Shari, and everyone

[Guest guest]

Shari,

you live near Tampa, Maybe this doctor would be a good contact for

you.

Thought this artical was good.

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.

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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

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

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