Monday, January 23, 2012

Banning Cosmetic Surgery Advertising - Good Idea or Bad?

I am a tad confused today.

I sit here trying to understand why I am a bit miffed on the call to ban Cosmetic Surgery advertising, and I think it comes back to a couple of simple points; it's unfair, unnecessary and ultimately pointless.

It wouldn't have made any difference to the current situation; the French have not been able to advertise Cosmetic Procedures to the public for years - but it didn't stop PIP manufacturing poor quality implants.

Let's wind back to what we are trying to achieve; a safer, more transparent industry with greater protection for patients. I agree that the way Cosmetic Surgery has been sensationalised in the media and the way it is often positioned to a prospective patient is inappropriate for a surgical procedure. The Groupon offers and 2 for 1 deals are just utterly ridiculous and should never have got passed by Advertising Standards.

I have spoken to a few of my Creative, Advertising and and Marketing colleagues and we agree (unusually) on one thing ;

A ban all advertising of the procedures will backfire, as it will remove the legitimate channels for informing patients, and probably lead to MORE instances of poor practice, due to the lack of available information for patients.

And there is a question over whether they're patients, clients or consumers? I would argue all three at one time or another; Consumer when they are looking for information, Client in the consultation and Patient thereafter. This is the problem of having an FMCG model in Medicine, and also now trying to get the genie back inside the bottle.

The results of Cosmetic Surgery are EVERYWHERE, and Boob Jobs are getting more press now that ever before. You can't suddenly erase 10 years of market conditioning by banning advertising of a product or procedure while the market still continues to stare at enhanced celebs on TV,covet them, and go onto the SoFeminine forums and discuss.

Which would you rather have, a process of communicating legitimate information to a prospective patient that can be reviewed, edited and regulated, or nothing at all and rely on heresay, myth and pseudoscience?

This is the issue with Botox; the most widely known Cosmetic procedure, that no-one knows what it is because it cannot be advertised, discussed or even looked at invitingly by manufacturers to patients. So you rely on the practioner to position it appropriately, and ensure that the patient is informed on the product. Now does that patient leave the consultation fully informed? Maybe, maybe not,  but if it was advertised they would have an idea of what to expect and what questions to ask.

The large Surgical Chains have made some horrendous errors of judgement, and rightly should be castigated for it; but this also has the feel of an attempted market share land grab. If you remove the big guns ability to advertise their procedures you reduce their power, but who will then give the patient the information they need? 

Where do they get this information from, are those calling for the banning of advertising going to fund a patient awareness campaign? Probably not, and good luck getting the Government and Suppliers to cough up for it! 

The industry has recently been lauding the FDA and US regulatory authorities as the bastions of good sense in the way they deal with regulation and product approvals, and yet in the US, BOTOX is advertised directly to patients. Is it now wrong to focus on improving the safeguards at point of entry, and focus on something that would be a nightmare to police and only really be effective if it was across both Surgical and Non Surgical procedures.

The issue is not the MEDIUM, the issue is the MESSAGE, and the Advertising Standards Agency are responsible for this. Recently I believe that Spire Healthcare were asked to remove an ad that appeared to trivialise a Cosmetic procedure, so the process obviously works and nothing would give me more entertainment than watching clinics grass each other up to the ASA.

Don't get me wrong, I think the BAAPS 6 Point plan is a great idea, and I support the intention wholeheartedly, however in my experience people can only really focus on 3 things well and only one will get any real attention.

I simply don't believe that banning advertising of cosmetic procedures will address any real need, and this discussion has diverted focus from the real issue which is the quality of the product that was implanted in 40,000 women in the UK. There is also a restraint of trade issue in this that needs to be looked at, has anyone even asked a lawyer if it is actually legal to do this?

So, in Marketing speak;  let's focus on the real issue (Product) and not get sidetracked into Placement and Positioning and let the ASA take up the slack in ensuring that the messages to the patient (Promotion) are ethical, legal, truthful and honest.

What do the ladies who have had the PIP implants think of banning ads? I bet they would want a quality result, from a Quality surgeon using a Quality implant and not really care about whether they read about it in Grazia.









Monday, January 16, 2012

4 Reasons why if you run a business you should go to the gym.

After an enforced separation, the gym and I are now friends again. My feeble body gave me the instructions back in September of "Rugby or Gym? I can't do both!"

