In recent months the newspapers have been filled with stories from celebrities and ordinary women alike, all worried about the possibility of their faulty breast implants rupturing. Because of the potentially dire consequences that this can bring, many of these women have taken the step of having their implants removed.
This furore is due to a specific French manufacturer, Poly Implant Prosthese (PIP), and their silicone implants. These implants have been found to contain industrial grade silicon (reportedly also used as mattress filler) rather than the more expensive medical grade variety, resulting in 1,262 of the estimated 300,000 breast implants in France rupturing whilst still inside their recipients.
Although the exact figure is unknown, the Medicines and Healthcare Products Regulatory Agency (MHRA), which regulates medical devices in the UK, has estimated that there may be over 50,000 women in the UK who have implants made of this substandard silicone.
A recent Government review has found that, although the MHRA followed clinical and scientific advice, questions still need to be asked about whether its communication of the possible risks of the implants to patients was clear enough.
To compound the situation further, both the French and the UK medical authorities are issuing different advice to women with PIP implants.
Whilst the French medical authorities are advising women with PIP implants to have them removed, the UK Government are advising that there is no need for removal unless it is ”clinically necessary”, such as when the implant has ruptured or is about to. The Royal College of Surgeons, however, insists that all patients should have access to an assessment and be given the opportunity to have the implants removed upon request, contradicting the Government’s advice.
Presently, the NHS will remove and replace PIP implants for any patient who received their implants from the NHS but will only grant removal for those who got their implants privately. It is estimated, in Scotland, that the majority of those women who are affected by these implants fall into the latter category.
But what legal challenges can these women mount to recover compensation for their losses? Does this compensation cover replacement implants or only removal? Is there, and should there, be a difference between the women who had their surgery through the NHS to those who had it done privately?
At first glance this might look like a medical negligence issue to the average person but legally it does not fall into this category.
An argument exists that surgeons should have been suspicious as to the quality of PIP implants due to their comparative cheapness compared to similar products. This is particularly so in the view of the reports questioning the implants’ safety which appeared in the British Journal of Plastic Surgery in 2005.
However, doctors the length of the country, in both NHS and private clinics, had been using the product for a number of years and there was an apparent legitimacy to PIP due to the MHRA’s approval of the implants. Therefore, in the absence of specific circumstances, it is unlikely that medical negligence would be an appropriate recourse for a victim of PIP implants to take.
The Consumer Protection Act 1987
A private or NHS patient can take proceedings against the manufacturer for the PIP implant if they can show that they suffered personal injury as a direct result of the product.
However, as the manufacturer has gone into liquidation there are unlikely to be any assets available to pay for such compensation. At present it is unclear whether the company’s public liability insurance would cover such claims, so this may not represent the best option for those affected.
The Sale of Goods Act 1979
This could represent the most straightforward and effective remedy, but would only apply to those who received their implants through private clinics.
By paying for their operations through private clinics, the victims become consumers whose rights are protected under this Act. Section 14 states that “goods have to be of a satisfactory quality”, which includes the product being safe and durable. It could certainly be argued that no reasonable person would consider implants that contained industrial grade silicone instead of a medical grade to be satisfactory.
Under the Act, if the goods are faulty then it is the responsibility of the supplier to replace them or offer a full refund.
Supply of Goods and Services Act 1982
Jan Miller, in the New Law Journal (162 NLJ 112), recently commented that “breast augmentation surgery may be classified as a works and material contract. The service (the surgeon’s skill and operation) is so substantial that it is in effect the substance of the contract: the goods (the implants) are ancillary.”
This may, therefore, give rise to another possible claim, as under the Act, the goods supplied must be of “satisfactory quality” and an important element that determines quality is whether goods are safe for use. If the goods are deemed unsatisfactory then the consumer may be entitled to a repair or replacement, within a reasonable time, unless this would be disproportionate.
This would therefore mean that whether the implants had ruptured or not would be irrelevant.
What can be claimed for?
At present a few private clinics are offering free removal of the implants, but they will not pay for a full replacement or refund. Other clinics will only pay for an assessment to ascertain if the PIP implants need removed.
If the Sale of Goods Act applies then a full replacement or refund could be claimed, and there is also the possibility of claiming for psychological damages.
While the recent Government report notes that there is no evidence that the MHRA and the Department of Health failed to do their jobs it does question how well they communicated the potential risks to patients and also whether they should have known about the matter sooner. The review also investigated a number of complaints regarding PIP’s stability between 2003 and 2010.
Recently a woman and her “faulty goods” had her credit card company file a chargeback against the clinic who supplied her with the PIP implants, highlighting the often novel methods in which compensation can be sought in this issue.
Further evidence may come to light at a later stage that could dramatically change the way in which the MHRA is regulated and identify what steps those seeking compensation could take. While at present the cases running in Scotland are under the Sales of Goods Act regarding the implants, it might be safe to say that this story has not yet concluded and there may be more twists and turns yet to come.