NEW YORK, NY (September 24, 2003) — Throughout
recorded history and in virtually all cultures
of the world, humans have been fascinated
by the female breast and its primordial
symbolism. Today, women have breast enlargement
options that were not dreamed of only a
few decades ago, and breast augmentation
has become the second most sought-after
cosmetic surgical procedure for women. According
to 2002 statistics from the American
Society for Aesthetic Plastic Surgery (ASAPS),
249,641 breast augmentation procedures were
performed last year.



The Beauty of Breast Augmentation



Breast augmentation, also called augmentation
mammaplasty, involves surgical placement
of an implant behind each breast to increase
its volume and enhance its shape. Implants
are inserted through an incision -- usually
made just above the breast crease, around
the pigmented skin surrounding the nipple,
or in the armpit -- and placed into a "pocket"
created by the surgeon behind the breast
tissue or the chest muscle. Breast augmentation
is requested to add volume to small or underdeveloped
breasts, or to restore volume lost as a
result of weight loss, childbirth, or aging.



Breast augmentation can be performed at
any age after the breasts are fully developed,
but there are regulatory restrictions on
the use of breast implants in women less
than 18 years of age. There is no scientific
evidence that breast augmentation increases
the risk of breast cancer, autoimmune disease
or any systemic illness, nor is there evidence
that breast implants affect pregnancy or
the ability to breast feed. In addition
to the positive aesthetic outcomes of breast
augmentation, data has shown that many patients
enjoy substantial psychological benefits
including enhanced self-esteem.



Breast Augmentation Then



Prior to 1963, and sometimes in the hands
of non-medical practitioners, experimental
methods of breast enlargement included paraffin
injections, silicone injections and the
insertion of sponges. None of these methods
achieved satisfactory long-term results,
and injections to the breast proved to be
extremely dangerous. Then, in 1963, the
first silicone gel-filled breast implants
were introduced, followed by the introduction
of saline-filled implants in 1965.



Beginning in the 1970s, several manufacturing
companies began mass-producing breast implants.
Options were enhanced with the introduction,
in 1974, of inflatable implants. A couple
of years later, in 1976, double lumen implants
appeared on the market; these implants had
an interior chamber filled with silicone
gel and an outer, saline-filled chamber.
In the late 1980s, textured-surface implants
were introduced on the theory that the textured
shell would modify the process of scar formation
and reduce the incidence of capsular contracture
(breast firmness caused by scar tissue contracting
around the implant, still the most common
problem associated with breast augmentation);
ongoing studies on the effectiveness of
textured-surface implants in reducing contracture
have shown mixed results. Throughout the
'70s and '80s, plastic surgeons, and especially
members of the American Society for Aesthetic
Plastic Surgery, gained significant
clinical experience with breast implants
and found that women generally were very
pleased with the results.



The Breast Implant Controversy of the
'90s



In the early 1990s, breast implants became
the subject of heated controversy as reports
of women claiming their implants had seriously
damaged their health became widely publicized
in the media. In 1991, implant manufacturer
Dow Corning lost a multi-million dollar
lawsuit based on claims that its implants
were the cause of a plaintiff's autoimmune
disease. Shortly afterward, in January 1992,
the U.S. Food and Drug Administration (FDA)
issued a voluntary breast implant moratorium,
and, in April, the agency issued an outright
ban on the use of silicone-gel filled implants
for cosmetic augmentation. Women seeking
breast reconstruction were still permitted
access to gel implants, and some other exceptions
applied. The FDA's actions, some claimed,
were not based on science but, rather, on
political and social pressure. Nevertheless,
even the proponents of implants had to admit
that hard scientific data to refute the
claims that implants might be associated
with autoimmune and other systemic illnesses
were lacking or incomplete.



Plastic surgeons were caught in the middle
of this controversy. Nearly 30 years of
clinical experience led them to believe
that implants were safe, and they sought
to reassure anxious patients. Nevertheless,
they recognized that manufacturers did not
have adequate data to fully address some
of the complex issues that had been raised.



