by Dr Mark Harrison, Director Harley Aesthetics
The Problem
The current situation is that over the last 10 years 40,000 women in the UK have been given PIP breast implants that contain industrial grade silicone rather than medical grade silicone. The direct result of this was that PIP made a £10 cost saving on the manufacture of each implant by using industrial silicone (suitable for use in mattresses) and its founder Jean–Claude Mas now faces criminal charges.
A number of governments including France, Germany, Israel, and Belgium have recommended that PIP implants should be removed due to high rupture rates.
The President of the British Association Aesthetic Plastic Surgeon, Fazel Fatah has argued that all the PIP implants should be removed as the quality of the silicone ‘is not fit to be implanted into humans’. Mechanical Tests also show the PIP implants are more likely to rupture in a manner so severe it is effectively a disintegration of the implant shell.
Clinical Data
But what about the clinical data on rupture rates?
The MHRA quoted an average rupture rate of 1{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} for breast implants, although the Medical Director of the NHS, Professor Sir Bruce Keogh stated a failure rate of 10{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} at 10 years.
The French government quote a rate of 5.6{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} and on a small sample of 108 patients Transform Medical Group found a rate of 7{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb}. (Transform inserted PIP implants on 4,000 women so their medical audit looks rather light). However, as breast augmentation is the most common cosmetic surgical procedure in the UK, surely the cosmetic industry regulator, the Independent Healthcare Advisory Service (IHAS), would have accurate data? The companies responsible for carrying out the majority of breast augmentations with PIP implants are members of IHAS, and therefore one would assume the organisation would have been checking this data regularly over the last 3 years. The IHAS is a small private company with a turnover of a couple of hundred thousand pounds.
Its director Sally Taber initially did not have any data to present at all, and when the IHAS finally did forward the statistics on rupture rate from its members (reported at 1-2{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} rupture rate for PIP implants) it was considered so under reported by the NHS medical director, Prof. Bruce Keogh, that it was totally disregarded.
Furthermore, an audit of 453 patients by two British Surgeons, Mr Jan Stanek and Mr Miles Berry, concluded that PIP implants exhibited a failure rate of between 16{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} and 34{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb}, compared with a failure rate of 0.9{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} among the newer implants they are using.
It certainly appears that the rupture rate of PIP implants will be significantly higher than other higher quality and more expensive implants, allowing industrial silicone (which is more liquid than medical grade silicone) to leak into surrounding breast tissues. We can also assume, as noted by the German Regulator, that due to the unsuitability of the implant shell, diffusion of the silicone into the surrounding tissues will also occur.
The Acid Test
When ANY new product or procedure is presented, my first question is “would I use it on myself, my wife or my mother?”
If my conclusion is no, then I would not use it on any patient, along similar lines if my sister, wife or mother had a PIP implants I would certainly be recommending removal. And for PIP implants older than a couple of years this should be a matter of some urgency.
The Blame Game
There is no doubt that PIP fraudulently used industrial silicone in the implants they manufactured. The PIP implants had a CE mark issued by an Independent German Company and was therefore acceptable to the MHRA. If the PIP implants had only been used by the NHS then the current situation, as out lined by the health secretary , Andrew Lansley, where the NHS will continue with its ‘duty of Care ‘and resolve the issue would be acceptable.
However 95{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} of the PIP implants were used by private clinics and hospitals for cosmetic enhancements. It would seem that these same clinics and hospitals who also opted for the cheapest available implant (saving £50 on a £3,000-£5,000 breast enhancement) should also continue with their ‘duty of Care’.
It would be unacceptable for the profits to rest in the private sector but for the complication to be paid for by the NHS. The consumers or patients have paid for medical grade silicone but have been given industrial silicone – not approved for human use.
But the initial position of Sally Taber (director of IHAS) was that her members should not be responsible for the cost of replacing the faulty implants, reasoning that the PIP implants had a CE mark and were approved by the MHRA.
The MHRA have countered that all but the most basic of medical products are always approved by an independent examiner. In this case a German company but unfortunately the inspections of the PIP factory were booked 15 days in advance which was sufficient time for PIP to hide all the evidence of fraudulent manufacturing.
A Chequered Past
However, suspicions about the practices employed by PIP have been raised much earlier. In March 2000 the US regulator the FDA, found 11 deviations from ‘good manufacturing practices’ at the PIP factory in France and refused FDA approval for the PIP saline implant, which were manufactured at the same site as the silicone implants.
Sky news reported from a solicitor, Paul Balen of Freeth Cartwright, who has been fighting PIP for 12 years. He said of PIP implants:
“They fail earlier, they are cheaper that other implants that could be used instead. It seems to be common knowledge in the profession”.
Sky news also obtained a copy of a letter PIP received from their insurers in 2006 accusing them of concealing complaints about the implants from surgeons and clinics.
‘Your company has therefore systematically concealed for many years the claims received from surgeons or clinics in relation to incidents and removals of your prosthesis. We hold that PIP by a deliberate, wilful and financially-rewarding violation of the regulations, prevented the authorities conducting an enquiry to try and stop the incidents’
The problem of increased rupture rates was eventually raised by French surgeons, and this highlights the lack of regulation and oversight in the UK where the IHAS was apparently not even collecting rupture rates from its members.
