Fw: More ASPS/ASAPS junk science

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From: " Kathi " <pureheart@...>

Sent: Friday, July 26, 2002 1:13 PM

Subject: More ASPS/ASAPS junk science

> From:

> " Rogene " <saxony02@...>

> To:

> " Kathi " <pureheart@...>

>

>

>

>

> http://www.plasticsurgery.org/mediactr/jps-798.htm

>

> JOINT POSITION STATEMENT

>

> American Society of Plastic Surgeons

> American Society for Aesthetic Plastic Surgery

>

> Contact: Maureen (ASPS) -- (847) 228-9900

> Leida Snow (ASAPS) -- (212) 921-0500

>

>

> SILICONE BREAST IMPLANTS: SCIENTIFIC UPDATE

> July 17, 1998

>

> The July 22-24, 1998 meeting of the Committee on the Safety of Silicone

> Breast Implants (Institute of Medicine, National Academy of Sciences) in

>

> Washington, DC represents an opportunity to review the substantial

> scientific and clinical data on breast implant safety that has been

> gathered

> since the Food and Drug Administration (FDA) placed restrictions on the

> use

> of silicone gel-filled breast implants in 1992. The American Society of

> Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic

> Surgery (ASAPS) believe that current data substantiates scientifically

> that

> women with breast implants are at no large risk for the development of

> connective-tissue disease (CTD), even in the case of implant rupture,

> and

> are at no increased risk for breast cancer or other cancers.

>

> The results of more than 20 important epidemiologic studies of CTD and

> breast implants have become available since 1992. These studies have

> been

> conducted by some of the most prestigious research institutions both

> nationally and internationally. The overwhelming consensus of

> researchers

> from a variety of medical specialties is that there is no scientific

> proof

> of an association between breast implants and the development of CTD.

>

> Findings regarding breast implants and cancer have been equally

> reassuring.

> Research has substantiated that women with breast implants have no

> increased

> risk for developing breast cancer, and a study by the U.S. National

> Cancer

> Institute showed a lower cancer risk among implant patients compared to

> women without implants. There is no scientifically proven explanation

> for

> why women with breast implants might have a lower rate of breast cancer.

>

> A study by the Alberta Cancer Board found that diagnosis of breast

> cancer in

> women with implants was not delayed. In this study, tumors were detected

> at

> an earlier stage among the implant patients compared to women without

> implants. However, plastic surgeons routinely counsel patients that

> implants

> will make mammography more difficult and require extra mammographic

> views.

> There is a theoretical possibility that an implant could block the view

> of a

> small breast tumor. Scientists are continuing efforts to develop

> radiolucent

> breast implant fillers that would allow breast tissue adjacent to an

> implant

> to be more easily seen.

>

> >From a scientific and clinical perspective, the major area of concern

> over

> breast implants is local complications. These primarily are implant

> rupture

> and capsular contracture, either of which may cause patients to undergo

> additional surgery with its attendant risks.

>

> Clinical data on the incidence of implant rupture vary widely; frequency

> of

> rupture (More) appears to be greater for certain implant models.

> However,

> reports of implant rupture rates are difficult to evaluate; they often

> are

> based on examination of women with suspected problems and may not

> represent

> the incidence of rupture in the implant population at large. A 1997 Mayo

>

> Clinic study of an unbiased patient population showed a rupture rate of

> 5.7%. Other studies have reported rupture rates of less than 6% and more

>

> than 50%, depending on the population sample.

>

> Unlike inflatable saline solution-filled implants, silicone gel-filled

> implants do not " deflate " and may produce no visible signs of rupture.

> The

> gel usually remains confined within the scar capsule surrounding the

> implant. While this confinement of the gel makes its subsequent surgical

>

> removal easier, it makes the diagnosis and scientific study of implant

> rupture more difficult. A well-designed, large-scale multicenter study

> is

> needed to close the gap in knowledge about the incidence of gel implant

> rupture.

>

> Capsular contracture (unnatural breast firmness caused by tightening of

> scar

> tissue around the implant) is the most frequent local complication

> associated with breast implants. Clinical data on contracture rates also

> are

> diverse. A number of studies show that, in the short-term,

> textured-surface

> silicone implants may reduce the incidence of capsular contracture, but

> it

> is unknown whether this effect is long-lasting. Some data suggest that

> saline implants are associated with a lower incidence of contracture

> than

> silicone gel-filled implants, but the evidence is inconclusive. Patients

> may

> be better candidates for a particular type of implant based on a variety

> of

> anatomic considerations as well as a prior history of contracture.

>

> The controversy over breast implant safety that dominated media coverage

> in

> the early 1990s had both negative and positive consequences. On the

> negative

> side, many thousands of women were exposed to misinformation based

> largely

> on anecdotal accounts of the alleged risks of implants as reported by

> the

> media. Some of this misinformation clearly was perpetuated by powerful

> special interest groups for monetary gain or media impact. The net

> result

> was a wave of panic. In some cases, women largely based their decision

> to

> assume the risks of additional surgery for implant replacement or

> removal on

> nonscientifically-based information.

