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History of Breast Implants and Breast Augmentation


  • Timeline of the History of Breast Implants


                                       History of Breast Implants on

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1890 - First surgical breast augmentation procedure was performed with paraffin          


  • Led to infections

  • Hardening of the breasts

  • Lump formations in the breast

  • By 1920s paraffin injections were removed from the market.


1920 - Introduction of fat transplants

  • Fatty tissue was surgically removed from the belly and buttock areas and transferred into the breasts.

  • A prominent scar from the actual removal site occurred.

  • This procedure proved unsuccessful because the body would reabsorb the fat, leaving the breast lumpy and lopsided.

  • Because of the undesirable result, this procedure was abandon by 1940.




1950’s - Polyvinyl sponges started to be implanted into the breasts for

                breast augmentation

  • Different types of synthetic sponges were also tried

  • The results were very temporary due to the fact it wouldn’t last longer than a year.

  • The sponges ended shrinking and becoming very harden.

  • Infections and inflamed tissue.

  • A link was found between this type of breast augmentation surgery and cancer.


1960's - Silicone injections directly into the breast

  • Japanese cosmetologists injected liquid directly into women’s breasts became so popular that silicone was difficult to find.

  • Chronic inflammation, infections, and lumps.

  • This free floating silicone would migrate to other organs in the body and cause lumps and organ damage.

  • There was a direct link at this time with the infections leading to mastectomies.

  • Because of the severity of these problems, silicone injections were quickly taken out of the mainstream. However, it is still being done today in certain underground circles. 


1961 - The first silicone breast implant was developed – First Generation Implants

  • Thomas Cronin, M.D. and Frank Gerow, M.D. two Houston, Texas, plastic surgeons developed the first silicone breast. prosthesis with the Dow Corning  Corporation in 1961.

  • The Cronin-Gerow implants were made of a (anatomical or tear drop) shaped silicone rubber envelope, filled with a and thick - viscous silicone gel with a Dacron patch (to reduce rotation of the implant) on the posterior shell.

  • These were the First Generation Implants.

  • The first woman was implanted with silicone implants in 1962, Timmie Jean Lindsey.

  • In 1963, breast augmentation surgery began to be marketed with constant improvements over the next 30 years.

  • These new silicone implants changed the history of breast implants forever, as they were extremely popular and the envelope design provided a natural shape and feel.

  • These included double-lumen, reverse double-lumen, triple-lumen, smooth surface, textured surface, polyurethane-covered, thick shell, thin shell, barrier shell, and  implants of varying gel cohesiveness.

  • The worst complication was capsular contracture in which in 1982, it was attempted to combat this with covering the implant with polyurethane foam.


1965 - A French surgeon developed the first saline filled prosthesis

  • Considered inferior by the medical community since it was prone to spontaneous deflation.

  • Women felt that the feel of saline filled prostheses weren’t as natural as those filled with silicone gel.




1970 – Second Generation Breast Implants were made in response to a more

             lifelike implant.

  • Silicone implants were redesigned in the 1970s with thinner, less cohesive gel and thinner shells.

  • It was these implants that had a greater tendency to rupture, and also had

  • significant “gel bleed”.

  • Complications of capsular contracture were very common.

  • Polyurethane foam coating on the implant shell which was very effective in diminishing capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule.

  • Predominantly implants of this generation were the ones involved in the United States class action-lawsuits against Dow-Corning and other manufacturers in the early 1990s.


1977 - First lawsuit filed against silicone implants.

  • Richard Mithoff, a Houston attorney, wins the first lawsuit for a Cleveland woman who claims that her ruptured implants a and subsequent operations had caused pain and suffering. She receives a $170,000 settlement from Dow Corning. Case receives little publicity.


1980 – Ralph Nader’s Group in Washington sends out a warning about silicone implants.


1982 - Silicone breast implants were withdrawn due to safety concerns.

  • During the decade that followed; over 100,000 women had gotten this type of implant with the polyurethane foam. It was during this time that the FDA released a study citing the polyurethane foam can break down inside the body and form a carcinogen.

  • During the late 1980s the silicone implants were also found to have substantial gel bleed out of the implant envelope, raising many concerns of free floating silicone in the body.

  • All silicone implants were taken off of the market to the general public.


