The FDA is looking to rework its guidance on all-metal hip implants, proposing a rule change that would require devicemakers to demonstrate the safety and effectiveness of their devices before they're allowed to keep selling them, The New York Times reports.
The agency expects to release a new draft guidance this week, responding to the growing chorus of concern over the high failure rate of metal-on-metal hip replacements that were mostly cleared through the 510(k) process, which doesn't require in-depth clinical study.
If the FDA finalizes its proposal, makers of all-metal hips would have 90 days to submit the necessary data to keep their devices on the market before they were barred from selling them, the Times reports. But implementation could be a ways away: Agency officials told the paper it will likely be a year before the guidance is final.
The FDA's move comes after an agency panel examined worldwide data on the implants and found no compelling reason to use metal devices over those made of plastic or ceramic.
And then there are the recalls: Johnson & Johnson ($JNJ) is facing more than 10,000 lawsuits over its yanked-off-the-market hips, and Stryker ($SYK) recently estimated its summer recall could end up costing $390 million in settlements and surgeries. Biomet has ended up in court with its M2a Magnum Hip System, and Smith & Nephew ($SNN) has issued a failure warning on its Birmingham metal-on-metal hip implants.
- read the Times article