Joan Hatfield, Clinical Manager Australasia, Plastic & Reconstructive Surgery Division Technologies shares her insider knowledge of the great implant industry in Australia in her ‘Memoirs of an Era’.
There is nothing more certain in the silicone breast implant industry than change.
Having joined Dow Corning in the late 1970s, in an already established market, I have witnessed constant change, stories of survival, falls from grace and ultimately industry growth over the past four decades. My recollections, spanning several multinational companies, numerous regulatory processes, much product design and innovation, multiple surgical societies, the media, marketing of medical practices, increases in patient awareness and education, just go to show how one industry can adapt over time.
Australia has, per capita, a lower rate of breast augmentation and breast reconstruction than the US. There have been many advances in aesthetic plastic surgery, equipment and implants during my tenure in the industry, most for the better… I have seen many “firsts”.
In 1984 I attended a meeting where liposuction was introduced to plastic surgeons in Australia for the very first time, using quite basic equipment. This has gone on to be a mainstay procedure in the industry and not only do we harvest and dispose of unwanted fatty tissue but we can also now harness the power and potential of the adipose tissue and its high stem cell content for a plethora of exciting uses.
With the improved liposuction techniques on offer today and a greater understanding of the processes, fat can now be harvested with minimal trauma to the cells and a consequent survival of up to 80 percent of the adipose cells.
The use of the BEAULI technique developed by German plastic surgeon Dr Klaus Ueberreiter (using the Body-Jet system) demonstrates that large volume fat grafting to the breasts for both augmentation and reconstruction is now possible.
The fat is grafted and moulded to perfect contours of the silicone implant edges, and solves other problems such as double bubble and rippling. More recently fat is being used to fully augment or reconstruct a breast. It can even be used to fill the breast, should an implant be removed due to capsular contracture and a further implant is inappropriate or undesired, with near perfect results.
The introduction of tissue expanders in the early 80s combined with silicone implants has vastly improved results of breast reconstruction for the women of Australia, along with earlier detection and significant improvements in the treatment of breast cancer.
The future for breast cancer sufferers in Australia, young or old, has never looked so positive. Direct-to-implant reconstructions using tissue support matrices and full breast reconstructions using the patient’s own fatty tissue are two of the most exciting options for women in this position at the current time.
The early years
• Dow Corning manufactured the first silicone breast implant in 1963, then gradually entered global markets.
• There were few regulatory processes, unlike today’s highly regulated markets. Dow Corning was discontinuing their original implant with a thick shell, thick gel and dacron fixation.
• It was thought at the time by industry leaders and surgeons that a new design was needed to lessen complications and improve outcomes.
• Introduced by both Dow Corning and McGhan (now Allergan) were implants with a soft gel, a softer smooth shell, with fixation optional, and in low profiles with the average size 180-200cc. Complications that followed were rippling and wrinkling, displacement, capsular contracture, ruptures at closed capsulotomy with subsequent spread of gel and silicone granulomas.
• The Australasian Society of Aesthetic Plastic Surgery was established for purely aesthetic meetings and at the time was considered very “different”. Advertising by surgeons was not permitted.
• Patients were sometimes augmented in public hospital
with no charge but this was halted in 1982.
• A much improved implant with a smooth and higher strength shell, bleed barrier, and more gel with increased gel cohesion was introduced. In Australia the main products were Silastic 11 by Dow Corning, and similar for McGhan. Entering were Mentor-Heyer Schulte, CUI, and polyurethane with Bristol Meyers.
The silicone breast implant crisis
By the late 80s complications were reported and growing with the original soft gel, soft shell implant.
There were implant ruptures with local gel spread, granulomas, and the suggested threat to women’s health was a major concern. Companies and surgeons were unprepared and there was a lack of autoimmune studies. Since then, with ongoing trials and research,it has been suggested there is no connection between autoimmune diseases and breast implants. Problems and disfigurement, although serious, unacceptable and most traumatic for patients, were contained locally.
There was international trial by media; science did not prevail and law firms were established to cash in – chaos for patients, surgeons and the medical device industry.
