MEMOIR OF A JUNK SCIENTIST

by Bernard M. Patten , MD, FACP, FRSM
http://www.humanticsfoundation.com/bernard_patten.htm

The former President of the American Society of Plastic and
Reconstructive Surgery called me a junk scientist. My lame, but
honest, reply is that I am a junk scientist because I have, for the
last fifteen years, been studying a piece of junk. That's what the
silicone breast implant was and is. Let me explain:
 

It all started years ago, never mind how many, when I decided to
switch my program at Columbia College from American History to premed.
My career seemed to go pretty well for a time. I graduated from
Columbia College summa cum laude and second in my class of 725
students. Thence I went to Columbia's College of Physician and
Surgeons where I also graduated second in my class. They elected me to
AOA, the national medical honor society in my junior year, and I took
the Mosby Prize for Scholarship at graduation. After internship at
Cornell Medical Center - The New York Hospital, I returned to Columbia
for residency in neurology and eventually, by unanimous vote of the
faculty was elected Chief Resident in Neurology at the Neurological
Institute of New York. After a fellowship year in human memory at
Columbia, I went to NIH where I became the assistant chief of Medical
Neurology and did neurological consultations for the clinical center
and many times for the United States Senate. So far so good. Not a bad
start for a junk scientist, wouldn't you say?
 

Along the way I published over 100 papers in peer reviewed journals,
gave over 500 lectures to national and international audiences and
received many prizes and awards for research in Parkinson's Disease (I
was there with Dr. George C. Cotzias when the first dose of DOPA was
given) and Myasthenia Gravis. (I was there with Dr. King Engel when we
pioneered the immune suppressive treatments) as well as a listing in
the usual places such as Who's Who in America, Who's Who in the World,
Who's Who in Health and Medical Education, Who's Who in Science and
Engineering and so forth. I had a loving wife who was also a physician
and two children and four cats and, yes, as unfashionable as it may be
to admit, I was happy. Happy, that is until that fatal day when I
decided to leave the sacred groves of NIG to take a job as Chief of
Neuromuscular Diseases and eventually Vice Chairman of Neurology at
the Baylor College of Medicine in Houston, Texas. Soon after that
mistake my troubles began.
 

At Baylor I made friends with Dr. Frank Gerow, one of the two
inventors of the silicone breast implant. Frank explained that he and
Cronin wanted to do something with plastic surgery that would match
the artificial heart the Dr. Michael Debakey was working on, something
that would draw national attention to themselves the way NASA,
situated only 40 miles south of Baylor, got national attention. First,
they tried direct injections of silicone into tissues to make bigger
breasts and the results were, of course, a disaster. I saw lots of
these women in consultation. They were by and large the wives of
medical students who had volunteered for the experiments. The silicone
caused marked fibrosis, hard, painful, disgusting looking breasts
which the women were ashamed to show. All others who tried to directly
inject silicone into human tissue have gotten the same terrible local
complications proving that silicone is not inert but is biologically
active enough to cause severe local inflammatory reactions.
 

The interesting thing that escaped my attention at the time was that
most of these wives also had weird neuromuscular and rheumatologic
diseases including myasthenia gravis, polymyositis, small fiber
sensory neuropathy and Sjogren's syndrome. In many cases, the
autoimmune diseases required treatment and I applied the treatments
the best I could without thinking that there might be a connection
between the silicone and the autoimmunity. Because direct injection
gave awful results, Gerow and Cronin decided to enclose the silicone
in a elastomer bag and put the bag into the breast area to make big
breasts. A lot of people thought the idea absurd, almost obscene, but
it did give the promise of what some women wanted and it was quick
giving immediate results. Of course, there ware lots of problems with
the surgery including infections and herniation of the implant through
the incisions and multiple redos because the implant had ruptured or
shifted or had developed a baseball hard capsule or the woman wanted
still larger and larger breasts and so forth. But the local
complications Gerow and Cronin could handle.   Besides whether you put
implants in or you took them out or you changed them, the surgeon
still got paid.
 

 Eventually, Baylor accumulated the first and the largest series of
implanted women in the world and as the neurologist that Gerow knew
and presumably trusted, I got the referrals of the women who had
complaints referable to muscles, nerves, spinal cord, or brain. And
there were many of them, a superabundance. Probably from 1986 to 1993
I personally saw and examined over 2000 such women. Their stories were
all quite similar: Sometime after the implantation, they felt weak and
tired, developed morning stiffness, excessive fatigue, dry mouth, dry
eyes and dry vagina. Most also had hot painful tender breasts with
contractures. I made it my business to examine the breasts of all
these women and got pretty good at
detecting ruptures, spills, and enlarged local lymph nodes. There were
many women with amazingly anesthetic nipples which Gerow told me was
because T4, the nerve to the nipple, had been cut on insertion of the
larger implants through the axillary approach. Quite a few women had
severe sharp shooting chest pains simulating heart attacks. Gerow had
an answer for that too: On insertion the implant forms a physical
barrier to the regrowth of severed nerves causing neuroma formation.
We even biopsied a few cases and proved the neuromas were present and
published two papers on chest pain in implanted women. One paper
appeared in Emergency Medicine and one appeared in the Southern
Medical journal. But the thing that impressed me the most about the
local situation was that the implant, in this selected group of women
that I saw, had failed miserably to deliver what it had promised.
Beautiful breasts they were not. In fact, the opposite was true: The
implant had made satisfactory breasts horribly deformed and ugly.
 

