Dr. Weiss?? Anyone know this man??

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Note: forwarded message attached.



FDA testimony of Dr. Weiss: National Endowment for PS

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Comments capitalized and in brackets are mine. Pam=====================================================DR. PAUL WEISS: Good afternoon. My name is Dr. Weiss and I am apracticing plastic surgeon in New York City. I am here representingthe National Endowment for Plastic Surgery and thank you for theopportunity to present today. I have no financial affiliations withthe manufacturer, its product or its direct competitors.As part of my practice of plastic surgery, I perform breast-implantsurgery both for reconstructive and aesthetic indications. I,therefore, derive a portion of my income from this type of surgery. The American Society of Plastic Surgeons is paying my travel expenses.The National Endowment for Plastic Surgery was established in 1994 toprovide an ongoing secure funding source for specialty-based researchprojects. The Endowment was established by and is maintained by thePlastic Surgery Education Foundation, [THE PSEF FUND DID PAY FOR THE1991 FLY-IN TO DC!!!] the research, education, domestic andinternational service arm of the American Society of Plastic Surgeons.The Endowment represents an unprecedented specialtywide cooperativeeffort and is funded solely through voluntary contributions of plasticsurgeons and grateful patients.The National Endowment is very important to organized plastic surgeryand was created to support initiatives that are relevant to theimmediate day-to-day clinical practice of plastic surgery. In 1991and 1992, the manufacturers faced the FDA's call for the PMAs forsilicone-gel-filled breast implants. [THEY FACED IT WITH THE 1991FLY-IN WITH 39 JANE DOES!] The impact of this request created acrisis for implant recipients. From that experience came therealization that, as a specialty, we needed to be much more proactivein our research efforts.With a commitment to our patients, sound science and quality researchdata, organized plastic surgery established the Endowment as aperpetual source of research funding for the specialty. Its missionincludes supporting research directed toward defining the efficacy andsafety of established plastic-surgical procedures, investigatinginnovative technology and plastic surgery, sponsoring researchscholarships and fellowships and charitable programs in plasticsurgery.The review process used by the endowment for awarding research grantsis rigorous. The process and the application form are modeled afterthose of the National Institutes of Health. The grant awards areselected by an expert panel of clinical and scientific researchers,many of whom have served on NIH review panels or are recipients of NIHgrants.While the Endowment is in the early years of awarding researchgrants, I would like to share with you information on the implantresearch funded to date. In 2001 and 2002, the National Endowmentprovided funding to establish and conduct research at the Center forImplant Retrieval and Analysis at Washington University in St. Louis,Missouri, and Bioaesthetic Plastic Surgery Center, also in St. Louis.The emphasis of this study was to determine the modes, causes andrates of implant failure. The study determined and demonstrated thetypes of scientific analyses needed for each type of implantabledevice used by plastic and reconstructive surgeons. The analyses weremacroscopic, microscopic, mechanical, chemical and physical.A significant outcome of this research is that a standardizedprotocol has been developed which gives surgeons a clear approach formanagement of explanted breast implants.Another research project funded by the Endowment is a two-year studythat measured the analysis of physical benefits of breast-reductionsurgery. Plastic surgeons and our patients have faced numerouschallenges in recent years. As a specialty, we are at the forefrontof both reconstructive plastic surgery and aesthetic plastic surgery. Perhaps, most importantly, we are more strongly committed than ever tofacilitating and conduction good research and being more responsive asadvocates for our patients.In conclusion, the studies funded through the National Endowment forPlastic Surgery will provide information that will help determine bestpractices and deliver safe and effective care to plastic-surgerypatients. We are confident that the FDA will review the scientificdata on silicone-gel-filled breast implants and make its decisionsbased on the best interests of patients.Plastic surgeons want safe products for their patients and fullysupport the FDA's ongoing regulatory process for breast implants. Plastic surgeons want good quality research data to drive the clinicaldecision-making.Thank you.DR. McGRATH: May I ask you a question, Dr. Weiss?DR. WEISS: Yes.DR. McGRATH: You said that you founded the Endowment in 1994. Ms.Kim Gandy, this morning, from NOW, made the comment or the statementthat--I believe she said large sums of money have been spent byplastic surgeons to convince patients that implants can be usedsafely.Could you tell us how you have used Endowment moneys, plastic-surgerymoneys, for that purpose, please.DR. WEISS: All of the Endowment funds are used to fund researchprojects and nothing more. There is no advertising or media moneyspent by the Endowment. [FUND IS UNDER THE UMBRELLA OF THE PLASTICSURGERY EDUCATIONAL FUND.]DR. MANNO: Barbara Manno. Doctor, have these studies been publishedin peer-reviewed journals, any of the data?DR. WEISS: The one study on the effects of Betadine in breastimplants has been published but mostly the work that has been doneregarding breast implants has been to establish protocols for theirstudy rather than reaching conclusions at this time.

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