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TISSUE
ENGINEERING OF THE LIPOSUCTIONED FAT
Fat
Recycling: New Tissues From Liposuctioned Fat
Treatment for Obesity and Osteoporosis a Possibility
Lake Buena Vista, Florida (May 13, 2000) -Liposuctioned fat tissue
may provide the raw material to manufacture new "engineered"
tissues. Using patented technology, plastic surgeons isolated special
cells, known as stem cells, from the fat tissue of elective cosmetic
surgery patients, according to a report at the Annual Meeting of
the American Society for Aesthetic Plastic Surgery (ASAPS) in Lake
Buena Vista. "Results from numerous experiments led us to conclude
that human fat tissue contains stem cells that can be turned into
bone, muscle, cartilage, fat and perhaps other tissues as well,"
says Marc H. Hedrick, MD. "Furthermore, these cells can be
isolated easily, in great numbers and without the ethical considerations
limiting stem cell research." The significance, according to
Dr. Hedrick, is that patients' own tissue can be "recycled"
to create new important tissues, perhaps in a very brief period
of time.
- While this tissue engineering technology is not yet ready for
patients, Dr. Hedrick says that such stem cells from liposuctioned
human tissue could eventually allow us to "manufacture"
an individual's bone, cartilage and fat tissues for aesthetic
and reconstructive purposes.
- This research may also have immense implications for the treatment
of "tissue excess" states such as obesity, and "tissue
loss" states such as osteoporosis, according to Dr. Hedrick,
as it may yield new ways to control tissue growth. He says the
research may be as little as a year away from clinical trials.
- Tissue engineering may also enable new techniques of breast
augmentation, which continues to be one of the most frequently
performed cosmetic surgical procedures.
Co-authors: Doctors A. Smith, A. Katz, C. Huang, M. Kang,
N. Park, P. Benhaim, H. Lorenz, M. Hedrick
###
ASAPS reporting on specific cosmetic treatments and surgical
techniques is based on current scientific, clinical or public
interest and, unless otherwise stated, is not an endorsement
of their safety or efficacy.
-
SAFETY
OF SALINE BREAST IMPLANTS
Plastic
Surgery Organizations Welcome FDA Ruling
on Saline-Filled Breast Implants
The two largest organizations of board-certified plastic surgeons
welcome today's ruling by the Food and Federal Drug Administration
(FDA) regarding the safety and efficacy of saline-filled breast
implants. The FDA ruled that saline-filled breast implants made
by at least one company, Mentor Corporation, are safe meet the agency's
requirements and may continue to be marketed. Decisions on whether
other breast implant companies will continue to market their products
will be determined are expected over the next few days.
- "This confirms what countless scientific studies have suggested:
that the benefits of saline-filled breast implants far outweigh
the risks, " Today there is ample scientific evidence supporting
the safety of saline-filled breast implants," said C. Lin
Puckett, MD, president of the American Society of Plastic Surgeons.
"We believe that Women should must be fully informed of the
potential risks and benefits of implants and should have the right
to choose. This ruling provides that option."
- "Studies have shown that the vast majority of patients
with saline-filled breast implants would make the same choice
again," says Fritz E. Barton, Jr., MD, president of the American
Society for Aesthetic Plastic Surgery (ASAPS). "The high
satisfaction rate and the determination of so many women to undergo
a surgery with the knowledge that it is not a perfect operation
suggests just how deeply the benefits are felt." This ruling
concludes months of investigation and research by the FDA. Saline-filled
breast implants have been available since the late 1960s. No breast
implant is guaranteed to last a lifetime, but Like most medical
devices, they have evolved in both design and production. Today's
This ruling marks the end of a regulatory process that began in
the 1980s, when the FDA categorized saline-filled breast implants
as Class III devices, requiring the highest level of premarket
review.
- In March,, 2000 the FDA's General and Plastic Surgery Advisory
Panel held hearings to determine whether the safety of current
safety and efficacy data for saline implants met the agency's
requirements for approval.. The FDA's regulatory process calls
for the agency to evaluate medical devices on a product-specific
basis, manufacturer by manufacturer. The panel found no evidence
that the saline-filled implants cause major disease, and recommended
approval for devices manufactured by Mentor and McGhan. Each company's
devices implants were evaluated on their own safety and effectiveness
data. A final FDA ruling on McGhan's saline-implant product is
expected within the next few days. A third implant company, Poly
Implants Prosthesis, was not recommended for approval by the Advisory
Panel.