To prove this point even further Horsham's formidable back row stopped me in my tracks and my left shoulder went on strike. It steadfastly refused not to hurt if I slept on it, and as for lifting anything, no chance it said. Talk to the hand. Or the elbow. Or Tebow even.

Evil Mickey
So a full 4 months later we appear to have agreed terms and the shoulder is back. Christmas in Houston Texas was a killer for fitness (damn you Cracker Barrel, Taco Bell, Wendys, Whataburger, Red Robin, Dennys, Starbucks, bottomless fries and 1ltr Rootbeers with free refills to name a few). Oh and Mickeys Big mouths. We liked them a lot.

So, I have finally mustered the willpower to embark on the 2012 crusade and hit the gym hard. I have invented "3 Class Friday", what is this, you say? Take a wild guess. Its where you must complete 3 classes on Friday, regardless of what they are. If your gym is like mine, the good ones get booked fast and all you are left with is Geriactric Tai Chi or Spinning (which I hate because it makes me feel a bit sick). But you get the point, it adds a bit of variety to the proceedings.

If my gym is anyway like yours it has no doubt been rammed full of those who have a monthly subscription for a gym, but only go in January and February. Now we have reached Spring - when the gym is deathly quiet and I am at my most motivated.

It was hilarious in Body Pump today - Mr One Rep Max walks in, looks condescendingly at  the feeble weights on offer and loads his bar, and the woman next to me says, "Just wait until the Bicep Track". Now, if you haven't ever done Body Pump it might not make any sense, but just in case you do, don't load the bar! Mr One Rep Max nearly had a stroke during the 4 mins of Bicep Curls, and me laughing at him didn't help. Bloody Mirrors.

Anyway, back to the plot; why should business owners go to the gym? Well, I haven't been for a little while and I missed it, today I realised for the first time that the gym is a crucial part of my business and here is why;

1. Goals

Goalsetting is the foundation for success, of this I have no doubt and training is FULL of them. Simply getting out of bed and going is a goal, especially at 6AM in January. Lifting a certain weight, covering a certain number of miles, all valid goals and the more you flex your goalsetting muscles the bigger they get.

2. Clarity of thought
I don't know about you, but I get most of my rubbish ideas when I think too hard about something. A quick swim or 1/2 hr on the bike and generally the sticky issue is less of an issue or solved completely.

3. Energy
The paradox is that the more you use the more you get. Strange but true

4. Networking
Great places to practice your elevator pitch on people who don't care. If you can engage them you can engage anybody.

The New Years resolutionists have gone - get in there!!!!

Friday, January 13, 2012

Everyone is leaving the table - who pays the bill?

So the PIP Implant issue truck rolls on. Harley Medical Group claim that they simply cannot afford to conduct reoperations on the patients they implanted with PIP. And in any case, they shouldn't have to because they were duped along with everyone else. Right?


And don't get me started on the regulator - IHAS, what exactly have they been doing since 2007.


Next weeks topic!

Well one thing is clear is Harley Medical Group simply can't afford this, as their published 2010 accounts put NET profit at only £489,000 from a turnover of £29M!

Uh Oh!!! NET Assets are only £3.2M, this isn't a balance sheet I would want to see. Costs too much to run this business, and not enough in the bank to weather any changes in the market.

One asks the question how can it cost £14.7M in cost of sales and another £14.7M operating expenses, as it wouldn't take much to push them out of business, such as a simple run of poor press and the resulting drop in sales revenue...................Ah.

Ok, so it looks to me like HMG are effectively dead, and not much they can do to recover from this unless Director and Investors dig deep and bail it out. This is something I wouldn't do as thanks to some shockingly poor decision making the Harley Medical Group Brand has become the "Villain of the Piece" and it's equity is diminishing by the second, so I wouldn't be putting investment in, I'd try and take it out.


Brand Values?
The other challenge with Harley Medical Group is that their business model uses leasing rather than capital investment, which means that they have little in the way of  fixed assets and unlike Transform and The Hospital Group they don't own a Hospital. The ultimate issue here is that they have an instant overheads of Theatre space, Anaesthetist, Surgeon and Implant cost for every Breast Enhancement performed, which is why they cannot perform 14,000 operations free of charge as it would cost them £39.2 Million. 

Mel Braham is telling the truth; They simply don't have it.