1985 - Third & fourth generation implants - from the mid 1980's, were introduced.

  • Advances in manufacturing with elastomer-coated shells to decrease gel bleed.

  • The implants were filled with a much thicker, more cohesive gel.

  • Both round and tapered implants were being used in the clinical studies.


1991 - FDA held an advisory panel meeting on silicone gel-filled breast implants.

  • Manufacturers were sent Pre-market Approval Applications (PMAAs) for review with listing of major and minor deficiencies of Silicone Implants.

  • Bristol-Meyers Squibb Company announced its decision to withdraw from the breast implant market and closed the plastic surgery unit of its Surgite subsidiary.




1992 - Only saline-filled implants were allowed in the American general market for

             cosmetic breast augmentation. Silicone breast implants were only available

             to patients who met the criteria through FDA Approved Trials.

  • FDA called for a 45 day moratorium on the sale and use of silicone gel-filled breast implants. Later moratorium extended  until 2006. Saline implant use allowed.

  • Mentor began its Core and Adjunct Studies.

  • Bioplasty announced withdrawal of its Pre Market Approval Applications for its Single and double-lumen gel-filled breast implants.

  • Dow Corning Corporation announced a withdrawal for PMAAs for silicone gel-filled breast implants.

  • FDA announced that silicone gel implants could be used in reconstruction only under

  • the study guidelines, however  not for cosmetic purposes.


Mid 1990's - Evaluation of "gummy bear implant" – Fifth Generation Implants

  • These implants were solid, high-cohesive, form-stable implants.

  • Preliminary stages in the United States during this time, but these implants have been widely used since the mid 1990s in other countries.

  • The chance of silicone migration is eliminated with these highly cohesive implants.


1994 – Mayo Clinic epidemiologic study is published.

  • The New England Journal of Medicine finds no increased risk of connective-tissue disease and other disorders that in women with silicone implants.


1994 - Anatomical Implants were introduced.

  • These implants created a more naturally sloped breast contour. 

  • Whether such implants actually produce a more natural breast shape is still controversial.


1995 – Dow Corning files for Chapter 11 Bankruptcy.

  • Dow at this time was facing 20,000 lawsuits, some with multiple plaintiffs and about 410,000 potential claims that had been filed in the global settlement.

  • Litigation was halted due to the bankruptcy.


1995 – Soybean Oil implants were introduced.

  • First launched in Europe, this implant was a tri-lucent breast implant filled with fat from soybean oil.

  • A natural approach to breast augmentation; over 9,000 women worldwide ended up receiving these implants.

  • Withdrawal from the market was in 1999.

  • This breast augmentation technique contained filler which when broken became toxic in the human body.

  • This implant never received approval in the United States.


1998 – Dow-Corning’s historic class action lawsuit in the amount of $3.2 billion is settled


1998 - McGhan received approval to initiate its Core and Adjunct Studies


1999 – (June) -The Institute of Medicine releases a 400 page report on the safety of

             silicone implants

  • It is concluded that although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause any major diseases such as lupus or rheumatoid arthritis.

  • The Institute of Medicine is part of the National Academy of Sciences, the nation's most  prestigious scientific organization.




2001 -   Brava Breast Enhancement and Shaping System was introduced

  • Bra-like device surrounded with silicone that creates a vacuum over the breasts that  induce the breast to possibly grow about one cup size.  Must be worn 10 hours a day for several months to create a breast augmentation effect.  The idea  here is an augmentation method without implants.

  • This device has not found any satisfactory result with breast augmentation.


2005 FDA approved Mentor's application to market-Memory Gel Implants



2006 November 17, the FDA (USA) re-approves silicone breast implants

  • After 14 year moratorium, the FDA approved silicone breast implants to women in the United States.

  • The new silicone implants are made with a much stronger shell/envelope, and the silicone gel viscosity is so much more cohesive in nature than the older style silicone implants.

  • The anatomical gummy bear implants were not approved for general use, and one still needs to be in a study in order to get these implants.

  • The American Society of Aesthetic Plastic Surgery applaud the FDA decision ASAPS Press Release of Silicone Implants Approval.



2007 – November - FDA approved Allergan's application to market its silicone

             filled  breast implants. 


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