Despite controversy, no evidence they’re not safe
To the editor:In response to Paul Harasim’s April 1 article, “Silicone or saline argument
goes on,” about the recent approval of silicone breast implants by the
After 14 years of study, including 80,000 women in the United States and more
than 1 million women worldwide, silicone breast implants are considered to
be the most extensively studied medical device in the history of the FDA. The
data used by the FDA in its decision is readily available to the public and
includes numerous peer-reviewed articles by physician researchers representing
multiple medical specialties. This includes the 400-page, landmark 1999 report
by the National Institutes of Health’s Institute of Medicine, which concluded
that, “A review of the toxicology studies of silicones and other substances
known to be in breast implants does not provide a basis for health concerns.”
Many points that are public knowledge are not discussed, such as the fact
that silicone implants were never taken off the market in Europe or South and
Central America, where they remain the most commonly used implant.
Silicone is ubiquitous in our society and is part of many implanted medical
devices (pacemakers, artificial hips, heart valves and even pacifiers). It
is also very important to note that the currently used silicone gel implants
are vastly superior to the implants that are often discussed with patients,
such as the patient referred to in the article. There has not been a well-conducted
study that has ever proven a correlation between silicone and illness of any
Complications of breast implants are local in nature and include firmness
of the scar that forms around the implant, and sometimes unhappiness with your
post-operative result. Currently used silicone implants, which have been used
for more than the past 15 years, have a thicker shell which will withstand
25 times the force of a standard mammogram without failure. They also feature
an additional barrier layer and the gel inside is more cohesive — meaning
it has the consistency of Jello, which lends to its more natural feel when
Breast augmentation was the most commonly performed cosmetic surgical procedure
in women in 2006, surpassing liposuction. According to the statistics gathered
by the American Society for Aesthetic Plastic Surgery, 42 percent of these
women were 35 to 50 years old, so it is not just a procedure for younger women.
Women seek breast implant surgery for a variety of reasons, including restoring
their breast size and shape following significant life events such as childbirth
and breast-feeding. The approval of silicone should be considered a positive
event for women, allowing them to make an intelligent and informed choice about
what device they would like to use.
I tell patients that if they have any concerns about the use of silicone,
I would prefer that they have a saline-filled implant. It is my job to educate
my patients and provide the best care possible, not to push them toward the
use of one implant or another.
Michael C. Edwards, M.D.
THE WRITER IS A PHYSICIAN SPECIALIZING IN PLASTIC AND RECONSTRUCTIVE SURGERY.