1889 - Austrian physician Dr. Robert Gersuny tested paraffin injections with disastrous results, but experimentation with the method continued until the 1920s.

1895 - German surgeon Vincenz Czerny attempted the first known breast “implant” using tissue from a benign growth on a woman's back.

1900 - 1940s - A wide range of materials were used in experimental cosmetic implants, including: polystan strips wound into balls, ground rubber, ivory, ox cartilage, terylene wool, polyester foam sponges and glass balls.

The 1920s brought about attempted fat transplants. Fat transferred from the belly or buttocks to the breasts didn't remain long, as it was quickly reabsorbed by the body. The procedure lasted for about 20 years until being discontinued in the 1940s because of the lumps, asymmetry and scarring it caused.

World War II - Silicone injections were used by some Japanese prostitutes. This sparked an underground trend that lasted until the 1960s, when problems arising from the injections (inflammation and lumps, among others) became widely known.

1950s - Several kinds of polyvinyl sponges were used as implants but only lasted for about a year, after which they began to shrink and harden.

1961 - The first silicone breast implant was developed by two Texas plastic surgeons, Frank Gerow and Thomas Cronin.

1962 - Timmie Jean Lindsey of Houston, Texas became the first woman to receive breast implants.

1963 - Silicone breast implants were first marketed to the public.

1964 - Saline implants were first manufactured in France.

1982 - In response to safety concerns about silicone breast implants, they were covered with a polyurethane foam. This practice lasted less than a decade.

1988 - Dow Corning, one of the largest implant manufacturers, settled a $3.2 billion class-action lawsuit for its silicone implants by 170,000 women.

1992 - FDA Commissioner David Kessler asked implant manufacturers to impose a voluntary moratorium on silicone implants in the U.S. He requested that silicone implants only be available in special circumstances and saline-filled implants be used instead.

1995 - Soybean oil implants were introduced in Europe, but were later withdrawn in 1999 when it was found that the oil could become toxic. In 1995, cohesive gel implants were also first introduced in Europe.

1998 - The American public became more aware of the potential problems and risks of silicone breast implants through popular media. On an episode of her talk show that year, Jenny Jones revealed her personal story of silicone breast implant failure and removal.

1999 - By Congressional request, the Institute of Medicine released a 400-page report concluding that silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants themselves don’t cause any major diseases.

November 17, 2006 - The FDA approved silicone breast implants, calling them "one of the most extensively studied medical devices.”

Today - In the U.S., the fifth generation of silicone implants is in its evaluation stage. Studies already show vast potential improvements in safety and effectiveness over older silicone implants, and new products like cohesive gel implants are being introduced.

The official FDA press release regarding the moratorium on silicone breast implants from January 6, 1992 :

"The Food and Drug Administration today called for a moratorium on the use of silicone gel breast implants until new information on their safety can be thoroughly reviewed by an independent advisory panel and the agency can make a final decision in light of the panel's review.

FDA Commissioner David A. Kessler, M.D., said, "We want surgeons to stop using these implants in patients until this new information can be thoroughly evaluated…Women considering breast implants deserve to know whether these products are safe enough for use. I'm calling for a delay in the use of these products until our advisory panel can meet to consider new information which was not available when it met in November. …” Read the full press release HERE

The official FDA press release approving silicone breast implants from November 17, 2006:

"After rigorous scientific review, the U.S. Food and Drug Administration (FDA) today approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.  The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif.

'FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products,' said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. 

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

Now that the products have been determined to be safe and effective, FDA will continue to monitor them by requiring each company to conduct a large postapproval study following about 40,000 women for 10 years after receiving breast implants.  FDA often requires postmarket studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events. " Read the full press release HERE

 

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