Dr. 's account of 1992 FDA hearings . . . VERY intersting

[Guest guest]

Thanks to Carolyn Wolf who sent this.

One note . . . Dr. Kessler, mentioned here, spoke to

the women who attended the March on Washington, D. C.

He spoke in our support. I believe that was 1993.

============================

Dr. Henry 's Fascinating Accounting of the

February 1992 FDA Hearings Here is a bit of history

that I had never read before...

All this time, and we are still fighting to keep

these bags of poison off the market... Carolyn

FDA MEETING - FEBRUARY 1992

Early in November 1991, FDA commissioner A.

Kessler planned a meeting to announce that silicone

gel-filled breast implants would remain on the market.

Under normal conditions this would not have affected

Dr. Norman , Professor of Internal Medicine at

Hopkins Medical Center and Chairman of the FDA's

Plastic Surgery Advisory Panel. He believed that the

silicone gel implants were safe for the public. As one

of the nine voting members of the Panel, he had

decided to vote in favor of the implants. A day or so

before that announcement, however, came into

possession of some documents implicating Dow Corning

in fraudulent conduct regarding cover-up research

which described the dangers of gel implants. Later on,

discovered that these Dow Corning documents

had been court-protected since the mid-1980's; that

the FDA's legal branch had the opportunity to crack

these court orders but, for their own reasons, chose

not to do so.

wrote a letter to Kessler urging him to place

an immediate moratorium on the implants. Kessler acted

upon the letter, and on November 9, 1991, the FDA

imposed a 90 day moratorium on all sales and

manufacture of gel-filled implants. Without giving

credit to , Kessler initiated the moratorium

as if it were his own idea. In response to pressure

from the manufacturers and plastic surgeons, Kessler

called for an emergency three day meeting to be held

February 18-20, 1992 in Bethesda. Three days before

the hearing, Kessler phoned , told him he was

biased, and removed 's right to a vote. On the

day before the hearing, Kessler said to , " It

would be best if you resigned completely from the

Advisory Panel. " refused and it was at this

point when he joined the side of the consumer. I also

personally experienced the FDA's modus operandi after

having been invited to be one of the speakers at the

hearing. It was the morning before the meeting while

having breakfast at the Bethesda Marriott Hotel that I

received a call from the FDA's Executive Secretary,

Tilton. Tilton was in charge of the arrangements

for the meeting, the one who determined who would

speak and who would not. We had always had pleasant

conversations by phone whenever I had spoken to him

from my home in California. Now Tilton was on the

phone saying " Dr. , I don't know how to break

this to you but the manufacturers have put pressure on

us and we cannot allow you to speak. " Since I was

taking this call from the breakfast lounge and in the

presence of some of the others who were attending the

hearing, I suggested that he call me back a few

minutes later in my room in order to speak freely.

The call came and Tilton repeated his statement. I

said, " Wait a minute. Are you telling me that the

manufacturers put pressure on you, and you're yielding

to them? You are a government branch, an agency to

protect the consumer, in this case, the women. This is

a public meeting, nothing private, no secrets! "

Throughout my tirade, Tilton kept repeating, " Well,

you know we can't change anything now and I'm sorry I

was unable to reach you sooner. " He had sent me a fax

which I had not received since I had already left for

the east coast. The fax read, " It's urgent, call me at

home, do anything you can to reach me. " I had only

found out upon my return to California that Tilton was

trying to tell me not to come to Washington, D.C.

" Don't feel sorry, Tilton " I replied. " First of all,

if you think that after having flown out here at my

own expense and that after not having been allowed to

speak after so many years, " I'm going to accept a gag

order from the upper echelons of the manufacturers,

you are wrong! Furthermore, if I'm not allowed to

speak, I'm going to raise the biggest scene that the

Fda has ever seen. If I do speak, what are you going

to do, call the police and have me arrested? This is a

public meeting and as far as I recall, we still live

in a country of free speech. At least, that is what we

have been telling the rest of the world. " When Tilton

finally understood that in no way would I restrain

myself, he became concerned and suggested we try to

handle this a bit differently. He then proposed that I

remain in my room for another 20 minutes which would

give him time to discuss it with others. " Sure, " I

responded. " As a matter of fact, I'll stay here in the

room for one more hour and then I'm leaving with my

wife for a visit to the White House and town. "

He agreed and seemed relieved. I waited the hour.

