How Should New Implants be Monitored in Canada?

Michael D. McKee, M.D., FRCSC
Professor of Orthopaedic Surgery, Division of Orthopaedic Surgery,
Department of Surgery, St. Michael's Hospital and the University of Toronto,
Toronto, ON

The Canadian public expects, with reason, that the implants orthopaedic surgeons routinely use in clinical practice are safe, reliable, and proven to be effective. They anticipate that this will hold true for both the implant itself (i.e. free from design and production flaws), and the method for which it is used (i.e. intra-articular "pain pumps" for postoperative analgesia). To a certain extent, the public, exposed to endless stories in the popular press regarding the success of the latest medical interventions (i.e. hand and face transplantation), cannot understand how implants with a high complication rate make their way into general practice without being identified and withdrawn from the market.

 

They are especially dismayed when the essentially self-policing medical profession fails to act promptly when there is obvious evidence that an implant or technique is faulty or inferior to established standards. These errors often result in large class action lawsuits: 1) intra-articular pain pumps (causing chondrolysis), 2) the ASR hip (with high failure rate), and 3) long-term bisphosphonate use (leading to atypical femoral fractures), are examples relevant to orthopaedics. A recent article by Wiater et. al. (which was generated by a court-ordered review of medical records) revealed a disturbing number of patients who developed shoulder chondrolysis (a devastating complication in a young individual) in the practice of one community orthopaedic surgeon following the introduction of intra-articular pain pumps that infuse (highly acidic) local anaesthetics into the joint post-surgery1. This was a complication that was quite simply rarely, if ever, seen before. The plaintiffs in this class action suit cannot be blamed for asking how it was that no one noticed this new and severe complication following the introduction of this new technology, and, that six years - six years! - after the first identified case in this study, twenty-six patients developed chondrolysis in one surgeon's practice with the use of this device.

 

MCKEEFigure_1
Figure 1: Locked intramedullary nails were vigorously promoted as a superior treatment for humeral shaft fractures until prospective trials revealed higher reoperation and complication rates with their use when compared to conventional plating2.

While it is reasonable to state that the majority of new implants and techniques that we introduce in orthopaedics are beneficial to our patients and do not become subject to medico-legal scrutiny, the examples described above clearly demonstrate that there is room for improvement. It is essential that this improvement develops from within, and that the stakeholders with the most to gain or lose, such as individual surgeons, organized groups (like the Canadian Orthopaedic Association), and industry should share in this process improvement. No single entity will be sufficient to effect change. The use of joint registries, that can detect early, subtle differences in implant survival, are to be encouraged and expanded to include other areas such as shoulder, elbow and ankle arthroplasties. Randomized and prospective trials, comparing new implants/techniques to established ones, and monitored by conflict-free panels, should be funded and promoted at every level. An industry that focuses on ethical promotion of new products and is sensitive and transparent in the reporting of novel complications (an unfortunate accompaniment of new technology, good or bad) is critical. It is clear that the individual surgeon, with the exception of the occasional perceptive "whistle-blower", is not in a good position to see the overall picture. However, we owe it to our patients to be more circumspect before we whole-heartedly embrace new technology. Hopefully the focus on evidence-based medicine now seen in medical schools and orthopaedic training programs will encourage the practicing orthopaedic surgeons to think more critically, and not to be "faddist". As a group, we need to recognize that we are in the best position to advocate for effective change that does not dampen the quest for improvement, lest undesirable change be forced or legislated upon us.

References

  1. Wiater B.P., Neradilek M.B., Polissar N.L., Matsen F.A. Risk factors for chondrolysis of the glenohumeral joint: a study of three hundred and seventy-five shoulder arthroscopic procedures in the practice of an individual community surgeon. J Bone Joint Surg Am. 2011;93: 615-25
  2. Bhandari M., Devereaux P.J., McKee M.D., Schemitsch E.H. Compression plating versus intramedullary nailing of humeral shaft fractures--a meta-analysis. Acta Orthop. 2006 Apr;77(2):279-84. Review.
Key Summary Points
  1. There is room for improvement in the monitoring of new orthopaedic implants in Canada.
  2. Of particular importance is the rapid recognition of novel complications associated with new implants.
  3. The solution lies with industry - surgeon - professional group co-operation

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