the big story

Published: 29/07/2004, Volume II4, No. 5916 Page 10 11

When faults were discovered with a manufacturer's cataract lenses it took a persistent consultant ophthalmologist and NHS trust to get to the bottom of things. Daloni Carlisle chronicles the struggle to uncover problems that some fear might not be over yet

Earlier this month, cataract lens manufacturer Bausch and Lomb agreed a compensation deal with 200 patients and 13 hospital trusts.

The details are secret, but the deal marks the end of a long and often tortuous journey for doctors, managers and patients. It also raises the question of why trusts were left to deal with the faulty lens problem in a piecemeal fashion and on their own initiative.

The story begins when Timothy Rimmer, consultant ophthalmologist at Peterborough Hospitals trust (now Peterborough and Stamford Hospitals foundation trust) saw a diabetic man whose vision was deteriorating, despite having had a new lens implanted in 2001. 'The thin membrane behind the implant had gone like frosted glass, ' he says. 'It is a common enough complication, but there was something that didn't look quite right.'

This was late 2002 and was the first of what turned out to be 115 cases in which artificial lenses implanted to restore vision to mostly elderly people with cataracts had become so opaque they needed replacing. All the lenses were of one type - the Bausch and Lomb Hydroview H60M intraocular lens. And they were all implanted between September 2000 and April 2001.

In February 2001, Bausch and Lomb issued a 'dear doctor' letter warning there was a problem with Hydroview. In the UK, Europe, Hong Kong and Canada, ophthalmologists were seeing calcification in which a deposit forms on the lens, making it opaque and requiring replacement. The problem was attributed to a packaging component affecting lenses manufactured since 1997.

By May 2001 the issue had been solved, Bausch and Lomb claimed.

However, it did admit problems could take 25 months to emerge.

The manufacturer said in its letter that the calcification rate was one lens in 4,000, but at that time Peterborough was experiencing rates of 25 per cent. And with over 88,000 of the affected lenses distributed to the NHS as a whole, Dr Rimmer suspected he was not alone.

By June 2003 the numbers at Peterborough had peaked and Dr Rimmer wrote to the Medicines and Healthcare products Regulatory Agency, the national agency charged with 'safeguarding the public health'.

But Dr Rimmer says: 'The MHRA said we did not need to do anything because the company had announced in May 2001 that it had resolved everything.'

So in October 2003 he conducted a survey of 12 other trusts said by Bausch and Lomb to have had cases of calcification to see what their experience had been.

Sure enough, many of these had higher-than-published rates.

Dr Rimmer's survey threw up similar problems in Wrexham, Peterborough, Cheltenham and Gloucester, Southampton, Glamorgan, Birmingham and Norwich.

All experienced much higher rates of calcification than had so far been made public and all but one case were from lenses implanted between September 2000 and April 2001.

At Borders General Hospital in Melrose, Scotland, consultant ophthalmologist Robert Murray's first case presented in 2000, earlier than in Peterborough. 'It was after the first two cases that I realised this was not down to chance but was something serious, ' he says.

He attributed it to a combination of the lens and a viscoelastic gel he had used in surgery from 1998 to 1999. Of around 200 patients who received the Hydroview lens, 50 were affected and 23 needed replacement.

'I notified Bausch and Lomb in 2000 and wrote a letter to one of the professional journals, ' says Dr Murray. Bausch and Lomb paid for him to present his cases to an international conference, 'but not much happened'.

'Then, of course, we began to get reports from elsewhere in the NHS. Had the lens been withdrawn at that point there would have been no more cases.'

With no reaction from the MHRA, Dr Rimmer was still anxious.He called a meeting of interested parties at the Royal College of Ophthalmologists in January 2004. Managers and ophthalmologists from 10 trusts as well as Bausch and Lomb and MHRA representatives discussed what was known and how different hospitals had reacted.

'There were three types of reaction from trusts, ' explains Dr Rimmer: wait for patients to present with symptoms, write to all patients and ask those with symptoms to present themselves or recall all patients for an assessment.

Gloucestershire Hospitals trust opted to recall all patients for a clinical assessment. In so doing it blew the lid off what had so far been kept quiet. In April 2004 the trust wrote to all 1,800 patients who had been implanted with the Hydroview lens and issued a press release.

