News, Articles & Commentary:
On May 11,
2000, the FDA approved Mentor and McGhan
saline breast Implants after recommendation for approval by an Advisory Panel. Implants previously
marketed in the U.S. by PIP/USA did not receive approval. Prior to
this approval in 2000, no implants had received approval in the U.S.
In November of 2006, the FDA
also approved Mentor and Inamed's (formerly McGhan) silicone gel breast
implants. Although saline implants had remained in use despite a ban
of silicone implants in 1992, silicone was not available in the U.S. to the
general public until the FDA's November 2006 approval.
The FDA Website includes the following important information:
-FDA Breast
Implants home page -
www.fda.gov/cdrh/breastimplants/
-Approval of Inamed Silicone -
http://www.fda.gov/cdrh/pdf2/P020056a.pdf
-Approval of Mentor Silicone -
http://www.fda.gov/cdrh/pdf3/p030053a.pdf
-FDA Press Release -
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01512.html
-Consumer Q & A -
http://www.fda.gov/cdrh/breastimplants/qa2006.html
-Manufacturer's Product Labeling -
http://www.fda.gov/cdrh/breastimplants/labeling.html (includes all of
the info the FDA requires the manufacturers to include in the product
inserts).
For
historical perspective, read info on saline approval in 2000:
Breast Implants On Trial - PBS:
From PBS (U.S. Public Television) - (A series of articles
questioning the wisdom of plaintiff’s lawyers and juries who dismiss the scientific
evidence - Be sure to click on the audio tour before beginning) http://www2.pbs.org/wgbh/pages/frontline/implants/
Breast Augmentation/ Augmentation Mammaplasty:
Breast Implant & Breast Augmentation information from the
American Society of Plastic and Reconstructive Surgeons. http://www.plasticsurgery.org/surgery/brstaugm.htm
Cosmetic
Breast Enlargements Are Making a Comeback:
From the New York Times - July 1998 - Article by Denise Grady
- NOTE: The NY Times site requires you to register, but the registration is free. www.nytimes.com/library/national/science/072198sci-implant.html
Skepticism.Net:
"Do silicone breast implants cause disease?
Many women who got the implants think they do and their lawyers have been very successful
in court, forcing Dow Corning, the manufacturer of the implants, into bankruptcy.
Unfortunately all of the available medical evidence indicates silicone breast implants are
not a health risk and in fact some studies show a slight health benefit to implants
(though this benefit is so small it is probably a result of statistical anomalies.)
If there's no good medical evidence that breast implants cause disease, why do women
keeping winning lawsuits? The essays and links here provide information to explain that
paradox. If you'd like more information about breast implants, visit our new bookstore
where you can order books on the implant controversy at a nice discount."
(This text is from the skepticism.net front page and no claim to copyright is
claimed). http://www.skepticism.net/breast_implants/index.html
Oldies, but
goodies, on the controversy and the courts:
Overview of the Breast
Implant Controversy
Breast implant science
and the courts
Information on the
Internet Main Page |
