The French health ministry issued a statement this week (23.12.11) advising 30,000 French women with 'PIP' (Poly Implant Prosthese) breast implants to have them removed. The cost will be covered by public health funds at an estimated £50m. Xavier Bertrand’s statement has caused 'unnecessary alarm' according to the Department of Health in the UK, which has issued a statement telling women not to panic about the implants and that there is no need for immediate removal.
What are 'PIP' implants?
They are breast implants made by the bankrupt French company Poly Implant Prosthese (PIP). Over a ten year period it manufactured around 100,000 implants a year, most of which were exported overseas to key markets in South America. The implants were investigated after many women reported irritation and ruptures and were found to be made of industrial grade silicone, which is cheaper and not designed for use in the body. The outer shell of the implants is weaker meaning that they are more likely to rupture exposing a woman's body to silicone. So far 5% of 'PIP' implants done in France have ruptured and 1% in the UK.
Many women who have the implants have reported illness, irritation, muscular pain and fatigue. 84,000 'PIP' implants have been sold in the UK since 2001, of which 411 have ruptured, according to the latest figures. This means around 42,000 women in the UK have them, and the implants have been sold in nine countries.
PIP was closed down last year after the news broke and Interpol, the international police agency, is trying to arrest its director Jean-Claude Mas for offenses concerning 'life and health' reports the BBC this week.
Is there a cancer link?
There is no evidence so far linking the implants to cancer but in France one woman has died from a rare form of cancer called anaplastic large cell lymphoma (ALCL). They have been linked to seven other cases of cancer and the French National Cancer Institute is to report on any findings. Because of the controversy of the case and the possibility that there is a loophole in the law regarding regulation, the French government has advised women to have them taken out. It is taking a precautionary approach and stresses that there is no need for immediate removal unless the implants have ruptured.
The British view
The Medicines and Healthcare Products Regulatory Authority (MHRA) has advised women not to panic. In a statement issued on 23.12.11 it said: 'Our current advice to women with 'PIP' breast implants continues to be that should they have any questions about their breasts or implants, that they should seek clinical advice from their implanting surgeon. There is currently no evidence to support routine removal of 'PIP' breast implants.' Women should go back to their treatment clinic and have the implants checked to make sure there is no weakening. They can then have a regime put in place for regular monitoring.
Sally Taber, director of the Independent Healthcare Advisory Services (IHAS) said: 'We are pleased to see that health and regulatory experts from the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark, Malta and Australia have all confirmed no evidence of any increase in incidents of cancer associated with 'PIP' breast implants and no evidence of any disproportionate rupture rates.' She argues that France's decision to recommend removal makes them look isolated and had caused 'unnecessary alarm'.
PIP implants compensation
The conflicting guidelines puts women who have the implants in a difficult position. The thought of having a silicone gel in your body that was designed for use in mattresses is hardly comforting. The UK government is not offering to cover the cost of removal and as women cannot sue PIP they will have to take legal advice regarding individual surgeons and clinics. What happens if the clinic they used is now bankrupt? It has raised questions around how the cosmetic surgery process is regulated. How do clinics choose implants? What kind of assessment process is in place for quality control, and what say do individual surgeons have regarding the materials they use? Clinics have a duty of care and ethics and plastic surgeons are highly paid. Many women will feel let down if their chosen clinic does not offer to pay or reduce the bill for removal.
This week the Daily Mail reported that around 270 women in the UK are considering taking legal action, directing claims against individual surgeons and clinics. Mark Harvey, a partner at Hugh James Solicitors said that the Department of Health should order clinics to pay for removal rather than asking women to pay again through no fault of their own. Hugh James is representing over 250 women who have had the implants done in the UK.
It will be interesting to hear Jean-Claude Mas' statement, if one is forthcoming, and hopefully this week’s events will see stricter regulations regarding the manufacture and sale of cosmetic surgery materials so that profit cannot come before public healthcare. Health organisations worldwide will continue to monitor all types of implants to see if there are any safety concerns.
Sources
Facebook PIP implant support group
Afssaps - French Health agency guidelines
British Association of Aesthetic Plastic Surgeons
British Association of Plastic, Reconstructive and Aesthetic Surgeons
BBC News: Breast implant scare - Interpol seeks French boss arrest. (accessed 24/12/11)
Nicci Talbot - Nicci Talbot is a journalist and author specialising in sex, health & wellbeing. She edits Rude Magazine, an online resource for better ...
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