Fw: Scandal of killer medical aids ~ Guardian 10/15/00

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From: " ilena rose " <ilena@...>

Sent: Sunday, July 15, 2001 7:49 PM

Subject: Scandal of killer medical aids ~ Guardian 10/15/00

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http://www.guardian.co.uk/Archive/Article/0,4273,4076806,00.html

Scandal of killer medical aids

German company linked to injuries of British patients

Special report: the future of the NHS

Antony Barnett, public affairs editor

Observer

Sunday October 15, 2000

In August, 29-year-old accountant Jan Temple responded to a Department of

Health urgent warning and had her soya oil breast implants removed. She had

learnt that they could cause cancer, kill foetuses and harm breastfeeding

babies.

The complex and unpleasant operation left her without movement in part of

her right arm. Because the soya is a natural product it becomes entwined

with the breast tissue and the implants have to be 'ripped out', which can

take more than five hours. In many cases the soya becomes putrid and the

rancid remains have to be treated as a biological hazard.

So far, 1,400 women in Britain have faced this horrific ordeal. But the

full story of how thousands of women have been emotionally and physically

scarred by these implants is only likely to come out in a US court next

year when their American manufacturer faces compensation claims. At the

same time, the case will shine light on how faulty medical technologies can

easily find approval for use in Europe.

Lawyer Balen, representing 1,500 women seeking compensation for

problems with the implants, has made repeated requests for information to

Munich-based TUV, which in 1995 certified the soya implants as safe for

sale throughout Europe. So far he has failed to get any response.

TUV is one of 60 companies which, under European legislation, can give

approval to medical devices, thus permitting the manufacturer to sell the

product across Europe.

An Observer investigation has revealed that the soya implants were not the

only potentially fatal mistake that TUV made.

In 1998 it certified a new type of mechanical heart valve made by the US

manufacturer St Jude Medical. The artificial valves control blood flow to

and from the heart. The St Jude's valve was coated with silver, whose

antibiotic qualities the manufacturers hoped would prevent cardiac

infection.

Yet, little over a year later, St Jude has been forced to withdraw the

valve after some users suffered strokes and at least one person in Britain

died. More than 30,000 valves were sold worldwide and over 700 were used in

the UK. It has emerged that the silver coating made the valve leak blood,

thereby increasing the risk of a heart failure.

Although details of British victims have not been made public, a US law

firm has filed a suit against the company after a woman from Massachusetts,

Baez, developed serious heart problems. She had her first St Jude

valve implanted in April 1999. Within a few months it began leaking and she

had it replaced in November. This, too, leaked and she had to undergo a

third open-heart operation. The lawsuit alleges the company was 'negligent

in designing, manufacturing and marketing a defective heart valve that was

not adequately tested'. It claims that 'the risk of serious bodily damage

exceeded the benefits associated with the design'.

One month after St Jude withdrew its valve, the company had to issue a

warning about its Affinity pacemakers which were found to be defective.

Once again these devices were approved for sale in Europe by TUV.

In May this year, another US company, Lifesciences, had to suspend

sales of a device known as a vascular graft, used to repair artery damage

around the heart, after it was found to fracture. Although the device had

not been approved in the US, TUV had certified it for Europe and it had

been used to treat more than 100 people. A spokesman for the US company

would not say whether any of these were British, claiming this information

was 'commercially confidential'.

The Observer passed on its information relating to TUV to the Department of

Health, which agreed to launch an immediate inquiry through its Medical

Devices Agency (MDA), which regulates medical equipment used in Britain. A

spokeswoman said: 'We take these allegations very seriously and will look

at any evidence The Observer has. We will make sure steps are taken to

ensure the public is not being put at any unnecessary risk.'

Despite such assurances, many in the medical and legal professions believe

the whole system regulating medical devices is flawed and in need of an

overhaul. Each year thousands of Britons are injured or killed by faulty

medical devices legally used by surgeons in the UK. Deficient heart valves,

pacemakers, hip implants and infant incubators have all caused serious

injury and there is little the British authorities claim they could have

done about it.

It is only when reports of fatalities or other serious problems emerge,

that a national authority, such as the MDA, can ban a product from its

domestic market.

Unlike drugs, medical devices do not require extensive clinical tests. Most

of the 60 bodies allowed to approve medical devices are commercial

organisations that profit from testing equipment. Government authorities

are supposed to vet the bodies but some countries are more rigorous than

others.

Maxwell, writer with Clinica, a newsletter for makers of medical

equipment, said: 'The number of companies testing medical equipment has

mushroomed over recent years and none has been stripped of its licence.

Questions are being asked as to whether being a testing body is an 'easy

ride'. There are also worries that some of these companies simply do not

have the medical expertise necessary to test this equipment.'

This year the MDA annual report revealed that over the past 12 months the

agency received reports of nearly 7,000 'adverse incidents', including 19

fatalities. Doctors and hospitals do not legally have to report problems,

and privately senior MDA figures believe the true level of injuries could

be as much as four times higher.

Balen said: 'I believe the whole licensing and monitoring procedures

throughout Europe need to be questioned.'

Dr Karsten Evert of TUV said: 'We test more high-risk medical products than

anybody else in Europe, about 800 a year, and unfortunately there will

always be one or two incidents.

'We cannot be 100 per cent safe and secure otherwise there would be no

progress in medicine but I assure you our testing team is among the best in

the world.'

* antony.barnett@...

* 'Safe' devices that hide danger

Ten medical devices, certain brands of which have been found dangerous

despite gaining the 'CE' seal of approval for sale in Europe:

* breast implants

* heart valves

* vascular grafts

* pacemakers

* hip implants

* infant incubators

* dialysis machines

* collapsible wheelchairs

* bedside rails

* ear syringes

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