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Enhancement facts

Example content imageSilicone gel implants were banned in 1992 by FDA.

Example content imageIf you have a ruptured silicone implant, you will be denied Health Insurance Coverage.

Example content imageSaline-filled implants tend to have a higher rate of leaking than silicone gel.

Example content image21% overall increase in breast cancers for women with implants.

More about implant and surgery

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early 250,000 women received breast implants for cosmetic reasons in the United States in 2002. Seen as an extreme byproduct of a beauty-obsessed culture by some and a valid method of self-enhancement by others, today's implants come out of a hundred-year history of efforts to enlarge the female bosom. Click on the timeline for key events in the quest for a bigger bust line.
1890s-1910s: Paraffin injections

araffin injections, developed by Austrian surgeon Dr. Robert Gersuny in the 1890s, mark the first medical approach to breast augmentation. Serious problems result, including infection, hardening of the breast and formation of tumor-like lumps, and the technique is abandoned by the 1920s.

1920s-1930s: Fat transplants

n the 1920s and '30s, surgeons experiment with fat transplantation in which fatty tissue is surgically removed from the abdomen and buttocks and transferred to the breasts. But the body tends to quickly reabsorb the fat, often in a lumpy, asymmetrical manner, sometimes leaving calcifications behind. The resulting scar at the removal site further limits the appeal of the procedure, which falls out of favor by the 1940s.

1940s to mid-1960s: Silicone shots

iquid silicone injections appear about the time of World War II among Japanese prostitutes, reportedly in an effort to appeal to American servicemen. The method, often performed by people without medical training using industrial-grade silicone, becomes popular among topless dancers in San Francisco and Las Vegas in the early 1960s. By the mid-'60s, reports of serious complications — including chronic inflammation and tumor-like lumps and infections that can necessitate mastectomy, as well as organ damage resulting from migration of the silicone — push the method out of mainstream medicine, though the practice continues to pop up in underground circles, most recently among thousands living in South Florida since 2000.

1950s to early 1960s: Plastic sponges

octors begin implanting polyvinyl sponges in breasts in the 1950s. Several other synthetic sponges made of materials such as nylon, polyurethane and Teflon become available in the '50s and early '60s. Women are initially satisfied but many find that the implants harden and shrink within a year. Removal proves to be disfiguring for some and impossible for others as the breast tissue can infiltrate the sponge's pores. Other complications, including infections and inflamed tissue, and a study linking polyvinyl to cancer in rodents prompt surgeons to search for a better solution. Doctors continue to experiment, attempting to implant glass and ivory balls, wool and ox cartilage.

Silcone breast implants1961: Silicone sacs

ouston plastic surgeons Drs. Thomas Cronin and Frank Gerow develop the first silicone breast prosthesis in conjunction with Dow Corning Corp. in 1961. The silicone rubber sac filled with a jelly-like silicone gel is first implanted the following year, and Dow Corning starts marketing the device in 1963. Dozens of improved models, with thinner, seamless sacs and thicker gel are developed over the next 30 years, but the basic design remains the same.

Saline breast implant1965: Saline implants

he saline implant is introduced by Dr. H.G. Arion of France in 1965. But the inflatable device, which consists of a silicone rubber sac filled with a sterile salt water solution after implantation, is initially deemed inferior to the silicone gel version by some doctors and patients because it is prone to spontaneous deflation and some women complain that the liquid filler doesn't feel as natural as gel. The device eventually comes to dominate the U.S. breast implant market in the 1990s.

1980s: Foam coating controversy

n an attempt to deal with the most common complication of silicone implants — capsular contracture, the formation of hard scar tissue around the implant — silicone gel-filled implants covered with polyurethane foam thought to ward off the problem become popular in 1982. By the time the FDA releases a report a decade later showing that polyurethane foam can break down in the body to form a carcinogen, more than 100,000 U.S. women have them. Manufacturers soon withdraw the implants.
      By the late '80s, surgeons, the FDA and consumer advocates begin to question silicone's safety as they find that the gel often leaks out of the sac into the body.

