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This information is from Candela's 10K filing with the SEC. Apparently, many cosmetic device manufacturers do this. I found a similar statement in Solta's (Fraxel) 10K filing. Before you allow one of these devices to be used on you, you may want to peruse their 10K filing to see if their device has been modified without FDA approval. Candela has been saying this in their 10Ks since 2003, maybe longer. This is from 2009. Since they merged with another maker, I could not find a recent 10K. I won't go into why the FDA does not do post-market inspections of these devices or why they are left on the market without further 501(k) re-filing. The FDA is useless. Quote:·We have modified some of our products without FDA clearance. The FDA could retroactively decide the modifications were improper and require us to cease marketing and/or recall the modified products.
· Achieving complete compliance with FDA regulations is difficult, and if we fail to comply, we could be subject to FDA enforcement action.
· We could incur substantial costs as a result of product liability claims, including but not limited to costs as a result of product failures for which we are responsible under warranty obligations and as a result of our customer’s potential unavailability of liability insurance coverage.
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Rank: Administration
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Sounds like they can be sued if their device screws up now.
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Rank: Advanced Member
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No, not really. They could be sued if these modifications were found to have caused the problems someone experiences (adverse side effects) but no one (victims) has the ability to do the research to know if the original design or a modification caused the issue. Plus, no way of knowing when/if the FDA goes back and approves those mods at some point. The companies come out with new devices or variations on the old ones, get approval on those, then mods the older one to match the newer ones with approval. This is sort of circular, so proving time lines would be a long process and proving what mod caused it nearly insurmountable for the average person.
What this information does is put everyone on notice that they may 'think' an FDA approved device is just that, 'approved', when in fact there's a good chance it has been modified without FDA approval. This sort of disclaimer needs to be on the front page of every device maker's website:
"Our products have FDA approval, however we have modified our devices WITHOUT FDA approval. These modifications could lead to side-effects not mentioned in our prior research or the 501(k) approval of these devices."
It should also be part of the informed consent that everyone signs prior to having laser/light treatments so patients are aware of the risks they may be taking.
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Rank: Administration
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I totally agree with you. It's wrong that the laser companies can change them without FDA approval but with past approval of a different set up. DCNGA wrote:No, not really. They could be sued if these modifications were found to have caused the problems someone experiences (adverse side effects) but no one (victims) has the ability to do the research to know if the original design or a modification caused the issue. Plus, no way of knowing when/if the FDA goes back and approves those mods at some point. The companies come out with new devices or variations on the old ones, get approval on those, then mods the older one to match the newer ones with approval. This is sort of circular, so proving time lines would be a long process and proving what mod caused it nearly insurmountable for the average person.
What this information does is put everyone on notice that they may 'think' an FDA approved device is just that, 'approved', when in fact there's a good chance it has been modified without FDA approval. This sort of disclaimer needs to be on the front page of every device maker's website:
"Our products have FDA approval, however we have modified our devices WITHOUT FDA approval. These modifications could lead to side-effects not mentioned in our prior research or the 501(k) approval of these devices."
It should also be part of the informed consent that everyone signs prior to having laser/light treatments so patients are aware of the risks they may be taking.
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