In 1992 the FDA moratorium on gel filled breast implants extended to global regulatory bodies. Several manufacturers left the market in the US and never returned.
Dow Corning filed for Chapter 11 and closed its medical division. Technology of silicone breast implants moved offshore from the US and implant markets moved momentarily to saline-filled implants. Only two out of many manufacturers remained in the US.
Post FDA moratorium – 1992 onwards
Australia (along with Europe) progressed quickly. By 1994 importing of gel implants was permitted, and available in Australia under “Individual Patient Usage” applications with the TGA.
In 1999 the ACCS (Australasian College of Cosmetic Surgery) was formed to provide standards in training to specialist cosmetic doctors. Members are from plastic surgery, facial surgery and ophthalmology, general surgery and dermatology.
The year 2000 saw the listing of silicone gel implants with the TGA. Australia and Europe had enjoyed continual access to new technologically advanced breast implants with choice in smooth, textured and polyurethane surfaces, gel consistencies, stronger shells, diversified shapes, surgical planning and techniques.
In the US, the FDA had a different approach and silicone breast implants were taken off the market completely, but available only for controlled trials undertaken by the major US manufacturers. They were finally approved in 2006 after two decades of effort from the industry and the medical profession and the government.
We are told by many US visiting surgeons that we are fortunate to have access to polyurethane breast implants. “A poly would have fixed that…” I’ve heard many say.
Polyurethane implants have returned to Australia and are today widely accepted as an excellent option for both primary use to help prevent the most common complication of capsular contracture, immediate and in the long term, as well as rotation and downward displacement, and for more difficult and revision surgeries. They are valuable for capsular-prone women after breast reconstruction and radiotherapy.
SILIMED, the major supplier of the polyurethane breast implant both in Australia and worldwide, has had strong clinical evidence published by prestigious surgeons in global plastic surgery journals since the 1990s, with more than 100 studies published about polyurethane.
Expectations of surgeons with implants today are a low capsular contracture rate, low gel bleed and rupture rates, high performance silicone gels, implant stability, multiple shapes, projections, widths and volumes (average volume today is 300cc-350cc ) and all with supporting clinical evidence and patient warranties.
The US has only three manufacturers approved by the FDA: Sientra (SILIMED implants), Allergan and Mentor.
In Australia manufacturers represented are SILIMED (Device Technologies), Mentor (J&J), Allergan, Nagor (Surgiplas), Polytech (JT Medical) and Eurosilicone (Surgical Supplies).
We have learned again recently, with the temporary suspension of the SILIMED implants due to a surface particulate matter/ manufacturing practice concern, that, in this industry, there is never a dull moment and both the manufacturers and their distributors hold themselves to the highest of standards. Only once, with PIP, has an implant company not done the right thing by both its surgeons and patients.
It was with an abundance of caution from all involved, including SILMED and Device Technologies themselves, that the temporary suspension was put in place in order to ensure the very highest of standards for Australian surgeons and patients were upheld. Device Technologies is looking forward to remarketing SILIMED breast implants in Australia and to offering surgeons and their patients continued choice. Not every breast surgery is the same, and different patients require different solutions.
Another first for Australia is the introduction of the Australian Breast Device Registry (ABDR). The ABDR aims to enhance the long-term monitoring of implanted breast devices and improve patient safety by providing key stakeholders with progressive reporting on the performance of implanted devices.
Patients will benefit from the register, with safety issues being identified and communicated
to them in significantly shorter timeframes. Its success will depend on surgeon and hospital/clinic participation and industry support.
The ABDR monitors the safety of breast devices and records their impact on the health and well-being of patients. It will also identify optimal surgical techniques and provide feedback on quality of care to surgeons and device manufacturers.
Australian Breast Device Registry
The Australian Breast Device Registry (ABDR) is a national clinical quality register for high-risk implantable breast devices: implants and tissue expanders. It provides a tracking system for breast devices and a structure for monitoring device performance and patient outcomes following breast surgery.
