One of the greatest mysteries of the last few years must be the rupture rate and the overall quality of PIP silicone implants. I always thought, based on my personal and relatively small experience with those implants, that PIP implants had a special tendency to break early. When I tried to discuss this personal point of view on this blog I had few violent comments. One particular company insisted (and still insists) that the rupture rate in their patients was, if I remember correctly, in the region of 0.18%. So it really was a case of me being such a poor breast surgeon.
I had a bit of time over Easter weekend, and I managed to read in full the decision taken on the 29th of March by the AFSSAPS in France, that, I discovered, has not been completely translated for British patients. The document not only explains the known problem with a silicone gel different from the one that was approved, but goes into a likely explanation for the high rupture rate of those implants. You can read it for yourself at the link above, but the main part says:
“Considérant par ailleurs qu’un rapport d’essai de transsudation de gel de silicone selon la norme de l’American Society for Testing and Material (ASTM) F 703 établi par la société POLY IMPLANT PROTHESE, montre une vitesse de transsudation du « gel PIP » de remplissage, supérieure de 30% à 8 semaines à celle d’un implant rempli avec le gel de silicone décrit dans le dossier de marquage CE.
Considérant que cette diffusion de silicone au travers de l’enveloppe peut générer une fragilisation de cette dernière et pourrait donc expliquer le taux de rupture observé en matériovigilance ; qu’une rupture nécessite une réintervention chirurgicale dont le risque pour les patientes n’est pas négligeable;”
My knowledge of French is poor, but I can confidently translate that the American Society for Testing and Material discovered a silicone leakage in PIP implants higher than expected, and that this leakage, according to the AFSSAPS, is the most likely cause for the high rupture rate of PIP implants.
In case this wasn’t enough to reinforce my old feeling that PIP implants tend to rupture a bit too often, the AFSSAPS even made clear, on the 30th of March, that they had to act following a high number of reports from surgeons, mainly involving ruptured PIP implants. This second document states:
“Le nombre d’incidents signalés à l’Afssaps dans le cadre de la matériovigilance concernant les implants mammaires pré remplis de gel de silicone fabriqués par la société POLY IMPLANT PROTHESE a augmenté sur les trois dernières années. Ces incidents sont principalement des ruptures de la prothèse et des complications locales. Ils nécessitent dans la grande majorité des cas une réintervention.”
Again I can translate this quite easily, especially when it says that the number of reports has increased over the last three years.
Now, how does this compare to the UK? Not well, I am afraid, and not only because some companies have been happily recommending PIP implants till the very morning of the 31st of March. We also had, in this country, popular surgeons writing reports to support the quality of PIP implants, and I wish I could see the ‘scientific’ data they used. I know every possible explanation has been tried to justify every single rupture that couldn’t be kept silent, and these explanation included: surgeons using an incision that was too short, surgeons damaging the implants with surgical instruments, use of iodine solutions or even hydrogen peroxide that could damage the shell of the implant, nail marks on the shell (I cannot believe this one, but I have been told PIP found a nail mark on an implant while investigating for the cause of rupture), and even the fact that some surgeons didn’t use drains was described as a possible magical cause of rupture.
No wonder the increased rupture rate wasn’t noticed in this country, and we had to wait for France to take action. We are also still waiting for France to tell us what to do. Should we rely on local surgeons and companies, we would know that PIP implants have a rupture rate of 0.18% and that they are the best implants on the market, certified by some of the busiest commercial cosmetic surgeons out there.
This could be true, obviously, even if it is not my personal experience. And it would not explain why some of the surgeons that wrote those ‘supportive’ reports are now so worried for their future.
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It has been such a long time since I last wrote about implants. I thought I was never going to write about breast implants again, since I had enough of the nasty comments I was getting every time I was discussing the quality of the different brands. One particular brand of silicone breast implants proved very dangerous to go close, and one particular company using those implants was even worse.
Today is a different day. The French medical device regulatory authority (AFSSAPS) carried out an inspection of the PIP manufacturing plant and established that most breast implants manufactured by the company since 2001 have been filled with a silicone gel with a composition different from that approved (you can read more about this on the MHRA web site). This is, I would say, absolutely not safe but also quite stupid, if you are, and want to remain, in this business.
