Silicone Implants Reconsidered;Some Say FDA Is Moving Too Fast

The women who have them and aren't admitting that they do may not even realize that they've got problems yet..There's also a lot of women out there, like my neighbors daughter'n'law, who was flat chested, had female troubles and was unable to have any children and was depressed and "had" to do something for HER, and had implants put in, and btw, went back again to have them enlarged! She's fully aware of the health effects but will tell you she doesn't care because she needed to do something to coverup her depression of not being able to have children! Her husband and family is fully aware of the facts but there's nothing he/they can say to her.

Sad but true, these women are gluttons for punishment! And guaranteed they will and might already have problems and will never admit it, nor will they go for the various tests that need to be done.

There's many women out there who will never admit that they have implants to anyone, including their family and closest friends, and don't want to hear the truth either.

www.implantinfo has some good information regarding the positive aspects of this surgery. It's not for everyone, but there are thousands of women out there who are very happy with their results. And they are not the stereotypical airheaded bimbettes either.

The silicone sisters who advocate that the tales of horror are the norm are not accurate or correct. But boy do they love to agitate things.

www.implantinfo.com is worth a look. Yes, it's sponsored by cosmetic and plastic surgeons, but you won't find more comprehensive information regarding this procedure anywhere.

So, it's your position that no women have had implants, love them, have had no problems, and will have no problems; and that all the women and doctors who say so are either ignorant or lying or haven't had inevitable doom fall crushingly on them yet?

Dan

I know... I was just giving you a hard time... no insult intended... :-)

Sorry it took so long to get back to you... just got into work. I told you I would give you the name of the lawyer's firm handling the class action suit for the breast implants (btw, there may be other firms involved, this is the one that I'm familiar with).

If you reread post number 25 & 30 you will see the firm's name (in post 30). I had the spelling wrong but it's close enough to show you I wasn't making up a name, and I didn't look it up on the internet.

The reason I know about this situation is a close relative had the procedure done in 1976, then had them removed in 1993 to 95 (can't remember exactly). They were in the shape I descibed yesterday. This close relative joined the class action suit immediately after the removal. Around 1996-97, she received part one of the settlement ($19,000 after the lawyers took their 1/3). At that time she was told that she would be receiving an additional settlement (not part of the first) due to the condition of her implants, and a few other determiners.

This second settlement is "supposed" to be paid to selected women but is in the appeal process at this time, and should be a similar amount to the first (The attorneys are the real winners). She received a letter from the firm several months ago saying it should be another 2-4 years before they reach a settlement or the appeal is won by the manufacturers.

The law firm is:

Krause & Rollins
Attorneys at Law
310 Groveland ave
Minneapolis, Minnesota, 55403
attorney assigned to my relatives action is James (Jim) Hovland.

Regarding someones question about males in the suit, I have no knowledge of that. I would assume there are males.

In conclusion, I don't know much more then what I've told you yesterday and today. The science is beyond me. However, I did see a perfectly healthy female grow exceedly diseased over a 15 year period.

If I offended anyone during our discussion yesterday I apologize. It is also possible I didn't get this to all the people involved yesterday.

Gary

Because they feel inadequate. Because their spouses told them they should. Because every airbrushed magazine cover and Hooters ad tells them they should. Because they're convinced they are unattractive without them. Because they buy their bikini tops 3 sizes smaller than their bottoms. Because they look like deflated balloons after a couple of rounds of breastfeeding. Because they're sick of wearing padded bras. Because men are visual creatures and even if they're fat and ugly slobs, they expect the women around them to look like Barbie. Take your pick.

Now, in Brazil, they do silicone BUTT implants... beauty is a cultural concept.

However, I did see a perfectly healthy female grow exceedly diseased over a 15 year period.

I have no doubts that your friend did grow sick over a period of 15 years. My question is "Did Silicone cause her health deteriation?". Silicone is in our food, in medical replacement organs, knees and joints, eyes, brain stints; and has been for nearly 50 years. There has NOT been any study that shows that silicone has caused health problems. Simply put, sometimes bad things happen to good people.

