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Simon Kay´s Cosmetic Surgery Blog
Welcome to my cosmetic surgery blog.
Cosmetic surgery generates a great deal of interest, but there is much misinformation floating around.
This blog is designed to provide real-time information about this rapidly evolving field.
Breast Implants: latest news as of Summer 2017.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Breast Implants: latest news as of Summer 2017.
There is a lot of media reporting just recently of the possible link between a rare form of immune system cancer, known as a lymphoma, and breast implants. The tumour is called an Anaplastic Large cell Lymphoma and is normally an extremely rare form of cancer. It comes in two types and one type appears to be associated with breast implants, appearing in the tissue immediately surrounding the implant (known as “the capsule”: a term used to describe the fibrous layer the body forms around a breast implant).
The French health agency concerned (l'Agence nationale de sécurité du médicament (ANSM)) has recommended that this risk be discussed with every woman having breast implants and that these implants essentially now come with a warning in France (http://www.lemonde.fr/sante/article/2015/03/17/l-institut-du-cancer-alerte-sur-une-nouvelle-maladie-liee-aux-protheses-mammaires_4594751_1651302.html).
The corresponding American agency, the FDA, has also made some important observations more recently (https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm).
Those interested in more detail may consult the American Society of Plastic surgeons website (authored by Dr Clemens, an acknowledged expert in this field) which has an excellent (if technically dense ) summary of the current state of our knowledge https://www.plasticsurgery.org/for-medical-professionals/quality-and-registries/bia-alcl-by-the-numbers
In order to try to help women who have breast implants or are considering breast implants with the choices they face, I have written this brief article and a list of things I think women should know at the time of writing (summer 2017). This is a rapidly developing area of knowledge so please check for latest updates through the web, through search engines, and if you want by discussion with me or your own surgeon.
BIA-ALCL is a new tumour, either not previously existing or not previously recognized, and is a special form of the more prevalent tumour ALCL (the BIA- tag referring to the fact it is found in Association with Breast Implants
Reports of this condition began to emerge in the first years of the 21st century but only in 2011 did the FDA recognize a firm link with the presence of breast implants. ALCL itself is a form of lymphoma, an uncommon cancer of blood cells. The full name of the tumour is Anaplastic Large Cell Lymphoma. The term “large cell” refers to the appearance under the microscope, and “anaplastic” refers to the cell type as being rather primitive in appearance and behavior, that is to say not appearing to have developed into a more specific identifiable cell type.
ALCL itself can develop at various sites around the body, and probably affects about 1500 people a year in the USA alone. The rare type of ALCL associated with breast implants appears to be very specific in its genetic make-up and so is now identified as BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma).
So, to summarise before moving on, lymphoma is a rare form of blood cancer and ALCL is a rare form of lymphoma, and BIA-ALCL now appears to be an even rarer form of ALCL, specifically occurring in women with breast implants.
Now here are ten things you might like to consider about this disease.
How common is BIA-ALCL? It is hard to be precise, but in the USA there appear to be fewer than 400 cases in total with 9 deaths, and that figure itself may be a substatial overestimate because some cases are misreported or reported twice. In the UK recent reports suggest there have been 23 reported cases with 2 deaths. Each of these reports may be subject to some errors but are the best estimates to date. An interesting thing is that when these are translated into an estimate of the risk each woman with implants faces, the current estimate in the USA is about 1:30,000 lifetime risk. That means that for 30 thousand women spending a lifetime with breast implants, only one will contract this disease. However, in some parts of the world the risk appears higher (Australia for example) and in other parts almost zero (India). We do not know whether these differences are due to reporting errors, genetic differences or environmental differences. But to put these risks into some perspective, for every eight or nine women in the UK one will develop conventional breast cancer in their lifetime.
What do we think causes it? This is conjecture at the current time, but it may be that something to do with the way the body reacts to alien objects inside it, or to long standing sub-clinical infection, may be part of the story. This is strengthened by the observation that some cases have appeared associated with metal implants used to repair bone. I anticipate that progress in understanding this field will be rapid in the years to come so watch this space!
Do implants cause it? The strong association with breast implants suggests some sort of link here but quite rightly the international agencies are being cautious in identifying a definite cause. We can say the disease is associated with breast implants and further that the FDA have identified from research sources that …”at this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.” This may prove to be important and at least one surgeon has called for an end to using textured surface breast implants. Some have gone so far as to claim that the disease is not seen with smooth surfaced implants (see below). Some manufacturers are making claims about their implanst having less risk than those of other manufacturers. This may or may not be the case, but the commercial issue sat stake are clear.
