Are you one of the thousands of individuals who underwent hip replacement surgery?  Even if you haven’t been notified by your doctor or received a letter from the manufacturer informing you that your hip implant has been recalled, you may still feel anxious about what the future holds.  You’ve probably heard about various hip implant recalls, seen news reports discussing studies on the dangers of metal hip implants, and are wondering whether your particular hip implant has been recalled.  In order to answer that question, you will need to be proactive. You can’t assume you will be notified.

The sad reality is that medical device manufacturers do not know exactly which patients have been implanted with their products. They only know which doctors and hospitals used their products.  Accordingly, after they announce a recall, they notify doctors and hospitals who’ve used their devices and rely on them to notify their patients.  Now, most doctors are very diligent about notifying their patients, especially if there is a reason to believe the implanted product can fail or cause damage.  After all, the doctor is usually as upset as you that the product he or she ordered from the manufacturer has been recalled.

What happens, however, if the implanting doctor retired? Or, if the doctor sent a letter notifying you of the recall to your old address?  There are many more reasons why you might not receive notice of the recall.

This exact problem of patients failing to receive notification that they have a recalled medical device has caught the eye of Congress and the FDA.  Other countries have registries, where detailed information about individuals who received implants is stored in a database.  These registries make it easier to notify individuals of a recall and also allow the regulatory bodies to keep track of the performance of these implants.  In fact, it was information collected by one of these registries on the performance of the DePuy ASR hip implant that triggered the DePuy ASR hip recall. Fortunately, there are bills in Congress right now to create such registries in the United States.

Until there is a better system in the U.S. to notify patients of medical device recalls, what should you do? You have two choices.  First, you can call your doctor’s office and ask them to tell you what type of implant you have.  You are entitled to this information.  They may tell you not to worry because your implant hasn’t been recalled.  Although this may be true, your implant may be recalled next week or still cause complications.  Just because a device hasn’t been recalled, doesn’t mean it’s not dangerous.  Accordingly, it’s important that you find out exactly what type of implant you have so you will have that information readily available in case you hear of another recall in the future.  Second, you can call the hospital where you underwent your original hip replacement surgery.  They may ask you to sign a release in order to get the information.  Make sure to ask for the operative report from the surgery as well as the product stickers.

You owe it to yourself to find out what products you have had implanted.  You may also want to consider writing your local representative to let him or her know that you believe it is important that we have a system in place to identify and monitor the performance of medical devices.

Published October 8, 2012 by