I did complete physical examinations on each of the women and found
that they all seemed to show much the same general pattern; they had
skin rashes, cold fingers and toes, dry eyes and dry mouths, and they
were weak. We weren't sure how strong a woman should be so I sent out
a medical student to get pinchometer and gripometer measurements in
normal and hospitalized women. The results confirmed that implanted
women, the ones referred to me at any rate, were, in relation to their
peers matched for age and sex, objectively weak, usually scoring less
that 50% of the controls on the dynamometer measurements.  On
neurological examination I found that ladies had more than the usual
trouble with simple mental status tests such as proverbs,
subtractions, serial sevens, naming the presidents and so forth. That
could have been because they came from poor education backgrounds,
which they did by and large. Except, even some high powered women who
had completed graduate school, Judges in Houston courts for instance,
or the former assistant postmaster general and other women of
achievement in journalism and science, also did poorly on these tests.
Gait and station testing showed most couldn't do a push up or a sit up
and most had glove and stocking sensory loss suggesting they had
neuropathy.
 

Laboratory tests confirmed that the women seemed to have something
autoimmune though just what that was we couldn't say. There were lots
of abnormal autodirected antibodies including ANA and rheumatoid
factors and antinerve antibodies but none of the ladies actually fit
into the currently accepted diagnostic criteria for the diseases
usually associated with those antibodies. Almost all the women who had
cognitive complaints had decreased cerebral flood flows as measured by
research physicians as part of the NIG approved Baylor-Methodist
Cerebral vascular research center grant. Almost all had positive tear
tests proving the ladies really did have dry eyes.
 

Most of the patients had surgical indications for implant removal and
I followed them during and after the surgery. I personally reviewed
the slides on all tissues removed and gradually learned to identify
free silicone in tissue, polyurethane, and the dense inflammation with
foreign body giant cells that surrounds the implant. We documented
with pictures the gross appearance of massive silicomas larger than
softballs and capsules thicker than magazines. We kept track of the
relations of examination results before to what happened after
surgery. In general, women with polyurethane implants did lousy and
got worse after explantation. Women who had massive spills of silicone
had teams of surgeons laboring over nine hours fail to get all the
silicone out. That group also did poorly. Women with high titers of
antiGM1 antibodies got progressively worse and sent down hill often
dying of a weird neuromuscular disease that resembled a combination of
dermatomyositis, lupus, rheumatoid arthritis, motor sensory
neuropathy, Sjogren's syndrome, and amyotrophic lateral sclerosis
with, believe it or not, signs and symptoms of multiple sclerosis!
 

Women who had minor spills that surgeons could remove and those with
intact implants did the best. Most in that group recovered within two
years. Three of these who had had complete remissions of well
documented diseases got tired of living with small tits and made the
mistake of getting reimplanted. The diseases, as predicted, roared
back thus fulfilling Koch's postulates. We found that the incidence of
ruptured implant correlated with the severity of autoimmune disease.
The proven rupture rate for our series of severely ill women with the
Multiple sclerosis, for instance, exceeded 70%. We published our
results in eight papers covering everything we could think of  from
the local to systemic problems. Under separate cover, I will send some
reprints of those to you. The citations of all papers appear in
Medline. My fellows, Britta and Glen, and I presented our data at
national and international meetings including the World Federation of
Neurology and the American Neurological Association and the American
Academy of Neurology. The Southern Medical Society and the Texas
Neurological Society gave us several awards for clinical research and
encouraged us to dig further. In many cases, our reports hit the front
pages of USA Today, The New York Times, The Wall Street Journal and so
forth. Little did I realize that that publicity would hurt us. Nor did
I realize, until it was too late, how much it would hurt.
 

About 1986 Dow-Corning paid me $4,800 to consult with them about their
product. I told them what we were finding and I told them especially
about my concern about the rupture rate (50% ruptures in ten years on
average) and the severe local complications we had seen due to
ruptures. I urged them to set up some form of free clinic to care for
the injured women and to make cowardly amends for what they had done.
Some months later they told me I was wrong and that the implant caused
no such problems. We went back to the drawing boards and redid much of
the research only to discover the same things we had discovered
before. I estimate the pause caused by the misinformation received
from the company delayed our progress for two years. As it was
misinformation, because to my chagrin, I learned on my way to
Washington to testify before the expert panel of the FDA, while
reviewing the secret company documents supplied to me by the FDA, that
the company clearly knew as far back as 1976 that silicone spread,
caused local inflammation, and in some animals resulted in autoimmune
diseases. I appeared before the panel a shaken man. The people who had
hired me as a consultant had deceived me. How naive I had been.
 

