FDA Decision Involves Area Patients; Indiana Physician Participated In 'Rigid' National Clinical Study

Local surgeons who perform
breast reconstruction and 'primary augmentation' for a large region of
Indiana and three surrounding states are applauding the Food & Drug
Administration decision (November 2006) to approve the manufacturing and
use of silicone gel- based breast implants for American women. Ronald
Downs, MD, FACS, former President of the Indiana State Medical Association
and founder of The Centre, P.C. based in Elkhart, participated for more
than ten years in the same national FDA study of silicone gel-based breast
implants that is now cited as the basis for approving their use.



"This is a sound decision following fourteen years of rigid study
protocol by the FDA," commented Downs. "The positive affect it will have on
women who need reconstruction or desire primary augmentation cannot be
overstated. Other national studies have clearly shown that women who opt
for reconstruction or augmentation benefit emotionally and physically. This
(silicone) is a safe, and much more natural looking option for women
compared to saline."



Downs adds that there has been a long-held misunderstanding of the
original 1990 decision by the FDA to restrict the use of silicone as an
implant option. "The FDA never commented on the safety of silicone
gel-based implants," according to Downs. "They simply said that they had no
medical evidence regarding the use of these devices and needed to study
them. The 1990 decision merely 'restricted' their use to patients who
agreed to be part of the clinical study. That study is the same one that I
have been part of -- the same study which the FDA mentioned in its November
announcement."



Surgeons at The Centre, P.C. along with other surgeons throughout the
country are already making the silicone gel-based implant available as an
option for their reconstruction and primary augmentation patients. "The
specific advantages of silicone over saline are more than just aesthetic,"
adds Downs. "Silicone implants don't show much rippling along a patient's
skin lines the way saline implants do. They look and feel much more
realistic. But, the implant envelopes themselves are also much stronger --
rupturing is unlikely. The gel itself is bonded to the inner side of the
envelope and has more of a Gummy Bear-like consistency than earlier
versions of the device. It simply doesn't 'ooze' even if there is a
rupture."



According to the ASAPS, approximately 358,000 women chose breast
reconstruction or augmentation in 2005. Both reconstruction and
augmentation have been proven in numerous studies to have psychological and
physical benefits for women who choose the procedures.



For more information on the recent FDA decision regarding silicone
breast implants and the national clinical study conducted by the FDA,
contact Ronald Downs, MD, FACS at The Centre, P.C. Downs is a member of the
American Society for Aesthetic Plastic Surgery (ASAPS), the American
Society of Plastic Surgeons (ASPS) and serves as an Alternate Delegate to
the American Medical Association (AMA).



The Centre, P.C. is a comprehensive plastic surgery practice with board
certified physicians who deliver professional care to patients throughout
northern Indiana, southern Michigan and the Chicago area. Reconstructive
surgery, cosmetic surgery, and non-surgical options including skin health
care and a medical spa are available.


The Centre, P.C.

TheCentrePC