Once again we have to listen to these fools who write embellished, poorly-supported articles of crap. I guess the one truth, is that the FDA is doing additional review. I think we can all agree to that.
Keep in mind the ASR still has an 80% survival rating for the 6 years or so that it's been around. I'd reference that, but I can't remember where I saw it. 80% is not awesome, but it doesn't suggest to me that there is a horrible MoM epidemic on our hands, like the journalists like to make it sound.
With regards to the ASR, how does the FDA approve the use of the ASR as a "similar" device, assuming they said it was similar to the BHR, or maybe C+, or biomet, when some of the highly experienced surgeons that reviewed the product before it went on the market, suggested that it would have problems and it is not similar? I guess it depends on the definition of "similar". Hemispherical vs. almost hemispherical? otherwise the fixation looks similar, the metallurgy is probably very similar, the surgical technique is probabaly similar,....I would love to try to spend a few days digging through the FDA file on the ASR. All of the media BS and the attorney-driven rhetoric has essentially destroyed any ounce of truth to the ASR's life and the lawsuit continues to ruin the reputation of the other products that have excellent ratings.
Why can't the FDA analyze McMinn's dataset, or Gross' dataset, or any of the other highly-experienced surgeon's datasets and show that the product and technique provide excellent results for a long time, longer than 4 years or whatever the media thinks. It might not have all the detailed QA/QC that is required for a bombproof FDA review, but it doesn't seem like they would come up with significantly different results from the rest of the world.