The rest as they say is history. FDA took implants off the market for
cosmetic augmentation. TV began to do shows about how bad a scientist
I was. Gerow staggered under the weight of over 13,000 malpractice
suits against him and Baylor. Trustees called Doctor Butler, the
President of Baylor, about a program about me put on by CNN. Frontline
even said in a voice over that I was under investigation by the FBI
for Medicare fraud. I was not, not then, not ever. But multiple
investigations were conducted on the basis on anonymous complaints to
the Texas Board of Medical Examiners. Seven so far have been dismissed
after years of investigation and reinvestigation. Every slide I ever
showed in any scientific meeting was seized and investigated as
possible evidence against me. Criminals broke into my office and stole
research data related to implants. The biopsy laboratory was broken
into and slides and reports on implanted patients looked into. A man
posing as my fellow copied the brain scans and charts of over 200
patients, a theft of medical records never solved. Death threats
arrived in the mail. People phoned in threats. One plastic surgeon
said I was part of a communist conspiracy to deprive American women of
their implants. And, yes, a dead decapitated animal, a rabbit not a
horse, arrived at the doorstep, just like in the movies.
 

Baylor restricted my teaching saying that they couldn't prevent my
research but they sure could stop me from talking to students,
interns, and residents about implants. They were careful to mention
that they were not restricting my research because they recognized the
rights of a tenured associate professor to publish what he wished. And
they affirmed that they wished me to continue my teaching in every
other aspect just as before. However, the chairman of the department
soon came upon the idea that he could stop my seeing implanted women.
I protested but Baylor administration remained intransigent. So
realizing the futility of trying to make further progress, I bowed
out.
 

Meanwhile, Cronin started to make rounds in the nude and was
discovered to be demented and Gerow, drinking a lot, refused to have
his protime checked. He had an artificial aortic valve for which he
took Coumadin. His subsequent death from a cerebral hemorrhage
prompted me to formulate the following epigram:
 

The silicone implant was:
Bad for those who made them
Bad for those who put them in
Bad for those who got them in
 

And bad for those who did research on them.
 

God rest his soul. Before he died Frank Gerow predicted what
subsequently came true: "The silicone implant, born in Houston, will
die in Houston."
 

And so it is with a kind of wispy regret that I make some suggestions
to future scientists who might consider doing implant research. First
of all, consider carefully, you men and women of the future, and if
you take my advice, don't do it. It isn't worth it. More than one
career has been ruined in this field and others are sure to follow.
The companies have massive amounts of money to defame even the most
sincere and diligent researcher. The chance that you will escape the
same fate as me is slim. But if the compulsion to do research that
will have a significant impact on the health of women for our time and
for all time is unavoidable, I suggest you consider the following:
 

Set up special free clinics to study women with implants. These ladies
have genuine medical problems, which are not being addressed.
Regardless of the cause of their physical and mental diseases they
need help which they are not able to get at present because for
various reasons they are locked out of the medical system.
 

Repeat the epidemiological studies. Most of those studies, by their
own admission, are flawed. The Mayo study more than the others. In
fact, the  Mayo study was reported in the same section at the annual
meeting of the American Society of Plastic and Reconstructive Surgery
that I reported the complication of giving a transfusion into an
implant. At that meeting the  version was that there was a high
incidence of autoimmune disease in the implanted patients compared to
controls particularly Hashimoto's thyroiditis.  For some reason,
partial deselection of evidence I presume, that item never  found its
way into the Mayo final report.
 

Even forgetting about possible causation for the moment, why not study
intensively the mechanisms of autoimmunity in patients with implants?
At  the time of my retirement I had collected 51 cases of ruptured
implants in patients with multifocal brain infarctions associated with
antiphospolipid  antibodies. Could that be an accident?
 

Follow all women with implants in a national registry. Require that
all have yearly screening examinations for local and systemic
complications. History and physical examinations is all that is needed
for effective screening.   Career researchers not connected with the
companies in anyway and not connected with the business of installing
or removing implants in anyway should do the screening. The companies
have spent 26 million dollars on spin to make themselves look good.
Why not spend a similar amount on some real  unbiased research?
 

Do animal studies injecting silicone mixed with blood proteins into
animals.   The results, I predict, will show that the animals develop
autoimmune diseases.
 

~~~~~~~~~~~
 

 This article is provided with the permission of its author, Dr.
Patten, and may be copied and distributed. It was written at the
request of the National Academy of Science, and expected to published
(perhaps in an edited format) sometime in 1999. Dr. Patten is not
alone, there are others who have suffered for the women's cause, and
lost their careers as a result. Still others are continuing to fight
(such as Dr. Patten is doing, by having written this article). Perhaps
this article would open the eyes of some journalists? If nothing else,
perhaps it will help you understand where these physicians are coming
from, why they are so afraid of this issue, and why they need your
patience (and your information!).