History of Breast Implants and Breast Augmentation
Timeline of the History of Breast Implants
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1890
- First surgical breast augmentation procedure was performed with paraffin
injections
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.
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