Tilton never called me back. Because of my personal

involvement and knowledge, I was probably the one many

feared the most. It had been 18 years since I had

warned the FDA, manufacturers and plastic surgeons of

the dangers of liquid silicone had silicone gel. None

of the people attending the hearing had been involved

for that length of time. After all many had assumed

that I was living peacefully in Switzerland. Then

suddenly I reappeared out of nowhere.

This is what I suspect happened behind the scene: The

manufacturers; McGhan, Mentor, Bioplasty and Dow

Corning, after having hated each other for so many

years, were now forced to band together to save the

silicone gel-filled implant. Together they managed to

convince Kessler and Tilton not to allow me to speak

knowing that my testimony would be devastating.

The FDA was also on edge. They knew that if I were

allowed to speak, I would publicly remind them about

my repeated warnings to them between 1974 and 1981. I

was the only plastic surgeon in the country who could

say, " I told you so. I gave you paraffin tissue block

containing the pseudo-capsule of a patient with an

intact Dow Corning implant, and yet your experts

failed to perform their own histology as they were

supposed to do. " On the first day of the hearings,

plastic surgeons and FDA scientists presented their

work on various aspects of silicone implants. Much of

this was not new.

One of the speakers was Boyd Burkhart, a plastic

surgeon who described in glowing detail the benefits

of gel-filled implants. When one of the women on the

Panel asked him what type of breast implants he was

using in his practice, he had to admit that he only

used saline-filled implants. It might have been of

great interest to the public and the panel members to

know that Burkhart had been deeply involved with

Mentor. He even posed for a centerfold picture,

dignified in a surgical mask, for Mentor's 1985 report

to the stockholders. What is even more incredible is

that he as a professional was conned by Conway,

President of Mentor and Condon, Conway's go-for, into

testifying at this hearing.

Dr. Stuart Nightingale of the FDA presented a paper on

Japanese research with injected liquid silicone, an

interesting retrospective study which for the most

part, went over everyone's head. The few of us who

understood the problem first hand were not allowed to

ask a question, as no question/answer format was

offered.

The FDA's a Wilkerson presented a positive

assessment of the saline-filled implant, which I took

as the best compliment the FDA could give me. It is

unfortunate that Tilton and Kessler did not take the

time to listen to some of their own people.

The next morning was filled with euphoric testimony by

representatives of Dow Corning and Mentor, followed by

those of McGhan and Bioplasty. They all expressed

interest in conducting research which they had covered

up in the past, claiming grave concern about the

health of the women using their products. Every

speaker promised to spend a fortune on future

research, no matter what the cost.

Why hadn't they done diligent research back in 1978

after having heard my warnings? Well, the truth is

they did do research but alas, they did not like what

research was proving. So, they simply covered up the

results.

In an indirect allusion to Dan Bolton's successful

lawsuit against Dow Corning alleging fraud, the

corporation's CEO, McKennon, announced: " Dow

Corning will not use the court orders to protect their

material but will offer it to the FDA. If it becomes

necessary to publish any of the protected material,

Dow Corning will do so. " Upon hearing this statement,

Kessler seemed to be moved. He took the microphone and

with emotion in his voice, expressed his gratitude to

Dow Corning. This was truly a significant moment in

the sense that it exposed Kessler's gullibility. The

evening session commenced at 7 o'clock on the second

day of the FDA hearing. The moratorium was already in

effect since the gel-filled implants were now reputed

to be dangerous, even lethal, according to articles

and the news on television.

The room was stale and the 500 plus crowd was tired,

restless and ready to go home. Totally dominating the

hearing so far had been the pro-implant speakers from

manufacturing corporations, and plastic surgeons.

Together they had applied their best efforts in trying

to convince the FDA that the gel-filled breast implant

should be allowed to remain on the market.

This last time slot had strategically been scheduled

for the so-called " lesser " speakers. This group

included Tom Talcott, a chemical engineer,

Resch, a mechanical engineer, Dan Bolton, a plaintiff

attorney, Pierre Blais, a biochemist and me. While the

pro-implant speakers had each been allotted thirty

minutes to testify, we were limited to a mere ten

minutes each. In addition to this, we were not allowed

a question/answer period. This scheme, according to

Norman , had been planned at the last moment

by the FDA and the manufacturers. Everything was

precisely arranged as in Kafka's The Trial.