It is the first of its type internationally as it includes breast surgeons, plastic surgeons and cosmetic surgeons. The ABDR is funded by the Commonwealth Government (Department of Health) and administered by Monash University, Department of Epidemiology & Preventive Medicine.
The ABDR aims to enhance the long-term safety and performance monitoring of implanted breast devices and improve patient outcomes. This is to be achieved by providing participating surgeons, health service providers and other key stakeholders, such as the Therapeutic Goods Administration (TGA) with progressive reporting on the long-term performance of the implanted devices. Patients will directly benefit from the register, with safety issues being identified and communicated to them in significantly shorter timeframes.
The ABDR will collect breast implant and tissue expander performance data related to treatment of recipients in order to:
• monitor the performance, and assess the safety and quality of breast implants and breast tissue expanders;
• identify current practice in surgical techniques, including identifying centres of excellence, and where treatment gaps exist and its effect on patient outcomes;
• provide outcome statistics to the surgeons to facilitate quality improvement activities;
• provide patients with access to their surgery details on request, which will aid surgeons practicing a revision;
• act as a communication tool between clinical governing bodies and other involved groups of surgeons and device recipients, particularly in the event of an adverse event;
• support consumer confidence that devices are being tracked; and
• provide validated data to mitigate adverse media reporting.
The ABDR collects the following information at time of surgery via a paper data collection tool:
• Patient name, Medicare no., Hospital Unique Reference no., date of birth;
• Patient contact details, including address and telephone no.;
• Treatment data, including device details, name of operating hospital and surgeon, date of operation and type of procedure;
• Outcome data, including revision procedure details, adverse events and death.
To understand the medium to long-term outcomes associated with breast device surgery, patients will be followed up 1, 2, 5 and 10 years post-procedure. The survey tool to be used for the purpose of follow-up is yet to be determined.
Use of data
The register will monitor safety and performance issues on an ongoing basis and statistical modelling will be used to detect aberrance at an early stage.
Data will be reported to key stakeholders on a regular basis; including hospitals, surgeons,
and government regulators. The register will produce an Annual Report. Under no circumstances will individually identifiable data, in respect of patients, contributing surgeons, or craft groups, be made available to parties other than the ABDR Steering Committee, authorised ABDR personnel, and members of working groups directed by and reporting to the Steering Committee.
The ethical aspects of this research project have been approved by the Alfred Hospital Human Research Ethics Committee Project No. 5/15.
Prof John McNeil, A/Prof Sue Evans, Prof Rod Cooter, A/Prof Colin Moore, Dr Elisabeth Elder
Dr Daniel Fleming
Dr Daniel Fleming is one of Australia’s most experienced breast implant surgeons. A former President of the Australasian College of Cosmetic Surgery, he has acted as an expert scientific adviser to the TGA and as an expert member of the Government’s Chief Medical Officer’s committee during the PIP breast implant crisis. He has instructed plastic and cosmetic surgeons from around the world in the use of polyurethane foam covered breast implants. Here he gives his opinion on polyurethane foam covered breasts implants.
Thousands of women choose to have a breast augmentation in Australia every year. Extraordinarily, the majority of them will receive “second tier” implants which are more likely to cause complications and more likely to need replacement earlier than polyurethane, a proven and fully TGA-approved alternative.
Every surgeon is entitled to their own opinion about what is best for their patient. However, they are not entitled to their own set of facts. When there is clear-cut evidence that one treatment or medical device provides better outcomes than another, surgeons have a duty to inform their patients of the facts so the patient can make an evidenced- based, informed decision.
Key facts (not opinions):
• Breast implants are not lifetime devices.
• At some point they will need to be replaced because they will no longer look or feel satisfactory.
• The commonest reason, by far, for replacement is capsular contracture, where the body’s own tissue behaves like shrink wrap, compressing the implant and making it hard and distorting its shape.
• With some implants this happens in about 20 percent of patients in the first 10 years (Source: FDA studies for Allergan and Mentor textured and smooth implants).