>

> On the positive side, the implant controversy encouraged greater

> attention

> to large-scale epidemiologic studies that now have provided doctors and

> patients with scientific facts and significant reassurance about the

> safety

> of breast implants.

>

> Patients' increased awareness about the advisability of periodic breast

> examination by their plastic surgeon has enhanced the overall quality of

>

> care and facilitated long-term monitoring of implant patients.

>

> It is the goal of board-certified plastic surgeons to foster scientific

> investigation of all issues that have been raised about breast implants

> in

> order to ensure the safety and well-being of patients; to assist in the

> accurate diagnosis of breast implant patients who complain of symptoms;

> to

> obtain accurate scientific assessment of the durability of breast

> implants

> so that patients can be advised about the incidence of implant rupture

> and

> appropriate surgical intervention; to attain a scientific understanding

> of

> the causes of capsular contracture and to develop more effective

> treatments;

> and to enhance overall patient satisfaction with the results of breast

> augmentation and reconstruction following mastectomy.

>

> More than $3 million in funding for breast implant research has been

> administered by ASPS, ASAPS and their respective educational foundations

>

> (Plastic Surgery Educational Foundation [PSEF] and Aesthetic Surgery

> Education and Research Foundation [ASERF]) under guidelines that ensure

> the

> independence and scientific integrity of approved research projects.

>

> The American Society of Plastic Surgeons (ASPS) represents 97% of all

> physicians certified by the American Board of Plastic Surgery (ABPS).

> ABPS

> surgeons perform both cosmetic and reconstructive plastic surgery. The

> American Society for Aesthetic Plastic Surgery (ASAPS) is dedicated to

> the

> continuing education of board-certified plastic surgeons in the science

> and

> art of cosmetic surgery. Together, these organizations educate the

> public

> about the benefits and potential risks of cosmetic surgical procedures.

>

>

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

--

>

> ----

>

> BIBLIOGRAPHY FOR U.S. AND INTERNATIONAL STUDIES OF SILICONE BREAST

> IMPLANTS

> AND CONNECTIVE TISSUE DISEASE

>

> Burns CJ, Laing TJ, Gillespie BW, Heeringa SG, Alcser KH, Mayes MD,

> Wasko

> MCM, BC, Garabrant DH, Schottenfeld D. The epidemiology of

> scleroderma among women: Assessment of risk from exposure to silicone

> and

> silica. The Journal of Rheumatology 1996;23:1904-1911.

>

> Deapen DM, Bernstein L, Brody GS. Are Breast Implants Anticarcinogenic?

> A

> 14-Year Follow-Up of the Los Angeles Study. Plastic and Reconstructive

> Surgery 1997;99:1346-1353.

>

> Duffy MJ, Woods JE. Health risks of failed silicone gel breast implants:

> A

> 30-year clinical experience. Plastic and Reconstructive Surgery.

> 1994;94:295-299.

>

> Dugowson CE, Daling J. Koepsell TD, Voigt L, JL. Silicone breast

> implants and risk for rheumatoid arthritis. Arthritis & Rheumatism

> 1992;35:S66.

>

> 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. The Journal of Rheumatology. 1998: 25(2):

> 254-260.

>

> Englert HJ, P. Scleroderma and augmentation mammoplasty- a casual

>

> relationship? Australian and New Zealand Journal of Medicine

> 1994;24:74-80.

>

> Englert H, D March L. Schleroderma and silicone gel breast

> prostheses - the Sydney study revisited. Australian and New Zealand

> Journal

> of Medicine 1996;26:349-355.

>

> Friis S. Mellemkjaer L. McLaughlin JK, Breiting V, Kjaer SK, Blot W,

> Olsen

> JH. Connective tissue disease and other rheumatic conditions following

> breast implants in Denmark. ls of Plastic Surgery 1997;39:1-8.

>

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

> Risk

> of connective - tissue disease and other disorders after breast

> implantation. The New England Journal of Medicine 1994;330:1697-1702.

>

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

> Complications leading to surgery after breast implantation. The New

> England

> Journal of Medicine 1997; 336(10):677-682.

>

> Giltay EJ, Moen HJB, Riley AH, Tan RG. Silicone breast prostheses and

> rheumatic symptoms: A retrospective follow up study. ls of the

> Rheumatic

> Diseases 1994;53:194-196.

>

> Goldman JA, Greenblatt J, Joines R, White L, Aylward B, Lamm SH. Breast

> implants, rheumatoid arthritis, and connective tissue diseases in a

> clinical

> practice. Journal of Clinical Epidemiology 1995 48:571-582.

>

> Gutkowski KA, Mesna GT, Cunningham BL. Saline-filled breast implants: A

> Plastic Surgery Educational Foundation multicenter outcomes study.

> Plastic

> and Reconstructive Surgery 1997;100(4):1019-1027.

>

> Hennekens CH, Lee I-M, Cook NR, Herbert PR, Karlson EW, LaMotte F.

> Manson

> JE, Buring JE. Self-reported breast implants and connective-tissue

> diseases

> in female health professionals. A retrospective cohort study. Journal of

> the

> American Medical Association 1996;275:616-621.

