PIP breast implants warning

Unsafe medical devices allowed into the UK without sufficient insurance for when things go wrong.

14 I 07 I 10

Hugh James reported in April and June news relating to the recall of the purportedly cohesive silicone gel implants manufactured by French company, Poly Implant Prothese (PIP).

Calls are now being made by victims and legal experts for British licensing agency – the Medicines and Healthcare Products Regulatory Agency (MHRA) – to introduce more stringent testing and regulation of medical devices being brought into the UK.

The faulty implants – manufactured by French company Poly Implant Prosthese (PIP) – were the subject of a Medical Device Alert (MDA) by the MHRA on 31 March 2010, ordering a recall on all stocks of the PIP implant. This follows an earlier issue with PIP implants using recalled Hydrogel solution in 2006. PIP has since gone into liquidation, leaving the company unable to fulfil legal claims from distressed victims.

With no chance of successful claims against PIP, the NHS is also having to meet the cost of removing many of these implants from affected women who are facing problems including ruptures and leakages.

Despite being aware of the 2006 problem with breast implants made by the same company, it has emerged that the MHRA – which is responsible for the safety and licensing of drugs and medical devices used in the UK – does not have the authority to check that manufacturers or distributors have liability insurance to cover their products.

In a Freedom of Information request – put forward by Hugh James solicitors – the MHRA confirmed that, “The MHRA is responsible for the regulation of medical devices in the UK. It is not within the remit of the agency to check that manufacturers or distributors have liability insurance to cover their products.”

Renowned campaigning lawyer Mark Harvey, Partner at Hugh James solicitors, is acting for women who want their PIP implants removed. The worry is that this licensing loophole could mean that other medical products could be affected – as well as breast implants. Mr Harvey has written to Health Secretary Andrew Lansley to call for more rigorous regulation by the licensing body. The licensing of the PIP implants was dealt with on a European level where the CE [European Conformity] marking of a device means that the manufacturer has full access to the EU market - including the UK, without the UK licensing authority undertaking its own checks.

Mr Harvey says, “It seems incredible that companies can import into this country without any satisfactory checks being taken out to ensure that they are in a position to deal with any repercussions of any devices that should subsequently become a problem. It ought to be a requirement that they must produce a certificate of insurance suitable to cover the appropriate claims.

“As well as causing substantial physical and emotional distress – not to mention financial distress – to these women, these faulty implants are now putting increasing pressure on the NHS, who are obliged to remove many of the implants due to ruptures.”

Almost all of the women who were given PIP implants were told in advance of their surgery that the implants could not leak - even if ruptured - because they contained a particular composition of silicone gel.

Yet many women have found that the PIP implants have ruptured prematurely, causing the silicone gel from inside the implants to leak out into the surrounding breast tissue. These leakages have resulted in deposits of silicone building in the lymph nodes and, in some cases, causing extensive damage to the breast tissue as well as severe pain and swelling.

Results are currently being awaited from the MHRA regarding ongoing tests into the possible long-term effects of the PIP implants. This week the Sunday Express has reported further on this issue, to read their story please follow the link below.

http://www.express.co.uk/posts/view/186233/Cancer-tests-ordered-on-breast-implant-gel

Contact

Mark Harvey

Partner, Head of the Claimant Division

Head of Harmful Products and Overseas Accidents Team

E mark.harvey@hughjames.com

T 029 2039 1174