Breast Augmentation: Then and Now

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.
 

About ASAPS
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body.  ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.

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