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According to the American Society of Aesthetic Plastic Surgery (ASAPS), nearly 400,000 breast
implant operations were performed in the USA during 2007, a rise of 4% on the previous year.
In the UK, data from BAAPS, the British Association of Aesthetic Plastic Surgeons shows that the
appetite for a full bosom is just as strong here as in America, with just under 6,500 breast
augmentation operations performed by its members in 2007, up 6% on the 2006 audit; making it
the most popular cosmetic surgery procedure in the UK, and accounting for 20% of all cosmetic
surgery operations carried out by BAAPS members.
Add to that data from The Harley Medical Group, one of the UK's largest cosmetic surgery chains,
who have seen the demand for breast enlargement rise by 39% in the last 25 years, and who note
that it accounted for 30% of all procedures performed in its clinics in the last 12 months, and it
shows the obvious popularity of this procedure.
Industry analysts Mintel also put the UK spend on breast augmentation in 2005 at
£100million with expectations that this will rise dramatically year on year.
With such a strong demand, it's no surprise to discover that both new developments in implant
technology and alternative techniques and procedures for breast augmentation have dominated
research by many aesthetic companies in recent years.
In this month's feature article we look at some of the new ways companies are offering to give you
the bust you always dreamed of.
A Brief History of Breast Augmentation
There are many reasons why women choose to seek a breast augmentation or enhancement
procedure. Whether for reasons of self confidence and dissatisfaction with the size and shape of
their breasts, or because of congenital abnormalities from birth, asymmetry, trauma, such as post
cancer mastectomies, or simply to regain the breasts that they feel they had before childbirth and
breast feeding. Breasts denote a feeling of womanliness and therefore hold great psychological
power over the female mind. Hence, methods of breast enlargement have been dabbled with,
sometimes with the most dubious of substances, from the early 1930s onwards.
The first breast implants were developed by two plastic surgeons from Texas, Frank Gerow and
Thomas Cronin, in the early 1960s. These were filled with silicone and signalled the beginning of
the breast implant revolution as we know it. Saline implants filled with a salt water solution were
introduced in 1965.
2. In the early 1990s, breast implants became the subject of heated controversy as reports of women
claiming their silicone implants had seriously damaged their health became widely publicised in
the American media. This, and a handful of court cases, caused the U.S. Food and Drug
Administration (FDA) to issue an outright ban on the use of silicone-gel filled implants for cosmetic
augmentation in January 1992. At the time many claimed that this was politically and socially
motivated rather than based on any scientific proof; and following the submission of large scale
clinical data from the various manufacturers involved, the ban was subsequently lifted in 2006.
Due to the 14 year gap, saline implants dominated the market in the U.S., whilst with no such ban
existing or ever having existed in the U.K. silicone implants have always been the favoured option.
Although with the more natural shape and feel achievable with silicone filled devices and the
advancements in their make-up during the interim period, many U.S. surgeons are now starting to
turn away from saline since the lifting of the FDA ban, with ASAPS statistics showing a move to a
60 - 40 split of saline versus silicone procedures last year, up from an 80 - 20 split in 2006.
Traditional taboos regarding breast augmentation have also fallen by the wayside in recent years,
with more and more woman in their thirties, wanting a natural outcome with a modest increase in
breast size, following pregnancy and childbirth turning up in the surgeon's waiting room. Breast
implants are no longer simply the choice of the glamour model, lap dancer or celebrity copying
teenager. Implant manufacturers themselves have also noticed a growing trend in the demand for
smaller implant sizes and more natural, anatomical shapes which are preferred by this
demographic.
So What's Involved in Breast Augmentation Surgery?
Aside from the type of implant to be used, the primary consideration involved in a breast
augmentation operation is deciding if the implant should sit above or below the pectoral or chest
muscle within the breast area.
If the implantation is carried out above the muscle, but below the glandular breast tissue, this is
referred to as 'sub glandular'. Conversely, an implant placed below or underneath the muscle is
referred to as 'sub muscular'. In both cases, an incision is generally made either below the base of
the breast, in the natural crease created there by gravity, or within the armpit area adjacent to the
breast. A pocket is then created by separating out the various tissues, into which the implant can
be safely and correctly fitted without causing any 'squashing' of the implant due to an inadequate
sized pocket.
The decision regarding the most appropriate method and implant type to use on an individual
patient is often reliant on the structure of the chest area prior to surgery, with considerations such
as how much natural breast tissue is already available and the integrity of it, as well as the BMI of
the patient all factoring into the decision making process for the surgeon.
