Message from Senator Blanche Lincoln

[Guest guest]

Dear Rogene:

Thank you for contacting me about the use of silicone

gel breast implants.

The Food and Drug Administration (FDA) has regulated

breast implants as medical devices since 1976. Due to

health concerns in recent years, the FDA has allowed

silicone gel implants to be used only in women who

have had mastectomies.

The use of breast implants is not without potential

hazards. In 2000, a National Cancer Institute study

reported a failure rate of 55% per implant in women

who have had implants for an average of 16 years. As

you know, on October 15, 2003, an advisory panel to

the Food and Drug Administration (FDA), voted nine to

six to allow for the moratorium to be lifted despite

the fact that data still showed long-term consequences

and complications with silicone gel implants.

In December 2003, I and several of my Senate

colleagues sent a letter to FDA Commissioner Mark

McClellan to delay a formal decision on silicone

breast implants until all relevant data was made

available and considered.

Soon after, the FDA issued a " not approvable " letter

for Inamed Corporation, a leading provider of silicone

breast implant devices. Since then, Inamed Corporation

and their competitor Mentor Corporation have filed

applications for approval with the FDA.

In April of 2005, the FDA's General and Plastic

Surgery Devices advisory panel voted against

recommending approval of Inamed Corporations's

silicone gel implants and voted to recommend approval

of Mentor Corporations silicone gel implants.

This occurred despite the fact that FDA scientists

found that both companies failed to respond

sufficiently to questions regarding the long-term

safety of their products.

I am concerned about the split decision by the FDA's

advisory panel because questions remain regarding the

safety of the implants produced by both Mentor and

Inamed. I believe the FDA's recent recommendations

appear inconsistent, despite similar findings on

safety.

For both Inamed and Mentor's devices, I have concerns

that both companies are unable to project long-term

failure rates.

You will be pleased to know that I, along with several

of my female colleges in the Senate have sent a letter

to Lester Crawford, Acting Commissioner of the FDA,

stating our concern over the safety of silicone breast

implants, specifically regarding the FDA's recent

split decision.

We are asking the FDA to note a distinction between

the use of implants for reconstruction and

augmentation.

Again, thank you for sharing your concerns. Please do

not hesitate to let me know whenever I may be of

assistance to you in the future.

Sincerely,

Blanche L. Lincoln BLL/dh

[Guest guest]

Very interesting ... thanks Rogene.

Unfortunately ... women who receive implants post mastectomy fare

even worse than augmented women ...

> Dear Rogene:

>

> Thank you for contacting me about the use of silicone

> gel breast implants.

>

> The Food and Drug Administration (FDA) has regulated

> breast implants as medical devices since 1976. Due to

> health concerns in recent years, the FDA has allowed

> silicone gel implants to be used only in women who

> have had mastectomies.

>

> The use of breast implants is not without potential

> hazards. In 2000, a National Cancer Institute study

> reported a failure rate of 55% per implant in women

> who have had implants for an average of 16 years. As

> you know, on October 15, 2003, an advisory panel to

> the Food and Drug Administration (FDA), voted nine to

> six to allow for the moratorium to be lifted despite

> the fact that data still showed long-term consequences

> and complications with silicone gel implants.

>

> In December 2003, I and several of my Senate

> colleagues sent a letter to FDA Commissioner Mark

> McClellan to delay a formal decision on silicone

> breast implants until all relevant data was made

> available and considered.

>

> Soon after, the FDA issued a " not approvable " letter

> for Inamed Corporation, a leading provider of silicone

> breast implant devices. Since then, Inamed Corporation

> and their competitor Mentor Corporation have filed

> applications for approval with the FDA.

>

> In April of 2005, the FDA's General and Plastic

> Surgery Devices advisory panel voted against

> recommending approval of Inamed Corporations's

> silicone gel implants and voted to recommend approval

> of Mentor Corporations silicone gel implants.

>

> This occurred despite the fact that FDA scientists

> found that both companies failed to respond

> sufficiently to questions regarding the long-term

> safety of their products.

>

> I am concerned about the split decision by the FDA's

> advisory panel because questions remain regarding the

> safety of the implants produced by both Mentor and

> Inamed. I believe the FDA's recent recommendations

> appear inconsistent, despite similar findings on

> safety.

