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John Hopkins

Stryker Hip Implants and Joint Device Regulation

» Written by // January 28, 2013 // , ,

Attorney Cal Warriner was interviewed by the Palm Beach Post as set forth in an article published in Sunday’s paper. Mr. Warriner raised as number of valid points, but two dealt with short cuts to FDA approval and a national joint registry:

Would any patients have been harmed by the Stryker Rejuvenate and the ABG II hip implants if short cuts to approval through the Food & drug Administration were prohibited?

Would less patients have been harmed by the Stryker Rejuvenate and the ABG II hip implants if the United States had an effective joint replacement registry in place similar to the one in Australia?

The FDA permits orthopedic device manufacturers to short cut the approval process if a manufacturer can demonstrate that a product for which they seek approval is “equivalent to a device” already approved by the FDA. If the manufacturer can demonstrate the substantial equivalence of their device, they may bypass the lengthy and expensive clinical trial and scientific scrutiny that new devices are put through.

But, what if the “new device” differs from the already approved device in ways that might create problems? The FDA is largely funded by the same device and drug manufacturers they regulate and they have little funding or staff to conduct independent device evaluation. If the manufacturer represents “substantial equivalence”, the device is likely to get approved if it appears to be a similar device.

The “short cut” process is great for device manufacturers, but reasonable suspicion exists as to its benefit for consumers.

The Australian Orthopaedic Association National Joint Registry has proved successful in repeated instances. Long before the FDA has recalled problem medical devices in the United States, Australia and the European Union (who also maintains a device database) have alerted to problems in devices such as Stryker’s Rejuvenate, Depuy and other joint replacement devices.

Does the United States maintain a device database? Yes. It has only a year ago begun to accumulate data; so, in fairness, it will be several years before we really can gauge its success. There does seem to be some differences between the AJRR (American Joint Replacement Registry) and the Australian registry.

The United States Registry includes, as contributors, manufacturers including:

  • Aesculap Implant Systems, Inc.
  • DePuy Orthopedics, Inc.
  • Exactech, Inc.
  • Stryker
  • Zimmer, Inc.
  • Biomet, Inc.
  • Consensus Orthopedics
  • DJO Surgical
  • Smith & Nephew plc
  • Wright Medical Technology, Inc.

So, of the 17 listed financial contributors to the American registry, 10 of them are some of the largest manufacturers of medical devices in the world. In contrast, the Australian registry is funded by the departments in the Australian government charged with regulating the medical device industry.

In all fairness, the FDA’s “short cut” to medical device approval seems like a process to benefit manufacturers more than consumers. But, an oversight organization, such as the American registry funded largely by the medical device manufacturers seems like a classic case of the fox guarding the hen house!

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