The audience included the nine voting members of the

FDA's General and Plastic Surgery Advisory Panel, the

non-voting members, women personally affected by the

gel-filled implants, women promoting the gel-filled

implants, manufacturers, plastic surgeons, attorneys,

major television networks, newspapers, radio stations,

etc.

That evening several women spoke about problems with

their breast implants. One of the speakers was Mrs.

Janet Shrout, whose moving account of her daughter's

death was described in " Criminal Negligence. "

Soon it would be time for my ten minute speech. Yes, I

was finally allowed to speak, but it was touch and go

until four hours before my presentation. Luck had it

that I was to speak just before Dan Bolton, known by

everyone as the San Francisco attorney who had won the

$7.3 million award for his breast implant client,

nne Hopkins.

By now most of the women present had learned that I

was Dr. , inventor of the saline-filled implant.

Some of my adversaries were present. Don McGhan

managed a strained smile. Some of the Mentor people

looked seasick around me. As one would naturally avoid

anyone with the plague, so was the attitude of several

of the plastic surgeons towards me. By the time it was

my turn to speak, it was 8 o'clock, people attending

were tired and many had already left to catch a plane

home. The audience had shrunk.

Originally, I had prepared a very precise summary of

my personal involvement in the breast implant affair.

It was only after all the harassment and intimidation

on behalf of the FDA and manufacturers that I felt

compelled to change the tune of my testimony. I had

been suppressed so long that my intact immune system

had developed marvelous antibodies. So I decided to

steady the tiller and navigate directly into the

storm. It was truly exhilarating to finally be able to

publicly blurt out the truth, noting every sing detail

of their attempts to silence me. My testimony had to

be concise since my time was very limited. Having to

summarize my fifteen year involvement with implants in

ten minutes was no easy feat. I briefly referred to my

first meeting with Mr. Rudy Schulte and the creation

of the first saline-filled breast implant in 1968. How

the FDA had claimed to have " lost " my first paper in

1974, and had ignored the devastating histological

evidence sent to them in 1978.

During my testimony, Tilton was whispering

something into the ear of Connell. I stopped

in mid-phrase, fixed my glance on Tilton who continued

to whisper totally oblivious to the fact that the room

had become dead silent. After what seemed like several

minutes, a doctor sitting to the right of Tilton,

elbowed him to attention. Pointing my steady finger at

him, I locked into his eyes and declared: " You Mr.

Tilton, you are the very man who told me that the

manufacturers had put pressure on everybody, and that

I would not be allowed to speak. I am talking to you,

Mr. Tilton. It was due to the same damn pressure that,

in 1978, you, the FDA, failed to take the necessary

steps to prevent what is happening today. "

Moments late, I was interrupted by Connell who

reminded me that I had three minutes remaining. This

was to moment to pack in the clincher: " Dr. Kessler,

what we all have been discussing here for the last two

days is really a DRUG DELIVERY SYSTEM, and the drug is

liquid silicone, the use of which has never been

legalized. Therefore, a very elegant way for you to

get out of your present predicament is to simply

classify the implant as a drug delivery system. " My

statement was immediately followed by applause from

the audience. Dr. Kessler quickly took the microphone

and hushed up the audience by saying that if

necessary, they were fully prepared to enforce order.

Connell interrupted again to inform me that my time

was up. Now, with my feet firmly planted near the

podium, I leaned still closer into the microphone and,

looking directly at Connell, said: " Dr. Connell, I had

the courtesy to wait while you and Mr. Tilton had your

private conversation during my testimony. Now I would

expect you show that same courtesy by letting me

finish what I have to say. " More applause. I quickly

summed up my talk and sat down to more cheering and

approval by an enthusiastic and fired-up crowd.

Dan Bolton was next to speak. In clear, logical terms

he explained to the panel members that the jury in the

case of Hopkins v. Dow Corning found Dow Corning

guilty of fraud. He mentioned how at one point, Dow

Corning had a count down of days to produce the

implant. They could not meet the deadline, so they

simply marketed the new implant anyway, in spite of

not having properly completed the quality control.

Tom Talcott, chemical engineer, next spoke on silicone

gel and its components. He had previously worked with

Dow Corning but said he chose to leave the corporation

in 1962 because he was unable to go along with what

they were doing. He had observed in laboratory tests

how the gel they were marketing was bleeding liquid

silicone. He said, " Let's find out why, " and they

replied, " no, we'll just sell it. Tom Talcott was

later employed by Heyer-Schulte, which is when I first

met him. Over the years I came to know him well and to

respect his integrity.

