imminent," said Amit Hazan, analyst for Suntrust Humphrey. "The companies have been in discussions with the FDA [about] conditions for approval, and my impression is that the discussions are pretty much over, that the FDA has gotten everything it needs." Hazan said that a finding on July 31 by a U.S. Senate committee is the strongest sign yet that FDA approval could happen any day. After a 10-month investigation, the Senate Health, Education, Labor and Pensions Committee cleared the FDA's recent review of the new applications for silicone implants from both Allergan and Mentor. This finding clears the way for the FDA to makes it decision. "To me, that means the Senate has given a green light to the FDA to approve the product," said Hazan. Approval this year? Spokespersons for Allergan and Mentor declined to discuss with CNNMoney.com their dealings with the FDA, or to provide any sales estimates. But Gal, analyst for Sanford C. Bernstein, said that Allergan and Mentor have both included revenue from silicone implants in their earnings estimates for 2006, a sign that the companies are confident they'll have the products on the U.S. market within months. "Both companies are guiding that they will get approval before the end of the year," said Gal.

He estimates that Mentor and Allergan will each total about $200 million in silicone implant sales in 2007, in addition to $140 million each in saline sales. Approval would most likely result in a stock price spike for both companies, analysts say, with the biggest bump going to Mentor, since its business is more heavily dependent on implants than Allergan, which also sells wrinkle remover Botox and is developing the dermal filler Juvederm . Also, Mentor has submitted a more advanced type of breast implant with the FDA, called Style 410 and nicknamed "Gummy Bear." Style 410 is comprised of numerous gel pieces that are clustered together like the rubbery candies, and its approval could result in more sales for Mentor and make the company more competitive. Gal said that Mentor, currently trading at about $47 per share, could see its stock price rise by $3 to $5 per share with the approval of silicone implants. In the last month, the company's price has jumped about 13 percent as investors anticipate FDA approval. "With Mentor, 85 percent of their revenue is [breast implants]," said Haresco, analyst for Merriman Curhan

Ford. "That's why it matters so much to Mentor's stock that it gets approved. If it doesn't happen by the end of 2006, Mentor's stock is really going to get hurt." Even if the FDA approves the implants right away, the agency might require the companies to do expensive follow-up check-ups that could cut into profits, said Haresco. That might be the only way the FDA could justify putting silicone back on the market for the general population. Unlike other analysts, Merriman's Haresco isn't so bullish about the FDA approving silicone this year. "Everybody said it's going to happen in 2005, then everybody said it's going to happen in the first half of 2006, and now everybody's saying second half of 2006," said Haresco. "But

I doubt that they would rush this. I am not one of the voices that's saying it's going to happen any day now. It'll happen when it happens." The analysts interviewed for this story do own stock in the companies mentioned here, though Merriman Curhan Ford does make a market in Mentor. Silicone breast implant study questioned

Get your email and more, right on the new .com

[Guest guest]

Sounds good to me! . . . I'd love to post them at the junior college where I study pottery. Rogene Tricia Trish <glory2glory1401@...> wrote: I've been thinking about printing up some business cards...they are free on www.Vistaprint.com (go to free business cards link, and you will just pay for shipping), and using these to hand out to anyone I think is in need of the contact info for the group, or

just to tack up on corkboards that are around town. Is anyone else interested in doing this too? I don't want to necessarily include phone numbers for local contact, although that is certainly an option, but my main thrust is to get women to come and look around for information regarding the dangers associated with implants on the Internet. If we can get business cards printed up and shared in communities all over this country, maybe we can get the word out even better. We have got to be prepared to do something....if silicone gel get approved and they come back on the market in droves, then more and more women are going to be getting sick and doctors are going to be even more embedded into the cement of "Implant safety" and telling them it's not the implants. We can't stay silent, but rather, we will need to become even more vocal. We are going to have to shout loudly,

