Today Show!!! (breast implants - response from the FDA)

[Guest guest]

i.e. . . .The FDA is not responsible!

I wonder if NBC has any idea how many women's and

children's lives were ruined with just that single TV

program?

Sad thing is, we'll never know. But, if what we see on

the support groups is any indication, there will be

much suffering.

Rogene

Note: forwarded message attached.

FDA does not regulate what a private physician says. Physicians are under

the jurisdiction of the state. Unless you can provide us with specific

statements made by a manufacturer of breast implants that goes beyond what

FDA has cleared/approved their products for then I do not know what the FDA

can do in this situation.

The Breast Implant website is proof that we are doing our best to educate

the public about the medical issues associated with the use of breast

implants.

I hope the information that I have provided is helpful.

M. Leonard

Public Health Advisor

Consumer Staff, HFZ-210

Division of Small Manufacturers, International,

and Consumer Assistance

Office of Communication, Education and Radiation Programs

Center for Devices and Radiological Health

Phone: 1-800-638-2041 extension 141

Fax: 1-301-443-8818

This response represents to the best of my judgment how the device

should be regulated, solely based upon a review of the information you have

provided. This response is not a classification decision for your device and

does not constitute FDA clearance or approval for commercial distribution.

Unless exempt from premarket notification submission (510(k)) requirements,

the official classification for your device will appear on the final

decision letter from any premarket review. All device types classified as

exempt from the 510(k) requirements are subject to the limitations of

exemptions. Limitations of device exemptions are found in the device

classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892

(e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I

believe your device falls within a device category classified as exempt from

premarket review requirements, that it is your responsibility to ensure that

you meet the exemption criteria and your device does not exceed the

limitations of exemption. If your device exceeds the limitations of

exemption, you must submit a 510(k) and receive a letter from FDA stating

that your device may be commercially distributed in the U.S. prior to

marketing your device.

This communication is consistent with 21 CFR 10.85 (k) and

constitutes an informal communication that represents my best judgment at

this time but does not constitute an advisory opinion, does not necessarily

represent the formal position of FDA, and does not bind or otherwise

obligate or commit the agency to the views expressed.

Today Show!!!

>

> Welp another crapy news report on breast implants.

> Just got done

> watching it. asked briefly at the end about

> health risks and

> possibility of it covering cancer in mammo's. The

> doctor said there

> are NO HEALTH RISKS, yes he said that and that it is

> just as easy to

> detect cancer with implants then if you didn't have

> them. i was very

> very very disappointed in this news cast. It was

> more of a

> advertisement for implants then anything else. Both

> ladies said it was

> a confidence boost and that they are so happy with

> there implants.

> also asked when you have to replace them. The

> doc. said like

> anything else of course you have to replace them but

> most women have

> them for 20-30 yrs w/o a problem. He said unless

> they break you don't

> have to replace them. What a great way to start the

> morning...I don't

> think are voices are ever really going to be heard,

> and it is sad!

>

> Jenna

>

>

>

>