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New surgical technology: do we know what we are doing?

The pace of development in new surgical procedures and technologies continues to accelerate, driven in part by manufacturers, surgeons and community expectations. Despite regulatory bodies such as the Therapeutic Goods Administration (TGA), new devices can enter the market with little or no evidence of their effectiveness, and even their safety can be poorly evaluated. The withdrawal of the DePuy Orthopaedics articular surface replacement hip prosthesis illustrates the difficulty in anticipating the unintended problems with a joint prosthesis that superficially appeared to be little different from hundreds of others already available on the market.1