>

> Hochberg MC, Perlnutter DL, Medsger TA Jr, Nguyen K, Steen V, Weisman

> MH,

> White B. Wigley FM. Lack of association between augmentation mammoplasty

> and

> systemic sclerosis (scleroderma). Arthritis & Rheumatism

> 1996;39:1125-1131.

>

> Lacey JV Jr, Laing TJ, Gillespie BW, Schottenfeld D. Reply re:

> Epidemiology

> of scleroderma among women: Assessment of risk from exposure to silicone

> and

> silica. Journal of Rheumatology 1997;24:1853-1855.

>

> Laing TJ, Gillspie BW, Lacey JV Jr, Garabrant DH, BC, Heetings

> SG,

> Alcer KH, Cho S, Mayes MD and Schottenfeld D. The association between

> silicone exposure and undifferentiated connective tissue disease among

> women

> in Michigan and Ohio. Arthritis & Rheumatism 1996;39:S150.

>

> McLaughlin JK, Fraumeni JF Jr, Olsen J. Mellemkjaer L. Correspondence

> Re:

> Breast implants, cancer, and systemic sclerosis. Journal of the National

>

> Cancer Institute 1994;86:1424.

>

> McLaughlin JK, Olsen JH, Friis S, Mellemkjaer L. Correspondence Re:

> Breast

> implants, cancer, and systemic sclerosis. Journal of the National Cancer

>

> Institute. 1995;87:1415-1416.

>

> Nyren O. Yin L. fsson S, McLaughlin JK, Blot WJ, Engqvist M,

> Hakelius L,

> Boice JD Jr, Adami H-O, Risk of connective tissue disease and related

> disorders among women with breast implants: A nation-wide retrospective

> cohort study in Sweden. British Medical Journal 1998, 316

> (7129):417-421.

>

> Park AJ, Black RJ, Sarhadi NS, Chetty U, ACH, Silicone gel-filled

>

> breast implants and connective tissue diseases. Plastic and

> Reconstructive

> Surgery 1998, 101(2): 261-268.

>

> -Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang

> MH.

> Silicone breast implants and the risk of connective-tissue diseases and

> symptoms. The New England Journal of Medicine 1995;332:1666-1670.

>

> Schusterman MA, Kroll SS, Reece GP, MJ, Ainslie N, Halabi S,

> Balch

> CM. Incidence of autoimmune disease in patients after breast

> reconstruction

> with gel implants versus autogenous tissue: A preliminary report. ls

> of

> Plastic Surgery 1993;31:1-6.

>

> Strom BL, Reidenberg MM, Freundlich B, Schinnar R. Breast silicone

> implants

> and risk of systemic lupus erythematosus. Journal of Clinical

> Epidemiology

> 1994;47:1211-1214.

>

> Weisman MH, Vecchione TR, Albert D, LT, Mueller MR.

> Connective-tissue

> disease following breast augmentation: A preliminary test of the human

> adjuvant disease hypothesis. Plastic and Reconstructive Surgery

> 1988;82:626-630.

>

> Wells KE, Cruse CW, Baker JL Jr, s SM, Stern RA, Newman C,

> Seleznick

> MJ, Vasey FB, Brozena S, Albers SE, Fenske N. The health status of women

>

> following cosmetic surgery. Plastic and Reconstructive Surgery

> 1994;93:907-912.

>

> Wigley FM, R, Hochberg MC, Steen V. Augmentation mammoplasty in

> patients with systemic sclerosis: data from the Baltimore scleroderma

> research center and Pittsburgh scleroderma data bank. Arthritis &

> Rheumatism

> 1992;35:S46.

>

> Wolfe F. Silicone breast implants and the risk of fibromyalgia and

> rheumatoid arthritis. Arthritis & Rheumatism 1995;38:S265.

>

> BIBLIOGRAPHY FOR U.S. AND INTERNATIONAL STUDIES OF BREAST IMPLANTS AND

> BREAST CANCER

>

> Brinton LA, Malone KE, Coates RJ, Schoenberg JB, Swanson CA, Daling JR,

> Stanford JL. Breast Enlargement and Reduction: Results from a Breast

> Cancer

> Case-Control Study. Plast Reconstr Surg 1996;97:269-275.

>

> H, Brasher P. Breast Implants and Breast Cancer-Reanalysis of a

> Linkage Study. N Engl J Med 1995;332:1535-1539.

>

> BIBLIOGRAPHY FOR U.S. AND INTERNATIONAL STUDIES OF BREAST IMPLANTS AND

> CONTRACTURE

>

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

> Complications leading to surgery after breast implantation. N Engl J Med

>

> 1997; 336(10): 677-682.

>

> Gylbert L. Asplund O, Jurell G. Capsular contracture after breast

> reconstruction with silicone-gel and saline-filled implants: A 6-year

> follow-up. Plast Reconstr Surg 1990; 85 (3):373-377.

>

> This is a partial list of available scientific studies.

> For a summary of any of these studies please call ASPS or ASAPS

> Communications.

>

>

>

>

>

>