So much for evidence-based health care

So much for evidence-based health care As one surgeon put it: 'you could go into your garden shed tonight and knock up a hip replacement and put it into someone the following day'. Eighty independent and NHS hospitals have used the faulty 3M Capital implants. The Medical Devices Agency had to issue a hazard notice advising all Health Authorities and Trusts of the poor short-term performance of the femoral component of the 3M Capital Hip System. Studies from three hospitals have shown that up to 21% of these implants failed within 5 years, compared with the national average of a 10% failure rate after 10 years. The total of 4669 implants represents only 2% of the total carried out over the period August 1991-March 1997. However, this has caused considerable alarm for many patients. 3M Health Care has agreed to meet the entire costs of identifying and reviewing all patients who have been implanted with their system and of any revision operations required on account of femoral loosening. This does, however, seem like shutting the stable after the horse has bolted. It would not be unreasonable for those with the implant to make claims against the company for any pain and discomfort caused or costs of additional care, loss of work etc. The additional costs of the latter would be far greater than the estimated s million for revision surgery. Patients' well being is paramount in these situations but there is a fundamental issue here. Should the drive for monetary profit take precedence over safety and tried and tested treatments? Should the

Journal of OrthopaedicNursing (i 998) 2, I 9 1998 Harcourt Brace& Co. Ltd

concept of evidence-based approaches apply only in some circumstances and not in others? Should patients be used in large numbers in trials of profit driven and little researched treatments or surgery? Ironically, as Editor, I had already accepted an article by O'Brien et al, contained in this issue of the journal (pp. 4-9), before the faulty hip alarm was raised. The article, 'Evidence based surgery - a brief report on the development of a cemented custom hip replacement', describes an incremental approach to development that does not ignore the benefits of previous tried and tested implants. It recognizes the need to pursue expensive, but necessary, follow-up regimes. The following editor's comment was written prior to the 3M hip scare:

Over the past few years there has been increasing criticism of the relatively irresponsible introduction of untried hip replacements. At present there are 62 types of hip implant manufactured by 19 different companies, ranging in cost from s to s Half of these implants have been introduced since 1990. In an era of evidence based treatment and care, surgeons and nurses are responsible for ensuring that patients are not put at risk as 'guinea pigs' in unnecessary and ill-conceived experimental trials. Peter Davis, Editor-in-Chief