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PIP implants: Taking the right decision and lessons to be learnt

Fazel Fatah, Consultant Plastic Surgeon, President of The British Association of Aesthetic Plastic Surgeons (BAAPS), Member of the Advisory Group on PIP implants

Tuesday, 31 January 2012

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Women who have had breast augmentation with PIP implants are genuinely worried if they are at risk of systemic harm from the deceitful use of non-medical grade of silicone gel in their implants. The DH was caught off guard when the story first broke out from France for two main reasons; lack of reliable data from MHRA and emphasis on rupture rate as being the main issue. Therefore, the original advice, in May 2011, failed to calm the nerves as news continued to trickle through from France associating ruptured PIP implants with a variety of problems in the breast, including cancer.

When the French government issued new guidelines before Christmas 2011 and recommended removal of the implants, pressure mounted on the DoH to come out with more appropriate advice based on sound scientific data. The Secretary of the State did the right thing. He asked for a panel of experts to study whatever data available to help him issue the correct advice under the circumstances. Reliable data on the implants used in the UK is still not available apart from the results of test in France and the UK done on the gel that showed there was no evidence of the gel causing breast cancer or systemic harm. However, the discussion was focused on what really mattered, not the rupture rate of the implant but the quality of the gel used in the manufacturing of the implants, originally developed to be used in mattresses.

" The Secretary of the State did the right thing. He asked for a panel of experts to study whatever data available to help him issue the correct advice under the circumstances.

There are now numerous incidents of reported ruptured PIP implants causing significant local reactions in the breasts and lymph nodes to alarm the surgical communities. PIP implants are simply not fit to be implanted in humans, at the British Association of Aesthetic Plastic Surgeons (BAAPS), we held this view from the beginning; that it is not the rupture rate that matters (all types of implants rupture to varying degrees), it is the non-medical grade of silicon that causes harm after heavy leak or rupture of the implant. Lymphadenopathy seems to last even after removal of the ruptured implants.

" Lymphadenopathy seems to last even after removal of the ruptured implants.  

It is for this specific reason of the irritant nature of the industrial silicone gel that, as a precaution, we recommend all women with PIP implants are given the opportunity of removal or replacement of their implants even in the absence of signs and symptoms of rupture by their original providers.

" Some of the private cosmetic surgery chain clinics [...] are not taking their responsibility [...]. This will leave thousands of worried women in a serious dilemma and their General Practitioners will be left with the task of providing guidance and support to them.

Like some of the clinics and hospitals in the private sector that used these implants for commercial gains, sadly some NHS trust decided to buy these implants as cost cutting exercise to reduce overhead and balance their books.

" The joint statement from the surgical associations at the Royal College of Surgeons provides clear guidelines for patients and all health professionals on the management of patients with PIP implants.

Nevertheless, the NHS is doing the right thing and offering all their patients the opportunity to have their PIP implants replaced. Some of the private cosmetic surgery chain clinics, however, are not taking their responsibility of duty of care to their patients seriously enough to provide them with the same level of care at no cost to the patients. This will leave thousands of worried women in a serious dilemma and their General Practitioners will be left with the task of providing guidance and support to them. The severe anxieties these women suffer are real and deserve the attention of our NHS. The joint statement from the surgical associations at the Royal College of Surgeons provides clear guidelines for patients and all health professionals on the management of patients with PIP implants.

So, what are the lessons to be learnt?

"  [This crisis] shows the failure of CE marking system that once obtained, anywhere in Europe, it allows manufacturers unopposed access to the rest of Europe.

This crisis has identified many inadequacies in the way medical devices are licensed and monitored, or not monitored. It shows the failure of CE marking system that once obtained, anywhere in Europe, it allows manufacturers unopposed access to the rest of Europe; our MHRA cannot overrule a CE mark or ask for more evidence of safety and efficacy unless something like the PIP happens. This is a European problem and all of the EU governments need to address it. 

Also, if we had a compulsory National Breast Implant Register that followed the history of all implants, the problem would have been identified years ago and we would always have reliable scientific data at our fingertips.

" To protect the public, BAAPS has long campaigned for regulation of the cosmetic surgery sector. The starting point is a total ban on advertising and promotion of cosmetic surgery procedures in all its forms.

Finally, it has brought under the spotlight the lack of regulations for the Wild West status of the commercial sector of cosmetic surgery in the UK. Shameless commercialisation of cosmetic surgery with free for all advertising in a fierce competition to recruit ‘clients’ for cosmetic surgery has turned serious invasive medical treatment into a commodity available on demand. It is the duty of our lawmakers to protect the health and safety of the people. To protect the public, BAAPS has long campaigned for regulation of the cosmetic surgery sector. The starting point is a total ban on advertising and promotion of cosmetic surgery procedures in all its forms.

Further links
The British Association of Aesthetic Plastic Surgeons
Medicines and Healthcare products Regulatory Agency
Department of Health - scope of PIP implant and cosmetic surgery reviews

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