Another Study by Plastic Surgeons, for Plastic Surgeons!

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Another Study by Plastic Surgeons, for Plastic

Surgeons!

http://news./s/usnw/20051017/pl_usnw/study_finds_new_type_of_silicone_i\

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Study Finds New Type of Silicone Implants Offer More

Natural-Looking Breasts with Low Complication Rate

Mon Oct 17,12:30 PM ET

National Desk, Medical Reporter, Health Reporter

Contact: La or Hugins, both of

American Society of Plastic Surgeons, 847-228-9900 or

media@...

ARLINGTON HEIGHTS, Ill., Oct. 17 /U.S. Newswire/ -- A

new type of silicone breast implant, currently

available to women who agree to be part of a clinical

study, offers breast augmentation and reconstruction

patients more natural looking breasts with a low

complication rate, according to a recent study in

Plastic and Reconstructive Surgery®, the official

medical journal of the American Society of Plastic

Surgeons (ASPS). The new gel implants will be the next

type of silicone implant produced by manufacturers if

the U.S. Food and Drug Administration (FDA) approves

the devices to be marketed and sold in the United

States.

" It is an extreme understatement to say our patients

are happy with the more cohesive gel implants, " said

Brown, MD, ASPS member and study author.

" These implants simply look and feel much more natural

than saline implants. My patients are thrilled with

their results. "

The new devices are more cohesive than those currently

being considered by the FDA. They have a gummy

consistency, which allows them to hold their shape

better than saline. According to the study, the gummy

consistency decreases the likelihood of rippling and

provides greater safety because, being more solid, the

silicone may not escape from the shell if it were to

rupture. The more cohesive silicone material and its

textured shell also give the implant a very natural

and proportionate breast shape.

" I think this is a great device, " said Walter Erhardt,

MD, chair of the ASPS Public Education Committee and

surgeon participant in the cohesive gel implant

clinical study. " It's not perfect and there is going

to be a learning curve for surgeons in terms of

educating them on how to use the more cohesive gel

implants. A big criticism of previous implants has

been silent rupture and re-operation rates. In my

opinion, this product has a good chance for a greater

longevity rate as well as less complications. "

According to the study, another benefit of the more

cohesive gel implants is the availability of a wide

variety of shapes and sizes to more closely match

breast shapes and chest dimensions. For example,

plastic surgeons can use a patient's breast

measurements to custom select an implant specific to

each breast.

Beyond the cosmetic advantages of the more cohesive

implants, these implants have a low complication rate.

In the study, only 3.4 percent of the 118 breast

augmentation patients experienced complications,

including hematoma, capsular contracture, and

asymmetry. Nineteen percent of the 32 breast

reconstruction patients experienced complications --

most were minor with only one patient requiring

re-operation. According to Dr. Brown, this rate of

re-operation for breast reconstruction patients is

remarkably low considering the inherent challenges of

breast reconstruction. He also noted that with an

average follow-up of 21 months (ranging from 16 to 36

months), longer term data will be needed to further

substantiate the promising short-term results.

" The more cohesive gel implants are going to play a

major role in aesthetic and reconstructive breast

surgery if they are approved for sale in North

America, " said Dr. Brown. " We have already seen their

potential through studies in Europe. Now, through our

own research, we are finding with these implants, re-

operation is rare, the complication rate is low and

patients are extremely pleased with their outcome. "

According to the ASPS, more than 264,000 breast

augmentations and nearly 63,000 breast reconstructions

were performed in 2004.

The FDA is currently considering the reintroduction of

silicone implants for sale in the United States, 13

years after it restricted access to them due to safety

concerns. In 1992, the FDA imposed a moratorium on the

sale of silicone implants and saline implants have

dominated the North American market. In the second

half of 2005, after the manufacturers presented data

at a panel hearing, the FDA issued " approval with

conditions " for the sale of silicone implants,

stipulating a number of conditions the manufacturers

must satisfy in order to receive FDA approval. Data

regarding this new type of silicone implant, the more

cohesive silicone implants, has not yet received an

FDA panel hearing.

For referrals to ASPS Member Surgeons certified by the

American Board of Plastic Surgery, call 888-4-PLASTIC

(475-2784) or visit http://www.plasticsurgery.org to

learn more about cosmetic and reconstructive plastic

surgery.

The American Society of Plastic Surgeons is the

largest organization of board-certified plastic

surgeons in the world. With more than 6,000 members,

the society is recognized as a leading authority and

information source on cosmetic and reconstructive

plastic surgery. ASPS comprises 94 percent of all

board-certified plastic surgeons in the United States.

Founded in 1931, the society represents physicians

certified by The American Board of Plastic Surgery or

The Royal College of Physicians and Surgeons of

Canada.

http://www.usnewswire.com/

/© 2005 U.S. Newswire 202-347-2770/