Mr Rajiv Grover, Consultant Plastic Surgeon, Secretary of the BAAPS and medical advisor to The
Consulting Room(TM) comments on a recently pioneered technique which he believes has
revolutionised his practice.
"The American surgeon John Tebbetts introduced the concept of the 'Dual Plane' which differs in
placing the implant below the muscle but also separating the gland from the muscle so the two can
slide on each other. This allows a woman who is thin and has a minor degree of droop to have
3. breast enlargement, but also the implant can give the nipple a lift without needing a specific uplift
which would leave scars on the breast."
"Most surgeons who perform a lot of this operation would probably agree that you need to place
the implant where it would look most natural for each patient. I use 65-70% under muscle (usually
with dual plane) and 30-35% above muscle (sub glandular)"; concludes Rajiv.
Other, more controversial techniques have been tried in recent years, including the placement of
saline implants in the breast area (prior to filling) following an incision in the umbilicus or belly
button area, aimed at avoiding any scarring in the breast area. Dissecting the pocket for the
implant from this access point is considered to be very inaccurate and creating the finer nuances
of symmetry and breast cleavage is not as controllable so many surgeons regard this as more of a
marketing gimmick rather than a tried and tested technique for breast augmentation.
Breast augmentation is primarily performed under a general anesthesia in a hospital setting,
although some offer a 'twilight sedation' method involving the use of a local anesthesia and a
sedative, so you remain awake throughout the procedure, but in a drowsy state with no feelings of
pain or discomfort. If there is no facility for an overnight stay at the clinic where the surgery is
being carried out, such ambulatory or out-patient practices may be more commonplace, especially
in America. Most surgeons would argue that the use of a full general anesthesia gives them
maximum control and safety and would generally recommend this as the best option for their
patients. Certainly this is the preferred option in the UK.
Surgery to enlarge or enhance the breasts isn't something to be taken lightly, and carries as many
risks as would be associated with other types of surgery, both from the anesthesia and the
possibilities of scarring or post-surgical infections.
A condition known as 'capsular contracture' is one of the most common risks or complications
following breast implant surgery. This happens because, if a foreign body, such as an implant, is
introduced into the chest, your body will automatically grow a wall of 'scar tissue' around it as a
protective process against the 'alien invader'. This scar tissue can then contract, pushing into the
implant and causing it to deform. Often, the implant becomes hard and, in some cases, painful.
The implant may then have to be removed, along with the capsule of scar tissue and replaced, if
appropriate, with another implant.
Recent changes in implant design with the introduction of textured implants (implants that have a
roughened surface as opposed to a smooth one) and cohesive silicone gel which does not leak or
bleed from the implant have reduced the likelihood of capsular contracture from an estimated 15%
of all cases, 10 years post surgery, to a rate of more like 4 - 5 %.
New Advances in Implant Technology
According to Millennium Research Group's Global Markets for Breast Implants 2008 report, the
U.S. breast implant market was worth over $378 million in 2007 and is expected to grow by at
least 10% a year to over $620 million in 2012, driven in large part by the FDA re-approval of
silicone breast implants.
The two market leading, global manufacturers of silicone and saline breast implants are Mentor
4. Corporation and Allergan Inc., (having previously bought out Inamed Inc. in 2006); although
several other smaller manufacturers exist, such as Nagor, Poly Implant Prosthesis, Eurosilicone
and Polytech Silimed.
All of Allergan's and Mentor's silicone gel implants are now made from an outer silicone shell and
an inner cohesive silicone gel filling, which means that the gel filler acts as a solid, rather than a
liquid, and cannot leak, whilst still retaining a natural feel that is said to better resemble actual
breast tissue. This advancement in silicone technology has yet further increased the safety rating
of silicone implants, compared to earlier more liquid developments.
In America, such cohesive silicone gel implants have been nicknamed 'gummy bear' implants due
to the comparison of the consistency of the implant, if you were to cut one in half, with that of the
children's jelly sweets.
Rajiv Grover believes the most revolutionary advancement in implant technology to arrive in recent
years is the introduction of the 'tear drop' shaped implant, which allows a more natural look for
women who have a thin chest, particularly after breast feeding.
The move away from the typical spherical or round shaped implant to more anatomically
contoured developments, which are thinner at the top than at the bottom, thus mimicking the effect
gravity has on normal breast tissue, has meant that surgeons are now able to offer their patients a
result which is more aesthetically pleasing; looking less like a person has actually had breast
implant surgery.