not just shout. I took a look the other day at what was offered on vistaprint for free, and thought the blue spider web one was good (that is symbolic, I thought!) I'll probably fill out the lines like this: Breast Implants? (Company name) Are they safe? (Message) Find out more (Full name) At our informative website! (Job Title) We are women like you (Address line 1) who will share our experiences, (line 2) answer your questions, (line 3) help you through any difficulties, (phone/other) Give you answers you won't find anywhere else (Fax/other) / (Web/other) Any other ideas anyone? Is there anyone who will join me in this effort? I could even order a whole bunch of them and send them out to whoever is interested in sharing them in your community. Let me know. PattyIlena Rose <colibrimama > wrote: Note from Ilena: I can hear the BI Industry licking their chops in anticipation. Interesting note ... at the bottom of this

article was a link to "doubts" the industry put on the platinum issue ... but nothing about the almost useless 'studies' done by the manufacturers which only included a small percentage of the women they were supposted to be studying. Here's that link ... http://www.nj.com/printer/printer.ssf?/base/news-8/11554444054100.xml & coll=1 Mentor was faulted by members of an FDA advisory panel and healthgroups last year for losing track of patients enrolled between

1992and 2002 in its Adjunct Study, with the company able to follow up on only about 19 percent of the women three years after surgery, and about 11 percent at five years. ~~~~~~~~~~~~~~~ http://money.cnn.com/2006/08/16/news/companies/silicone/ Silicone breast

implants may soon be back Allergan and Mentor are both poised to profit if the FDA does lift its 14-year ban. By , CNNMoney.com staff writer August 16 2006: 2:51 PM EDT NEW YORK (CNNMoney.com) -- For the first time since 1992 - the year Bill Clinton was elected, Gotti was convicted, and Los Angeles spiraled into riots - silicone breast implants may once again be available in America. Allergan (up $1.42 to $113.27, Charts ), which owns breast implant maker Inamed, and rival implant maker Mentor Corp., ( Charts ) are both trying to get silicone implants back on the U.S. market. They've each filed applications with the Food and Drug Administration for new, improved implants, and

now they're waiting to see if the agency will lift its 14-year silicone ban. There seems to be little doubt that the FDA will ultimately approve the silicone-filled implants, which could double the $350 million U.S. market for implants, currently dominated by saline. The question is exactly when, and how.

The FDA banned silicone implants for most women back in 1992, because of growing concerns about ruptured shells and leaking gel. Since that time, only women requiring post-mastectomy reconstructive surgery have been permitted to use silicone-filled implants in the U.S. Women who want implants for cosmetic purposes have had to be content with the less-popular saline-filled implants, or willing to jet off to the thriving silicone markets in Europe and South America. Allergan and Mentor, both based in California, currently sell silicone implants to overseas markets, but the

international arena only accounts for about a quarter of the companies' implant sales. Both Allergan and Mentor received "approvable" letters last year from the FDA, a step in the regulatory process that is generally seen as a move towards final approval in the U.S. Since then, analysts and insiders have been trying to guess when the agency will make its final decision, and there are bold signals that approval could come this year. "I think it's imminent," said Amit Hazan, analyst for Suntrust Humphrey. "The companies have been in discussions with the FDA [about] conditions for approval, and my impression is that the discussions are pretty much over, that the FDA has gotten everything it needs." Hazan said that

a finding on July 31 by a U.S. Senate committee is the strongest sign yet that FDA approval could happen any day. After a 10-month investigation, the Senate Health, Education, Labor and Pensions Committee cleared the FDA's recent review of the new applications for silicone implants from both Allergan and Mentor. This finding clears the way for the FDA to makes it decision. "To me, that means the Senate has given a green light to the FDA to approve the product," said Hazan. Approval this year? Spokespersons for Allergan and Mentor declined to discuss with CNNMoney.com their dealings with the FDA, or to provide any sales estimates. But

