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Jan 07 2012

“French-maid Breast Implants”

I’ve been struggling a bit with the story of PiP and the breast implants, because every time radio presenters say “French-made breast implants”, I hear “French-maid breast implants”.

The BBC has a useful Q&A on the subject here. Essentially the problem is that PiP manufactured breast implants using industrial rather than medical grade silicone, subsequently there have been reports, initially in France, that the rupture rate of these implants is significantly higher than expected. There is no evidence that the implants lead to an increased risk of cancer, given the prevalence of breast cancer it isn’t surprising that some patients with the implants have gone on to develop cancer. The striking thing is that the implants were banned for use in 2010 because they were found to be using industrial grade silicone gel, surely it was at this point that they should have been recalled (i.e. the decision made to remove those already implanted)?

The situation in the food industry is quite different: if a company discovered that one of its suppliers had provided non-food grade ingredients then the product that the company made would be withdrawn from sale pretty much immediately. There would be no waiting around to see if the ingredient was actually hazardous, it would be withdrawn on the grounds that it was out of specification. I’m pretty sure similar applies in the car industry, and the aviation industry. I know this because Mrs S used to work in the food industry; food scares on the morning news always led to an exciting day at work as every retailer sought confirmation that the company she worked for did not use any of the products involved in the scare. Food companies trading legally would have this traceability information.

Healthcare does offer a slightly different scenario, in the sense that carrying out an operation to remove breast implants does carry a risk which means there is a downside to removal, but this is the only relevant consideration: all other things being equal the implants should be removed, by the original installer where possible.

Some people seem to feel that women having breast implants have brought this on themselves, that they shouldn’t be helped on the NHS. Clearly the first port of call for removal is the installer but there are cases in which the installer no longer exists; the NHS is a universal service – if someone has a qualifying medical problem then regardless of how they came by it (excessive eating, drinking, drug taking, climbing, skiing) they are treated free of charge. The same should apply to people who have medical problems arising from surgery outside the NHS – the liability is with the original supplier but sometimes they no longer exist, the patient should not be punished for this.

The Medical and Healthcare Products Regulatory Agency (MHRA) is responsible for regulation in the UK. There is a page on their website about the subject of the PiP breast implants here. Other medical devices, such as replacement joints, appear to be handled differently: alongside the MHRA there is the National Joint Registry, which attempts to register all joint implants, here on the National Joint Registry there is a list of alerts for joints. The MHRA has issued a series of alerts, dating back to March 2010, regarding PiP breast implants (you can see them here), the emphasis has been on establishing the potential toxicity of the filler material. This, presumably, can be done using lab-based testing. The problem seems to be that the rupture rate is relatively unknown, this report in the Telegraph says:

A UK Breast Implant Registry was established in 1993 on the recommendation of the Department of Health to track implant patients’ health, but it closed in 2006 as too few women wished to take part in the scheme.

The final report of the UK Breast Implant Registry is here, and the MHRA confirms that the scheme closed because too few patients would consent to remain in long term follow-up here. This would seem to be the significant factor in this case: there is some follow-up for medical devices but it is voluntary and in the case of breast implants the uptake rate for follow-up was not considered high enough to warrant continuing the process.

It still leaves the question as to why the removal of breast implants made from out of specification materials is not assumed, except for considerations of the safety of the removal operation.