Research and Studies
- November, 2006
Allocating Funds to Regulatory Programs—Health Canada
Health Canada
EXCERPT: "When Canadians use products regulated by Health Canada—whether household products such as cribs, medical devices such as blood test kits, or prescription drugs—they expect that as long as they follow directions, the product will be safe to use. Programs that regulate these products need enough resources to ensure that Canadians are adequately protected from risks to their health and safety. Health Canada, as a regulator, needs to be able to demonstrate that it is fully meeting its regulatory responsibilities."
- November, 2006
Junk Science Puts Thacker Against Milloy, American Chemical Society, White House
www.thinkandask.com
EXCERPT: "Thacker was a science reporter for the Environmental Science and Technology journal, the media arm for the American Chemical Society, and it was after he was fired that he exposed evidence of an entire industry built upon spinning science propaganda through the media and Internet in order to benefit corporate interests. "
- July 06 , 2006
Mortality among Canadian Women with Cosmetic Breast Implants
by Paul J. Villeneuve et al. American Journal of Epidemiology
EXCERPT: "There is widespread concern about possible long-term health effects among women who have received breast
implants for cosmetic purposes; few studies have reported on the mortality patterns of such women. The authors
examined cause-specific mortality in a cohort of 24,558 women with breast implants and 15,893 women who
underwent other plastic surgery procedures in Ontario and Quebec, Canada, between 1974 and 1989. Deaths
through 1997 were identified through linkage to the national mortality database "
- June 06, 2006
The perverted irony of Health Canada's Special Access Programme
Editorial letter by Timothy K.S. Christie and Julio S.G. Montaner
EXCERPT: "The SAP is designed for patients with serious or life-threatening conditions and who require "emergency" and/or "compassionate" access to drugs not authorized for use in Canada, when conventional therapies have "failed, are unsuitable, or are unavailable."
- April 19, 2006
Breast Implant Study Results Reflect Funding
Press Release, http://www.center4research.org
EXCERPT: "As the FDA considers whether to approve silicone gel breast implants for the first time, three newly published peer-reviewed studies provide information that makes the decision more difficult for the FDA."
- March, 2006
Breast implant infection with Mycobacterium fortuitum group:
report of case and review
Abstract, by Vinh DC, Rendina A, Turner R, Embil JM., www.pubmed.gov
EXCERPT: "This report summarizes the case of a young female who underwent augmentation mammoplasty who presented shortly thereafter with clinical evidence of an infected breast prosthesis. Despite a protracted course of empiric antibiotic therapy and multiple surgical interventions, she failed to improve.."
- 2005
Cancer incidence in a cohort of Ontario and Quebec women having
bilateral breast augmentation
by Jacques Brisson et al. Publication of the International Union Against Cancer
EXCERPT: "The possibility that women, who receive breast implants for cosmetic
purposes, have increased long-term risks of developing
cancer continues to be debated. The objective of our study was to
prospectively examine cancer incidence among women who received
breast implants. A cohort was assembled of 24,558 women,
18 years of age and older, who underwent bilateral cosmetic
breast augmentation, and 15,893 women who underwent other
cosmetic procedures in Ontario or Quebec between 1974 and
1989."
- September 1, 2005
Cohesive Silicone Gel Breast Implants in
Aesthetic and Reconstructive Breast Surgery
Mitchell H. Brown, M.D., M.Ed., Robert Shenker, M.D., and Samuel A. Silver
Excerpt: Cohesive silicone gel breast
implants are composed of a textured silicone elastomer shell and are filled with
cohesive silicone gel. Cohesive gel is
formed by increasing the number of cross-
links between gel molecules, which results
in an implant that has better retention of
shape and is less likely to fold or collapse,
especially in the upper pole.
- April 4, 2005
Pathology of Lymph Nodes From Patients With Breast Implants: A Histologic and Spectroscopic Evaluation
by William E. Katzin, MD, PhD, JoseŽ A. Centeno, PhD,Lu-Jean Feng, MD,
Maureen Kiley, MS, and Florabel G. Mullick, MD
Excerpt: There are only a few published reports describing the
pathology of regional lymph nodes from patients with silicone breast
implants. Systematic analytical chemical verification of foreign ma-
terial has not previously been reported. In this study, biopsies of
regional lymph nodes from 96 patients with breast implants were
studied ...
- January 31, 2005
Cohesive Silicone Gel Breast Implants in
Aesthetic and Reconstructive Breast Surgery
by Mitchell H. Brown, M.D. et al, American Society of Plastic Surgeons
EXCERPT: "Cohesive silicone gel breast
implants are composed of a textured silicone
elastomer shell and are filled with
cohesive silicone gel. Cohesive gel is
formed by increasing the number of crosslinks
between gel molecules, which results
in an implant that has better retention of
shape and is less likely to fold or collapse,
especially in the upper pole."