HINTS
ON TEXTURED IMPLANTS
Breast
Implant Texture Impacts Patient Perception
But Not Overall Satisfaction
Lake Buena Vista, Fla. (May 13, 2000) - Patients with textured
implants are more than five times as likely to be bothered by wrinkling
and palpability as those patients with smooth breast implants, according
to a paper presented at the Annual Meeting of the American Society
for Aesthetic Plastic Surgery (ASAPS) in Lake Buena Vista. Despite
these problems, overall patient satisfaction after breast augmentation
remains extremely high, at over 95%.
- In a study analyzing 154 consecutive patients undergoing primary
breast augmentation by a single plastic surgeon, V. Leroy Young,
MD, overall satisfaction scores were fairly similar for the textured
and smooth implants, but those patients who were not completely
satisfied had significant differences: The textured group rated
palpability (22%), wrinkling (15%), and capsular contracture or
breast firmness (2.2%) as factors. With smooth implants, altered
sensation (7.4%), palpability (3.7%), wrinkling (2.8%), capsular
contracture (0.9%), and asymmetry (.9%), were the reasons patients
were not perfectly satisfied. Mean follow-up for textured implants
was 62 weeks and for smooth implants 19 weeks. There were no cases
of implant deflation or infection requiring reoperation in either
group.
- While the patient base of this study was relatively small (154
cases), Dr. Young says, "It seems to indicate that smooth
implants may be superior to textured implants for aesthetic appearance
with no increased risk of capsular contracture, infection or deflation."
- Patient satisfaction is primarily based on the creation of a
breast that looks and feels natural, has normal sensation, and
is free from complications. A recent study, with a minimum follow-up
of ten years, shows nearly 96 percent of women with saline-filled
breast implants who were surveyed would make the same choice again.
The University of Minnesota (UM) multi-center retrospective study,
designed in consultation with the Food and Drug Administration
(FDA), included 450 patients (most for augmentation). Ninety-three
percent (93%) reported they were "satisfied" or "very
satisfied" with their breast implants. Co-authors: C.B. Boswell,
MD, V. Leroy Young, MD of St. Louis, MO.
กฎหมายใหม่ของ
เต้านมเทียมซิลิโคนใช้ฝังในร่างกาย
0419
กฎหมายใหม่ของ เต้านมเทียมซิลิโคนใช้ฝังในร่างกาย
การผ่าตัดเสริมทรวงอกหรือการเสริมเต้านม
ไม่ว่าจะเป็นการฝังวัสดุหรือฉีดสารเข้าไปเสริมน่าจะมีความปลอดภัยหากผู้ที่กระทำเป็นแพทย์ที่มีความเชี่ยวชาญเฉพาะ
แต่เนื่องจากกลุ่มผู้หญิงที่ต้องการเสริมทรวงอกมักจะรู้ไม่เท่าทันโดยไปใช้บริการจากผู้ที่ไม่มีความรู้หรือความเชี่ยวชาญจนก่อให้เกิดอันตรายขึ้น
สำนักงานคณะกรรมการอาหารและยาจึงประกาศให้เต้านมเทียมซิลิโคนใช้ฝังในร่างกาย
เป็นเครื่องมือแพทย์ที่ผู้ผลิตหรือผู้นำเข้าต้องแจ้งรายการละเอียดต่อสำนักงานคณะกรรมการอาหารและยา
ซึ่งกฎหมายนี้จะมีผลบังคับใช้ในวันที่ 30 มีนาคม 2541 เป็นต้นไป
เต้านมเทียมซิลิโคนใช้ฝังในร่างกายเป็นผลิตภัณฑ์ที่ใช้ฝังในร่างกายเพื่อทดแทนเต้านมส่วนที่ขาดหายไปหรือ
เพื่อให้เกิดความสวยงามรวมทั้งการใช้ฉีดสารเข้าไปด้วย การใช้เต้านมเทียมชนิดนี้จะต้องใช้โดย
ผู้ประกอบวิชาชีพเวชกรรมเท่านั้น นั่นก็คือจะต้องให้แพทย์เป็นผู้ผ่าตัดฝังหรือฉีดซิลิโคนให้แก่
ผู้ที่ต้องการและควรจะเป็นแพทย์ผู้เชี่ยวชาญเฉพาะทาง คือ แพทย์ทางศัลยกรรมตกแต่ง
หรือเรียกง่ายๆ
ว่าเป็น หมอผ่าตัดที่ฝึกมาทางการตกแต่งเสริมความงามเพื่อให้เกิดความปลอดภัยและตัวผู้ถูกผ่า
ไม่ต้องกลายเป็นหนูทดลองสำหรับหมอ แล้วท่านจะได้มีทรวงอกที่สวยงามตามที่ต้องการอีกด้วย
สนใจรายละเอียดติดต่อ
Email: prac@fda.moph.go.th

ABOUT
PAUL TESSIER
Dr.