The Doomsday Scenario

The danger I see is that if the Government continue to push the private hospitals hard to fulfil their moral obligation and provide the operations the path of least resistance is simply to cease trading. If this happens patients stand absolutely no chance whatsoever of getting any recourse and will have to pay to have the implants removed, or the NHS will be forced to pick up the tab. 

The Third Way?

There is another way - the NHS becomes Harley Medical Groups banker to the tune of £39M and provides the operations on their behalf at cost, which would be significantly cheaper than using a private hospital. Nagor UK have already offered to provide implants free of charge, so patients get the op, NHS recovers the money and HMG don't turn a profit for 80 years!

Maybe not - but there needs to be some creative thinking because neither the current scenario or the Doomsday are really acceptable.



Thursday, January 5, 2012

PIP Debacle Shames our industry.


 It is truly horrific watching this play out in the media, and if it were not such a serious issue, it would almost be funny. I was gobsmacked at the general level of arse covering going on, and it was only a matter of time before the blades were drawn in this battle over the PIP Patients.

I have friends who have had PIP implants (before we met obviously) and I am writing this for them.

They know what industry I am in and I want to look them in face at the school gates.

They seem to have become the forgotten in this battle for power; I am fortunate that if anyone I know wanted to have a Breast Augmentation (BA) I know which surgeon they should see and what products they should be using. A patient who has had a BA recently must be terrified, and not really have anywhere to turn.

This is my view on this debacle, the mechanics that allowed it to develop and possible solutions to the saga.

Who am I to have an opinion?

Well, let's be clear on this; I am NOT a surgeon, but for 8 years I worked in Sales for one of the largest manufacturers of breast implants - Allergan - and for 3 of those years I worked with the major clinic chains that have previously used PIP.

What is it that is the problem with PIP?

There are 3 major issues at hand with PIP implants;

·        The quality of the product
·        The rupture rate
·        The numbers sold

Product Quality

Breast Implants need to be made to exacting standards, this point is clear. The Implant shell needs to be robust, the silicone used of a specific type and sterility maintained throughout the implant.

The silicone used in the PIP implants was of an industrial grade and was not meant for use in medical devices. It is rumoured that PIP changed the construction of the implants without notifying the authorities, and why did they do this?

Who knows,but it must be for simple profit. It was cheaper to use this silicone and this is their crime

The main factors that affect implants are Capsular Contraction, and Rupture.

Capsular Contracture(Cap Con) is a process where the body effectively builds a collagen barrier around the implant that hardens and contracts. This can be painful for the patient, and in certain circumstances will require the implant removal.

It is measured using the Baker Scale, I – IV and grade III and IV Cap Com require the implant to be removed. Grade III is at the Surgeons discretion.

Cap Con happens with all implants, and the surface texturing design of the implant can assist with a reduction in the rate at which this happens.

Ultimately there are a number of factors which contribute to this process, and the implant is only one of them. However, the Cap Con rate of a surgeon is a question that should be asked by any potential patient, as it is a matter of keeping quality records.

But we will come onto that!

 Rupture Rate

Rupture is where the shell integrity of the implant is compromised, or, in other words it splits open. The Shell layers are the protection against this, and the Natrelle range had 6 layers whereas PIP (I think) had 2 at most.

The shell also prevents gel diffusion, where the gel bleeds through the shell regardless of rupture.

One of the issues facing the industry presently is the lack of reliable data on any of these issues, and this is can be seen through a whole range of statistics being presented on the rupture-rate of PIP implants:

·        MHRA/IHAS=  1-2%
·        FRANCE=  5%
·        TRANSFORM=  7%

Let’s take the median = 4.6%, this is as accurate as the data the MHRA have, but probably has a greater scientific basis!

Numbers Sold

If as is claimed that there are 30,000 PIP implants in the UK market, with an illustrative rupture rate of 4.6% this would mean that 1,380 patients would have ruptured implants during the life of the prosthesis.

However, due to the quality of the silicone, the call is for the UK to follow the lead of France and have ALL PIP implants removed from all patients. Bravo! But who pays for this?

How did we get to this point anyway?

The wider issue

What we are seeing now is the culmination of a process that began when it became so easy to get credit for breast augmentations. When I was 23 I couldn’t get a loan for a motorbike but in more recent years an 18 year old could get a cheap loan meaning that ANYONE could afford to have this procedure.