Through the meeting, there were murmers passed that

Tom Talcott had been fired. In addition, Dow Corning

researcher, Dr. LeVier, had publicly branded

Talcott a " junk scientist. " This of course, colored

the opinions of Panel members prior to Talcott's

testimony. Taking the bull by the horns, Talcott said,

" Andy by the way, I want the Panel members to know

that one of your members, and I know which one, has

spread the rumor that I was fired. It is untrue and I

expect a letter of apology. "

Tom Talcott elucidated the dangers of making the

envelope thinner and the gel less viscous in order to

market a more natural feeling implant. He pointed out

that women would be exposed to more and more liquid

silicone, and that the thin envelope would break much

easier exposing body tissue directly to the silicone

gel.

Dr. Mike Resch, a mechanical engineer at the

University of Nebraska, said in clear and simple terms

that the silicone gel implants were never made for

longevity. " They were designed to last between five

and seven years.

The last speaker was Dr. Pierre Blais, undoubtedly the

most knowledgeable Biochemist in North America, who

possesses a formidable background in the field of

silicone prostheses. He held the job as director of

the Canadian equivalent of the FDA. In 1991 he had

declared the polyurethane covered breast implants to

be dangerous and prohibited the sale of the product in

Canada. Due to direct pressure from Surgitek, a

Minnesota-based manufacturer of polyurethane covered

breast implants and its main distributor in Montreal,

as well as pressure from Bristol-Myers Squibb, he had

to resign from his job. Over the last fifteen years,

Dr. Blais has accumulated a great number of explanted

breast implants of all varieties. He discovered that

one group obviously showed gross rupture, another

showed small areas of abrasion and areas of impending

failure. Many of the cultures obtained from these

implants that are sent to him from all over the world,

are positive for staphylococcus epidermidis,

staphylococcus aureus, Escherichia coli and others.

Furthermore, he has discovered fungus growing in

implant material.

The audience once again broke into laughter and

applause when Piere Blais, in his brilliant yet benign

manner, apologetically stated, " Members of the Panel,

I'm afraid that if the implant were a horse, you would

have to shoot it. "

Despite all the setbacks, the hearing was a success,

although I am sure the press did not fully grasp the

extent of the scandal. There were some women in the

audience who taped it. The Advisory Panel voted to

take the silicone gel implant off the market, except

for use by a few breast surgery patients in controlled

studies. They declared that the only legally available

breast prosthesis was the saline-filled inflatable

implant.

What was the cause of this success? Certainly not the

few of us who told the truth.

It was tanks to the women and the lawyers. The voting

members of the Panel had read the newspapers, watched

television and listed to the radio. They knew hundreds

of women were seriously ill and they had heard from

attorney Dan Bolton that $6.5 million of the $7.3

million dollars awarded by the jury to nne

Hopkins represented Punitive damages and not

compensatory damages for her enormous medical

expenses. Why? Because the jury found Dow Corning

guilty of fraud. Still no one acknowledged that the

manufacturers had done anything wrong. No apologies

came forth.

On the second day of the hearing, Dow Corning had

announced that they would spend any amount of money on

research. On the third day, one Panel Member made a

motion regarding the permissibility of the use of the

gel-filled breast implants. The chairwoman, Connell,

was asked to repeat it so that the motion could be

seconded. Not for all the tea in China was she able to

repeat that simple motion. After her second

unsuccessful attempt, she capitulated and someone else

had to restate it. A well-trained parakeet would have

done much better.

After the Advisory Panel voted down the gel implants

and the FDA backed their decision, Dow Corning stated

at a press conference that they would NOT make their

implant anymore. So much for the promise made only the

day before when Dow announced their eagerness to spend

any amount of money on research! It was time to move

on and make their millions in other areas.

To be sure, Dr. Kessler is in a very difficult

situation. What this country desperately needs is to

replace Kessler with a capable person who also

possesses the principles and integrity necessary to

withstand any amount of pressure from powerful

entities. The government is supposed to protect the

consumer and if that breach is mandate, they become of

negligence, even fraud and criminal conduct.

[Retyped from the book, " Siliconegate " - by Henry

MD - pages 225 - 238]