FDA Approves Silicone Implants, But Breast Cancer Patients Again Denied Access To Reconstruction Gel Implants
Main Category: Breast CancerAlso Included In: Cosmetic Medicine / Plastic Surgery; Women's Health / Gynecology; Medical Devices / Diagnostics
Article Date: 29 Nov 2006 - 14:00 PDT
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In 1992 the FDA imposed a moratorium on all breast implants. Due to an outcry from breast cancer patients who were denied access to reconstructive implants, the FDA approved gel implants for these patients on grounds of compassion. Reconstructive gel implants have been used successfully since then.
On November 17th, 2006 the FDA approved Silicone Gel Implants for general use. But unbeknown to most , did not include reconstructive implants such as - adjustable gel implants (Becker Implants) or anatomical implants, which are crucial for reconstruction procedures.
The FDA has thus once again denied American women access to the only gel implant that allows one stage breast reconstruction following mastectomy.
The expander gel implant has been the most common implant used in immediate reconstruction and is currently used in all major countries throughout the world.
The anatomical gel implant which is used to replace a temporary expander is also no longer available.
Source: Hilton Becker M.D.
Dr. Becker has been in plastic surgery practice since 1981 and is certified by the American Board of Plastic Surgery
http://www.beckermd.com
Visit our breast cancer section for the latest news on this subject.
MLA
14 Feb. 2012. <http://www.medicalnewstoday.com/releases/57795.php>
APA
http://www.medicalnewstoday.com/releases/57795.php.
Please note: If no author information is provided, the source is cited instead.
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And The Reason For This Decision Was...?
posted by Elizabeth F Cole MD on 7 Dec 2006 at 5:58 amWas it deemed a legal problem if there was recurrence after implant. Anyone really study this ?
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