Fw: Patti Z on: Important PR Memo on Breast Implants from 1991

[Guest guest]

From: " Patti Zahn (by way of ilena rose) " <pattiz1122@...>

Sent: Tuesday, March 20, 2001 6:18 PM

Subject: Patti Z on: Important PR Memo on Breast Implants from 1991

> Hi all,

> Since I don't have a PR Firm to represent me, I'm certain that this will

> never reach ears that need to hear it.

> In March,1990 I was hospitalized with a red a swollen (l) breast. I

> thought I had ruputured it because I had hit my left breast on the car

> door getting into the car, however,the doctor on call for my PS that night

> suggested that I be admitted to the hospital because my fever was almost

> 103 and rising therefore she was inclined to believe that I had an

> infection. That was an understatement.

>

> As it turned out several months later, after removing the implant,

> draining fluid many times and IV antibiotics for six months, the

infectious

> disease doctor (Dr. Ellie Goldstein, Santa , CA), found out that I

> had an " infection called Mycobacterium Avium Intracellulare in the left

> breast.

>

> I was told at the time that this infection was once found in the lungs of

> " miners " 40-50 years ago, however, now, it was being seen in AIDS

> patients. This bacteria is a TB bacteria and is found in silica, gee I

> wonder how I got it.

>

> I was put on a drug study with Abbott Laboratories so that I could be put

> on Clarythromyacin (not sure on the spelling), a new drug at the time

being

> used in AIDS patients with the same TB bacteria. My infectious also

> published a paper, I believe the title was " Mycobacterium Avium

> Intracellulare " found in breast of " Immune Competent Woman " .

>

> (Patti ... found this so far ... ilena)

>

> ~~~~~~~~~~~~~~~~~~~~~

>

>

> http://www.sma.org/smj1999/jansmj99/

> Mycobacterium avium Infection in a Patient With the Acquired

> Immunodeficiency Syndrome and Silicone Breast Implants

>

> Dina A. Eliopoulos and Glenn Lyle

>

> ABSTRACT: We describe a case of Mycobacterium avium-intracellulare

> infection in a silicone augmented breast of a female patient with the

> acquired immunodeficiency syndrome and disseminated Mycobacterium avium

> complex. Explantation and treatment with appropriate antibiotics led to

> resolution of the breast infection.

>

> ~~~~~~~~~~~~~~~~~~~~~

>

> The article went on to say that the same infection had been seen twice

> before in Asian women who subsequently died from it and had been injected

> with silicone back in the 60's or 70's.

>

> So, where is the junk science to this??

>

> Is this just a coincidence?

>

> I think not, those B-----ds.

>

> Silicone has never been innocious!!!

>

> Any way maybe Mr. Moyer will get this info before he does his show.

>

> I know the article written by Ellie Goldstein, MD and (Harvey Zarem, MD

my

> plastic surgeon} was mentioned in the article.

>

> I believe the article was published in the Plastic Surgury Journal

> sometime in 1991 if my memory serves me correctly. It' makes for some

very

> interesting reading, go ahead and look it up under Dr. Goldstein's name.

> Every time I read this sh-- it absolutely drives me to distraction, I

just

> thank G-d for saving my life those multiple times that I almost died and

> for giving me the strenghth to heal my heart and move on. Please forward

> this to whoever might want to read it. Love,

> Patti Z

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

>

> They were saying the same thing then ... as they say now ... look at this

> quote from 1991 ... what " science " did they have to base it on ? Wishful

> thinking. They funded the two " infamous " junk studies that NEJM's Marcia

> Angell publishd ... and voila ... same results ...

>

> Note too their remark about the 800#. I'll dig up what happened when they

> were shut down for lying outright to the callers! This all fits in with

the

> Bill Moyers PBS Special next Monday (3/26/01) on this topic ... the buying

> of junk $cience ...

>

> written in 1991

>

> QUOTE:

> " However, the incidence in women with implants is no greater

> than the accepted rate in the general population. "

>

> (based on ??????)