Such contoured or 'tear drop' implants are available in a variety of shapes according to two
differing parameters, known as implant height and implant profile or projection. The height refers
to the size and shape of the implant footprint, i.e. the section that sits against the chest itself once
implanted. This choice will vary according to how wide or narrow the patient's chest is. The profile
or projection refers to how far outwards the 'drop' on the tear comes away from the chest, as a
natural breast would. The actual cup size or volume can then be decided on once the anatomical
shape has been established.
Another recent advancement in implant technology is the adjustable implant designed to correct
the problem of asymmetry or 'lop-sided breasts', where one breast is either significantly smaller
than the other, sometimes by as much as one cup size, or where one sits higher than the other on
the chest. Asymmetry can arise due to congenital defects that a person was born with, or acquired
through trauma or childbirth and breastfeeding. Such problems can cause self consciousness and
low self image, which can dramatically impact on lifestyle and relationships.
Consultant Plastic & Reconstructive Surgeon, Mr. David Ross, who heads Plastic Surgery
W1 in Central London, says: ''There is no doubt that breast asymmetry can have a profound effect
on many women's quality of life. For these women it is important to correct this, which is why they
opt for surgery."
According to a recent UK survey of 2,500 women carried out by Mentor Medical Systems, a third
of those polled were not happy with the shape of their breasts, with 15% only being happy once
they had added some form of padding to the area. 1 in 10 respondents also claimed a whole cup
size difference between their breasts, while a third said one sits lower than the other.
5. Mentor has now developed their unique Spectra® range to address the problem of moderate
asymmetry. Their round implant is designed on the principle of a bag-within-a-bag, whereby an
outer textured silicone casing holds an adjustable inner chamber which is filled with a saline
solution via a self-sealing valve system and tubing. This enables the surgeon to alter the volume of
each implant individually during the operation until the desired level of symmetry is obtained, at
which point the tubing is removed.
This system differs from a traditional single shell saline implant as the outer silicone casing comes
in a variety of densities with a differing size inner vessel for saline inclusion. This gives the
implants more of the natural breast mimicking qualities of cohesive silicone gel implants but with
the added adjustability created by the addition of saline within to correct any asymmetries.
Alternative Solutions for Breast Augmentation
Fat Transfer
The potential use of fatty tissue for breast augmentation has been talked about for years, both
within the medical field and amongst the layperson. Most women out there will admit to having
thought at one time or another, "wouldn't it be great if only I could move the fat in my bottom up to
my breasts instead".
Previously, although some surgeons have tried to graft liposuctioned fat from the thighs, buttocks
or abdomen into the breast region, transplantation has been far from successful with results
remaining only temporarily as the fat is ultimately absorbed by the body. Additional more serious
complications, such as fat calcification or hardening of the injected fat cells, which cause benign
lumps within the breasts, have also been reported. Such lumps create both worry and confusion
during routine mammogram checks for breast cancer tumours.
Further studies evaluating the safety, efficacy, technique and appropriate patient selection for this
type of procedure are ongoing in American funded by the Aesthetic Surgery Education and
Research Foundation.
Meanwhile, Cytori Therapeutics Inc. has developed the Cellution(TM) System designed to
automate the extraction and isolation of stem and regenerative cells from liposuctioned fat, ready
for reinjection into a patient.
Adipose or fat is one of the body's richest and most accessible sources of regenerative cells.
Adipose-derived regenerative cells include adult stem cells in addition to other important cell types
that have been shown to improve tissue retention compared to non- 'cell enhanced' tissue
transfers. For this reason, Cytori believe that these cells potentially may improve fat transfer
procedures, as well as enable more predictable outcomes and retention when applied to cosmetic
and reconstructive surgery.
The system is currently undergoing substantial clinical trials both in Japan and in Europe to
examine the effect of adult stem and regenerative cells derived from adipose tissue in breast
augmentation. In the studies, a patient's breast is augmented with her own liposuctioned fat, which
has been combined and enhanced with her own fat-derived stem and regenerative cells. The
6. results and volume retention will then be evaluated at regular intervals by independent evaluators.
Current studies are focusing on breast reconstruction applications, such as following partial
mastectomy, however if proven successful the technology will no doubt be commercialised as an
alternative to traditional breast implant operations.
