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HAIRMAX LASER COMB
Finds New Type of Silicone Implant Offers More Natural Looking Breasts with
Low Complication Rate|
(press release from ASPS)
ARLINGTON HEIGHTS, Ill. – 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 Mitchell 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
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
"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 year 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
where you can also 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.
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