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.

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 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 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.

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 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 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.

Yet, as the development of the non-surgical marketplace has shown us, better and long lasting results for facial rejuvenation and body contouring can be achieved with more minimally invasive techniques than was previously thought, so this theory has extended into the realms of breast enhancement. This area of exploration can only continue to grow at an exponential rate.

Women would all love a quick fix; to wake up one morning with the perfect breasts. Some may see this as a shallow desire, but there’s no getting away from the fact that breasts are the number one feature that define a woman, both on a sexual level and on a more natural level, as the giver of food and nutrition for our offspring, so it is no wonder that a woman can feel less than whole when she doesn’t have the breasts that she feels she should have or once had.

Surgery is however a big step to take, both financially and due to the risks involved, so as more and more companies look to ways to develop less invasive alternatives, more and more women will be queuing up to give them a try.

As experience with these technologies evolves you can be sure that we will be here to update you with the facts as they emerge.

Bibliography

The Brava External Tissue Expander: Is Breast Enlargement without Surgery a Reality? Schlenz, Ingrid M.D.; Kaider, Alexandra M.Sc. Plastic & Reconstructive Surgery. 120(6):1680-1689, November 2007.

Copyright © 2008 The Consulting Room.