Tuesday, June 19, 2012

Another medical device bites the dust - the Smith & Nephew R3 acetabular system

Here we go again. Now it's the Smith & Nephew Acetabular System, being voluntarily recalled by the manufacturer, Smith & Nephew Surgical Pty Ltd. Here is an announcement carried through the Australian Therapeutic Goods Administration (TGA). In 2010, the company had actually been issued a warning letter by the FDA about non-compliance with Good Manufacturing Practice. Doesn't this sound similar to the recent mess about the DePuy hip implant recall?

Well, now they finally have to issue a voluntary recall of the hip implant prosthesis, after unusually high failures recorded in Australia and UK. Launched in 2007, apparently about 7700 of these metal liners have been used globally. There is no record of how many of these metal upon metal implants have been used in Singapore itself. To date, it is uncertain how this recall is being implemented in Singapore. One of the recognized problems with metal on metal implants is the potential for erosion and resultant cobalt and chromium poisoning. The recommendation now is for patients who have had such implants to be subjected to life-long screening for toxicity.

So more questions for the HSA:

a] Do we know how many of these implants have been used in Singapore?
b] Do we have a record of patients who have received these implants, and are there processes in place to recall these patients for observation and toxicological screening?
c] How is this being tracked? How are patients expected to know?
d] Why is there no public dissemination of this information? Is this recall being implemented at all in Singapore?

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