Breast Enlargement Questions
Question about breast implants and device tracking?
I am having breast enlargement surgery and I noticed the following sentence in the disclosure: All breast implants are subject to device tracking as mandated by federal law. What does that mean exactly?
Device tracking is something the FDA uses in conjunction with medical industry that provide the public with prosthesis and implants of all kinds, not just of the breast. It involves “tracking numbers” which are given to each device. Also, personal information about who the devices are used on is kept in a database by the FDA, so that the can keep track of trends involving who is using the implants, who is getting them removed and why, and who is having complaints. If a particular product gets a lot of complaints, the FDA will step in and take action. It is most valuable pertaining to silicone implants and other less known implant material such as teh new “Gummy Bear” implants. Close tracking of clinical study implant used is required for the FDA to make decisions which protect the public.
Breast Enlargement – Questions from a Patient
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