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 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”.
“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.
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