Thanks to Carolyn Wolf who sent this for us all.

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 Jenny'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 David 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 Anderson, Professor of Internal Medicine at
John 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, Anderson 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,
Anderson 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.

Anderson 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 Anderson, 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 Anderson, told him he was
biased, and removed Anderson's right to a vote. On the
day before the hearing, Kessler said to Anderson, "It
would be best if you resigned completely from the
Advisory Panel." Anderson 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,
Paul 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. Jenny, 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 Georgetown."
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 Paula 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, Keith 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, Michael
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 Anderson, 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,
Marianne Hopkins.

By now most of the women present had learned that I
was Dr. Jenny, 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, Paul Tilton was whispering
something into the ear of Elizabeth 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. Robert 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 Marianne
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
Jenny MD - pages 225 - 238]

~~~~~~~~~

www.BreastImplantAwareness.org