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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 Satisfactio
n

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  year’s  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.  Tessier’s  techniques,  as  well.

In  fact,  all  specialities  that  deal  with  the  cranial  and  facial  areas  have  benefitted  from  Dr.  Tessier’s  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.  Tessier’s  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  children’s  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.  Tessier’s  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). 

 

Version : Thai / Eng


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