My question is "Did Silicone cause her health deteriation?".

I don't know. Scientists on both sides disagreed on what may have caused the illnesses. I've just posted what I know about it... which is very little.

yes..and many are too shamed or embarrassed to admit that they have them because it's personal as you can imagine..and many may attribute whatever happening to them as "aging" or whatever when indeed it's the implants...

If you were to take an implant and place it on a stack of papers, within 3hrs you would see the implant "bleed" into the paper...just think what it does to your body..and there's NO ridding it from your body either.

Some doctors don't give the complete truth about implants.

My first plastic surgeon did not give me the complete truth.

My second plastic surgeon did. She told me that you usually have to have implants replaced after about 6-10 years. Most implants will rupture or cause scar tissue, and the implants have to be replaced. She told me that I would probably have less nipple sensation. She told me the risks of each implant.

I do know if a doctors says the risks are minimal, than he is lying. If he says they are maintenance free, than he is lying.

I don't go around talking about implants, so I don't know of anyone else that has had them. I have to go by what I have read, and by what my 2nd doctor said.

I think that if women are aware of the real risks, and still want to have the surgery, then they should go for it. I certainly look better, and I have not had any problems with my second set of implants. I have saline implants now, and I like them much better than the silicone ones. I think they are much more realistic feeling (hubby agrees).

I had that done to me when mine hardened up. It hurt!

I was young (a very immature 20 year old) when I got mine. My mom convinced me. (More like nagged me into it.) I just really wanted her to leave me alone. She said she's paid for them, and I thought the risks was minimal.

I found out 5 years later that my mom is a manic depressive. One thing about manice depressives is that they are perfectionists. I did not turn out perfect in her eyes, and so she wanted me fixed.

It's hard to have a good self image if your parents keep on telling you that you are inadequate. When I got to be a teenager, my mom made a point of emphasizing that I was flat chested. She would tell me not to wear certain clothes because it made me look flatter. Then I had a boyfriend that wanted me to get a boob job. He royally dumped me after a year of dating.

Put the demeaning mom, and getting dumped by a boyfriend, and I got them. Stupid yes.

My girls will not get the same treatment from me if they are flat chested. Actually, I personally think my kids are perfect just the way they are. My kids all know that mommy thinks they are either beautiful or handsome (and they are).

vjc webpage
MEMOIR OF A JUNK SCIENTIST

BY
BERNARD M. PATTEN, MD, FACP, FRSM

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 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 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.

http://www.howdyneighbor.com/JusticeDenied/page31.html

I hope you're having the proper tests done to ensure that you're ok..always know that the saline ones have silicone shell and do bleed..I don't have any idea how old you are, but please don't attribute any ache, pain, or whatever, to aging..please have the necessary tests and go to an implant dr who knows what's going on...

Thanks for getting back to me...

I do believe that the men w/ the penile implants do qualify in the global settlement..

BTW, I opted out of the global settlement.

Another thing..there's a part of the settlement for the attys.

I'm 41. I don't know of any tests. Can you inform me? How would I find an implant doctor? The main problem I have is with my thyroid, and I don't know if that could be attributed to implants.

So far, I've been rather healthy, but I'll be on the watch for any problems.

Thanks!

I know you didn't ask me, however, I agree with Bella. Most plastic surgeons can send you to a doctor who can tell you if it is possible you're having a reaction to your implants. Possibly get a second opinion. I hope you find help soon.

As far as the class action suit is concerned I believe it is closed to new claimants. However, to make sure, you can contact the attorneys I listed in post number 85. If you want their phone number contact me using FR Email. I do not want to post their number for fear of them being freep'd by those who may disagree.

Good luck

I'm going to freepmail you w/ the info on this..Please give me until tomorrow due to not feeling well today..Where do you live so I can get a dr for you...Thanks!