How does it appear, that is to say what should women with implants look out for? It seems the disease first appears in the thickened tissue (capsule) that the body creates to surround an implant. It then makes fluid, and so the breast swells and becomes tense and hard. Some fluid and some tension are normal but a sudden change occurring at any time (months or years) after the implant has settled down initially, and causing one side to swell, should immediately be reported and expert advice sought. Any woman with settled implants who develops new swelling in just one breast should immediately seek advice. Some agencies have recommended routine scanning or mammography screening but that is not currently the advice in the UK. Again, your surgeon is an appropriate person to advise you.
How is it treated? Pleasingly, the way forward in treatment is becoming clear and the results are reassuring. The key thing appears to be that surgical excision of the tumour is essential, and this can often be achieved by simply removing the capsule that surrounds the implant. Where the disease is reported early and is appropriately treated when still confined to the breast, 93% of women have no further sign of the disease 3 years later. This is of course no cause for complacency, but is reassuring for those women affected. Other means of treatment include chemotherapy or radiotherapy for disease that cannot be removed.
Should I insist on smooth implants, or have mine changed to smooth implants? I can only give a personal view as at the moment I do not believe there is a right and wrong answer to the question. The reason most surgeons in the UK have preferred textured implants is that there is evidence to show they are less likely to harden with time (capsular contracture). Given that hardening can spoil the result, and is quite common, and given the risks in general of surgery (small but real), and the very small (but again real) risk of BIA-ALCL, it is a difficult balance to decide whether to use smooth implants and whether to change implants. The only reasonable answer to this question is that the patient and the surgeon should put time aside to discuss these issues prior to surgery, and be clear about what is covered in the aftercare and what is not under the terms of the surgery. As the FDA puts it “before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants. If you have breast implants, there is no need to change your routine medical care and follow-up”.
Should this put me off having breast implants? Let me answer this as I do for all my patients: there is no such thing as totally risk free surgery. All surgery can cause health problems, and carries risks which can range in frequency and in severity. For this reason I have never accepted that breast augmentation is simply a life style issue. Patients should only undergo aesthetic surgery to address distress about appearance, and the degree of that distress should be sufficient to warrant the risks a procedure entails. For breast implants the risks remain either infrequent but important (e.g. B IA-ALCL) or more frequent but less severe (e.g. scarring or loss of sensation etc: see other advice on this site). In other words, patients requesting breast augmentation face the task of balancing risks and benefits as they do for any procedure and your surgeon should help and guide you objectively in this matter. Often it helps to consult more than one health care professional before reaching a decision which should in any case never be rushed or impulsive. Breast implants can be greatly life enhancing and in the past this has not, I believe, been adequately recognised. But they also carry potential consequences which must be understood.
I am very willing to consult with any patient who is worried by this development. If you are worried it is perfectly reasonable to schedule an appointment with your surgeon or GP, and you should certainly do this is you have any of these symptoms:
Increase in size of one breast
Progressive hardening of one or both breasts
Pain in one or both breasts
A lump found in a breast
Discharge from a nipple
As always, women should be vigilant about their breast, examining them monthly, and reporting any change. One in eight women will develop breast cancer in their lifetime, compared to the roughly one in thirty thousand women with implants who may develop ALCL. So check your breast whether you have implants or not please. (see http://www.breastcancer.org/symptoms/testing/types/self_exam/bse_steps)
Simon Kay Summer 2017
PIP implants: update
PIP breast implants
I have never used PIP breast implants and all my patients may be assured that they have not received such an implant.
Like many surgeons I have agreed to remove and replace PIP implants at a very much reduced cost, recognising that despite reassuring women about the lack of any evidence of harm from these devices, many women remain sceptical and want them out soon.
The full report of the government’s investigation into PIP implants can be found at http://www.dh.gov.uk/health/2012/06/pip-report/ and I hope this will ad weight to the reassurance offered to those patients who had such devices implanted elsewhere.
I sat on the committee that advises the government at the time these implant failures came to light and I know the great lengths gone to to establish as quickly as possible what risks there might be to women. It soon became clear that tests around the world showed no serious threat to health, other than a local reaction (tenderness and inflammation, occasional swollen gland in the armpit). Most importantly the tests used to tell whether something might cause cancer are reported as negative.
When we efer to an implant rupturing it sounds as if the implant has burst: in fact most of the “ruptures” are failure of the silicone rubber bag that contains the gel, and are not caused by trauma.
Failure can happen in any breast implant, after which the gel escaped in to the cavity behind the breast where the implant sits. This cavity is sealed off from the rest of the body by a shell of tough scar tissue (the capsule) and in many cases the gel just remains there and the patient may never be aware there has been an implant failure. They suffer no known harm and have no symptoms.