Tessier receives Jacobson Award
Paul
louis Tessier,
MD, FACS
(Hon), became
the sixth
recipient of
the College
Jacobson Innovation
Award during
a ceremony
on June 9,
2000, in
Chicago, IL.
Initiated in
1994, the
award honors
living surgeons
whose pioneering
efforts have
led to
innovations in
and the
advancement of surgical
care. The
award is
made possible
through a
donation from
Julius Jacobson
II, MD,
FACS. Dr.
Jacobson is
a general
vascular surgeon
known for
his pioneering
work in
the development
of microsurgery
and director
emeritus and
distinguished service
professor of
surgery at
the Mount
Sinai School
of Medicine
of the
City Umiversity
of New
York.
Dr.
Tessier was
selected for
this years
award because
his innovative
studies and
procedures led
to the
creation of
craniofacial surgery,
a discipline
now taught
in postresidency
fellowships in
Europe and
America and
recognized by
the American
Council for
Graduate Medical
Education. His
principles of
wide exposure
of subperiosteal
areas of
the face
and orbit
have changed
completely the
way surgeons
perform reconstructive
procedures on
the face.
Dr. Tessier
has demonstrated
the superiority
of autogenous
bone grafts
and how
these may
be taken
from the
hip, rib,
skull, and
tibia. Other
areas of
surgery, particularly
plastic, trauma,
and anesthetic
surgery, have
been
significantly altered
by Dr.
Tessiers techniques,
as well.
In
fact, all
specialities that
deal with
the cranial
and facial
areas have
benefitted from
Dr. Tessiers
work, including
neurosurgery, ophthalmology,
otorhinolaryngology,
and oral
and maxillofacial
surgery. Dr.
Tessier is
an outstanding
example of
a person
who dissolved
barriers separating
specialties and
created an
entirely new
one-one that
greatly benefitted
patients with
craniofacial deformity
and injury,
said James
C. Thompson,
MD, FACS,
Persident of
the College,
when he
presented the
award to
Dr. Tessier.
Just
as he
broke down
the walls
between the
surgical specialties,
Dr. Tessiers
work has crossed
national boundaries.
Perhaps the
strongest measure
of his
impact is
that nearly
everyone in
the world
now practicing
craniofacial surgery
has been
trained either
by Dr.
Tessier or
by someone
whom he
has trained,
Dr. Thompson
said. For
years, the
only way
to learn
craniofacial surgery
was to
go to
Paris and
watch him
work.
Training
in the
U.S. became
easier when,
in 1972,
Dr, Tessier
regularly began
spending one
to two
months a
year operating
at childrens
hospitals in
Boston, MA,
Philadelphia, PA,
and Kansas
City, MO,
as well
as at
St. Joseph
Hospital in
Houston, TX,
the University
of Illinois-Chicago,
and other
institutions. Additionally,
he has
presented international
workshops on
craniofacial surgery.
Dr.
Tessier graduated
from medical
school at
Nantes and
served in
the French
military from
1939 to
1941. He
was a
prisoner of
war during
the latter
portion of
his service.
Upon reentry
to civilian
life, Dr.
Tessier interned
in Nantes
and received
his doctor
of medicine
degree from
Paris in
1943. His
early training
was in
general surgery,
but he
went on
to train
in maxillofacial
surgery, pediatric
orthopaedic surgery,
plastic surgery,
and ophthalmology.
He spent
two years
in the
maxillofacial service
at the
Foch Hospital,
where he
cared for
patients wounded
in World
War II.
In 1946,
he went
on to
work in
London with
Harold Gilles,
MD, and
his colleagues
on congenital
midfacial retrusion,
an experience
that contributed
to his
in terest
in exploring
craniofacial surgery.
In
addition to
being granted
Honorary Fellowship
in the
College, Dr.
Tessiers accomplishments
have been
recognized with
honorary degrees
in Sweden,
an honorary
fellowship in
the Royal
College of
Surgeons in
London, and
special awards
from plastic
surgery societies
in America.
The
Jacobson Innovation
Award is
administered by
the Honors
Committee of
the American
College of
Surgeons. Recipients
are selected
based on
the demonstration
of original
thought in
combination with
the furst
presentation of
work that
has led
to a
milestone in
the advancement
of surgical
care.
Previous
recipients of
the award
are: Francois Dubois,
MD(1994, laparoscopic
cholecystectomy), Thomas
E. Starzl,
MD, FACS
(1995, liver
transplantation), Joel
D. Cooper.
MD, FACS
(1996, lung
transplantation and
lung volume
reduction surgery),
Juan Carlos
Parodi, MD
(1998, treatment
of arterial
aneurysms, occlusive
disease, and
vascular injuries
using endovascular
stented grafts),
and John
F. Burke,
MD, FACS
(1999, burn
care).

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