Re: Dr. Weiss?? Anyone know this man??

[Guest guest]

Not I - never heard of him.

>

> Note: forwarded message attached.

>

> Support Information - FDA testimony of Dr. Weiss: National Endowment for

PS

> FDA testimony of Dr. Weiss: National Endowment for

PS

>

> Guest

>

>

>

>

> Comments capitalized and in brackets are mine. Pam

>

=====================================================

>

> DR. PAUL WEISS: Good afternoon. My name is Dr. Weiss and I am a

> practicing plastic surgeon in New York City. I am here representing

> the National Endowment for Plastic Surgery and thank you for the

> opportunity to present today. I have no financial affiliations with

> the manufacturer, its product or its direct competitors.

> As part of my practice of plastic surgery, I perform breast-implant

> surgery 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 to

> provide an ongoing secure funding source for specialty-based research

> projects. The Endowment was established by and is maintained by the

> Plastic Surgery Education Foundation, [THE PSEF FUND DID PAY FOR THE

> 1991 FLY-IN TO DC!!!] the research, education, domestic and

> international service arm of the American Society of Plastic Surgeons.

> The Endowment represents an unprecedented specialtywide cooperative

> effort and is funded solely through voluntary contributions of plastic

> surgeons and grateful patients.

> The National Endowment is very important to organized plastic surgery

> and was created to support initiatives that are relevant to the

> immediate day-to-day clinical practice of plastic surgery. In 1991

> and 1992, the manufacturers faced the FDA's call for the PMAs for

> silicone-gel-filled breast implants. [THEY FACED IT WITH THE 1991

> FLY-IN WITH 39 JANE DOES!] The impact of this request created a

> crisis for implant recipients. From that experience came the

> realization that, as a specialty, we needed to be much more proactive

> in our research efforts.

> With a commitment to our patients, sound science and quality research

> data, organized plastic surgery established the Endowment as a

> perpetual source of research funding for the specialty. Its mission

> includes supporting research directed toward defining the efficacy and

> safety of established plastic-surgical procedures, investigating

> innovative technology and plastic surgery, sponsoring research

> scholarships and fellowships and charitable programs in plastic

> surgery.

> The review process used by the endowment for awarding research grants

> is rigorous. The process and the application form are modeled after

> those of the National Institutes of Health. The grant awards are

> selected by an expert panel of clinical and scientific researchers,

> many of whom have served on NIH review panels or are recipients of NIH

> grants.

> While the Endowment is in the early years of awarding research

> grants, I would like to share with you information on the implant

> research funded to date. In 2001 and 2002, the National Endowment

> provided funding to establish and conduct research at the Center for

> Implant 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 and

> rates of implant failure. The study determined and demonstrated the

> types of scientific analyses needed for each type of implantable

> device used by plastic and reconstructive surgeons. The analyses were

> macroscopic, microscopic, mechanical, chemical and physical.

> A significant outcome of this research is that a standardized

> protocol has been developed which gives surgeons a clear approach for

> management of explanted breast implants.

> Another research project funded by the Endowment is a two-year study

> that measured the analysis of physical benefits of breast-reduction

> surgery. Plastic surgeons and our patients have faced numerous

> challenges in recent years. As a specialty, we are at the forefront

> of both reconstructive plastic surgery and aesthetic plastic surgery.

> Perhaps, most importantly, we are more strongly committed than ever to

> facilitating and conduction good research and being more responsive as

> advocates for our patients.

> In conclusion, the studies funded through the National Endowment for

> Plastic Surgery will provide information that will help determine best

> practices and deliver safe and effective care to plastic-surgery

> patients. We are confident that the FDA will review the scientific

> data on silicone-gel-filled breast implants and make its decisions

> based on the best interests of patients.

> Plastic surgeons want safe products for their patients and fully

> support the FDA's ongoing regulatory process for breast implants.

> Plastic surgeons want good quality research data to drive the clinical

> decision-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 statement

> that--I believe she said large sums of money have been spent by

> plastic surgeons to convince patients that implants can be used

> safely.

> Could you tell us how you have used Endowment moneys, plastic-surgery

> moneys, for that purpose, please.

> DR. WEISS: All of the Endowment funds are used to fund research

> projects and nothing more. There is no advertising or media money

> spent by the Endowment. [FUND IS UNDER THE UMBRELLA OF THE PLASTIC

> SURGERY EDUCATIONAL FUND.]

> DR. MANNO: Barbara Manno. Doctor, have these studies been published

> in peer-reviewed journals, any of the data?

> DR. WEISS: The one study on the effects of Betadine in breast

> implants has been published but mostly the work that has been done

> regarding breast implants has been to establish protocols for their

> study rather than reaching conclusions at this time.

>

>

>

>

>

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[Guest guest]

Ah. THere is another Dr. Weiss. He is Dr. Weiss in Palm Bay, Florida, but

he is a

neurologist. He is very good.

> Thank you for posting this, Molly I thought that you had mentioned a Dr.

> Weiss. We had discussed that Ted Weiss might have been taken out. Could

> there be another Dr. Weiss?? I do tend to get things wrong though.

>

> Love to all...Lea

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``````

> Dr. Weiss?? Anyone know this man??

>

>

> >

> > Note: forwarded message attached.

> >

> >

> >

> > Opinions expressed are NOT meant to take the place of advice given by

> > licensed health care professionals. Consult your physician or licensed

> > health care professional before commencing any medical treatment.

> >

> > " Do not let either the medical authorities or the politicians mislead you.

> > Find out what the facts are, and make your own decisions about how to live

> > a happy life and how to work for a better world. " - Linus ing,

> > two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

> >

> >

[Guest guest]

So do I .... that's our excuse & we're sticking to it? Seriously, I don't know

if I mentioned

he was a neurologist or not.

> >> Thank you for posting this, Molly I thought that you had mentioned a Dr.

> >> Weiss. We had discussed that Ted Weiss might have been taken out. Could

> >> there be another Dr. Weiss?? I do tend to get things wrong though.

> >>

> >> Love to all...Lea

> >> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``````

> >> Dr. Weiss?? Anyone know this man??

> >>

> >>

> >> >

> >> > Note: forwarded message attached.

> >> >

> >> >

> >> >

> >> > Opinions expressed are NOT meant to take the place of advice given by

> >> > licensed health care professionals. Consult your physician or licensed

> >> > health care professional before commencing any medical treatment.

> >> >

> >> > " Do not let either the medical authorities or the politicians mislead

> >> > you.

> >> > Find out what the facts are, and make your own decisions about how to

> >> > live

> >> > a happy life and how to work for a better world. " - Linus ing,

> >> > two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

> >> >

> >> >