GAITHERSBURG, Md.
"We are pleased
that the panel based its decision on scientific evidence,
not on special interests, emotion or anecdotes
," said James Wells, MD, ASPS
past president. At the forefront of their ongoing education
campaign
is the recently launched joint website
http://www. ASPS
comprises 94 percent of all board-certified
plastic surgeons in the United
States.plasticsurgery.
http://www. TEL-AVIV, Israel, UltraShape
Ltd.
subsidiary headlines
surgery reconstructive
Plastic Surgery Societies Applaud FDA Panel Recommendation That Mentor's Silicone Breast Implants
Be Approved With Conditions
He has proven
experience in launching new technologies, creating
new markets and developing
and leading high performance sales organizations" said Eshel. The Company
's products are marketed in over
20 countries.plastic concept
UltraShape received CE mark approval in June
2005 for the Contour I
system, the first non-invasive ultrasound device for body contouring.com.
Press Contact:
Abigail Marks
Marcom Manager
abigail@ultrashape.medicine certification
According to ASAPS, nearly 335,000 women chose breast
augmentation in 2004.surgery.com
+972
-3-645-7100
plastic patient
"By doing so, Mentor can move forward to reintroduce silicone
implants as an
option for American women.
The safety
and effectiveness of the UltraShape surgery-free
solution has been clinically
proven in hundreds of patients. is a privately held company founded
in 2000.certifications subspecialties
Organized plastic surgery is
enthusiastic about working with the manufacturer to ensure
women's health and
safety," said ASAPS President-Elect Mark Jewell, MD. Breast reconstruction has
been proven in numerous
studies to have many psychological and physical benefits for women who have
undergone a mastectomy. Since 1967, ASAPS has been the authoritative source in
cosmetic surgery
education and research., an
innovator in non-invasive aesthetic medicine, today announced that Robert
E.
Gerberich was responsible for launching a non-invasive tissue tightening
technology and led
the effort in building sales to $50 million.certifications headlines
, The FDA advisory panel's 7-2
vote today to recommend
to the FDA that Mentor's silicone breast implants be
approved with conditions is applauded by the
American Society of Plastic
Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery
(ASAPS), the two largest plastic surgery membership organizations. Mr.patient certification
This
recommendation comes
13 years after the FDA restricted access to the silicone
implants because of safety concerns. Prior
to today's decision, ASPS and ASAPS have taken a leadership role in physician
education, patient
informed consent, and development of a registry. "We are hopeful that a similar favorable recommendation
will be
issued in the near future to Inamed if it can satisfy the FDA's remaining
concerns," says
Dr.
An increasing number of women are choosing breast augmentation to enhance
their appearance
. Prior to
Thermage, he led the sales force at INAMED Aesthetics (formally McGhan
Medical) to achieve
market leadership position in the distribution of
specialty products to plastic surgeons, dermatologists
, and other physician
specializing in cosmetic and reconstructive procedures. and its
unique technology
for ultrasonic assisted liposuction. Gerberich holds a
Bachelor of Science from Illinois State University
, IL.cosmetic thoracic
This should go a
long way to assure the FDA and the public that the panel's recommendation
is
prudent and sound.org. With more than
5,000 members, the society is recognized as a leading
authority and
information source on cosmetic and reconstructive plastic surgery. Our unique product
offering meets a significant and currently unmet physician and patient need
for non-invasive body
contouring. The UltraShape
proprietary technology is based on focused ultrasound waves that selectively
disrupt adipose (fat) cells without affecting surrounding tissues.aaps surgery
Patient information on plastic
, cosmetic, and reconstructive surgery.
exam payments
More than 62,000 women had breast reconstruction in
2004
, according to ASPS. ASAPS' 2,200 plastic surgeons are
elected to membership and are certified by
the American Board of Plastic
Surgery or the Royal College of Physicians and Surgeons of Canada.
Gerberich served as the Vice President
of Marketing and Sales and Vice President of Sales at Thermage
Inc. The
Company is dedicated to providing healthcare professionals with leading edge
solutions
that enhance the lives of patients worldwide.concept practices
"UltraShape is an exciting company with a proprietary
technology
supported by sound science and extensive research.concept surgery
Gerberich has been appointed as
the President of UltraShape North America and
will lead US activities in the United States.
Yoram Eshel, PhD, CEO of UltraShape, said: "With over 15 years of
successful sales and marketing
experience in aesthetic medical devices, Bob
is the ideal person to lead our United States operations
. Before Inamed, he was
part of a core management team responsible for launching LySonix Inc.
For
more information visit http://www.surgery plastic
org .cosmetic subsidiary
"
Both societies are prepared to work with the FDA and
Mentor to fulfill the
conditions which include physician education, patient education, a registry
,
and a commitment from the manufacturers for continued data collection.
On April 12, the FDA
advisory panel issued in a 5-4 vote a
"non-approvable" recommendation to Inamed's application for
approval of its
silicone breast implants.
To that end, the two societies believe continued
data collection and study
of the procedure and device are essential, and they are committed to being
active participants in post-market monitoring of the implants. This will be the authoritative website
for both saline and silicone breast implants and offer objective and science-
based information
.
About UltraShape:
UltraShape is redefining aesthetic medicine by developing, manufacturing
,
and marketing innovative non-invasive devices for body contouring.certification plastic
"Plastic surgeons are
committed
to helping women make informed choices about their health care based
on all the available and accurate
information about these devices.headlines aaps
The panel encouraged Inamed to address its
remaining concerns and
then request panel review of its application for
approval. http://www.UltraShape Appoints Robert
E. Gerberich to Lead United States Operations
.matching prepaid
concept cosmetic
breastimplantsafety. 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. I look forward to being part of the
UltraShape senior management
team and leading the company's operations in the
United States," said Robert Gerberich. UltraShape
Ltd.ultrashape.numerous subspecialties
Jewell.thoracic surgery
The American Society of Plastic Surgeons (ASPS) is the largest
organization
of board-certified plastic surgeons in the world.reconstructive realtime
"
ASPS and ASAPS are optimistic that the FDA
will follow the panel's
recommendation.org . Mr.surgeons numerous
"The comments by Josh Levine, Mentor's CEO, during
his
summation confirm Mentor's long-term commitment to safety.
The American Society for
Aesthetic Plastic Surgery (ASAPS) is the leading
organization of board-certified plastic surgeons
specializing in cosmetic
plastic surgery.
Prior to joining UltraShape, Mr.surgeons contributions
In addition
, ASPS and ASAPS will continue to offer assistance to the
manufacturers with additional conditions
set forth by the FDA related to
physician and patient education.thoracic certifications
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