PVA question

[Guest guest]

This is in response to a question Carla had on why the manufacturers of

PVA don't track their users according to FDA guidelines. FDA doesn't

require tracking of all implants - in fact, they've reduced the number

of devices they DO require tracking on. As of April, 1999, FDA no

longer requires tracking on any of the breast implants or penile

implants, Angechik reflux, or gel-filled chin implants. I've been

working with device manufacturers as a consultant, and the facial

implant folks have never had to conform to tracking requirements. Right

now, only 11 devices are required to be tracked, includng TMJ

prostheses, pacemaker pulse generators and electrodes, replacement

heart valves, etc. FDA says they are now only tracking devices which

are life-sustaining or life-supporting when used outside a user

facility (plus implanted over 1 year). So that would explain why the

PVA manufacturers aren't doing the tracking. Interesting stuff!

Chris