Breast Augmentation: From Controversy to Innovation

By Dr. Scott W. Mosser

Since the beginning of recorded history, men and women alike have worshiped an idealized female body form and have been obsessed with obtaining whatever perfect shape was defined as ideal according to time and fashion. An integral part of the ideal female body contour is the female breast, with its erotic and reproductive functions as well as its esthetic attributes.

Enhancing the breast to conform to artistic and fashionable ideals has, throughout history, taken forms ranging from the scientific to the ridiculous. Belts, corsets and pushup bras have been constructed from materials ranging from iron to straw, with almost all contraptions sharing one characteristic in common – discomfort. Gadgets to exercise, manipulate, or stimulate breast tissue growth have for centuries been successful and lucrative ploys of charlatans and well intentioned inventors alike.

Breast augmentation inventions and innovations remained on the outside of the body until the late 1890s when advancements in medical science introduced possibilities for enhancing breast size and shape internally. Experiments were made injecting paraffin into the breast tissue, but serious complications caused this to be abandoned after some years. Direct injection reappeared in the 1940s when a new material, silicon, was used in Japan. In spite of evidence that medical problems developed, apparently as a result of silicone eventually migrating to other parts of the body, the procedure continued for some years.

Silicone Comes on the Scene

Silicone was first used in the U.S. in the 1950s as subcutaneous injections for breast augmentation, but medical studies soon revealed the risks of migration and infection, as well as other drawbacks such as hematoma, visible implantation lines, and – most frequently – scarring from the body’s reaction to liquid silicone. Alternative substances, such as polyethylene and polyglycomethacrylate derivatives, were advocated for short periods during the 1950s and early 60s, but all resulted in negative side effects and were abandoned.

In 1963, two Houston surgeons, Thomas Cronin and Frank Gerow, developed a preshaped silicone sack which could be filled with either saline or a silicone gel made by Dow Corning, a jointly owned subsidiary of Dow Chemicals and Corning Glassworks. Dow Corning introduced the silicone product in 1964 as a medical device.

When this prosthesis showed a tendency to develop encapsulation, or hardening around the implant, various surgical techniques were developed throughout the 1960s and 70s, including insertion of the implant under the muscles of the chest wall (submuscular augmentation mammaplasty), and covering of the implant with polyurethane foam.

Improved saline-filled silicone implants reappeared in the 1970s, and both saline and silicone gel implant breast augmentation was widely practiced throughout the following two decades, with silicone gel being preferred for its more natural texture and breast form. Implants were granted FDA approval in 1976, having already been used for many years previously as a medical device.

Breast Augmentation Becomes an International Health Issue

Over the years, various medical reports raised questions about the long term safety of breast augmentation implants, and several women’s health organizations began to receive complaints from women who had experienced health problems following breast augmentation, either as reconstructive surgery following mastectomy for breast cancer or in conjunction with plastic surgery performed for purely aesthetic motives.

In 1990 the first Congressional hearings were held on the safety of silicon implants. The claim was that the improved surgical procedures being used for breast augmentation had only served to mask long-term side effects of silicone leading to major medical problems in some patients. A $7.3 million dollar damage claim against the developer of the gel implant, Dow Corning, made worldwide news, and further legal suits were initiated, with plaintiffs claiming symptoms ranging from chronic fatigue, rheumatoid arthritis, lupus, immune system damage, scleroderma (a hardening of skin and internal organs), and even emotional problems. The Dow case was settled in 1998 for $3.2 billion distributed among 170,000 women plaintiffs.

In 1992 the FDA declared a moratorium on silicone gel implants, pending further medical studies, although the FDA committee could find no direct evidence that many of the reported illnesses were due to silicone implants.

Throughout the remainder of the 1990s and into the 21st century the demand for silicone gel implants declined, being limited by the FDA only for reconstructive surgery subsequent to a mastectomy or replacement following prior silicone implant surgery. However, the overall demand for breast augmentation surgery continued and increased.

Back to the Drawing Board

And because women still continued to demand breast augmentation, medical science went back to the laboratory and intensified its search for better breast implants, and surgeons continued their efforts to develop techniques to avoid complications or negative side effects.

