Breast implants – my PIP tips
Many of you will have read or heard about the potentially defective breast implants provided to approximately 40,000 women in the UK. One of our clinical negligence experts – Rosamund Rhodes-Kemp – looks at the situation and how to avoid similar problems in the future…
These implants were manufactured by the French company Poly Implant Prostheses (PIP) from cheap, industrial-grade silicone designed for filling furniture such as sofas and chairs. At just £5 per litre, industrial-grade silicone is approximately seven times cheaper than the medical grade material (£35 per litre) which should have been used.
In the UK, the cheap implants were sold to cosmetic clinics and the NHS – some for breast augmentation, others for re-constructive surgery after breast cancer. Between two and three thousand women have had the implants performed on the NHS.
These PIP implants were banned in 2010 after it emerged that they had an increased risk of rupture.
How was this situation allowed to happen?
Because silicone implants are classed as medical devices, they’re not subject to the same vigorous testing as, for example, medicines, to be licensed for sale. A company producing a medical device needs only to get a CE (European quality) mark. Even this basic standard is easier to get in some countries compared to others, and it seems that the French company who produced the PIP implants actually went to Germany for theirs.
Companies with the CE mark are inspected. But, in this case, the head of the organisation Mr Jean-Claude Mas has admitted using cheap silicone to cut costs and hiding any damaging documentation from inspectors when he was given notice of their intending inspection.
In the UK we have a further regulatory authority – the Medicines and Healthcare Products Regulatory Authority (MHRA) – to which problems should be reported. But the MHRA has no responsibility for approving medical devices. All it can do, upon receiving complaints about products, is send out a letter warning relevant doctors of the issues that have been raised.
So there is precious little effective regulation of quality and procedures when it comes to medical devices. Precious little protection for potentially vulnerable patients. And, alarmingly, the situation is much the same for devices like cardiac pacemakers and artificial joints.
What is being done about it?
The company who manufactured PIP implants has gone bust. The French government has said that all such implants in France will be replaced at the expense of the state.
In the UK, the health secretary, Andrew Lansley, has confirmed that the government will pay for PIP implants provided on the NHS to be replaced free of charge. He has also called on private cosmetic clinics to offer the same, but at least two cosmetic companies have said that they cannot afford to do so.
What can you do if you think you’ve had a PIP implant?
If you’ve had implants that you think might contain PIP silicone gel, you should see your GP to discuss your concerns. If you had them on the NHS and would like them replaced, explain this to your GP. If your PIP implants were provided within the private sector, you must write to the head of the clinic at which you were treated regarding free replacement of the implants.
If you remain dissatisfied, you may wish to seek the advice of a lawyer specialising in this type of claim.
What should be done to help those affected?
- There should be an agreement between the government and the private clinics that all PIP implants will be replaced free of charge. After all private clinics were happy enough to take the money when the implants were inserted and should carry insurance for this.
- The government should call on the goodwill of the surgeons that carried out the replacements to see if they will help with the replacement at no cost.
What should be done to ensure a safer future?
- A compulsory database should be kept for all implants and, in particular, those relating to cosmetic surgery. In the past this has been voluntary and many women didn’t co-operate, so the information we have is very poor. Currently it’s impossible to know how many women are affected and to alert them of the potential risks.
- There should be better and tighter regulations and surveillance for all surgical implants.
- The MHRA should have a greater role in the licensing of medical devices. At present, they are only involved in licensing medicine.