FDA revises silicone breast implants data needs
Although an FDA advisory panel recommended market approval of Inamed's silicone breast implants in October, rather than accepting that panel's advice , last night the FDA deferred a decision on Inamed's breast Implant, pending submission of additional information.
Today, the agency also issued a new Guidance Document expanding the data needed from any manufacturers looking to get FDA market approval for breast implants.
The Guidance Document was issued to "more clearly define FDA's recommendations for breast implant marketing applications and to reflect the availability of new information about the framework for assesing the safety and effectiveness of these products."
While many media oulets have reported this development as the FDA Denying silicone implants, a letter sent to Inamed last night stated that a desicion on the company's petition could not be issued without the benefit of the additional information requested.
...The ASPS (Americna Society of Plastic Surgeons) continues to support the FDA regulatory process and FDA's request for additional information prior to completing its review of silicone breast implants."...
From the PSNews Bulletin
What would you like to do now?
Find the right plastic surgeon for you...
See breast implants before and after pictures...
Try your ideal breast implants size...
See breast implants surgery information...
Go back to plastic surgery news... |