Gal, analyst for Sanford C. Bernstein, said that Allergan and Mentor have both included revenue from silicone implants in their earnings estimates for 2006, a sign that the companies are confident they'll have the products on the U.S. market within months. "Both companies are guiding that they will get approval before the end of the year," said Gal. He estimates that Mentor and Allergan will each total about $200 million in silicone implant sales in 2007, in addition to $140 million each in saline sales. Approval would most likely result in a stock price spike for both companies, analysts say, with the biggest bump going to Mentor, since its business is more heavily dependent on implants than Allergan, which also sells wrinkle remover Botox and is developing the dermal filler Juvederm . Also, Mentor has submitted a more advanced type of breast implant with the FDA, called Style 410 and nicknamed "Gummy Bear." Style 410 is comprised of numerous gel pieces that are clustered together like the rubbery candies, and its approval could result in more sales for Mentor and make the company more competitive. Gal said that Mentor, currently trading at about $47 per share, could see its stock price rise by $3 to $5 per share with the approval of silicone implants. In the last month, the company's price has jumped about 13 percent as investors anticipate FDA approval. "With Mentor, 85 percent of their revenue is [breast implants]," said Haresco, analyst for Merriman Curhan Ford. "That's why it matters so much to Mentor's stock that it gets approved. If it doesn't happen by the end of 2006, Mentor's stock is really going to get hurt." Even if the FDA approves the implants right away, the agency might require the companies to do expensive follow-up check-ups that could cut into profits, said Haresco. That might be the only way the FDA could justify putting silicone back on

the market for the general population. Unlike other analysts, Merriman's Haresco isn't so bullish about the FDA approving silicone this year. "Everybody said it's going to happen in 2005, then everybody said it's going to happen in the first half of 2006, and now everybody's saying second half of 2006," said Haresco. "But I doubt that they would rush this. I am not one of the voices that's saying it's going to happen any day now. It'll happen when it happens." The analysts interviewed for this story do own stock in the companies mentioned here, though Merriman Curhan Ford does make a market in Mentor. Silicone breast implant study questioned Get your email and more, right on the new .com

[Guest guest]

That's a great idea Patty ... I used to leave flyers everywhere ...

the State Capitol bathrooms, Hooters, all over the campuses in San

Diego etc. etc. etc. etc.

Frequently I'd get calls ... sometimes even years later. Women would

say they stashed the info ... I'd also hear from family members

frequently.

www.BreastImplantAwareness.org

> Note from Ilena: I can hear the BI Industry licking

their chops in anticipation.

>

> Interesting note ... at the bottom of this article was a link

to " doubts " the industry put on the platinum issue ... but nothing

about the almost useless 'studies' done by the manufacturers which

only included a small percentage of the women they were supposted to

be studying. Here's that link ...

>

> http://www.nj.com/printer/printer.ssf?/base/news-

8/11554444054100.xml & coll=1

> Mentor was faulted by members of an FDA advisory panel and health

> groups last year for losing track of patients enrolled between 1992

> and 2002 in its Adjunct Study, with the company able to follow up

on

> only about 19 percent of the women three years after surgery, and

> about 11 percent at five years.

>

>

> ~~~~~~~~~~~~~~~

>

>

> http://money.cnn.com/2006/08/16/news/companies/silicone/

> Silicone breast implants may soon be back

> Allergan and Mentor are both poised to profit if the FDA does

lift its 14-year ban.

> By , CNNMoney.com staff writer

> August 16 2006: 2:51 PM EDT

>

> NEW YORK (CNNMoney.com) -- For the first time since 1992 - the

year Bill Clinton was elected, Gotti was convicted, and Los

Angeles spiraled into riots - silicone breast implants may once

again be available in America.

> Allergan (up $1.42 to $113.27, Charts ), which owns breast

implant maker Inamed, and rival implant maker Mentor Corp., (

Charts ) are both trying to get silicone implants back on the U.S.

market. They've each filed applications with the Food and Drug

Administration for new, improved implants, and now they're waiting

to see if the agency will lift its 14-year silicone ban.

> There seems to be little doubt that the FDA will

ultimately approve the silicone-filled implants, which could double

the $350 million U.S. market for implants, currently dominated by

saline. The question is exactly when, and how.