It would be easy to say that I was suspecting this more than a couple of years ago (and you can read the articles in the archive of this blog). It would be even funnier to tell you that one of the biggest companies using PIP implants immediately changed the web site today, and wrote everywhere that they use a different brand of implants (I feel sorry for them, but they did have a manager and a medical director, and sometimes I wonder what they were paid for).
In reality, the situation is not funny, at the moment. PIP implants cannot be implanted any more, and the MHRA will give further advice about clinical management of patients implanted with these devices as soon as the particular type of silicone used will be studied a bit more.
I will probably write again about this once we will know more about the problem. Just don’t panic if you have got PIP implants. They are surely not the best pair of implants a woman could get, but right now there is no evidence that the silicone used for them can affect their safety.
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I know, it has been a long time since my last blog post. I just didn’t feel like writing, and I would always follow my mood. The main culprit for my silence, I suppose, must have been a video I have seen on the web few months ago, with a surgeon describing the so-called dual plane technique for breast enlargement. A very posh and well-mannered surgeon, that managed to show in less than five minutes how little he knew about breast surgery and how dangerous the web can be, in the wrong hands. This guy was explaining that dual plane and retro-pectoral positions are the same, and that the other option, the complete retro-muscular pocket, was obsolete (and, in fact, it is). If you listened, you would have had the impression that all the retro-pectoral implants were in reality dual plane, as this is what the surgeon genuinely had in his mind. Poor mind.
I really don’t want to sort this mess out, but, to clarify a bit, implants can be in several submuscular positions: retro-pectoral (the classic and most used one), dual plane (with three different sub-versions), completely submuscular (now mostly abandoned, it involves lifting more muscles, mainly the serratus and pectoralis minor). I know, it is boring. I didn’t want to write about it, but I am noticing a surprising increase in the number of surgeons pretending to perform dual plane breast enlargements, and I have got the feeling that at least some of them have got, consciously or not, the wrong concept. For anybody with an interest, the ‘real’ dual plane breast enlargement was first described in 2001 on Plastic and Reconstructive Surgery Journal in this article: “Dual Plane Breast Augmentation: Optimizing Implant-Soft-Tissue Relationships in a Wide Range of Breast Types” by John Tebbetts. If you happen to discuss dual plane breast enlargement with a surgeon, I would suggest to ask the difference between type I, II and III. If the surgeon doesn’t know the answer, it is time to look for somebody else.
On a lighter note, I really missed the comments I was getting on this blog and the chance to chat. Did you notice how many times the word ‘confidence‘ has been recently appearing in cosmetic surgery advertisements? I couldn’t figure out exactly why, till I saw the advertisement of a cosmetic surgery company next to the one for a famous deodorant. They actually use the same strategy, and they both advertise along your tube escalators, wherever you go. I find that quite intriguing, especially since I have been told that those ads are actually working quite well. When I was in training, we were taught that the best candidates for cosmetic surgery were confident people, possibly young and extrovert females. Now that I am getting older, cosmetic surgeon look for a definitely different group of patients, especially males with confidence problems. Is this because there is only a finite amount of confident women around? Or, as I would rather think, confident women don’t recognise themselves in this very aggressive, if not cheap, modern concept of cosmetic surgery any more?
I promise I will try to write few more posts soon. I think I have finally digested that web video, and I have got quite a lot to say…
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During the last couple of days I have seen this crazy story everywhere, and even the BBC paid a lot of attention. Apparently, “four people have been arrested in Peru on suspicion of killing dozens of people in order to sell their fat and tissue for cosmetic uses in Europe“.
The story in itself looks like a powerful urban legend, but what is really silly is the market price of the human fat sold: about $15,000 (or £9,000). I don’t really know any commodities worth less than human fat in this age of obesity and liposuction, still so many journalists were ready to write about this story.
Trying to clarify more, a liposuction that removes one liter of fat would currently cost in the UK something like £3000-3500, and most surgeons would do a 3-liter liposuction for about £4500. The destiny of the removed fat is almost always the same: stored in 2-liter disposable bags it is mixed with a disinfectant and a powder that turns it into a solid gel, and then safely disposed and destroyed.