Not all innovations were successful. In 1995, the trilucent breast implant was released in Europe. This soybean-oil-fat-based product was regarded as a natural approach to breast augmentation, and about 9,000 women worldwide underwent the treatment prior to its 1999 withdrawal. Again, this breast augmentation implant was found to contain a substance—in this case a filler—that could become toxic as it deteriorates. Trilucent implants were never approved for use in the U.S.

In 1999, the Institute of Medicine, part of the National Academy of Science, a nonprofit, non-government, organization, issued a 400-page report that concluded that silicone breast implants do not cause major illnesses. The report did, however, acknowledge the tendency for the implants to leak or rupture, leading to infections, hardening and scarring, but scientists had found no link to more serious systemic disease.

Rupture remained a concern with saline implants as well. Although saline (salt water) filled, inserts had been marketed for years and saline presents no threat to the body when reabsorbed, the FDA had not yet approved them. In fact, the FDA issued a warning because of the high rate of saline rupture, which often mandated additional breast augmentation surgeries. To date, issues with saline implants have not been fully resolved.

More Research – More Innovation – More Demand

In 2005 alone, more than 291,000 U.S. women had breast augmentation solely for cosmetic reasons, making it one of the most frequently performed cosmetic plastic surgeries—and representing a 37% increase since 2000. In 2005, the most recent year for which statistics are available, a full 49% of these patients fell in the age group of 19-34, and 42% in ages 34-50, together comprising the bulk of all cases. The western region of the U.S., including California, saw the largest number of breast augmentations performed; 34% of the total.*

Also in 2005, 58,000 women had breast reconstruction after mastectomies, according to the American Society of Plastic Surgeons. During the same period, 25,000 women with cosmetic implants and 15,000 women with reconstruction implants had them surgically removed.*

In spite of the on-going controversy over this emotionally charged issue, breast augmentation implant surgery has evolved into a practice more commonplace than, for instance, hip replacement.**

Good News…and a Broader Choice of Implants

In November 2006 the FDA announced the approval of silicone implants manufactured by Allergan, Inc. and Mentor Corp. for use in cosmetic breast augmentation surgery, ending restrictions imposed some 14 years ago on this type of implant for cosmetic use.

“The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices,” the FDA stated in making the ruling. “This information is available in the product labeling and will enable women and their physicians to make informed decisions.”

This newer form of silicone implants—with a thicker, cohesive gel—has been widely used in the US for some time for breast surgery designated as “reconstructive”; that is, anything from breast lifts combined with implants to post-cancer restoration.

The new silicone implant gel technology is cohesive, which means that it defies diffusion when rupture occurs, behaving more like a viscous gel than a liquid. Would a leak to happen, this material would be less likely to seep into local tissues and cause inflammation.

An alternative cohesive implant, the Inamed 410, or “gummy-bear” implant, shows promise, although until receiving FDA approval in November 2006 has been unavailable to all but the handful of US surgeons involved in the product’s original study. This implant boasts superior shape and is anticipated to become very popular for cosmetic implantation of silicone implants. The implant is manufactured by Inamed, now part of Allergan, Inc.

The FDA approved the implants for use in cosmetic surgery on women over the age of 22 after carefully reviewing safety data over the past decade. The FDA has also stipulated that the manufacturers must continue follow up safety studies. As a condition of the implants’ approval, each company agreed to conduct a study tracking 40,000 women for ten years after receiving silicone implants and must also continue lab studies on implant failures.

This development, coupled with recent studies disproving any link between silicone implants and systemic disease, have now lessened the fear and greatly broadened the options available to any woman seeking cosmetic breast augmentation. The decision of whether to use saline or silicone implants is still one, which should be made by a Board-Certified Plastic Surgeon and should be tailored specifically to the individual patient.

Throughout its turbulent history, one fact remains clear: Breast augmentation retains its place as the highest-rated plastic surgery in terms of patient satisfaction. †

*Source: American Society of Plastic Surgeons, Procedural Statistics report, 2005.
**Source: Center for Disease Control, National Center for Health Statistics, Inpatient Procedures report, 2005.
†A 2004 study by the American Society for Aesthetic Plastic Surgery of 3,000 women with silicone and saline implants showed that 69% of the silicone patients and 77% of the saline patients referred to getting implants as “a great decision.” (1,362)

Copyright © 2006 by Dr. Scott W. Mosser. This article may not be copied or reproduced in any form without the written permission of Dr. Scott Mosser. Internet links to the sub-page containing this article are permitted.