Dr. David Kessler1992: Stop to silicone

n response to concerns that silicone breast implants might precipitate autoimmune diseases, FDA commissioner Dr. David Kessler declares a voluntary moratorium on their use in January 1992. A few months later, after manufacturers are unable to prove safety to the government's satisfaction, the agency rules to severely restrict the availability of silicone gel-filled implants. They remain an option only for women who need a replacement for a failed implant or for those who desire reconstruction after cancer or injuries. Women whose desire is solely cosmetic can use only saline implants.
      Dow Corning leaves the breast-implant business, as do two other makers — Bristol-Myers Squibb and Bioplasty.
      Meanwhile, the ruling sparks a flurry of research on alternative implant fillers such as peanut and soybean oil, and sugar and starch mixtures.

Trilucent breast implant1995-2000: Soybean implant scare

rilucent breast implants, filled with fat from soybean oil, are launched in Europe in 1995. Marketed as a "natural" alternative to silicone, about 9,000 women worldwide — about half in Britain — receive them before they are withdrawn in 1999 due to concerns that the filler may become toxic in the body as it breaks down. The U.K. Medical Device Agency recommends in 2000 that all women with the implants have them removed and warns women who have the implants not to get pregnant or breast-feed before the removal surgery as a precautionary measure. The scare prompts the reevaluation of breast-implant safety in Britain, and the government subsequently pulls two hydrogel (a mixture of salt, water and sugar) implants from the market because of lack of safety data. Soybean and hydrogel implants have never been approved for sale in the United States.

breast enhancement1998: Stunning settlement

ow Corning, once the biggest maker of silicone breast implants, settles a class action lawsuit brought by 170,000 women for $3.2 billion. The agreement is included in the company's bankruptcy plan.

1999: Landmark report

he Institute of Medicine — the medical arm of the prestigious National Academy of Sciences — issues a 400-page report concluding there is no reason to believe that silicone breast implants cause major illnesses such as rheumatoid arthritis, lupus or other systemic diseases. The main safety concern, the report says, is the implants' tendency to leak or rupture, which can lead to infections, hardening and scarring of breast tissue. Plastic surgeons say the report opens the door for the return of silicone breast implants for cosmetic use.

Saline breast implant2000: Saline implants OK’d

DA approves two saline implants that have been on the market for years. (They had been available without an official safety decree because of a provision that allowed products already on the market when the agency first began regulating medical devices in 1976 to continue being used.) The FDA does, however, warn that saline implants break at "alarmingly high" rates and tells the manufacturers, Mentor Corp. and McGhan Medical, they will be allowed to continue selling the devices as long as women are informed that many of them will need additional surgery.

The Brava Breast Enhancement and Shaping System2001: Vacuum bra

he Brava Breast Enhancement and Shaping System, a bra-like device that consists of two hard plastic domes ringed with silicone that fit over the breasts, covered by what looks like a sports bra, hits the market in 2001. The air is sucked out of the domes, creating a vacuum that the product's McGhan cohesive gel implantmanufacturer says induces the breast tissue to grow approximately one cup size. The device, which must be worn for 10 hours a day for months, is available through plastic surgeons, dermatologists and gynecologists. Also in 2001, manufacturers begin clinical trials of cohesive gel implants made from silicone. The more viscous filler is thought to reduce the risk of gel migration.

Silcone breast implants
Alex Wong / Getty Images
2004: Key FDA decision

DA votes to continue its ban on most silicone gel breast implants, saying serious questions remain about how often the devices break apart and the physical damage that can result, as is shown in this photo of breasts with silicone implants removed. The agency outlines new guidelines for all manufacturers on the scientific issues that must be settled if the devices ever are to return to the market. Inamed Corp., which led the effort to legalize the products, pledges to seek FDA approval again.

 

More: Evils of breast enhancement surgery

Sources:

“Venus Envy” (Johns Hopkins University Press, 1997); American Society of Aesthetic Plastic Surgery; “History of Breast Prostheses,” Plastic Surgical Nursing, Vol. 19, No. 2, 1999; MSNBC research.