While the controversy raged, saline-filled
breast implants continued to be generally
available for both breast reconstruction
and augmentation.



In 1994, so-called "anatomical implants,"
aimed at creating a more naturally sloped
breast contour, were introduced on the market.
Whether such implants actually produce a
more natural breast shape is still controversial.




Saline Implants Win FDA Approval



A turning point in the breast implant controversy
occurred with the June 1999 release of a
comprehensive report on breast implants
by the National Academy of Science's Institute
of Medicine (IOM). By this time, there had
been a number of major studies failing to
find an association between implants and
autoimmune diseases or cancer. The scientists
who prepared the IOM report reviewed all
the available studies and concluded that
there was no solid scientific evidence of
a connection between breast implants and
any disease. Similar findings were published
by health agencies in the United Kingdom
and by the European Committee on Quality
Assurance and Medical Devices in Plastic
Surgery (EQUAM).



In May 2000, the FDA gave its official approval
to saline-filled breast implants, finding
them both safe and effective for breast
augmentation and reconstruction. Saline-filled
implants provide excellent results for most
women, and the popularity of breast augmentation
surgery appears to be ever increasing. Still,
the search for the "perfect" implant --
one that creates a naturally shaped, natural-feeling
breast and avoids the problems of capsular
contracture -- continues. One implant-filler
alternative that appeared promising was
the soybean oil-filled implant, but, in
2000, questions of long-term safety and
effectiveness led to its discontinuation
by the manufacturer.



A handful of physicians from various specialties
have promoted breast enlargement by fat
injection as a safe and effective alternative
to implants. The American Society for
Aesthetic Plastic Surgery issued a position
statement warning about the potential dangers
of this procedure. Besides the fact that
this method of breast enlargement may produce
only temporary results due to absorption
of the injected fat, a more serious consequence
is fat calcification and its impact on mammography
and early detection of breast cancer.



Breast Augmentation Now



Currently, almost all women in the U.S.
undergoing breast augmentation receive saline-filled
implants. Approximately 10% of women undergoing
breast procedures receive silicone gel-filled
implants, but this is permitted only for
breast reconstruction, implant replacement,
and severe breast ptosis (sagging). In October
2003, the FDA will review new data on silicone
gel-filled implants that is derived from
ongoing clinical studies and has been submitted
by implant manufacturers with the hope of
winning FDA approval for reintroduction
of silicone gel-filled breast implants for
general use in breast reconstruction and
augmentation. Silicone gel remains a potentially
popular implant choice primarily because
it produces a very natural-feeling breast
and is particularly desirable for women
with minimal breast tissue. Recently, a
new formulation of silicone gel, which is
thicker than previous gels and retains its
shape even in the event of a tear or rupture
of the implant shell, has been developed
and is undergoing clinical trials. Called
"cohesive silicone gel", this new filler
innovation has already been used extensively
outside the U.S., and eventual FDA approval
is widely anticipated.



The use of sustained mechanical force to
induce tissue growth in the breasts has
recently been touted as a new method to
achieve modest enlargement of the breasts.
While some physicians have reported promising
results with this technique, others claim
widespread failure to achieve satisfactory
results with consequent patient disappointment.



What lies ahead, in the more distant future,
for breast augmentation? Some researchers
say that new tissue engineering technology
using stem cells derived from liposuctioned
fat may someday be used to "grow" breast
tissue. Or breast enlargement may be achieved
through manipulation of hormones or other
chemical or biological substances.



These and other innovations are likely to
provide increased options for breast augmentation
in the 21st Century. In the meantime, women
seeking breast enlargement have a variety
of choices, and most breast augmentation
patients will achieve a high level of satisfaction
with the current methods and devices. In
fact, surveys have shown that the overwhelming
majority of women who undergo breast augmentation
say they would make the same decision again.