Silicone
News Update
Note: The
Mentor Corporation has generously shared some of the information
provided on this web page regarding Breast Implant Safety and
Silicone Cohesive Gel Implants.
Breast
Implant Safety Study Information
There
is a lot of confusion and myths when it comes to breast implants,
and breast implant safety. We would like to present you with
the facts of cohesive gel breast implants as well as the safety
of silicone gel in general.
For
the past several years, there have been many reports in the
media about women with breast implants who have autoimmune disease
or breast cancer. Also during this time, many respected medical
professionals and institutions have conducted scientific studies
about the safety of breast implants.
Institute
of Medicine
In
June 1999, the National Academy Institute of Medicine issued
a report that included the following conclusion: "In an
overall consideration of the epidemiological evidence, the committee
noted that because there are more than 1.5 million adult women
of all ages in the United States with silicone breast implants,
some of these women would be expected to develop connective
tissue diseases, cancer, neurological diseases or other systemic
complaints or conditions. Evidence suggests that such diseases
or conditions are no more common in women with breast implants
than in women without implants."
Independent
Review Group
The
Independent Review Group (IRG) on Silicone Breast Implants was
assembled by the Chief Medical Officer of the UK to review the
possible health issues associated with silicone gel breast implants.
Members of the IRG were selected for their independent views,
their knowledge and understanding of the issues, and lack of
any financial interest in the conclusions they reached.
The
IRG reported in 1998 that there is no scientific evidence of
an association between silicone gel-filled breast implants and
any established connective tissue disease. The complete report
is available on the Internet at www.silicone-review.gov.uk.
European
Committee on Quality Assurance
In
July 1998, the European Committee on Quality Assurance and Medical
Devices in Plastic Surgery released a report that contained
the following conclusions: "There are conclusive scientific—clinical,
immunological, epidemiological—data, that silicone gel-filled
breast implants do not cause any autoimmune nor connective tissue
diseases." Their report also stated, "Updated studies
continue to show that silicone gel-filled implants do not cause
cancer nor other malignant disease."
Mentor’s
Memory Gel™.
Let’s
start with the nature of silicone implants. They are made of
two parts: the silicone shell and the silicone gel filling.
The first is the outer envelope that is made from a material
called silicone elastomer; this is simply a term that means
silicone rubber.
The
word “cohesive” is a new term being used today to
describe the nature of the fill compared to the more liquid
fill that may have been used in silicone implants in the early
1970’s. This is not new science, this is not new technology – cohesive
is simply a word that’s being used today to describe the “sticking
together” nature of the gel.
The
inside of the gel implant is filled with Mentor’s proprietary
Memory Gel. It is a cohesive gel formulation that makes sure
the gel acts as a unit rather than a liquid - it holds together
uniformly and retains the natural give that resembles actual
breast tissue. It also helps prevent migration, or running,
of the gel in the event of a rupture. This type of silicone
gel has been used since 1985.
There
are a number of studies that have been published that demonstrate
the safety of silicone gel breast implants. The most extensive,
a comprehensive study by the Institute
of Medicine on the safety of silicone breast implants,
showed no evidence that implants are associated with major diseases
or weaken the immune system, and that, in general, silicone
is safe.
In
addition, a peer reviewed article published in the Annals of
Plastic Surgery (2004) confirms earlier results published by
the Independent Review Group, the Institute of Medicine, and
the National Science Panel that concluded there is no evidence
of an association between breast implants and connective tissue
disease.
Saline
Implants
Saline-filled
breast implants are filled with a saltwater solution similar
to the fluid that makes up most of the human body. Each breast
implant has a self-sealing valve used to fill the device during
surgery. A variety of textures, sizes and shapes are available
to provide you with the greatest possible flexibility toward
achieving breast enhancement goals.