• With other implants this is dramatically reduced and in the order of one to two percent. (Source: Numerous studies referenced in Biomaterials in Plastic Surgery – Breast Implants, Ch. 5: “Polyurethane foam covered breast implants”, Fleming, D. Woodhead Publishing, Cambridge.)
• Other common complications causing the need for replacement surgery are displacement (bottoming out) and rotation, which makes shaped or teardrop implants appear deformed.
• These complications are also reduced by the use of polyurethane foam covered implants.
Breast implants are available in three different surfaces:
1. Smooth – like plastic bag
2. Textured – the smooth surface is
roughened or texturised
3. Polyurethane foam covered –
smooth implants with an extra layer of polyurethane foam bonded to the surface.
Smooth were the original implants introduced in 1963, but high capsular contracture and displacement rates caused surgeons to seek a better alternative. Polyurethane foam (also known as P-URE implants from P-oly-URE-thane) were first used in 1968 and resulted in much lower contracture and displacement rates. They achieved this because the patient’s own collagen, which forms the membrane around any implant, weaves into the foam and adheres like Velcro. This stabilises the capsule, preventing the shrink wrap and hardening, and also keeps the implant in place. However, the original technology of using glue to bond the foam to the implant was not perfect. Thus a vulcanisation process was developed to create the secure attachment of modern P-URE implants.
Some 16 years after the P-URE implants were introduced, textured implants were first offered, in 1984. It was thought the same Velcro-like attachment would occur with the same benefits, but the long-term evidence has shown that it does not. Some brands of textured implant never attach and others usually do not attach. Thus the US FDA studies showed that textured implants behave like smooth implants and have the same 10-year contracture rates of one in five.
Un-evidenced claims that P-URE implants are unsafe or too difficult to remove abound not only in cyber fantasy land but also shamefully put before patients by surgeons and clinics who ought, and sometimes do, know better.
The reason for this “economy with the truth” are threefold:
1. Not all surgeons can admit what the FDA knows – that complications are all too common with smooth and textured implants.
2. P-URE foam implants are more difficult to use. There is a learning curve and many surgeons are unwilling or unable to master the techniques required.
￼3.P-URE foam implants cost more and in the era of discount breast implants thisis a hurdle for clinics seeking to be price competitive.
Ironically, for patients the cost in the long run may be much less, with less need for earlier re-operation.
The safety of P-URE implants is long established and that is why the TGA approved them for unrestricted use in Australia.
There is no perfect implant and P-URE implants are not a panacea. Complications can and do still occur. However, there is no logical, evidence-based reason for a patient not to choose P-URE foam implants. By choosing smooth or textured implants all she does is increase her risk of complications and earlier re-operation.
Other leading breast implant surgeons from around the world agree:
“There is nothing… to suggest that polyurethane foam, or its in vivo breakdown products, pose a threat to the health or safety of patients. Polyurethane implants have measurable advantages over smooth and mechanically textured gel-filled prostheses and do not appear to be associated with an increased risk of complications or morbidity.” (Handel, N. Long- term safety and efficacy of polyurethane foam-covered breast implants. Aesthetic Surgery Journal Vol. 26 2006)
Dr Roderick Hester, Dr John Tebbetts and Dr Patrick Maxwell from Georgia, Dallas and Nashville respectively, reviewed the literature on, and their experience with, polyurethane covered breast implants. The senior author concluded: “During the span of this author’s practice, he has never been able to match the number and quality of superior results exemplified by these patients when using other devices.” (Hester T.R., Tebbetts, J. Maxwell, G.P. The polyurethane- covered mammary prosthesis: Facts and fiction (II). Clinics in Plastic Surgery Vol.28 2001.)
Professor James Frame, Professor of Aesthetic Plastic Surgery in London, has stated,
“I think the evidence in favour of preferable use of PU covered implants is overwhelming compared with smooth or textured implants and it is clinically negligent to not put these facts to the patient.”
The two companies who make P-URE foam implants know the P-URE foam product is their premium implant and their textured and smooth implants are second tier implants. This is why although they guarantee all of their implants against rupture, they only guarantee the P-URE implants against capsular contracture, rotation and displacement. They know these complications happen too frequently with the smooth and textured implants and they would be paying out too often.