Medical Audit and Medical Insurance
But what about the medical governance that should have been provided by the medical director of the private clinic and hospitals that chose to use the cheapest possible implants? One would expect the GMC to be looking carefully at the various Medical Directors who would be expected to carry out medical audit of complications especially in an industry worth £100s million per year.
With rupture of breast implants a known complication one would expect that all individuals, clinics and hospitals carrying out the procedures would have comprehensive insurance for this eventually.
Surely the industry regulator would insist on such insurance?
The debate should be between the private clinics or hospitals and their insurer as to who is responsible for footing the bill for replacement implants; it should not be left to the NHS.
If a provider is no longer trading their insurance company would still be liable for surgery performed during the trading years, or, as a last resort the industry regulator should be holding pooled funds as provision for members who cease trading. This is common in other industries. The reliance of the private sector on the NHS to sort out its mess must stop.
A wretched Industry
At the time of writing both Nuffield, Spire and BMI have ‘stepped up to the plate’ and agreed to replace the PIP implants they are responsible for.
However both Transform (4,000 PIP patients) and Harley Medical Group (almost 14,000 PIP patients) have both refused. The position of Transform is bizarre given that they are more than 40{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} owned by General Healthcare Group, who also own BMI. BMI have already agreed to free replacements! However the real villain of the piece is Harley Medical Group who claims to be the ‘innocent victim’ and seek to blame the MHRA. This position defies the fact that they chose to ignore the FDA findings in 2000 and made the commercial decision to use the cheapest available implants. They attempt to suggest a level of oversight by the MHRA that has never existed. Taken to its conclusion this argument would hold the MHRA responsible for every complication of every medicine and medical device in the uk. Clearly this is ridiculous and also ignores the fact that every European regulator acted in the same way.
The chairman of Harley Medical Group, Mel Braham has stated that replacing the implants will ‘put them out of business’. But there would be merit in ‘going out of business’ trying ‘to do the right thing’. The alternative maybe Harley Medical Group ‘going out of business’ being held in contempt by patients, the medical profession and the media for failing in their moral duty to their patients. They chose to use the cheapest possible implant and the minimum level of medical and corporate governance would dictate that they take adequate insurance to protect against this decision. It is likely that the silicone shell itself is as much if not more of a problem than the use of inappropriate silicone.
NHS Wales has agreed to replace the PIP implants if the private provider refuses but will then do ‘everything to hold the private provider to account’. We can expect the ‘heat to be turned up’ on the rogues shirking their responsibility!
Current Regulatory Environment
The IHAS was tasked with improving the regulatory environment of the Medical Aesthetics industry in 2007. Of the 3-4,000 independent practitioners in the UK none are currently listed as members on the IHAS website!
These independent practitioners being Nurses, Doctors and Dentist all have their own professional bodies (NMC, GMC and BDA) that regulate their entire medical practise. They would argue there is no need to spend £500 to subsidise the regulation of the handful of private clinics and hospitals that are registered with the IHAS. A previous BAAPS president, Nigel Mercer has characterised IHAS as being sold to the profession on the basis of marketing rather than patient safety.
The various quotes and sound bites from the IHAS have done little to convey the image of an independent regulator with the aesthetic patient’s best interests at its heart. Audited data on complication rates must surely be the starting point for any medical regulator. The sound bite from sally taber that the aesthetics industry ‘was reasonably well regulated’ (by IHAS) must surely sound hollow in both medical and non medical circles. There is now a gather chorus of government ministers, doctors, MPs and patients calling for effective regulation of the aesthetics Industry.
The Way Forward
We have independent government bodies with statutory powers to protect consumers from water, electricity, gas and telephone companies so perhaps the same should be available for cosmetic surgery.
This new body should include:
- Compulsory Membership
- Membership fees of £20,000 or 1{19761799e1353b7a6a49a5f02d3172230495afcde52b198895f8f3ba7ac759cb} turnover whichever is greater
- Power to fine, censure and prevent a company from trading
- Power to fine, censure or report to the GMC any Medical Director that is negligent in their medical or corporate duty
- Insurance to indemnify the NHS against complications following cosmetic surgery
- Pooled funds to indemnify against the liabilities of any member that ceases to trade.
Trouble Ahead
The current media coverage has thrown up a number of issues that any new regulator will need to address as a matter of urgency:
Practitioners
- Increasingly beauticians are passing themselves off as aesthetic practitioners and administering both Botulinum Toxin and Dermal fillers.
- Physiotherapist, ODA, Paramedics and dental Hygienists are also ‘jumping on the band wagon’.
- Guidance is required from the royal college of surgeons as to acceptable procedures for non surgeon to carry out e.g. Vaser, Smartlipo, fat transfer and Macrolane.
Products
- There are over 160 Dermal Fillers available in the UK including the permanent filler Bio Alcamid.
- We know from our experience with Novobel, Puregen and Nu-fill that Dermal Fillers should be classified as Medicines both to control their casual use in humans and to allow an audit trail back to the prescribers who are supplying beauticians.
With the continued growth of the aesthetics industry there now exists the urgent need for the Minister of Health to establish a government body to provide effective regulation.
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