> @-->-->-- @-->-->-- @-->-->-- @-->-->--

>

>

> Burson Marsteller

> One East Wacker Drive .na Hart s

> Chicago Illinois 60601 1854 Senior Vice President

> 312 329 9292

>

> September 9, 1991

>

> MARTY GOLD/HOWARD LIEBENGOOD

> GOLD AND LIEBENGOOD

>

> RE: Tuesday's Meeting

>

> The people who will be coming with me to Tuesday morning's

> 9:30 meeting at your offices are:

>

> O Dr. Norman Cole, Louisville

> incoming president of American Society of

> Plastic & Reconstructive Surgeons (ASPRS)

>

> O Dr. Garry Brody, Los Angeles secretary, ASPRS

>

> O Dave Fellers, Chicago Executive Director, ASPRS (on

> the job for a week was with him in Santa Fe and believe he's

> pleased with what we have to offer despite staff fears of a

> " big pr firm taking over " )

>

> O Kent, Washington

> Kent & O'Connor (ASPRS lobbying firm)

>

> O Morrie Newell, B-M Chicago

>

> O Jeff Dixon, B-M Chicago

>

> Morrie, Jeff and I did the Heartguide program which involved

> somewhat similar behind the scenes work on behalf of a

> client. The difference here is that Burson will stay behind

> the scenes too, and the ASPRS docs and their patients will

> be the visible participants.

>

> ASPRS is not our client, Dow corning and Dow Corning ,

> its subsidiary that makes breast implants, are. Morrie, Jeff

> and I have been working with them for several months. They

> will support ASPRS in the efforts we'll be discussing

> tomorrow. However, that knowledge, the meeting, and our

> working with ASPRS, and particularly the knowledge we have

> of Weiss's pressure on Kessler, need to be kept

> confidential.

>

> If you remember, I was not going to put this in writing,

> but wanted you both to be up to speed and there's too much

> information for you have to listen to it all verbally. With

> the FDA'S new penchant for walking into ad agencies and

> demanding to look at documents, I hope you'll give this a

> toss once you've read it.

>

> What follows is more than you ever wanted to know about

> breast implants and the issues DC/DCW face. Plese give me a

> call if you'd like to discuss this once you've had time to

> read it. I leave for the airport about 4:15, Eastern time.

> If we miss each other, I'll be at the Park Hyatt tonight.

>

> Situation: Breast implants and other medical devices have

> long been grand fathered in by the FDA and have not gone

> through the usual FDA approval process. In late November

> 1990 implant manufacturers (in an expected move) were told

> to submit research on breast implants.

>

> On December 10, 1990 the Connie Chung show aired with horror

> stories about women who had become ill because of their

> breast implants. The most common illnesses indicated were

> connective tissue diseases/illnesses of the immune system

> such as scleroderma, lupus, arthritis, joint pain and

> fatigue, among others. There were also rumors of implants

> causing cancer. The horror stories were compelling and other

> media jumped on the bandwagon. Since that time there have

> been almost 2,000 stories, 74% of them negative.

>

> Research (USC study of 3000 women over 11 years) indicates

> that there is no greater incidence of breast cancer in women

> with implants than in those who do not have them. Connective

> tissue diseases are not so easy to quantify. There are no

> clear records of the incidence of connective tissue disease.

> However, the incidence in women with implants is no greater

> than the accepted rate in the general population.

>

> No one really knows why the women who have problems have

> them. It may be just two major events in a woman's life,

> implants and disease, with no connection, as is true with

> many things. It may be that hearing the horror stories, and

> being egged on by people like Sid Wolfe, the plaintiff's bar

> (two major players on this issue are Dan Bolton and

> Dunleavy,) and others, some women are blaming unrelated

> problems on implants.

>

> It may be that there are women with an allergic reaction to

> the silicone gel that in minute particles leaks out of the

> implants. This is unlikely because silicone in other forms

> is so pervasive in our lives. It's in Digel, on the tips of

> iv needles, in the coating of capsules and in beer as an

> antifoaming agent. It's also used to make a number of

> artificial joints and tubes for implantation.

>

> DC's main product is silicone, hence the need to protect it.

> They could walk away from manufacturing implants tomorrow

> and save money because of the dollars spent on research and

> lawsuits. They're good people, sincerely concerned about

> women with problems, and concerned too about their company's

> reputation.

>

> On July 9, along with other breast implant manufacturers

> DC/DCW submitted its PMA (premarket approval) as required to

> the FDA. At that time DC also made public thirty years of

> proprietary research (see lead release attached.)

>

> August 22 FDA sent DC/DCW a form letter, sent also to the

> other manufacturers who were not turned down, indicating

> fileability of -their submission. Fileability letter from

> FDA stated that further information would be required and

> that by September 13, FDA would indicate to manufacturers

> what the information would be.

>

> o Advisory panel hearing will be in November further

> information from manufacturers due by then.

>

> o January 8, 1992 FDA final decision.

>

> Issue:

>

> We now believe that Kessler plans to take implants off the

> market entirely. The one exception may be for use in

> reconstruction after breast cancer. (Evidently FDA had

> planned to disallow all PMA's thereby effectively taking

> implants off the market in August. However, doing it in that

> way would take longer than going through the current

> process.) We believe the pressure is coming from Congressman

> Ted Weiss, who along with Sid Wolfe, have stated openly

> their desire to have implants banned.

>

> It is believed that we have the window between now and an

> unknown date in November when the advisory panel hearings

> will be held to influence this decision. While we have

> programs in place to help change misperceptions caused by

> current negative media coverage, they are longer term. This

> new information requires immediate activity to inform

> Kessler of the opposition to his proposed move and to

> influence him to leave implants on the market.

>

> If our information is faulty, the need still exists to

> create as soon as possible an atmosphere that makes it more

> comfortable for the FDA to approve implants and less

> comfortable for them not to approve.

>

> What DC/DCW/BM have done:

>

> o made safety and efficacy data public through public

> release of 30 years of proprietary research.

>

> o established Implant Information Center 800#.(These two

> steps resulted in the only positive media coverage to date.)

>

> o launched two major studies

>

> NYU to study any causal relationship between breast

> cancer/implants

>

> University of Michigan to study any causal relationship

> between connective tissue diseases such as scleroderma and

> implants

>

> o private meetings with influential plastic surgeons to

> discuss the issue and what they might do.

>

> o Dan , CEO, DCW, spoke at 8/31 meeting of 350 breast

> implant surgeons in Santa Fe informing them of FDA stance

> and the need for action. Handouts on " what to do " were given

> out.

>

>

> Current DC/DCW/ASPRS/BM programs:

>

> o patient grassroots program

>

> beginning stages of qualifying spokeswomen

>

> spokeswomen to write letters to FDA/Congress, letters to

> editor op-ed pieces, speak to local groups

>

> will probably not be up and running in time to have enough

> influence for November deadline

>

> DCW patient relations person in place Joy Murray

>

> o surgeon grassroots program

>

> 36 surgeons to be trained as spokespersons September 21 at

> ASPRS annual meeting in Seattle

>

> Dr. Norman Cole to give " Call to Action " speech at business

> meeting. We will provide handouts. Handouts to include

> addresses of key legislators, regulators, active reporters,

> women's groups and bullet points for speaking/letters

>

> handouts to include response mechanism to Dave Fellers,

> Executive Director, ASPRS, so follow up letters can be sent

> to nudge those not participating and to track what's being

> done

>

> handouts to be mailed out immediately to those not present

> under Dr. Cole's cover letter

>

> later handouts to include videotape and speech for

> presentations

>

>

> DCW professional relations person in place Gene Jakubczak

>

> o Dr. Cole also to speak at Seattle meeting of plastic

> surgery nurses.

>

> o Dr. Brody to speak at plastic surgery office

> administrators meeting.

>

> o ASPRS leadership attempting to set up meeting with

> Kessler.

>

> The strategy that we would like your help in carrying out is

> how to influence Kessler and Weiss through other

> Congressmen.

>

> o We are suggesting that doctors with their patients visit

> their own Congressmen and Senators along with those on the

> appropriate committees with oversight as well as

> Whitten's Appropriations Committee.

>

> o The thrust of this effort will be getting women angry

> about having the right to make their own decision about

> implants taken away from them. One approach is " How dare two

> men who are only tangentially involved, try to make this

> decision on behalf of the millions of women involved. "

>

> o We also want to place regional, and if possible, national

> media stories on the need for keeping this option open to

> women. (Focus groups and congressional testimony indicate

> that for many women with breast cancer who have had

> mastectomies, breast implants let them look in the mirror

> without being reminded of their cancer every day.) While

> these are only 15 25% of implant patients the rest are

> augmentation they engender more sympathy.

>

> Over two million women have had breast implant since they

> were developed thirty years ago, less than a hundred have

> had problems. However, those are the vocal ones. Even most

> of those, most notably Sybil Goldrich and Kathleen Annekens

> who have formed a group called Command Trust Network, don't

> say that implants should be banned. Just that doctors should

> give more information to their patients and that women

> should make a careful decision based on all the information

> available.

>

> That until now has been the FDA position too. DC/DCW are in

> complete agreement. Women who call their implant information

> center can get the package insert among other items. It

> gives every possible and potential complication. One of the

> problems is that the physicians, as is their wont to do,

> haven't wanted to bother the pretty little heads of their

> patients with all this information. The manufacturers, at

> least DC/DOW, have provided it to the docs and they haven't

> always passed it on. No point in irritating Norm or Garry

> with this. They know some of their own have dropped the ball

> in this regard. They are sincere and eager to move forward,

> evidenced by their changing surgery schedules for tomorrow's

> meeting.

>

> This is a lot of information -- thanks for taking the time

> to go over it. Look forward to seeing you tomorrow.

>

>

>