美國食品藥物局發佈對注射溶脂手術的警告April 8, 2010

April 8, 2010 — The US Food and Drug Administration (FDA) has issued warning letters regarding false or misleading online statements about drugs claimed to eliminate fat in a procedure called "lipodissolve."

2010年4月8日,美國食品藥物局發出警告信函,警告目前網上宣稱可以融脂藥物的誤導問題

The letters were issued to 6 United States–based medical spas and a company in Brazil (Zipmed Mesoone), whose Web site today states that they no longer sell the products used for the procedure, also referred to as mesotherapy, lipozap, lipotherapy, or injection lipolysis.

警告信函發給美國境內上述的六家醫療產品公司後,這些公司當天就宣佈,已經停止販售溶脂針劑。

"The agency urges this company and all companies and individuals to stop making misleading or false claims about the drug's benefits," said Kathleen R. Anderson, PhD, deputy director of the Division of New Drugs and Labeling Compliance, with the FDA's Center for Drug Evaluation and Research.

食品藥物局發言人Kathleen R. Anderson博士為美國食品藥檢局副主管,根據藥檢中心研究結果報告,要求所有販售溶脂針劑的業者,停止宣稱誇大不實溶脂效果。

According to Dr. Anderson during an FDA press briefing yesterday, claims have been made that the lipodissolve procedure can eliminate unwanted fat, has an outstanding safety record, and is superior to other fat-loss procedures. She added that claims have been made stating that lipodissolve products can treat medical conditions, such as male breast enlargement, benign fatty growths, and surgical deformities. "FDA is not aware of any credible scientific evidence to support any of these medical uses," she emphasized.

Anderson博士於昨天對媒體的簡報中說明,業者所宣稱比其他方法更好的溶脂針劑效果,包括男性女乳治療,肥胖組織改善,以及甚至手術後不規則情況的改善等,美國食品藥物局,從未獲知任何可用來支持這些說法的科學證據。

Medical associations, including the American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgery, have issued position statements regarding this procedure, stating concerns about the short- and long-term safety of the products used.

各醫學會,包括美國整形外科醫學會,以及美國美容外科醫學會等,都針對注射溶脂手術的短期以及長期安全顧慮,發表了一些言論。

The drugs most often included in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate. Other ingredients, such as vitamins, minerals, and herbal extracts, may also be incorporated.

溶脂針劑含有上述各種化學物質。

Adverse events associated with these agents include injection-site reactions, such as prolonged swelling, redness, and pain; skin reactions, such as panniculitis, ulceration, abscess, necrosis, and scarring; and skin infections. According to the FDA, these adverse events may be caused by the drug itself, the injection technique, and/or the formulation of the solution.

注射上述各種溶脂針劑以後,可能產生的副作用包括:長期紅腫、疼痛,皮肉潰爛、壞死以及疤痕反應等。FDA認為,藥物本身,溶劑,以及不良注射技術等,都可能是導致不反應的原因。

In addition to the Brazilian manufacturer and distributor, the following health spas in the United States must respond in writing to the FDA letters within 15 days explaining how they plan to correct these violations and prevent similar violations in the future. The companies are Monarch Medspa, King of Prussia, Pennsylvania; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Maryland; Innovative Directions in Health, Edina, Minnesota; PURE Med Spa, Boca Raton, Florida; and All About You Med Spa, Madison, Indiana.

除了巴西製造以及經銷商外,下列這些體療機構,必須於15天之內,寫信給FDA,說明他們目前以及將來,對於這些不反應的預防以及治療計畫。這些機構包括:Monarch Medspa, King of Prussia, Pennsylvania; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Maryland; Innovative Directions in Health, Edina, Minnesota; PURE Med Spa, Boca Raton, Florida; and All About You Med Spa, Madison, Indiana.

Adverse events potentially related to injectable lipodissolve products should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch/report.htm, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

注射溶脂針劑而產生各種併發症的案例回報,請聯絡:電話:1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch/report.htm, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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