Cosmetic Surgery was booming, and became very competitive. Within that industry, there have always been two camps; The Independent surgeon and the Corporate Chain

The BAAPS/BAPRASregistered Independent Surgeon had the freedom to choose implants based on the criteria they chose, and most choose wisely.

I believe firmly that the majority of surgeons have acted in the patients’ interest and used quality implants, which is great because otherwise the issue would have been far greater.

This is also the group who knew that PIP were poor, and levied the Government for a register of Breast Implants to help track the safety profile. Great idea, until theGovernment removed the funding, then they asked the manufacturers to support this register, which is again a great idea but it takes time to extract cash from a supplier, even after they have been convinced.

The Corporate Chains also had the freedom to choose, but have different criteria and price factored higher in the equation, especially in the early days of the boom. They have shareholders to appease and are highly skilled at attracting and converting patients to have BA and other procedures.

The majority of PIP augments were carried out by this group, though they didn’t imagine that the implants were filled with fuel additives and industrial silicone.

Approaching them with Non Ruptured PIP Implants demanding a revision won’t work while the Government are still contradicting those advocating a full recall.

And in the event of an order to remove PIP implants, who is liable, the surgeon or the company?

I am afraid that the best you can really hope for is a reduced fee reoperation.

But don’t be too hard on these guys; they were duped like the rest.

What happened to the steps that could have prevented this?

Ahh, let the buck-passing commence. So who carried out adequate checking of PIP Facility to ensure standards were met and maintained by authorities who provide the CE mark?

Let’s not forget that the MHRA has approved these for use in the UK, despite having concerns since 2006, and having issued a Medical Device Alert (MDA) on 31 March 2010 are still saying that they are safe and is no need to remove them.

Problems First Noted in 2000

“The US Food and Drug Administration sent an investigator to inspect a plant run by the manufacturer, Poly Implant Prothese (PIP), at La Seyne Sur Mer in southeastern France in May 2000. Shortly afterwards, the FDA sent the company's founder, Jean-Claude Mas, a warning letter saying the implants were"adulterated" and citing at least 11 deviations from goodmanufacturing practices.

The problems had to do with PIP's saline implants,a different line from the silicone implants that French authorities ordered off the market in 2010 for using industrial-grade silicone instead of medical-grade silicone, leading to the French firm's bankruptcy. Still, the plant inspected by the FDA was used to manufacture the silicone implants for PIP

Finally, what about the price of the implants?  Wasn’t £100 per pair the give-away?

The UK distributor of PIP implants could have at any time checked for quality and should have; you put your name to the products you sell.

I sold breast implants for Allergan with a price between £600 and £1000 per pair, high quality warrantied implants that I would recommend to friends and family, because I had faith in our reputation for quality. 

Just so this doesn’t sound too much like an Allergan tub thumping, Nagor and Mentor implants are also of a high quality, but no one wanted to listen to the greedy arrogant American Pharmaceutical company.

So where do we stand currently?

Well, rightly or wrongly this is where we are, and what can we do about it?

My god, I had a boob job18 months ago with Corporate Chain X!! Have I got PIP Implants?

Well, if memory serves, most of the corporate groups had switched to Allergan Implants by mid-2009, so if it was within the last 2 years unlikely.

If you had aprocedure prior to then almost certainly a PIP implant.

Bloody great! So will they be the ones filled with Engine and Mattress Silicone?

No one knows for certain when PIP switched to their incredibly dubious methods, and Jean Claude Mas is on the run and PIP in liquidation, so assume that you do.

Ok, so what do I do?

This is the million dollar question, and frankly it is disgraceful that no one has an answer to this.

The Government line
“No, it’s fine. Yes there is a problem but it’s not that bad so leave them in. Oh, sorry it might be bad but they’re still OK.

The Surgeons Line
“OH MY GOD!!”They must be removed immediately!! What? No I’m not doing it; get the guy who put them in to do it”.

 The Corporates Line
“Ok, not a great situation, and yes we’ll replace them for £3,000”.

The French Line
Let’s just take them out

The Bottom Line

The Truth is no-one wants to pick up the bill, so if you are a PIP patient, my advice is to go and see the group who carried out the procedure, try to negotiate a fee to have them removed and pay it. I know it’s not fair and they have a moral obligation to help you,but morals have a price.

The real reason we are in this situation is that no one wanted to deal with the 10 ton elephant in the room, and that is that everyone made it far too easy for PIP to do this.