Time always tells the truth
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 want to congratulate you Snake, you’ve been one of the few surgeons who’s had the guts to speak out about this. And I’m personally very pleased to see you finally vindicated.
I appreciate your remarks about the need not to worry too much about safety until we know more.
But, it seems to me, that regardless of the safety issues involved, it’s actually now transpired that PIP was selling a knock-off product!! That is, it was selling implants with the CE mark of approval when they did not contain CE tested materials. To me this is akin to buying an iPhone from Apple only to discover it’s just a clone made in North Korea. Who cares whether it looks the same and performs the same functions, it’s a fraudulent product sold to me through false advertising!
Anyway, I appreciate it’s going to take a long time to unravel all this. My main point here is to, once again, thank you for being brave enough to have kept warning us all about your suspicions.
A xx
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Dear Annie,
thanks for your message. I really wish the messages about the quality of PIP implants could have been taken more seriously years ago, but some companies, one in particular, have been very good in selling them against all the evidence.
It is a shame that so many patients actually believed stories like ‘PIP are the best implants’, but I can assure that even some of the staff in those companies using PIP implants actually believed that they were selling a great product. As for the management, I am not so sure that they didn’t know what they were offering, but this is going to be matter for the solicitors, now.
At this point, it is quite likely that patients will be told to keep their PIP implants unless they have signs of problems, and that the particular silicone gel used is not dangerous. This will be another way to overlook the rupture rate of those implants, that has never been properly investigated and that seems to be, at least in my own experience as a surgeon, well above normal.
What would I do if I had PIP implants right now? The same as two years ago: replace them immediately with something more tested and more reliable.
Snake
Dear Snake
You clearly highlighted concerns about PIP implants some years ago. As a relatively new reader of your blog I read back quite a bit, but not until this article did I realise how long ago you flagged the potential for problems with some implants.
Excuse my ignorance, but I’d find it really useful if you could explain exactly what the US FDA look for/assess versus our European equivalents. I understand that the FDA somehow have higher standards as they clearly only authorise a couple of implants. But what do they do differently? Is it more stringent criteria or totally different ones?
You’ve made me think really hard about the concept of living the the ‘product’ for all those years and focusing on this, rather than on the ‘brand’ that’s selling it to you.
An idiot’s guide to approvals would be most welcome.
PR Mum of 2
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Dear PR Mum of 2,
the FDA approved the implants after running a controlled trial, which is actually still ongoing in order to evaluate longer term risks. In Europe the so-called CE mark is more a certification of the manufacturing process and materials. I can’t really write a guide to the approval systems, especially since it is not my specific field of expertise.
What I would recommend to people considering cosmetic surgery is to trust an expert surgeon, somebody that actually managed to build a good reputation over time and not a young handsome guy that just came out of the training program and is looking for quick money. A reputable surgeon is not going to risk his/her business on cheap implants, while young surgeons have been regularly blackmailed by one the biggest companies using PIP implants (something like: “Fine, you don’t want to use these implants, we will stop sending you patients for breast enlargement”). I do know that a lot of surgeons were concerned about PIP implants, but most were in a very weak position and didn’t have the gut the go against the company that was feeding them. It is sad, and it is probably just another reason why cosmetic surgery companies should be strictly regulated.
Snake
Hi Snake,
I had no idea about the bad press around PIPs when I had them implanted through HMG 6 weeks ago.
I wish I knew then what I know now. I want them out, and replaced with a more reliable product, and am not prepared to wait until they rupture before this happens.
What worries me most is that I am small fry compared to this huge company, and I wouldn’t know where to start fighting them.
Emma
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Dear Emma,
I have no idea of what decisions the Harley Medical Group is taking, but they are probably the company with the highest number of patients with PIP implants, so I am sure they will come out with a plan to deal with this. A lot will depend on the guidelines that the MHRA will issue, and also on the type of aftercare they included in your package (that I am pretty sure would not cover such a situation, anyway).
There is quite a good chance that you may be left with your PIP implants, if they are considered ‘safe’ by the HMRA, so you would have to pay for the replacement. I know this is not going to make you happy, but I am not optimistic about seeing companies replacing more than 40000 PIP implants out there for free. Your only chance is that, given the very high number of patients with these implants, a group of solicitors may find that this situation is worth some interest.
