LEA:Re: Dr. Vasey on Silicone Disease

[Guest guest]

In fact, Lea, you need to forward this on to that Fumento DUDE and

tell him that if they don't ASK the RIGHT questions to find the

truth, they will NEVER FIND the right answers. They will only

continue to live in a world of delusions and false information.

He didn't put you in your place....but you have a chance to put him

in HIS. He says he is in this to spread the truth...well, then, let

him look at the FACTS as presented in Dr. Vasey's article which

references several studies that reveal why all the other studies

were flawed.

Patty

Lea wrote:

It looks like this man has put me in my place...love....Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~```

Re: Letter to Ottawa Citizen]Also letter responding to Mr.

Fumento's article:

Dear Lea,

Last I heard millions of woman had voluntarily received silicone

implants, not complained about them. Pray where did you get that

number? And tell me, at what rate do the implants rupture. If your

life has been destroyed, it is because of people like you. Don't

blame

me for your problems. It's not fair to me and it won't help you. I

have been writing about implants since 1992 including a monograph

with

many citations. You'll find all this material on my website at

www.fumento.com. I found your friend Dr. Hardbutt on PubMed. He's

published a handful of papers on the toxic effects of heavy metals,

but there was nothing on implants. Then I found one on the Web where

he's blaming platinum and implants for causing asthma. Going back to

PubMed, I found no other articles linking implants and asthma. Thus

Hardbutt came up with what scientists and doctors call " unverifiable

results, " meaning useless until someone else comes along and finds

the

same thing. Finally, insofar as I don't have a lot of money and I'm

really not sure how much power I have either, you'll have to choose

C): In this to spread the truth.

Sincerely,

Fumento

> Why oh Why oh Why does the FDA not LOOK AT THE STATISTICS that

have shown the TRUTH regarding symptoms of illness?

>

> Dr. Vasey has done some fantastic work and pointed out the truths

that need to be focused upon. He should be recognized for doing so.

> See the highlights in bold, below.

>

> Also note his observations on EXERCISE.

> Thanks for this excellent link, Ilena!

> Patty

>

>

>

> Editorial

> -------------------------------------------------------------------

-------------

>

> Where There's Smoke There's Fire: The Silicone Breast Implant

Controversy Continues to Flicker: A New Disease That Needs To Be

Defined

> FRANK B. VASEY, MD,

> Professor and Director;

> S. ALIREZA ZARABADI, DO;

> MITCHEL SELEZNICK, MD;

> LOUIS RICCA, MD,

> Division of Rheumatology,

> University of South Florida,

> Tampa, Florida, USA

> Address reprint requests to Dr. F.B. Vasey, Division of

Rheumatology, University of South Florida, 12901 Bruce B. Downs

Blvd., MDC 81, Tampa, FL 33612.

>

> -------------------------------------------------------------------

--

> The bonfires of the silicone breast implant controversy in the

1990s have been reduced to coals in 2003. The burning medical and

legal issues have been extinguished. The spark in North America

occurred in 1979 when a woman in Pittsburgh developed an acute

illness suggesting toxic shock immediately post implant placement.

No organism could be cultured and she had to have her silicone

breast implants removed 10 days after placement. She made a complete

recovery1.

>

> Case reports and case series as well as press coverage of this

formerly emotionally charged issue resulted in epidemiologic studies

focusing on defined connective tissue diseases as well as undefined

symptom complexes. Studies of defined diseases were either

negative2,3 or showed only a small but statistically significant

relative risk4. Studies of systemic lupus erythematosus (SLE) and

systemic sclerosis did not show an association with silicone breast

implants, but studies of symptoms did (Table 1)5-10. Because of a

lack of consistency in methodology of symptom searches and in study

findings some reviewers do not believe there is fire to be found11.

Since then, a Dow Corning-funded study (2496 reduction mammoplasty

patients versus 1546 silicone breast implanted women, 1/6 of whom

had saline-filled silicone envelope implants) has documented that

all 28 symptoms were increased in silicone patients (16 of 28 were

statistically increased)5. In a comparison study, there was a

> statistical correlation between local problems and systemic

problems.

>

> Table 1. Symptoms/signs associated with rupture of silicone

breast implant.

>

> Also important, in the first full article detailing the benefits

of silicone breast implant removal on symptom expression, the

authors cautiously interpreted their data as showing a " temporary "

improvement in that they had only 6 months of followup post-

removal9. Our study with 21-month followup confirms and prolongs

these observations12. Prompt onset of local and systemic symptoms,

delayed removal after becoming symptomatic, and ruptures found at

the time of removal all predict delayed improvement. Exercise-

induced exacerbations of pain, fatigue, and bladder irritability

help separate women with silicone-related symptoms from " personally

driven " fibromyalgia, in which exercise helps.

> In women with defined diseases, case reports and case series

showed a suspiciously high improvement rate post implant

removal13,14. These observations suggested women could have a

combination illness expressing both a naturally occurring defined

rheumatic disease with co-expressing silicone component.

Rheumatologists were urged to suggest the consideration of silicone

breast implant removal in women with SLE or scleroderma. Insurance

companies who deny benefits to very symptomatic women who only

worsen while implant removal is delayed particularly frustrate all

concerned. The women become disabled, lose their insurance, and have

no way to fund removal.

> The literature suggests that the vast majority of symptomatic

women had a fibromyalgia/chronic fatigue-like illness, which has

still not been defined. It is time for organized medicine to convene

a group of clinicians who understand the disease (rheumatologists,

plastic surgeons, and others) and epidemiologists who know how to

define the disease in order to document the medical necessity of

implant removal. Eosinophilia myalgia, with only 3500 sufferers, was

defined within 4 years of the initial case reports. In Table 2, we

propose criteria to be tested. Other authors have proposed and

tested criteria, but they have not been published15.

