x-ray studies = response from the FDA

[Guest guest]

Note: forwarded message attached.

This is in response to your email to the Food and Drug Administration (FDA),

regarding an MRI detecting leaking silicone.

According to the Office of Device Evaluation (ODE), the office responsible

for conducting scientific reviews of medical devices and radiation products,

leaking silicone gel will definitely appear on an MRI. The

technician/radiologist needs to know that leaking gel is what is being

looked for, for example, in the axilla, to get views of distant areas and

not just the breast. Also, different T-weighting is needed to look for

migrated silicone. MRI can also detect inflammation and granuloma formation

( as well as migrated silicone) in lymph nodes which drain the breast (i.e.

axillary).

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.

Re: x-ray studies

Lana,

I'm copying your message to Mrs. Leonard at the

FDA . . . Maybe she knows the answer. I'm dumbfounded!

I don't know why they think MRI's would detect leaking silicone!

Rogene Schorer

--- Lana Transue <lanadearest@...> wrote:

> Rogene,

> I am really confussed here. If general practioners

> and surgeons know that an

> MRI won't show migrated silicone gel, then why is

> the FDA allowing the

> manufactures to use MRI's to detect silicone

> migration for their study? I

> don't get it! Call any regular doctor and or surgeon

> and they will tell you

> that the silicone particles become to minute to show

> up on an MRI once they

> migrate out of the implant site. How are we ever

> supposed to know and or

> prove what the silicone and or it's componets are

> doing to our bodies, if we

> can't even see where the silicone went? I think it

> would be a whole lot

> harder from the manufactures to say that silicone is

> safe if the right

> x-rays were used. Lana

>

>

>