>

> For both Inamed and Mentor's devices, I have concerns

> that both companies are unable to project long-term

> failure rates.

>

> You will be pleased to know that I, along with several

> of my female colleges in the Senate have sent a letter

> to Lester Crawford, Acting Commissioner of the FDA,

> stating our concern over the safety of silicone breast

> implants, specifically regarding the FDA's recent

> split decision.

>

> We are asking the FDA to note a distinction between

> the use of implants for reconstruction and

> augmentation.

>

> Again, thank you for sharing your concerns. Please do

> not hesitate to let me know whenever I may be of

> assistance to you in the future.

>

> Sincerely,

>

> Blanche L. Lincoln BLL/dh

[Guest guest]

> >Very interesting ... thanks Rogene.

> >

> >Unfortunately ... women who receive implants post mastectomy fare

> >even worse than augmented women ...

> >

> >

> >--- In , Rogene S <saxony01@y...>

wrote:

> > > Dear Rogene:

> > >

> > > Thank you for contacting me about the use of silicone

> > > gel breast implants.

> > >

> > > The Food and Drug Administration (FDA) has regulated

> > > breast implants as medical devices since 1976. Due to

> > > health concerns in recent years, the FDA has allowed

> > > silicone gel implants to be used only in women who

> > > have had mastectomies.

> > >

> > > The use of breast implants is not without potential

> > > hazards. In 2000, a National Cancer Institute study

> > > reported a failure rate of 55% per implant in women

> > > who have had implants for an average of 16 years. As

> > > you know, on October 15, 2003, an advisory panel to

> > > the Food and Drug Administration (FDA), voted nine to

> > > six to allow for the moratorium to be lifted despite

> > > the fact that data still showed long-term consequences

> > > and complications with silicone gel implants.

> > >

> > > In December 2003, I and several of my Senate

> > > colleagues sent a letter to FDA Commissioner Mark

> > > McClellan to delay a formal decision on silicone

> > > breast implants until all relevant data was made

> > > available and considered.

> > >

> > > Soon after, the FDA issued a " not approvable " letter

> > > for Inamed Corporation, a leading provider of silicone

> > > breast implant devices. Since then, Inamed Corporation

> > > and their competitor Mentor Corporation have filed

> > > applications for approval with the FDA.

> > >

> > > In April of 2005, the FDA's General and Plastic

> > > Surgery Devices advisory panel voted against

> > > recommending approval of Inamed Corporations's

> > > silicone gel implants and voted to recommend approval

> > > of Mentor Corporations silicone gel implants.

> > >

> > > This occurred despite the fact that FDA scientists

> > > found that both companies failed to respond

> > > sufficiently to questions regarding the long-term

> > > safety of their products.

> > >

> > > I am concerned about the split decision by the FDA's

> > > advisory panel because questions remain regarding the

> > > safety of the implants produced by both Mentor and

> > > Inamed. I believe the FDA's recent recommendations

> > > appear inconsistent, despite similar findings on

> > > safety.

> > >

> > > For both Inamed and Mentor's devices, I have concerns

> > > that both companies are unable to project long-term

> > > failure rates.

> > >

> > > You will be pleased to know that I, along with several

> > > of my female colleges in the Senate have sent a letter

> > > to Lester Crawford, Acting Commissioner of the FDA,

> > > stating our concern over the safety of silicone breast

> > > implants, specifically regarding the FDA's recent

> > > split decision.

> > >

> > > We are asking the FDA to note a distinction between

> > > the use of implants for reconstruction and

> > > augmentation.

> > >

> > > Again, thank you for sharing your concerns. Please do

> > > not hesitate to let me know whenever I may be of

> > > assistance to you in the future.

> > >

> > > Sincerely,

> > >

> > > Blanche L. Lincoln BLL/dh

> >

> >

> >

> >

> >

> >Opinions expressed are NOT meant to take the place of advice given

by

> >licensed health care professionals. Consult your physician or

licensed

> >health care professional before commencing any medical treatment.

> >

> > " Do not let either the medical authorities or the politicians

mislead you.

> >Find out what the facts are, and make your own decisions about how

to live

> >a happy life and how to work for a better world. " - Linus ing,

> >two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

> >

> >