Hyaluronic Acid
In March this year, we reported on the introduction of Q-Med's Non-Animal Stabilised Hyaluronic
Acid (NASHA) technology in its new Macrolane(TM) VRF product being used for volume
enhancements including breast augmentation.
Macrolane(TM) VRF is currently indicated and CE approved for 'volume restoration and shaping of
body surfaces', for example, shaping of the breasts, calves and buttocks and also for evening out
discrepancies in skin surface such as those sometimes caused by liposuction.
Although the use of Macrolane(TM) in the breast is currently available under the 'body shaping'
indication, and can achieve approximately a one to one and a half cup size increase in most
women, ongoing research is being conducted to further evaluate the efficacy of its use in this area
and to establish the best techniques and protocols for the procedure.
Treatment involves a small 2-3mm incision in the crease under each breast, and the injection of
the substance (100ml per breast) using a thin cannula or large gauge spinal needle deep into the
subcutaneous skin layer above the muscle, under local anaesthetic. The product is placed
underneath the breast tissue, much like an implant, so does not threaten the functioning of the
breast in the event of future breast feeding.
Initial patient feedback is very positive, with many noting that they are unable to feel anything
significantly different in their treated breasts from how their own natural breasts felt; this is
particularly noted in those patients where only one breast is treated for asymmetry, giving an
immediate split-body comparison. Additionally the free movement of the breast to create a natural
cleavage and to fit correctly in underwear is said to be unaffected, areas which are often
dramatically altered with the addition of traditional breast implants.
According to Q-Med, Macrolane(TM) is intended to last for 12-18 months in the body, depending
on the amount of volume used, although it recommends that each individual treatment programme
includes a yearly top-up, as required, to maintain the optimal results, and that potentially over time
this top-up may reduce in quantity. It will be some time however before long term data on the
average duration is properly known.
With costs for treatment starting in the region of £2,800, with top-up treatments of
£1,400, this could prove to be more costly than traditional breast augmentation in the long
term. However, the more temporary and less invasive nature of the procedure may well appeal to
a wider audience than surgical options.
Mechanical Stimulation
The use of sustained mechanical force to promote tissue growth in the breasts, and hence cause
7. the breasts to enlarge, has been touted as a new method to achieve a modest ½ to 1 cup
size improvement in breast size for a number of years now.
The Breast Enhancement and Shaping System, marketed under the brand name Brava®, is
much like wearing a very large bra which is fitted with two silicone domes and a motor and worn
by the patient for a minimum of ten weeks, for ten hours a day, (usually at night). The principle of
the procedure is that the breasts are gently stretched by the motor in the bra which causes them to
expand during the night.
While some doctors have reported promising results with this technique, others claim widespread
failure to achieve satisfactory results. Consequently, patients have often been disappointed with
this treatment.
However, one study carried out in Europe and published in November 2007, reported that the
majority of women who completed a trial using the Brava System increased their breast size by an
average of 155cc, or well over one full breast cup size, (range: 95cc to 300cc).
Of the 40 women (aged 17 - 53 years old) who completed the study, the average participant used
the system for 11 hours per day for an average of 18½ weeks (range: 14 to 52 weeks).
Overall, 75% were said to be either "satisfied" or "very satisfied" with their results. However,
12.5% were reported to be disappointed because of little growth, which the investigators put down
to lesser intensity of wear of the device and low body mass individuals. Over 85% stated that they
would "recommend it to a friend", although 12.5% who had acknowledged enlargement of their
breasts considered the treatment too bothersome. All of the surveyed participants indicated that
"the treatment was painless."
All 40 women were evaluated at an interval averaging 10 months after discontinuation of treatment
(range: 7 to 20 months). It was shown that not only did they maintain their breast volume growth,
but sustained it long after the stabilisation phase.
The investigators concluded that to avoid disappointment and early discontinuation with the
device, women should be well informed about the time and lifestyle commitment required.
The manufacturers of the Brava System hailed this as a significant clinical result since previous
published medical studies had demonstrated an average breast size increase of 100cc, or one-
cup size, when wearing the Brava System for 10 weeks. Although one could argue that the
chances of it producing a more pronounced result after more prolonged wear were highly likely in
the first instance.
The cost of Brava systems start from approximately $1,300 (£650).
Summary
With more and more women simply not prepared to sit back and do nothing about breasts that
bother them and cause them to be self-conscious, and with an increase in the social acceptance
of breast augmentation, fuelled somewhat by media coverage and celebrity stories, it is no wonder
that this is now the number one global cosmetic surgery procedure.