Pro & Con

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Dr.View #1

Dr.View #2

My Story




 FDA 2011

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

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 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 theyall 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 positivetear 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 assistant postmaster general and other women of achievement in 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 stared 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 thefollowing:

*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.