Find Your Mesh in the 510(k) Process
For those readers who want to know more about the mesh they may have had implanted for pelvic organ prolapse, stress urinary incontinence or hernia, the process is made easier if you have the Medical Device approval number from the FDA.
Below is a handy list of 510(k) approvals which you must look up under the manufacturers name. Click through the manufacturer, find your mesh and see its approval “K” number under the 510k decision which is how it’s classified within the FDA.
Under an FDA 510(k) approval process a similar device already in existence needs to be named by the manufacturer. The new device must be the “substantial equivalent,” whether it actually is or not. On that basis, the manufacturer is issued an approval to sell the device.
Once you have the 510(k) approval number of your device, you can search the MAUDE database within the FDA for any adverse event complaints. Note* Mesh is known as “mesh, surgical, polymeric.”
Here is the resource to look up your mesh via company name:
How to post an Adverse Event with the FDA and search the MAUDE database: