Ever wonder how this mess happened? . . . These documents give you a peek at the thinking of the plastic surgeons

[Guest guest]

Thanks for posting Pam. This document from the breast implant litigation evidentiary files,

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Burson-Marsteller One East Wacker Drive na Hart s Chicago , Illinois 60601-1854 Senior Vice President 312-329-3292

September 9, 1991

MARTY GOLD/HOWARD LIEBENGOOD GOLD AND LIEBINGOOD

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 fire taking over")

o Kent, Washington Kent & O'Connor (ASPRS lobbying firm)

o 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 Bureau 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. , 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.

BM 005140

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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. Please 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 grandfathered 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.

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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 (pre-market 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 file ability of -their submission. File ability 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.

· Advisory panel hearing will be in November - further information from manufacturers due by then.

· January 6, 1992 - FDA final decision.

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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 end 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

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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 nailed out imediately to those not present under Dr. Cole's cover letter

--later handouts to include videotape and speech for presentations

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-6- -DCW professional relations person in place - Gene Jakubcsak o Dr. Cole also to speak at Seattle meeting of plastic surgery nurses.

o Dr. Brody to speak at plastic surgery office administrators nesting.

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 well 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.

BM 005145

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/DCW, 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. BM 005146