Let’s see what happens, anyway (companies have got very good legal help, and they know they will be fighting for survival, this time).
Snake
Thanks for your reply Snake. Your comment about reputable surgeons leads me to a question I’ve been meaning to ask. Why are some surgeons registered with their professional body (BAAPS or the other similarly-hilariously named one) and others not? I note you mentioned on one post that breast surgery is only a very small part of the qualification for one of the bodies and I recognise that plastic surgery is way more diverse than just this procedure.
In my industry registration with a professional body is not mandatory. But I choose to be a member as it signifies I am serious about my profession and that I will abide by the high standards that body sets. It also commits me to a program of continuous professional development, something which I’m sure many other professions commit to and which is surely a good thing in your field?
So why would some surgeons be members or a professional body and others not? Is it an indicator of their technical ability or the quality (or not) of their work? The major companies focus on the GMC registration, which as far as I can see is a license to practice, not a measure of quality.
Your informed opinion, as always, would be very welcome.
PR Mum of 2
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Dear PR Mum of 2,
most plastic surgeons are registered with their main national association. Since some of the surgeons practicing in the UK are actually not British, there is a significant number of doctors registered with their association in a different country. This should be fine, as long as the association is part of the IPRAS (www.ipras.org).
There is a problem with doctors practicing cosmetic surgery without being on the specialist register for plastic surgery, which is possible and legal if they were practicing cosmetic surgery since at least, I believe, the year 2001. They are usually older surgeons that didn’t specifically train for cosmetic surgery, but matured significant experience over time. They also cannot register with the national association of plastic surgeons, which surely creates some confusion.
Hope this helps.
Snake
Hi, i have been reading your blog on pip implants, unfortunately after 3 months of hospital appts after finding a lump on my breast I have discovered that my pip implants have ruptured and leaked. MRI scan showed 2 more lumps under my armpit. I have an appt this week to see a surgeon about replacing them, they have mentioned Nagor implants… Could you give me your opinion on this make of implant and to your knowledge what are the safest on the market, also any other questions i need to be asking?
Should i be paying towards the cost of replacements?…. I don’t think so but they have mentioned paying towards hospital fees.
Thanks Karen
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Dear Karen,
yours is a very typical PIP story. I can’t really give an opinion about what implants are the best, and I already said that I would rather trust the brands that went through the FDA approval process (Allergan Natrelle and Mentor). Nagor seems the new choice for many small companies and surgeons that were using PIP, but being honest I have only used them many years ago, and I don’t know anything first hand about their latest products. Paying or not depends on your preoperative agreements.
Snake
Hi Snake,
Just looked through your blog and am quite impressed. I wish to have your comments on my Sebbin implant that I just had 2 months ago, the product is recommended by a reliable doctor. I heard that SEBBIN was banned to market its gel silicon implants in 2000 and was resumed in 2004. Any comments on SEBBIN gel silicon??! Thanks so much,
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Being honest, I have very little experience with Sebbin implants. I never used them, and it seems that they are not very popular at the moment. They are cheaper for very big sizes (more than 1000 cc), and I suppose that is their biggest market.
I have never heard of any ban involving their silicone implants, but again it could be that I missed it do to the fact that I never used them and that I very rarely see patients that had those implants.
I can’t comment a lot, other than saying they are part of a big group of breast implants sold mainly on price.
Snake
Hi snake
After reading all the comments, it all sounds hit or miss whether or not you receive a trust worthy implant! Do you know if there is a difference between the Allergan Mcghan and Natrelle implant as i’ve been told they are the same.
Thanks for you help
laura
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Hi Laura,
Natrelle implants and McGhan implants are actually the same. Allergan changed the name to Natrelle, but is still selling some implants with the old package, so there are few patients really worried out there, after receiving an information booklet with the name McGhan on, instead of Natrelle (the booklet comes out of the implant’s package, and it is given to patients after the operation…). I believe that Allergan could make this more clear, maybe just adding a simple leaflet explaining the situation.
Snake