15th July 21:54
New Disease That Needs To Be Defined FRANK B. VASEY, MD, (malaise systemic sclerosis bladder scleroderma lupus)
Where There's Smoke There's Fire: The Silicone Breast Implant
Controversy Continues to Flicker: A New Disease That Needs To Be
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 do***ented 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
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 do***ent 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
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.
Search PubMed for:
1. Uretsky BF, O'Brien JJ, Courtiss SH, et al. Augmentation
mammoplasty associated with a severe systemic reaction. Ann Plast Surg
2. Gabriel 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. Sanchez-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
7. Edworthy SM, Martin 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, Adams WP, Beran S, Conner WCH. A prospective
****ysis 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.
11. Tugwell P, Wells G, Peterson 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.
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, Solomon G.
****ysis 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.
For links to this and other important articles and studies, you are
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