Response from FDA regarding message about heart problems after implants

[Guest guest]

Mrs. Leonard . . .

Thank you for your response. . . Oh if it were only

that simple!I'm copying your response to

and SiliconeKids groups. I hope you'll be hearing from

other women.

Most plastic surgeons simply deny there is ANY

connection between symptoms women experience and their

implants. Some are extremely rude in saying so! Many

women go from doctor to doctor trying to find answers.

Usually their tests come back normal. The most popular

response from doctors appears to be that the woman

should get psychiatric help!

As long as the FDA gives their approval to saline

implants, and tacit approval for gel implants

(presumably through a study), the medical profession

will continue to be skeptical that women's health

problems that show up shortly after implants are

related to implants! . . . It appears that one reason

the suicide rate of implanted women is almost four

times that of other plastic surgery patients is the

treatment they receive from the medical professions.

Not just their plastic surgeon either!

What we need is for the women who have become sick

after implants to be studied - not dropped from

studies when they have their implants removed! . . .

We need to know WHY they are getting sick. After forty

years, there are plenty of women who would be happy to

participate in any study the FDA proposes! . . . As

long as the plastic surgeons aren't involved! We don't

trust them!

Some of the group participants have been active in

implant support for many years. . . All together we

have seen at least ten thousand women who have gotten

sick after being implants AND have gotten much better

after having them removed! We are the proof!

Sincerely,

Rogene Schorer

--- " Leonard, M. " <nancy.leonard@...>

wrote:

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

> Drug Administration (FDA),

> regarding heart problems after implants.

>

> A woman should be going back to her physician and

> reporting any problems

> with her breast implants. That physician should be

> following up on it.

> While FDA has some jurisdiction on clinical studies,

> there is limited

> purview over patient care for patients with approved

> devices.

>

> 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: Heart problems

>

> Hi Shirley,

>

> I've seen a few women reporting heart issues.

> Kristi,

> whose story was told on MTV a few years back and

> which

> can also be read in our files section, discussed her

> many symptoms that included a heart attack...and she

> was only 20! Here is part of it:

>

> " I had my implants put in May of 1996. I had no

> prior

> medical problems and was very active, no allergies

> or

> anything. Six months after I got my implants my

> blood

> pressure started suddenly dropping and I would pass

> out. Finally to the point that I was clinically dead

> for a few minutes. My cardiologist put me on meds

> which worked for awhile, but I steadily became

> worse. Eventually I was

> fainting again. Next the doctors found and ulcer, so

> I was treated for that.

> Then my vision started getting really bad and I was

> having terrible

> headaches. So my prescription was changing every few

> months. Well by 1998 I

> was having seizure like spells and diagnosed with

> epilepsy. I didn't believe

> I had epilepsy so I ended up making an appt with one

> of the best

> neurologists in the U.S. He saw no epileptic

> activity. Once again I was told

> it was my blood pressure. By this point I was seeing

> doctors all over the

> south. By the summer of 99 I could not even

> function. My hair had fallen out

> like crazy, I could not remember anything. Went from

> a 4.0 to a 2.0,

> eventually got to the point where I would not even

> recognize my parents. (I

> was back living at home by this time) So my parents

> packed me up and brought

> me to Houston to a diagnostic center.

>

> After many doctors, tons of tests and 18 tubes of

> blood.. The doctors told me that I had an autoimmune

> disease caused from silicone and that I needed to

> have

> my implants removed.

>

> I had them removed about a month later and now a

> year

> later I am fine. I have not passed out in over a

> year,

> I no longer need glasses. I graduate college

> tomorrow

> and I feel great. I left out many episodes in here

> like the heart attack. "

>

> I can also tell you that my stepdaughter, who got

> implants behind her father's and my back after

> telling

> us she would never get them, ended up in the

> hospital

> with some mysterious heart problems. They were

> trying

> to say that these were congenital heart problems

> that

> were there since birth (although never evident

> before), and lo and behold, just decided to show up

> after her implantation. It all sounds too fishy to

> me.

>

>

> So, my belief is that the implants can affect our

> hearts, either through the autoimmune process,

> (lupus

> can have a negative affect on many organs, for

> instance) inflammation issues (also bad for organs),

> or whatever it is that is making us sick without

> clear

> abnormal blood work. Looking at it from a physical

> standpoint, they are RIGHT THERE, ya know? Pretty

> darn

> close, almost too close

> for comfort....

>

> Shirley, are you having symptoms that you are

> concerned about?

>

> Let us know,

>

> Hugs,

>

> Patty

>

>

>

>

>

> Does anyone know if there is any correlation between

> breast implants and heart related problems? Shirley

>

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