| On
Wednesday 4/14/05, the FDA health advisors recommended
removing the 13 year old ban on silione-gel breast
implants. This move came about as Mentor Corp. persuaded
the FDA that its newer silicone implants are much
more safe and durable than older versions. The company
may use these implants only under the following safety
conditions set forth by the FDA.
-
Prospective patients must sign a consent form acknowledging
that they understand the risks of a silicone breast
implant including the fact that they may break and
require replacement or removal. |
 |
- Mentor may only sell silicone breast implants to board-certified
plastic surgeons who complete a special hands-on training
program to learn how to insert the implants in a way that
minimizes the odds of it breaking.
-
Mentor must create and maintain a registry to track the
long term results patients have with the implants.
-
Patients must be educated about the fact that if an implant
breaks, the effect of the breakage generally does not cause
immediate symptoms. Further they are advised to have an
MRI scan after five years and every two years thereafter
to check for breakage.
-
Mentor must conduct a 10 year study to determine the percentage
of breast implants that will break in that time.
-
The study must be reviewed by an independent data monitor.
-
The results of Mentor's breast implants will be reviewed
by the FDA in five years to verify that the implants are
performing as expected.
Silicone-gel
breast implants began selling in 1962 and were banned in
1992 amid health fears. Research since then has shown that
they do not cause serious diseases like cancer or lupus
but that they can cause infection and scar tissue if they
leak and are untreated.
Approximately
264,000 breast enlargements and 63,000 breast reconstructions
were performed in the United States in 2003 - the vast majority
using salt water filled implants that are sold without restriction.
It is estimated that if the silicone breast implants return
to the market, 200,000 women may have them installed within
the first year.
About
the Author
Steven
is a freelance writer that writes for The Nutrition Guide
at http://www.thenutritionguide.com
and My Attorney Finder http://www.myattorneyfinder.com.
Article
Source: http://EzineArticles.com/ |
