Double lumen saline implants feel more natural

by **COOKIE** 11th September 2012, 5:46 pm

Investigational implant also shows lower rate of capsular contracture at two years compared to current single-lumen saline implants

Women like to have options, the more options the better. Some women
don't like the look and feel of currently available saline-filled
breast implants, which are prone to scalloping or wrinkling, but also
aren't comfortable with silicone gel options. An investigational

breast implant,
one filled with saline but with design features intended to provide a
more natural result, may be just the answer they need. Results at two
years with a novel, double-lumen, saline-filled breast implant, known as
the IDEAL IMPLANT, reveal high patient and surgeon satisfaction, a low
rate of wrinkling, and a surprisingly lower rate of capsular contracture
compared to current, single-lumen, saline-filled implants. "Two-Year
Outcomes With a Novel, Double-Lumen, Saline-Filled Breast Implant,"
which provides full details on the two-year results of this ongoing
study, appears in the September issue of the Aesthetic Surgery Journal.

"Currently available saline-filled implants have only a single lumen.
This means they are essentially balloons filled with freely-moving
fluid, which can result in an unnatural feel or suboptimal aesthetic
result," said co-author and clinical trial investigator Larry S.
Nichter, MD, Voluntary Clinical Professor of Plastic Surgery at
University of Southern California and University of California, Irvine
and Chairman of the Department of Plastic Surgery at Hoag Memorial
Hospital in Newport Beach, California. "The two-year clinical data from
this study show that the IDEAL IMPLANT may provide a good alternative to
current saline- or even silicone gel-filled implants. One of our most
significant and unexpected findings was the low rate of capsular
contracture for the investigational, double-lumen implant compared to
current single-lumen saline implants."

The IDEAL IMPLANT is a saline-filled breast implant with a baffle
structure, two lumens, and a series of shells of increasing size nested
together - a design meant to better control saline movement and provide
internal support to the implant edge and upper pole. This device is
being investigated in a 10-year, U.S. clinical trial evaluating safety
and effectiveness in women seeking primary breast augmentation or
replacement of existing augmentation implants. Two-year follow-up visits
were completed by 472 of the 502 women (94.0%) enrolled at 35 private
practices, 378 of whom had undergone primary breast augmentation and 94
of whom had received replacement augmentation.

Patient-reported satisfaction with the outcome was 94.3% for primary
augmentations and 92.3% for replacement augmentations; surgeon-reported
satisfaction was also high (96.5% and 93.4%, respectively). The
incidence of moderate-to-severe wrinkling was 3.8% (primary) and 12.0%
(replacement). Baker Grade III and IV capsular contracture rates were
3.8% (primary) and 8.2% (replacement). These two-year rates are lower
than those reported for current single-lumen saline implants at one
year. Deflations, none of which were caused by a shell fold flaw,
occurred in 4.8% of primary augmentations and 3.3% of replacement
augmentations.

"There is a clear need for saline-filled implants that offer a more
natural result for patients who don't want silicone gel-filled devices.
The early results with this new implant design appear to be very
promising, particularly with regard to capsular contracture, which is
always a concern with breast augmentation," said Foad Nahai, MD,
Editor-in-Chief of Aesthetic Surgery Journal. "I know that many surgeons will be interested in following up on the long-term outcomes of this study."

source HERE

Really interesting reading about the lower rate of capsular contracture. Double lumen saline implants feel more natural 1978086825

Double lumen saline implants feel more natural 1978086825

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