- 2004
Mortality and Suicide Among Danish Women With Cosmetic Breast
Implants
by Poul Harboe Jacobsen, MD et al, Archives of Internal Medicine [abstract only]
EXCERPT: "Epidemiologic studies indicate that women with cosmetic breast
implants have a significantly increased risk of suicide. Our objectives were to
examine mortality among Danish women who underwent cosmetic breast implant
surgery and to evaluate the baseline prevalence of psychopathological disorders
as measured by admission to a psychiatric hospital among
women seeking cosmetic surgery. "
- March, 2004
What exactly was wrong with the Trilucent breast implants? A
unifying hypothesis.
by Monstrey S et al,. Department of Plastic Surgery, Gent University Hospital, Belgium [abstract only]
EXCERPT: "Trilucent soybean oil-filled breast implants were initially announced as the
ultimate prostheses for breast augmentation. However, after an increasing
number of reports of local complications and hazardous metabolites
attributable to lipid oxidation, first the United Kingdom Medical Devices
Agency and later the Belgian National Ministry of Health urged all plastic
surgeons to contact their patients and advise them to have the implants
removed and, if desired, replaced with another type of prosthesis."
- 2003
Health Care Utilization Among Women Who Have Undergone Breast Implant Surgery
by Aleina Tweed, BC Centre of Excellence for Women's Health.
EXCERPT: "The health consequences of breast implant surgery range from
the well-established local complications to the very
controversial systemic complications. Complications often lead
to additional surgeries. Although most women receive implants
through privately-funded health care, when they experience
complications
they enter the public health care system. This
research study tests the hypothesis that receiving breast
implants results in increased use of the public health system."
click here for a short article summarizing the study.
- 2001
Cohesive Silicone Gel Breast Implants
Dr. Steven Teitelbaum, www.drteitelbaum.com
EXCERPT: "Cohesive breast implants were invented in the early 1990s, and have been used
throughout the world for about 10 years. Only the United States has yet to
approve these devices. Though the experience of these implants overseas will
be taken into account, the FDA requires that a prospective large-scale study be
done in the United States, adhering to their rigorous guidelines and scrutiny."
- McGhan Medical Corporation
Style 410 Silicone-Filled Breast Implant Clinical Study
EXCERPT: "The following information is the Informed Consent that patients received when they were entered into the McGhan Style 410 Cohesive Silicone Breast Implant Study for silicone breast implants. As you can see, women are much more informed regarding the risks and benefits of breast implants. The breast implant study information provided here is very thorough, and informative. "
- Dr. Steven Teitelbaum, www.drteitelbaum.com
EXCERPT: "Cohesive breast implants were invented in the early 1990s, and have been used
throughout the world for about 10 years. Only the United States has yet to
approve these devices. Though the experience of these implants overseas will
be taken into account, the FDA requires that a prospective large-scale study be
done in the United States, adhering to their rigorous guidelines and scrutiny."
- May, 1997
Explantation of silicone breast implants
by Thomas WO 3rd et al, Department of Surgery, College of Medicine/Medical Center, University of
South Alabama, Mobile, USA [abstract only]
EXCERPT: "Silicone gel-filled breast implants have been employed clinically for
decades for aesthetic augmentation or postmastectomy reconstruction.
Most patients and surgeons attest to the efficacy and safety of these
devices. However, more recently in the medical literature and popular
media, silicone gel-filled breast implants have been claimed to incite an
array of clinical sequelae such as capsular formation, granulomatous
disease, arthritis, arthralgia, fibromyalgia, autoimmune collagen vascular
disease, human adjuvant disease, siliconosis, silicone-related disease,
and silicone implant-associated syndrome."
- Births and perinatal health of infants among women who have
had silicone breast implantation in Finland, 1967-2000.
by Hemminki E et al, [abstract only]
EXCERPT: "Potential problems with breast implants have been
widely discussed, but few data exist on the childbearing and offspring
of women with implants. The purpose of this study was to investigate
the occurrence and conditions of pregnancies of women who have had
cosmetic breast implantation (exposed women), and the health of their
newborns."
- A Case Report of Prefilled Polysaccharide Hydrogel Breast Implant Rupture:
Clinical, MRI, and Pathologic Findings.
by Lee CJ et al, Department of Plastic and Reconstructive Surgery, College of Medicine, Inha University,
Incheon, South Korea [abstract only]
EXCERPT: "A case of a ruptured prefilled polysaccharide hydrogel breast implant with its radiologic
and pathologic findings is presented."
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