Although a crude form of cosmetic surgery has been around for centuries, it was not perfected until after World War I, following the popularized use of plastics, anesthesia and modern surgery.

Similarly, breast implants and their founding science have also evolved throughout the latter half of the twentieth century, despite the fact that their roots began much earlier.   

Late 1800s To Mid 1900s

1889 marked the first period of serious investigation and invention, when physicians injected a wax substance called paraffin into the breast. However, the injections failed, instead causing the original breast tissue to die. After physicians learned the detrimental effects of the paraffin, they experimented with various other substances, including the patients’ own fat, ox cartilage, glass balls, sponges, rubber and—in the middle of the twentieth century—Teflon.


During World War II, Japanese prostitutes who believed that American soldiers preferred women with larger breasts used paraffin, sponges and silicone as makeshift breast implants. Frontline cites this as one of the first uses of silicone. 

1950s and 1960s

Unlicensed practitioners continued to experiment with different substances, returning to paraffin and petroleum jelly as injectable solids, as well as samples of silicone jelly mixed with vegetable oil, beeswax and epoxy. All of these treatments caused significant damage and even death. 

By this time, Dow Corning had developed a medical grade silicone that some physicians were using, and complications suffered began to decrease significantly.


After Dr. Thomas Cronin and surgical resident Thomas Biggs created a prototype of a silicone breast implant and placed it in a dog, Timmie Jean Lensey received the first silicone breast implants in the United States. These implants were not injections, but rather silicone-filled implants. Injections lost favor after this period. 


The FDA allowed Dow Corning’s silicone to be used as an experimental medical device in the United States. They did not, however, condone the silicone's use in the breast, yet many physicians were still injecting with silicone. Complications of direct silicone injections included: cysts, breast disfigurement, respiratory illnesses and liver dysfunction. 


Nevada outlawed breast injections. 

Congress passed the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.  Breast implants were considered medical devices and were classified into Class II of the Act, meaning they were not tested before they were marketed.


The FDA reclassified breast implants as Class III medical devices.  As Class III devices, breast implants now had to undergo rigorous testing before they could be marketed. 


The FDA permitted silicone breast implants to remain on the market, following testing and public hearings.


The FDA recommended that silicone breast implants be taken off the market. Later that year, the FDA recommended that silicone implants only be used for women who were undergoing reconstructive surgery or having implants replaced. 


The FDA approved the use of two types of saline-filled breast implants


The FDA again approved the use of silicone breast implants but required a minimum age for each patient. 


In 2010, nearly 320,000 American women and 10,000 British women had breast implants performed, as reported by The Guardian.


French company Poly Implant Prosthesis (PIP) was accused of making silicone breast implants with non-medical grade silicone. Women in France and Great Britain were encouraged to have their breast implants removed.


Sientra Inc., an American implant manufacturer, received approval for its silicone breast implants, but was required to continue post-surgery studies to investigate their safety.

Regulatory commissions are still investigating the safety of the device. For a more thorough history of regulation in the United States, visit the FDA’s history of implant regulation.