Breast implant controversy
Since the early 1990's, nearly a dozen comprehensive systemic reviews have been commissioned by various governments' health ministries to examine the alleged links between silicone gel breast implants and systemic diseases. A clear consensus has emerged from these independent scientific reviews that there is no clear evidence of a causal link between the implantation of silicones and connective tissue disease. The conclusions of these reviews are summarized:
| Year
| Country
| Systemic Review Group
| Conclusions
|
| 1991-1993
| United Kingdom
| Independent Expert Advisory Group (IEAG)
| The IEAG concluded that there was no evidence of an increased risk of connective tissue disease in patients who had undergone silicone gel breast implantation and that there was no scientific case for changing practice or policy in the UK in respect of breast implantation
|
| 1996
| USA
| US Institute of Medicine (IOM) [1]
| Not "sufficient evidence for an association of silicone gel- or aline-filled breast implants with defined connective tissue disease".
|
| 1996
| France
| Agence Nationale pour le Developpement de l'Evaluation Medicale (ANDEM)[1]
| "Nous n’avons pas observé de connectivite ni d’autre pathologie auto-immune susceptible d’être directement ou indirectement induite par la présence d’un implant mammaire en particulier en gel de silicone..." (We did not observe connective tissue diseases to be directly or indirectly associated with (in particular) silicone gel breast implants)
|
| 1997
| Australia
| Australia’s Therapeutic Devices Evaluation Committee review
| "current high quality literature suggest that there is no association between breast implants and connective tissue disease-like syndromes (atypical connective tissue diseases)"[2]
|
| 1998
| Germany
| Germany’s Federal Institute for Medicine and Medical Products
| concluded that "silicone breast implants neither cause auto-immune diseases nor rheumatic diseases and have no disadvantageous effects on pregnancy, breast feeding capability or the health of children who are breast fed. There is no scientific evidence for the existence of silicone allergy, silicone poisoning, atypical silicone diseases or a new silicone disease" [2]
|
| 2000
| USA
| Review request of the United States Federal Judiciary[3]
| "no evidence of an association between...silicone-gel-filled breast implants specifically, and any of the individual CTDs, all definite CTDs combined, or other autoimmune or rheumatic conditions."
|
| 2000
| European Union
| European Committee on Quality Assurance & Medical Devices in Plastic Surgery (EQUAM)
| "Additional medical studies have not demonstrated any association between silicone-gel filled breast implants and traditional auto-immune or connective tissue diseases, cancer, nor any other malignant disease....EQUAM continues to believe that there is no scientific evidenxce that silicone allergy, silicone intoxication, atypical disease or a 'new silicone disease' exists."[3]
|
| 2001
| Great Britain
| UK Independent Review Group (UK-IRG)
| "there is no evidence of an association with an abnormal immune response or typical or atypical connective tissue diseases or syndromes"[4]
|
| 2001
| USA
| Review for court appointed National Science Panel [4]
| The panel evaluated both established and undifferentiated connective tissue diseases and concluded that there was no evidence of an association between breast implants and these CTDs.
|
| 2003
| Spain
| STOA Report to the European Parliament Petitions Committee
| Regarding new scientific evidence, the currently available information shows that there is not solid evidence linking SBI to severe diseases (such as breast cancer or connective tissue diseases). [5]
|
Thousands of women have still claimed that they have become ill from their implants. Complaints include systemic fungus, neurological and rheumatological problems.
Additional recommended knowledge
As studies have followed women with implants for a longer period of time, more information has been made available to assess these issues. A 2004 Danish study, reported that women who had breast implants for an average of 19 years were no more likely to report an excess number of rheumatic symptoms then control groups.[5]
A large study of plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but a relatively increased risk of lung cancer deaths in breast implant recipients compared to other forms of plastic surgery. The authors attributed this to differences in smoking rates.[6] Another large study of nearly 25,000 Canadian women with implants recently reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind.[7]
References
- ^ Brinton LA, Malone KE, Coates RJ, Schoenberg JB, Swanson CA, Daling JR, Stanford JL (1996). "Breast enlargement and reduction: results from a breast cancer case-control study". Plast Reconstr Surg 97 (2): 269-75. PMID 8559808.
- ^ Template:Cite ref
- ^ Janowsky EC, Kupper LL, Hulka BS (2000). "Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases". N Engl J Med 342 (11): 781-90. PMID 10717013.
- ^ Tugwell P, Wells G, Peterson J, Welch V, Page J, Davison C, McGowan J, Ramroth D, Shea B (2001). "Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel". Arthritis Rheum 44 (11): 2477-84. PMID 11710703.
- ^ Breiting VB, Holmich LR, Brandt B, Fryzek JP, Wolthers MS, Kjoller K, McLaughlin JK, Wiik A, Friis S (2004). "Long-term health status of Danish women with silicone breast implants". Plastic and Reconstructive Surgery 114: 217-226. PMID 15220596.
- ^ Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN (2006). "Mortality rates among augmentation mammoplasty patients: an update". Epidemiology 17 (2): 162-9. PMID 16477256.
- ^ Villenueve PJ, et. al (June 2006). "Mortality among Canadian Women with Cosmetic Breast Implants.". Am J Epidemiol. PMID 16777929.
External links
- U.S. Food and Drug Administration (FDA) - breast implant page
- Health Canada breast implant homepage
- U.K. Medicines & Health Care Products Regulatory Agency (MHRA) - breast implant page
- Australia's Department of Health & Aging Therapeutic Goods Administration breast implant portal
- 2006 European Union International Committee for Quality Assurance, Medical Technologies and Devices in Plastic Surgery(IQUAM) Position Statement
- Institute of Medicine (IOM) Report on Silicone Implants
- National Science Panel report "Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction"
- Summary of Silicone Implant Safety (E-medicine)
- Breast Implant Safety.org
- "Absolutely Safe" Film by Carol Ciancutti-Leyva
- Science On Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case 1997 book by Marcia Angell, former editor of the New England Journal of Medicine.
|