What was different in PIP implants was that the gel was irritant to the capsule and sometimes some silicone products penetrated the capsule and ended up in the lymph nodes in the armpit. So far we have seen no evidence of health damage from this (and I doubt we will) , but understandably it is alarming for the patient.
My advice to patients with PIP implants? Read the government’s largely reassuring report at http://www.dh.gov.uk/health/2012/06/pip-report/ , consult a plastic surgeon in a reputable hospital (either privately or on the NHS, and your GP will be well placed to offer advice here) and after that consultation consider the advice you received carefully. In the absence of known health risks you do not need to be forced into a quick or wrong decision and you can afford to take time to consider the facts.
Breast Augmentation Procedure: What Happens In Surgery Step By Step
If you've ever considered getting a boob job (let's face it, most of us have) then it's worth knowing exactly what goes on during the procedure. To demystify breast augmentation and how it is done, I wrote an article for the sofeminine.co.uk website.
You can read the full article by clicking the following link
Announcing a review of cosmetic surgery
“Cosmetic surgery: review to stamp out grubby practices” was the BBC’s headline announcing the review by NHS Medical director Sir Bruce Keogh of what he refers to as “the cosmetic surgery industry”.
In the accompanying video piece (http://www.bbc.co.uk/news/health-19264798) Sir Bruce starts with a denouncement of the PIP implant fiasco, lamenting that the regulation of the devices was inadequate and that there was no central register of women who had had these devices, so slowing the process of recalling or contacting them. It is worth pointing out that neither of these lapses was a failure of the so-called “industry”, but each were a failure of the arm of government responsible.
And to be fair to the MHRA (the body responsible for supervising the safety of devices such as breast implants) none of the processes were designed to deal with what appears to have been a deliberate fraudulent flouting of the manufacturing standards in another sovereign European country (France). Perhaps now, when counterfeiting designer brands is so common, the regulators will be more vigilant. But because of the free trade within the EU this will require some fairly tough European standards and can’t be left to individual countries: in other words it will be a federal issue and require European legislation. That will never happen quickly.
Sir Bruce’s second point about a register is an important one. I used to sit on the MRAs Committee for the Safety of Devices, and I have seen the uphill task that committee faces in terms of the sheer volume of medical devices of all sorts that require expert regulation. It is impossible to make such a system watertight.
We used to have a voluntary breast implant register in the UK but many women did not want their details entered onto it, nor to be contacted again, preferring discretion. I am in favour of ALL devices from breast implants to heart valves, hips to lenses being registered and I would like to see that register held centrally by the MHRA ad updatable remotely and anonymously. This could be done by implanting a chip at the same time as the device (either incorporate din the device or close by) so that simple information about the history of the implant can be retrieved by a simple scan (similar to the scan on a supermarket check out) and the information updated via the web.
As to grubby practices: here I think Sir Bruce refers to some of the high pressure sales employed by some clinics, the discounted surgery, the two-for-one deals, or even the untrained surgeons unsupervised and often not monitored or only visiting the UK briefly (making regulation very difficult). There is a lot to clean up there and Sir Bruce will have to recognise that there are faults in many areas, not just with the doctors and nurses, but also with some government agencies.
Patients can be assured hospitals like Spire and BMI are well regulated, exact high standards from their surgical teams and conform to all the guidance and standards of the Care Quality Commission, the General Medical Council and other overseeing bodies. We are proud to offer cosmetic surgery in proper hospitals where al the facilities you might possibly need to be safe and secure are on hand. I, my colleagues and our hospitals, have nothing to fear from this review and we are all delighted that at last some of the outrageous claims of much less competent clinics and surgeons will be exposed as misleading, unethical or as the BBC puts it “grubby”. The sooner the better, so that the true high quality of the care we offer can be established.
My New Website
Welcome to my new web site. The old site at www.plastic-surg.co.uk will soon close (and eventually reopen with a guide to my reconstructive surgical practice) whilst this new site www.leedscosmeticsurgery.com will be the main site for my practice in independent cosmetic surgery.
Like the last site, this one has been constructed by Alison Trafford (www.alisontrafford.com) whose eye for design and capability in site building gets stronger and stronger. It is impossible to recommend her too strongly, and anyone looking for a great site with fresh ideas will find her a professional partner.
I hope by keeping the updates regular and as frequent as possible this site will become a useful resource for those seeking guidance on cosmetic surgery. Clearly at the same time it is designed to provide an insight into my own practice and the team I rely upon, but it will also include commentary on cosmetic surgery issues in the news and for the first time I shall start to populate the galleries with images that inform my prospective patients.
I hope this site will grow and be a valuable resource for you whether or not you are one of my patients. If you want to find out more simply get in touch through the site or through the e mail addresses above. You can also follow our team on facebook (leedscosmeticsurgery) and on twitter (leedscosmeticsurgery).