> Table 2. Proposed definition of silicone-related disorder.

>

> Dow Corning recently quietly sent settlement packages to

distribute 4.6 billion dollars to injured women. Other manufacturers

including Bristol Myers Squibb, 3M, and Baxter have largely settled

their cases as well.

> In this issue of The Journal, Dutch investigators throw fuel on

the fire by further correlating the high rate of self-reported

envelope rupture with statistically increased frequency and severity

of symptoms including muscle pain, joint pain, memory loss, and post-

exertional malaise, among others. The mechanism behind this

phenomenon remains unproven; however, the loss of envelope integrity

would allow a greater load of silicone/silica gel to escape into the

surrounding tissues, regional lymph nodes, and possibly into the

bloodstream (if the element silicon can be taken as a marker for

silicone polymer). They also reported compelling data to demonstrate

that the symptom complex of silicone breast implant recipients with

chronic fatigue differed markedly from those patients with

the " naturally occurring " chronic fatigue syndrome16.

> It's time to end the burning disagreements over silicone breast

implants. Happily, informed consent before silicone breast implant

placement has gone from a few paragraphs to many pages.

Nevertheless, we believe the significant problems of eventual

undetected silicone envelope rupture and risk of systemic symptoms

should dictate removal of silicone gel-filled breast implants from

the market as too dangerous for human use as the physiologic

equivalent of the injection of loose silicone gel into the human

body.

> An extensive informed consent does not deter women who are

obtaining silicone breast implants at a higher rate than ever. They

do not appear to understand that " saline implants " have a silicone

envelope. Some of our patients with " saline implants " have the same

symptom complex and local complications as patients with gel-filled

implants, but they should be safer because there is less silicone

load and any rupture releases saline.

> Plastic surgeons as well as rheumatologists and clinical

epidemiologists who are on the front lines in seeing these patients

need to be involved in the definition process. A definition that

surgeons and everyone else can use should improve insurance coverage

and speed implant removal in women requiring it.

> REFERENCES

> Search PubMed for:

>

> 1. Uretsky BF, O'Brien JJ, Courtiss SH, et al. Augmentation

mammoplasty associated with a severe systemic reaction. Ann Plast

Surg 1979;3:445-7.

> 2. SE, O'Fallon WM, Kurland LT, Beard CM, Woods JE, Melton

LJ. Risk of connective tissue diseases and other disorders after

breast implantation. N Engl J Med 1994;330:1697-702. [MEDLINE]

> 3. -Guerrero J, Colditz GA, Karlson EW, Hunter BJ,

Speiterzer FE, Liang MH. Silicone breast implants and the risk of

connective tissue diseases and symptoms. N Engl J Med 1995;332:1666-

70. [MEDLINE]

> 4. Hennekens CH, Lee IM, Cook HR, et al. Self-reported breast

implants and connective tissue diseases in female health

professionals: A retrospective cohort study. JAMA 1996;275:616-21.

[MEDLINE]

> 5. Fryzeck JP, Signorello LB, Hakelius L, et al. Self-reported

symptoms among women after cosmetic breast implant and breast

reduction surgery. Plast Reconstr Surg 2001;107:206-13. [MEDLINE]

> 6. Giltay EJ, Moens HJB, Riley AH, Tan RG. Silicone breast

prosthetics and rheumatic symptoms: A retrospective follow up study.

Ann Rheum Dis 1994;53:194-6. [MEDLINE]

> 7. Edworthy SM, L, Barr SG, Birdsell DC, Brant RF, Fritzler

MJ. A clinical study of the relationship between silicone breast

implants and connective tissue disease. J Rheumatol 1998;25:254-60.

[MEDLINE]

> 8. Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone

gel breast implant rupture, extracapsular silicone, and health

status in a population of women. J Rheumatol 2001;28:996-1003.

[MEDLINE]

> 9. Rohrich RJ, Kenkel JM, WP, Beran S, Conner WCH. A

prospective analysis of patients undergoing silicone breast implant

explantation. Plast Reconstr Surg 2000;105:2529-37. [MEDLINE]

> 10. Wells KE, Cruse CW, Baker JL, et al. The health status of

women following cosmetic surgery. Plast Reconstr Surg 1994;93:907-

12. [MEDLINE]

> 11. Tugwell P, Wells G, J, et al. Do silicone breast

implants cause rheumatologic disorders? A symptomatic review for a

court appointed national science panel. Arthritis Rheum 2001;44:2477-

84. [MEDLINE]

> 12. Vasey FB, Aziz NA, Havice DL, Wells AF. Prospective clinical

status comparison between women retaining gel breast implants vs.

women removing implants [abstract]. Arthritis Rheum 1996;39

Suppl:S52.

> 13. Vasey FB, Havice DL, Bocanegra TS, et al. Clinical findings in

symptomatic women with silicone breast implants. Semin Arthritis

Rheum 1994;24 Suppl 1:22-8.

> 14. Wallace DJ, Basbug E, Schartz E, et al. A comparison of

systemic lupus erythematosus and scleroderma patients with and

without silicone implants. J Clin Rheumatol 1996;2:257-61.

> 15. Colin M, Borenstein D, Espinoza L, Silverman S, G.

Analysis of preliminary operational criteria for systemic silicone

related disease (SSRD) [abstract]. Arthritis Rheum 1996;39

Suppl:S51.

> 16. Vermeulen RCW, Scholte HR. Rupture of silicone gel breast

implants and symptoms of pain and fatigue. J Rheumatol 2003;30:2263-

7.

>

>

> Return to October 2003 Table of Contents

>

>

> © 2003. The Journal of Rheumatology Publishing Company Limited.

> All rights reserved.

>

> __________________________________________________

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