Reading this story, I should now feel desperate, thinking about how much money I have been throwing away in my career. Even being very conservative, I am calculating that I could have made more than £1,000,000 out of liposuction fat alone. And think about the fortune some people are carrying around: if you could just liposuction them regularly a new successful type of business would arise. We would need security in the operating theatre, where in a day you could easily put together more than £200,000 worth of human fat.
What a wonderul dream this is, at least for us cosmetic surgeons. I love when journalists jump on everything, and I hope that some of them will now be willing to write about my new business. For a limited period of time, I will be planning to offer human fat at the greatly discounted price of £1,000 per liter, without killing anybody and including the stem cells that can potentially be extracted from there. Any buyers please post a comment with the quantity needed and your offer.
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They say that those born after 1980 have no knowledge of a world without computers: an interesting thought for somebody like me, that still keeps vivid memories of a world where there was nothing digital, watches had no batteries, plastic was a futuristic material and where if you saw somebody with a suitcase you could be sure they were going on holiday (did you notice how many people carry a suitcase around, nowadays?). There is one more thing that the generations of 1980 and followers never experienced: a paid consultation for cosmetic surgery. Free consultations with the cosmetic surgeon were possibly the single biggest innovation introduced by companies, and they played a critical role in making cosmetic surgery a product for everybody.
When the free consultations appeared for the first time, the companies offering them gained an immediate edge over those competitors (mainly traditional surgeons) that still pretended to charge for their work. It was an easy game to play, since patients could perceive the value of the offer, and couldn’t wait to see a plastic surgeon for free. I remember days, in a not-so-distant past, when the clinics had to turn away patients, and surgeons couldn’t stop for a minute. Incidentally, companies were still paying surgeons for consultations in those times, but any cosmetic surgeon that started working for companies after 2005, more or less, has no knowledge, like the generation of 1980, of a world where doctors were paid to see patients.
Times change, and right now free consultations seem to be well past their prime, at least judging from the current market situation. The number of patients that book a consultation and then ignore their appointment is now close to 50% of the total bookings in some clinics, and interesting behavioral patterns are beginning to appear. In general, as a surgeon, you are not in luck if you have to consult in the morning and it is sunny outside (not only because you are most likely sitting in a room without windows, but also because your patients will not want to miss the sun for something that is free and that can be rescheduled at any time). I have seen experienced patient coordinators failing to understand this simple fact of life, and lose their marbles trying to phone call all the patients to make sure they would attend their appointments.
Gladly, this is when some patients have their chance to play games with their coordinators, instead of being as usual on the receiving end of the tricks. I have seen patients being phoned, answering that they were on their way, just minutes away from the clinic, without ever showing up for their consultation. I have got funny memories of an ‘older’ coordinator moaning about how rude patients were becoming, while at the same time worrying that nothing else was in her power short of walking out and grabbing people in the street. I have also heard group of girls saying that they came for a consultation (all of them together) just because they were bored in the street, and joking about having a breast enlargement seemed a good way to have a bit of fun. I cannot blame them, considering that you also get a free cup of coffee and few biscuits while you wait, but I cannot believe that mature people, in any business, would still try to sell a surgical procedure to somebody that admits coming purely to escape boredom. One company, at least till recently, would even give you a discount voucher just for turning up at your appointment, which is as close as they can go to paid consultations, meaning consultations where the patient, and not the surgeon, is actually paid.
I believe most companies are trapped in their own marketing scheme, but would happily charge for consultations, if they could. If only they were not in a price war with each other, if the surgeons they use were actually able to deliver a proper, full consultation worth some money and if, what a big if this is, the generation of patients they nurtured had an interest in something more than just the final price they can get after all the available discounts and special offers.
Like a sad theatre where the actors must keep the show on at all costs, some modern cosmetic surgery clinics seem to think that the no-show must go on, till the last competitor will be out of the market and they will be able to change their price policy. I am not sure this is clever or right. What I am increasingly afraid of is that, with a free consultation, your risk is getting exactly what you have paid for.
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