Consider if this situation existed with another medical implant, hips or heart valves for example, where one type of implant had a 20 percent serious complication rate at 10 years and another performed 10 to 20 times better. There would be a scandal if patients were not informed or indeed, if the less safe implants were even offered to patients. Breast implants should be no different and it is time the profession faced up to the evidence. Our patients deserve no less.
Further details of the evidence supporting the safety and use of P-URE foam implants is available at www.breastimplantsaustralia.com
Dr Darryl J Hodgkinson
Saline implant update
I have been practicing plastic and reconstructive surgery for over 30 years and have performed approximately 7,000+ breast augmentations here and in the United States. I have used every sort of implant through every sort of incision and yet 50 percent of the time I now use saline implants.
It is interesting that in the US saline still represents a high proportion of the implants inserted. Saline was the first ever implant produced. The problem that saline implants had initially was that they had a higher rate of deflation, and once the silicone gel implants were introduced into the market they tended to replace the saline implants for a certain period of time.
However, the complications of the gel implants, with 50 percent of the patients developing capsular contraction, plus the moratorium on the silicone implants implemented in 1992 by the FDA, encouraged surgeons to come back to saline implants. So surgeons in the US, without the silicone gel implant until 2006, had to learn to use the saline implant and they did so successfully in the majority of cases.
Why I like saline implants is that they do have the same rate of rupture as a gel implant, that is, approximately one percent per year.
The removal of a ruptured saline implant however is so much easier than that of a gel implant. It is easy to detect a ruptured saline implant whereas a gel implant is often associated with symptoms and signs which require more sophisticated and expensive examinations such as MRI to detect rupture.
Several other reasons that led me to choose saline implants are if the patient doesn’t want to be too big. For example, for no more than a D cup they well may be a candidate for a saline implant. If the patient has a nice thick breast tissue and I can get a good muscular cover with a partial subpectoral approach then it’s nearly impossible to feel a saline implant. Also, a saline implant has the smallest incision of any implant as it is supplied empty and has to be inflated with a tube in the operating room.
It is nice to be able to adjust the size of the implant so that small discrepancies in the symmetry of a patient can be corrected. This is done on the operating table with the patient in the upright position.
I also like the saline implant because of the movement of the implants; they are not ‘’glued on’’. Many of the implants don’t move well but saline implants do, and saline was always the preference for small breasted women and dancers in high class cabarets in Europe and Las Vegas because of the natural breast movement and the “shimmy factor’’ of saline implants.
It is suggested that patients with gel implants should be assessed for a replacement of their implants at 10 years but this is not the case with the saline implant. The rate of capsular contraction for saline implants is low and breast exercises don’t have to be performed.
In my practice, 50 percent of patients are good candidates for saline implants. There has never been a ‘‘saline scare’’ and saline implants have never been taken from the market. The retraction of gel and foam implants from the market has been very distressing for patients with these implants, but with saline implants there is no such “distress’’. The only issue which can arise is that if a patient loses weight and a significant amount of breast tissue, often due to pregnancies, then the implant can be slightly more palpable than a gel implant and can lead to some dissatisfaction. In those cases an exchange of implant is indicated.
All in all, the saline implant for myself and a large number of surgeons in the US has resulted in a headache-free breast augmentation for patient and surgeon.
Dr Jeremy Hunt
Dr Jeremy Hunt is one of Australia’s most highly regarded and in-demand plastic surgeons. He is a Fellow of the Royal Australasian College of Surgeons and member of the Australian Society of Plastic Surgery, and has also completed a Fellowship at the prestigious University of Texas in the United States.
I have 15 years’ experience in private practice, and have used the full breadth of implants available. I have no affiliation with any implant manufacturer; the decisions I make when selecting an implant provider are purely evidence-based.
Currently, we are using so-called 5th-generation implants. The 1st-generation silicone implants of the 1960s had a more liquid consistency, a thinner shell and were more prone to rupture and leakage.
