Implantable Devices - The effects of surgical scaffold implanted into the human body

#1
This video illustrates the effects of surgical scaffold implanted into the human body to reinforce tissue during surgical procedures

Please discuss

 
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#3
Joanne,

what the specific aspects of surgical meshes / this video would you like to discuss?

Yes of course.

What are your views on the safety and efficacy of surgical mesh?

If you're a Regulatory Affairs professional, would you have signed off these devices as safe and effective?

If you would have signed them off initially, would you sign them off now, after knowing there had been more than one adverse event?

Would you sign off any device if you knew it had the potential to harm patients?

Would you sign off any device that had the potential to kill patients?

Thank you
 

planB

Trusted Information Resource
#4
Joanne,

I think FDA recently provided a thread on meshes quite to the point that addresses most of your questions. And since FDA has undoubtedly much more insight than at least me ( I am not associated to a mesh manufacturer), I personally prefer to refrain from commenting this specific case from my un-educated point of view.

Generally, class III = high-risk devices imply potentially severe or life-threatening hazards. In the end, it comes down to a documented and demonstrated positive-enough risk-benefit ratio.

Having said this, still every suffering patient is one too many, and I feel deeply sorry for the lady in the video.
 

pkost

Trusted Information Resource
#5
I'm inclined to agree with PlanB - I'm not an expert on the product or the field therefore I would refrain from giving my opinion. I wouldn't want to second guess the people involved without the documentation that they had access to; it would be unfair to judge. It is clear that there are risks, I do not know what the risk/benefit assessment looked like but 20/20 hindsight is a wonderful thing.

You question whether a device that had the potential to harm patients should be signed off - would you sign off a tourniquet? If misused that has the potential of resulting in limb loss. Your questions allude to black and white when the world is very complex and gray.

You questions devices that can kill, what are your thoughts about chemotherapy (pharma) and radiotherapy (meddev)?
 
#6
I'm inclined to agree with PlanB - I'm not an expert on the product or the field therefore I would refrain from giving my opinion. I wouldn't want to second guess the people involved without the documentation that they had access to; it would be unfair to judge. It is clear that there are risks, I do not know what the risk/benefit assessment looked like but 20/20 hindsight is a wonderful thing.

You question whether a device that had the potential to harm patients should be signed off - would you sign off a tourniquet? If misused that has the potential of resulting in limb loss. Your questions allude to black and white when the world is very complex and gray.

You questions devices that can kill, what are your thoughts about chemotherapy (pharma) and radiotherapy (meddev)?
Thank you.

Any device has the potential to cause harm if misused and reasonably foreseeable misuse is required to be considered by the manufacturer to prevent that type of harm to the patient by the tourniquet. So yes I would sign off a tourniquet that has this reasonably foreseeable misuse considered and where a WARNING has been communicated in the information for use to that effect.

My thoughts on chemotherapy and radiotherapy are deep as safer alternatives exist in many cases, such as prevention and reversal even when patients have been given a death sentence by the medical profession.

But if there are cancers we are unable to control, where the cause can't be determined/eliminated and there is no other option, then benefits may clearly outweigh the risk of a death potential.
 
#7
Joanne,

I think FDA recently provided a thread on meshes quite to the point that addresses most of your questions. And since FDA has undoubtedly much more insight than at least me ( I am not associated to a mesh manufacturer), I personally prefer to refrain from commenting this specific case from my un-educated point of view.

Generally, class III = high-risk devices imply potentially severe or life-threatening hazards. In the end, it comes down to a documented and demonstrated positive-enough risk-benefit ratio.

Having said this, still every suffering patient is one too many, and I feel deeply sorry for the lady in the video.
Thank you for the link and for watching.

While Class III devices maybe associated with more potentially severe hazards, this is not in relation to unsafe and ineffective devices. So for example we would not reclassify a sticky plaster used on the patient's skin as a Class III device because it killed someone. We would ensure it never killed anyone again by controlling those risks appropriately.
 
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