Re: Another cancer patient suffers from breast implants!

[Guest guest]

Mrs. Leonard,

The last thing a woman sick from breast implants wants

is a hostile surgeon . . . or a surgeon who is afraid

of their patient.

This is truly a no-win proposition for implanted

women. There are only a handful of plastic surgeons in

the country who can be counted on to remove implants

properly.

Women are borrowing money and traveling across the

country to find good surgeons! Even then, sometimes

they promise to remove their implants properly, then

don't.

Most plastic surgeons tell women that having their

implants removed won't improve their health . . . Then

proceed to botch the surgery. We've found that

virtually all women do get well IF their implants are

removed " en bloc " to ensure that the contents of the

implants are not spilled into the chest cavity and no

contaminated tissue remains behind. This applies to

both saline and gel implants.

Sincerely,

Rogene

--- " Leonard, M. " <NML@...> wrote:

> This is in response to your email to the Food and

> Drug Administration (FDA),

> regarding physicians.

>

> Physicians are under the jurisdiction of the state

> and if there is a

> complaint about a physician, it should be made to

> their State Medical

> Bureau. FDA has no jurisdiction over physicians and

> what they say to

> patients.

>

> 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.

>

>

>

>

>

>

> Another cancer patient suffers from breast

> implants!

>

>

> Ms. Leonard,

>

> Why is it that plastic surgeons who recommend women

> get implants turn their backs on them when they get

> sick from them?

>

> How does this figure into the improved self-esteem

> they claim cancer patients gain from implants?

>

> Sincerely,

>

> Rogene

>

>

>

>

> >

> > hi...i was reading the advice about having a PS

> with

> > skill and the

> > caring to do an explant correctly...and i need to

> > tell the story of

> > what is going on with me, and ask, again, if

> anyone

> > has specific

> > information, or can direct me.....my PCP finally

> > agress, since i have

> > neuropathy and pain 24/7, which is increasing,

> that

> > yes, the implants

> > from my reconstruction, not augmentation, should

> > come out....i have

> > called 25 PSs listed on my aetna plan.....half no

> > longer take

> > insurance, one quarter won't see me as they don't

> do

> > explants, and

> > the from others, i have not received return

> > calls.....given this

> > reality, i am just totally

> discouraged....yesterday,

> > i asked the PA @

> > my PCPs office to make calls, hoping that one

> doctor

> > will respond to

> > another perhaps...........i get confused about the

> > specifics you all

> > talk about, if i should ever find a PS to do this

> > surgery.....there

> > was NO flesh left after the mastectomy....from

> what

> > i can determine,

> > the implants are being held up by almost nothing,

> as

> > i am extremely

> > thin...they are migrating, which is why i believe

> my

> > symtoms are

> > increasing....so, is there still a capsule? will

> i

> > still need

> > drains? and who can i complain to if NO doctor

> will

> > take me on as a

> > patient? my insurance is supposed to cover this,

> as

> > it is cancer

> > related....at least, that is the opinion of my

> PCP,

> > and most of the

> > individuals at Aetna.......i am really

> > depressed....even using the

> > mouse/keyboard this long to write this post has

> set

> > off even more

> > numbness and tingling....and i can no longer wash

> my

> > own

> > hair...raising my arms at all also increases all

> my

> > pain...and the

> > one implant feels as though it is under my arm, in

> > the way when i

> > drive, and i swear it is swollen.....although my

> > doctor's office is

> > helping, i also feel that they treat me like i am

> > still slightly

> > nuts, and imagining all this........thanks for

> > anyone who read this

> > far......i need so much to have someone listen...i

> > have isolated the

> > last couple of years, as my health has

> > deteriorated......thanks again

> >

>

>

[Guest guest]

you know, this lady has a knack for missing the point.....how can i

complain about one physician, when NONE will take my case? her

answer to your excellent letter is ridiculas....thanks for your

continuing efforts to make someone at the FDA listen! i just spoke

with my PCP...they are having no luck finding a PS to do the explants

as of yet........

blessings,

kathie

>

> > This is in response to your email to the Food and

> > Drug Administration (FDA),

> > regarding physicians.

> >

> > Physicians are under the jurisdiction of the state

> > and if there is a

> > complaint about a physician, it should be made to

> > their State Medical

> > Bureau. FDA has no jurisdiction over physicians and

> > what they say to

> > patients.

> >

> > 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.

> >

> >

> >

> >

> >

> >

> > Another cancer patient suffers from breast

> > implants!

> >

> >

> > Ms. Leonard,

> >

> > Why is it that plastic surgeons who recommend women

> > get implants turn their backs on them when they get

> > sick from them?

> >

> > How does this figure into the improved self-esteem

> > they claim cancer patients gain from implants?

> >

> > Sincerely,

> >

> > Rogene

> >

> >

> >

> >

> > >

> > > hi...i was reading the advice about having a PS

> > with

> > > skill and the

> > > caring to do an explant correctly...and i need to

> > > tell the story of

> > > what is going on with me, and ask, again, if

> > anyone

> > > has specific

> > > information, or can direct me.....my PCP finally

> > > agress, since i have

> > > neuropathy and pain 24/7, which is increasing,

> > that

> > > yes, the implants

> > > from my reconstruction, not augmentation, should

> > > come out....i have

> > > called 25 PSs listed on my aetna plan.....half no

> > > longer take

> > > insurance, one quarter won't see me as they don't

> > do

> > > explants, and

> > > the from others, i have not received return

> > > calls.....given this

> > > reality, i am just totally

> > discouraged....yesterday,

> > > i asked the PA @

> > > my PCPs office to make calls, hoping that one

> > doctor

> > > will respond to

> > > another perhaps...........i get confused about the

> > > specifics you all

> > > talk about, if i should ever find a PS to do this

> > > surgery.....there

> > > was NO flesh left after the mastectomy....from

> > what

> > > i can determine,

> > > the implants are being held up by almost nothing,

> > as

> > > i am extremely

> > > thin...they are migrating, which is why i believe

> > my

> > > symtoms are

> > > increasing....so, is there still a capsule? will

> > i

> > > still need

> > > drains? and who can i complain to if NO doctor

> > will

> > > take me on as a

> > > patient? my insurance is supposed to cover this,

> > as

> > > it is cancer

> > > related....at least, that is the opinion of my

> > PCP,

> > > and most of the

> > > individuals at Aetna.......i am really

> > > depressed....even using the

> > > mouse/keyboard this long to write this post has

> > set

> > > off even more

> > > numbness and tingling....and i can no longer wash

> > my

> > > own

> > > hair...raising my arms at all also increases all

> > my

> > > pain...and the

> > > one implant feels as though it is under my arm, in

> > > the way when i

> > > drive, and i swear it is swollen.....although my

> > > doctor's office is

> > > helping, i also feel that they treat me like i am

> > > still slightly

> > > nuts, and imagining all this........thanks for

> > > anyone who read this

> > > far......i need so much to have someone listen...i

> > > have isolated the

> > > last couple of years, as my health has

> > > deteriorated......thanks again

> > >

> >

> >

>