IMPLATNS AND FDAhttp://www.fda.gov/bbs/topics/NEWS/2004/NE

[Guest guest]

ANOTHER GOOD ARTICLE BUT STILL NOT THE ORIGINAL, HELP PLEASE, STILL

LOOKING THROUGH ARCIVES, LOVE MICHELLE

--- In , " Dave & Patty " <fdp3@c...>

wrote:

----- Original Message -----

From: Zuckerman

ifriends@c...

Sent: Friday, January 09, 2004 7:29 PM

Subject: note re implants and the FDA

Dear Friends,

This is just a quick note to thank all of you for all your efforts.

It shouldn't be so shocking that the FDA did not approve a product

that was not proven safe, especially after hearing so many

heartrending stories of women's health disasters. But a lot of

people were very surprised.

I always knew that the truth would be powerful. But we all know that

it wasn't easy to get some people to listen.

The FDA's decision to reject Inamed's application for approval for

silicone gel breast implants is an enormous victory for those of you

who worked so hard to inform the FDA about the many women who have

been harmed by implants. It is an even bigger victory that the FDA

has developed new guidelines about the kinds of research that implant

makers need to do to prove that any breast implants, regardless of

the " filler, " are safe.

What will happen next? It is my understanding that the Inamed PMA

application for approval is now officially dead and that Mentor

acknowledged that their submission of approval for silicone gel

breast implants (made 3 weeks ago) would not satisfy the new

requirements either. I can't predict the future, but it seems

unlikely that the FDA will consider approval of any silicone gel

implants anytime this year, and even next year seems unlikely.

I think it more likely that the next application will be for

the " new, more cohesive gel implants " but any companies making them

will presumably need at least a few years to gather data before they

can be considered by the FDA.

Meanwhile, silicone gel breast implants will continue to be available

to many breast cancer patients (or women with deformities) and many

women with broken silicone gel implants. Silicone gel breast

implants should be unavailable to the vast majority of first-time

augmentation patients. If you hear that plastic surgeons are not

abiding by these restrictions, please let us know.

Yesterday, the FDA has asked the public for comments on their new

guidance for the research needed to prove that any breast implant

(whatever its made of) is safe. See

http://www.fda.gov/bbs/topics/NEWS/2004/NEW01003.html for more

information. Let's work together to provide good information to the

FDA, and to continue to educate women and doctors, so that women will

have the information they need to make the decisions that are best

for them -- whether they are considering implants, or considering

having their implants removed.

I hope that in a week or so our website will provide an analysis of

the new FDA guidance, and some samples of comments submitted to the

FDA.

Meantime, I hope you'll all feel good to know that the FDA heard your

concerns and as a result, many women will avoid the implant problems

that so many of you have experienced.

Best wishes,

Zuckerman, Ph.D.

President

National Center for Policy Research for Women & Families

1901 Pennsylvania Avenue, NW, Suite 901

Washington, DC 20006

202 223-4000

www.center4policy.org

Support CPR through the United Way or CFC #9884!

--- End forwarded message ---