In contrast, 5th-generation implants contain a cohesive gel and are firmer with less of a liquid consistency, giving more control in shaping the breast and a lower rate of capsular contracture. This ‘memory’ gel is better equipped to maintain shape (essentially to behave more like a “gummy bear”) and to offer more predictability in both the short and long term.
My preferred implant is a cohesive gel implant with a textured shell, either round or anatomical depending on the patient’s preferences and anatomy, and my preferred implant manufacturer is Mentor.
Mentor implants offer numerous advantages both short term and long term, but for me I am impressed with their track record; current 10-year follow-up data shows Mentor has a very low reported risk of key complications in primary breast augmentation at 10 years, which translates to less capsular contracture, less rupture and less rotation.
I am also impressed with Mentor’s commitment to teaching, training and research, and overall good service by its company representatives. Its breadth of shapes and sizes is also beneficial to the surgeon, offering an implant to fit just about every patient’s needs and anatomy.
An additional advantage is Mentor’s SILTEX Texture technology in its range of textured implants. There is evidence that textured implants have a lower rate of capsular contracture; there is stronger evidence to this effect when the implant is placed under the muscle, and less so when it is placed in front of the muscle.
Looking to the future, the focus is on creating a harmonious balancebetween the natural breast tissue and the implant to create the patient’s desired outcomes – for both short and long terms. With ongoing research and development, we hope to evolve the next generation of implants to achieve even better results than what we are achieving today.
In my opinion, the best product we have currently is the one that provides great results today and even better results in the long term. For me, that product is Mentor implants.
Dr David Caminer
This is my 21st year in a very busy private practice. I had a further six years of training, which included two years as a plastic surgery fellow in the prestigious Cleveland Clinic in America as well as a plastic surgery unit in Bordeaux, France.
During my time at the Cleveland Clinic I gained much experience with implants, with a large proportion being explantation as this was in the middle of the Dow Corning silicone saga and all of these patients were concerned about having silicone implants in their body.
I have performed a large number of breast surgeries – reductions, augmentations and also a lot of breast reconstructions, both implant based and autologous tissue reconstruction. I have analysed my results as well as many other surgeons’ results that come through my door. I have thus gathered techniques that I know to work and give the best outcomes.
My preferred implants are undoubtedly anatomical implants. Round implants do not make much sense to me; they fall short of giving nice lower pole fullness with a very sudden superior takeoff. Anatomical implants give you all what round implants do not – and a lot more. I believe you can fill the upper pole better with anatomical implants as you can vary the height compared to the width, which you cannot do with round implants. The only thing that a round implant does is give you breast volume and a sudden takeoff whereas an anatomical implant imparts a much better shape to the breast.
I also believe that cohesive silicone gel gives the best look, shape and feel to the breasts when comparing them to saline implants. With saline implants, if you want a soft breast you need to underfill the implant, which results in wrinkling of the implant. If you don’t want the wrinkling, you must overfill the implant, giving the breast a harder feel. Because of the wrinkling of the implant shell, you also need to place the implant in a subpectoral pocket to camouflage the wrinkling. With gel implants, a submammary or a subpectoral pocket can be used, depending on the patient’s subcutaneous thickness and cover.
Over many years in practice, I have grown to like the Allergan 410 anatomical series very much. I also have used the Mentor range and use both of these implant companies exclusively as they are consistently reliable and tested for many years without any hiccups as in some of the newer implant companies.
I believe that the core study data on both Allergan and Mentor implants are very comparable, hence I do not hesitate to use either.
Depending on the patient’s preference, each company’s implants varies in dimension, and I try to choose the different dimensions of the different implants (base width, projection and implant height) to fit the patient’s physical characteristics. I always use sizers and choose the most appropriate implant to give the patient her ultimate wishes.
Most of my patients request a very natural look and the most important dimension for this is the implant base width. There is a range within 1.5cm and depending on the patient’s wishes with size, I can usually give them exactly what they request for in size.
All in all, breast augmentation remains a very popular operation due to the fact that implant technology is continually improving, offering excellent results with few complications and mostly very happy patients.