Question marks over the approval of breast implants

Authors:David Lawson is a barrister and Public Law specialist at Hardwicke. Leon Glenister is a pupil barrister.

The risks of untested and under-tested medicines are well known.  The Thalidomide scandal saw 10,000 children born with disabilities, probably because the drug was not tested on pregnant women or animals.  It was one of the early spurs to the reform of drugs regulation.  More recently – in 2006 – 6 volunteers suffered organ failure when the first human clinical trials of TGN1412 showed that it caused a reaction in humans at much lower doses than in animals.  This is an issue where the risk is not all one way – the early treatment of HIV saw a campaign by people infected with HIV who wished to hurry promising drugs through the approval process to general availability (where they have proved very successful).

Following the recent scandal around defective breast implants, we ask where the balance is to be drawn for medical devices, rather than medicines.

The Approval of Medical Devices

A medical device is, basically, any medical product for humans other than drugs: fillings, hip replacements, heart valves, hearing aids and silicone breast implants – but also those used in treatment, like syringes and hospital beds.  It’s a large range of products.  Perhaps some of them might not be approved if invented now. For example, the campaign to ban mercury amalgam fillings might gain some traction if there was not such a long record of their apparently successful use (although some epidemiologist might yet make their name by showing the flaw with amalgam fillings).  A more pressing example of a product which would not be approved now is the PIP breast implant – said to have been used for 400,000 women.

In order to obtain approval to market a medical device in the EU the manufacturer has to obtain a Confirmité Européenne (CE) mark.  This shows that a product conforms to the mandatory requirements of applicable EU Directives and is a basis for marketing the product throughout the EU.  It has been argued that the CE mark applies the same system to breast implants that is used for light bulbs and toys but this is – barely – half the picture: the content and procedure is more exacting for products which risk greater harm even if the endpoint – EU wide marketing approval – is the same.

A CE mark is obtained from a notified body, a private sector organisation accredited by a member state of the EU to assess compliance of a product with a relevant directive.  Manufacturers can choose any one of the 81 accredited bodies to certify their product (exactly the sort of system the government has suggested led to “grade inflation” in English exams as the assessors compete for business).  The reply might be that the problem in the PIP breast implant scandal was a breach of the rules rather than inadequate rules – it has been alleged that PIP breached its certification by using cheaper industrial grade silicone, though perhaps aided by being given warnings of inspections of its factories.

Medicines

Medicines are subject to direct state assessment.  The Medicines and Healthcare Products Regulatory Agency (MHRA), a statutory body, has control which starts with the approval of clinical trials conducted in the UK and continues into formal approval to market the product (initially with a mark to show that it is new and should be watched carefully).  There is also of course a process for EU wide approval through various routes and a relevant agency (European Medicines Agency).

Monitoring Safety Concerns

The MHRA explains that in practice devices are always tested for mechanical and electrical safety but, unlike medicines, they are not automatically subject to clinical trials.  As with medicines manufacturers must report any important defects, which can lead to “alerts” (warnings to doctors), product recalls or, in extreme cases, prosecutions.  In 2007 the MHRA issued 30 alerts about medicines and 79 about devices.  The MHRA explains that this system concluded that silicone gel breast implants were safe but that another type of implant should be withdrawn and identified a fault with a particular heart valve.  Two alerts were published on the MHRA website the day this note was written.

The difficulty with this system – as has recently become apparent – is for those people given a heart valve or breast implant which is then withdrawn from use.  The MHRA acknowledges that there have been more concerns about medical devices recently but points out that there are many more medical devices.  For example, Leigh Day is bringing a group of claims on behalf of people who claim to have suffered ill effects from a particular type of hip implant.

The issues are practical and theoretical.  At a theoretical level the question is the balance between risk and benefit.  At a practical level the question is who pays to replace possibly faulty work carried out using approved medical devices.  That question will perhaps be resolved in Court.

**This article was also posted on the Hardwicke website, and can be viewed here.