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.
************************************
(Press release from the American Society for Aesthetic Plastic Surgery (ASAPS)
September 24, 2003)
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.
The 2100-member American Society for Aesthetic Plastic Surgery (ASAPS)
is the only plastic surgery organization devoted entirely to the advancement of
cosmetic surgery. ASAPS is recognized throughout the world as the authoritative
source for cosmetic surgery information, education and statistics. U.S. and
Canadian members are certified by the American Board of Plastic Surgery (ABPS)
or the Royal College of Physicians and Surgeons of Canada.
Toll-free referral line: 888.ASAPS.11 (272.7711). Web site:
www.surgery.org
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