The PIP Scandal - The Legal Context

Contrary to some assertions in the media, the issues surrounding PIP implants are not straightforward. There seems to be a strong case that those who, pursuant to a patient contract, used PIP implants in breast enhancement surgery may be liable under domestic laws. However, in the absence of voluntary action, it is only likely to be litigation which clarifies the position. This article considers some of the relevant legal issues.

Background

The French firm Poly Implant Prothese (PIP) manufactured and supplied silicone breast implants worldwide. Since 2000 more than 300,000 PIP implants have been sold in 65 countries and approximately 40,000 women in Great Britain have been treated using the implants, mainly for breast augmentation. Private clinics / hospitals performed 95% of the related operations; the remainder were carried out by the National Health Service. The French authorities have confirmed recently that PIP implants made before 2001 may contain industrial silicone. This means that an estimated 7000 additional women who were treated using PIP implants prior to 2001 may also be affected.

A problem arises because, as is now well known, the implants contain industrial rather than medical grade silicone. In addition it has been alleged that the implants were not treated with a protective coating to minimise the risk of rupture and the leakage of their contents into the surrounding tissue.

Following the recall of the implants by the French medical regulatory authority, PIP went into liquidation.

The rupture rate of PIP implants is a matter of controversy. The French authorities state that it is 5%. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) claim that the rate is 1%. Other bodies claim other rates.

The issue, for patients and their legal advisers is, however, a more pressing one of what is to be done and who is to pay. In the UK the Health Secretary has stated that the NHS will remove and replace implants inserted into women by the NHS and remove, but not replace, implants fitted privately if the company concerned is unwilling to do so itself. So for patients treated privately who, if anyone, is legally responsible for the predicament in which they now find themselves?

Domestic Law

Breast argumentation surgery is a works and materials contract and is governed by The Supply of Goods and Services Act 1982 (SGSA), which requires goods supplied under such contracts to be of satisfactory quality (SGSA section 2). This...