The MHRA was effectively bounced into producing its own reaction in the form of a medical device alert, timed to coincide with the Gloucestershire press release.

According to HSJ sources, it had just one day to get the alert prepared and approved.

From a management perspective there were a number of issues to be addressed. Who should pay for the surgery for replacement lenses? What about compensation for patients? The lawyers were already involved and a number of law firms had begun looking for affected patients in the hope of putting together a class action.

Dr Rimmer felt strongly that patients should receive compensation, not least because calcification had not been raised as a risk factor. 'It was brought home to me by one patient whose other eye was artificial.He was shaking because he was so nervous about the risks of the operation.'

Earlier this month Bausch and Lomb agreed a protocol with solicitors' firms Hunt and Coombs and Hugh James representing 200 patients at 13 hospitals (see list). It will ensure that patients receive prompt treatment, in the private sector if necessary. Bausch and Lomb has agreed to pay all costs associated with replacement surgery, including a flat fee of£2,250 per operation, with additional payments for visits to screening clinics and for setting up helplines.

To Bausch and Lomb's credit, all involved in this saga speak highly of the company. Mark Harvey of solicitors Hugh James says: 'They recognised the problem promptly, said they wanted to sort it out. As a solicitor, this is not something I often have the opportunity of saying.'

What caused the peak of cases seen so clearly in the UK trusts?

Bausch and Lomb's written statements have moved since 2001, from blaming the packaging to saying other problems may have had an effect. Spokeswoman Kristine Morrill admits there was a peak in the past but adds there is no evidence that this means the company's original claim about the numbers affected is inaccurate.

Should the lens have been withdrawn earlier? No, say most involved. 'It was a good lens, widely used and the problem affected only a minority, ' argues Dr Murray.

The MHRA comes in for rather more of a hammering - albeit anonymously. 'It has been a complete waste of space, ' says one doctor involved. 'It might as well have been left to the people from the Royal College of Ophthalmologists and a patient representative.'

The MHRA would not respond to HSJ's queries, except to reiterate the advice in its alert.

Is the case closed? On the technical side, the results of Gloucestershire Hospitals trust's recall exercise are still to come. The Royal College of Ophthalmologists is conducting a survey of every unit that used Hydroview. The results will be discussed at a meeting in September.

Bausch and Lomb says there have been no reports of calcification since May 2001. Ms Morrill adds: 'Hopefully by now people will be aware.'

The royal college agrees.

But Dr Rimmer is not so sanguine. 'It is possible there are patients who have not been recalled.This is a group of vulnerable, mostly elderly people who will shrug their shoulders and say: 'Well, I had my surgery and it didn't work. I'll just have to live with it'.'And that doesn't seem right.

The long view: how one hospital reacted

Peterborough Hospitals trust handled its response to the Hydroview lens as a serious untoward incident. It convened a high-level management and clinical group to combine clinical perspective with clinical governance knowledge, risk management, legal expertise, communications and accountancy support.

The group contacted all 950 patients at risk, asking them to call a freephone helpline if their vision had deteriorated.Local optometrists and GPs received written guidance.

In the event, 258 people called the helpline and over 200 patients needed to be seen in clinic.Of these, 115 required replacement lenses.Patients enquiring about compensation were referred to a firm of solicitors.Bausch and Lomb is paying£2,250 for each operation,£100 per patient for screening clinics and£4,382 for setting up the helpline.

The approach avoided a media scare; it ensured that all those who needed to be seen were contacted while avoiding seeing patients who were unaffected.As Dr Timothy Rimmer says: 'It was fantastic to have that degree of management support.'

For more information, e-mail surgical general manager Adrian Stone at adrian. stone@pbhtr. nhs. uk

Unlucky 13: the affected hospitals

The Bausch and Lomb protocol to ensure swift treatment for affected patients covers these hospital trusts:

Birmingham Heartlands and Solihull Borders General Hospital Gloucestershire Hospitals Norfolk and Norwich University Hospital Northampton General Hospital North East Wales Peterborough Hospitals Plymouth Hospitals Royal Berkshire and Battle Hospitals Southampton University Hospitals United Bristol Healthcare United Lincolnshire Hospitals Waterford Regional Hospital, Ireland