> The FDA banned silicone implants for most women back in 1992,

because of growing concerns about ruptured shells and leaking gel.

Since that time, only women requiring post-mastectomy reconstructive

surgery have been permitted to use silicone-filled implants in the

U.S. Women who want implants for cosmetic purposes have had to be

content with the less-popular saline-filled implants, or willing to

jet off to the thriving silicone markets in Europe and South

America.

> Allergan and Mentor, both based in California, currently sell

silicone implants to overseas markets, but the international arena

only accounts for about a quarter of the companies' implant sales.

> Both Allergan and Mentor received " approvable " letters last year

from the FDA, a step in the regulatory process that is generally

seen as a move towards final approval in the U.S. Since then,

analysts and insiders have been trying to guess when the agency will

make its final decision, and there are bold signals that approval

could come this year.

> " I think it's imminent, " said Amit Hazan, analyst for Suntrust

Humphrey. " The companies have been in discussions with the

FDA [about] conditions for approval, and my impression is that the

discussions are pretty much over, that the FDA has gotten everything

it needs. "

> Hazan said that a finding on July 31 by a U.S. Senate committee

is the strongest sign yet that FDA approval could happen any day.

After a 10-month investigation, the Senate Health, Education, Labor

and Pensions Committee cleared the FDA's recent review of the new

applications for silicone implants from both Allergan and Mentor.

This finding clears the way for the FDA to makes it decision.

> " To me, that means the Senate has given a green light to the FDA

to approve the product, " said Hazan.

> Approval this year?

> Spokespersons for Allergan and Mentor declined to discuss with

CNNMoney.com their dealings with the FDA, or to provide any sales

estimates.

> But Gal, analyst for Sanford C. Bernstein, said that

Allergan and Mentor have both included revenue from silicone

implants in their earnings estimates for 2006, a sign that the

companies are confident they'll have the products on the U.S. market

within months.

> " Both companies are guiding that they will get approval before

the end of the year, " said Gal. He estimates that Mentor and

Allergan will each total about $200 million in silicone implant

sales in 2007, in addition to $140 million each in saline sales.

> Approval would most likely result in a stock price spike for

both companies, analysts say, with the biggest bump going to Mentor,

since its business is more heavily dependent on implants than

Allergan, which also sells wrinkle remover Botox and is developing

the dermal filler Juvederm .

> Also, Mentor has submitted a more advanced type of breast

implant with the FDA, called Style 410 and nicknamed " Gummy Bear. "

Style 410 is comprised of numerous gel pieces that are clustered

together like the rubbery candies, and its approval could result in

more sales for Mentor and make the company more competitive.

> Gal said that Mentor, currently trading at about $47 per share,

could see its stock price rise by $3 to $5 per share with the

approval of silicone implants. In the last month, the company's

price has jumped about 13 percent as investors anticipate FDA

approval.

> " With Mentor, 85 percent of their revenue is [breast implants], "

said Haresco, analyst for Merriman Curhan Ford. " That's why it

matters so much to Mentor's stock that it gets approved. If it

doesn't happen by the end of 2006, Mentor's stock is really going to

get hurt. "

> Even if the FDA approves the implants right away, the agency

might require the companies to do expensive follow-up check-ups that

could cut into profits, said Haresco. That might be the only way the

FDA could justify putting silicone back on the market for the

general population.

> Unlike other analysts, Merriman's Haresco isn't so bullish about

the FDA approving silicone this year.

> " Everybody said it's going to happen in 2005, then everybody

said it's going to happen in the first half of 2006, and now

everybody's saying second half of 2006, " said Haresco. " But I doubt

that they would rush this. I am not one of the voices that's saying

it's going to happen any day now. It'll happen when it happens. "

> The analysts interviewed for this story do own stock in the

companies mentioned here, though Merriman Curhan Ford does make a

market in Mentor.

> Silicone breast implant study questioned

>

>

>

>

>

>

> ---------------------------------

> Get your email and more, right on the new .com

>