The French court ruling with regard to whether TÜV Rheinland should pay compensation to thousands of women who were fitted with defective breast implants has been announced, and the German firm has been ordered to pay damages*. This comes only shortly after the European Commission opened a public consultation on the safety of the breast implants.
Despite varying reports over the last few years with regard to disputes over the conclusions of the investigation, evidence prompting total removal in Sweden, and more recently, that there is ‘no cancer link’ to the implants, the fact remains that over 400,000 women worldwide were fitted with implants made from sub-standard silicone gel, causing many of the implants to rupture.
Whether or not the ruptures are directly linked to a greater risk of cancer, hundreds of thousands of women have been duped and have faced years of worry and insecurity — and many are unable to afford the costs to have these implants removed. In the UK, the government announced that women given PIP breast implants on the National Health Service (NHS) could have them removed for free, but this has not always been the case in other countries, and does not cover implant replacement.
While a recent European study ruled that ‘there is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach’, and that ‘there is a need for women with PIP breast implants to seek regular clinical examinations, and where deemed appropriate, individual counselling and imaging with ultrasonography or MRI’, I sincerely doubt this will put minds at ease. To continue to visit a medical setting for long-term check-ups can be distressing at the best of times, but to constantly worry that your breast implant may or may not have ruptured must be a living hell.
On the results of the aforementioned study, President of the British Association of Aesthetic Plastic Surgeons, Rajiv Grover, said: ‘Regardless of these results, there is simply no justification for the continued presence of these substandard implants within the human body … The reality is that these implants are defective … It makes a mockery of the system. If they were cars, they’d be recalled.’
I, for one, wholeheartedly agree. In simple terms, if you are mis-sold a product or sold a faulty product, then you would expect either a refund or exchange for something better. Patients and plastic surgeons have been mis-sold on PIP, so it is certainly time for a refund.
It is also time for Europe to put its house in order with regard to regulation. In the past there have been criticisms over variability in performance of regulatory bodies, and device product safety and controls have certainly been lax. We are in desperate need of equal standards throughout Europe to avoid a similar scandal from happening again — a fear that many cosmetic surgeons in the UK now fear.
* Jean Claude Mas, founder of PIP, remains on trial for fraud in Marseilles.
The verdict is expected on 10 December.