FDA Regulation of Medical Devices, Including the Status of Breast Implants: Joint Hearing Before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, First Session, August 1, 1995 |
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Page 2
... litigation feeding frenzy that now threatens to devour other devices and biomaterials , even those scientifically determined to be safe . In such a litigious environment , let it be clear that we are not here to produce evidence for any ...
... litigation feeding frenzy that now threatens to devour other devices and biomaterials , even those scientifically determined to be safe . In such a litigious environment , let it be clear that we are not here to produce evidence for any ...
Page 12
... litigation that arose from the breast implants scare has forced the Nation's raw materials suppliers to restrict their sales to medical device manufacturers . Recently , DuPont , Dow Chemical and Dow Corning have announced that they ...
... litigation that arose from the breast implants scare has forced the Nation's raw materials suppliers to restrict their sales to medical device manufacturers . Recently , DuPont , Dow Chemical and Dow Corning have announced that they ...
Page 26
... litigation , or any lawsuits for that matter , but for some personal reasons which I will tell you about , I am very interested in the problem of avail- ability of these medical devices . In 10 years of private medical practice , I ...
... litigation , or any lawsuits for that matter , but for some personal reasons which I will tell you about , I am very interested in the problem of avail- ability of these medical devices . In 10 years of private medical practice , I ...
Page 28
... litigation , or any lawsuits for that matter . For personal reasons which I will explain , I am very interested in the problem of availability of medical devices . In ten years of private medical practice I cared for many patients ...
... litigation , or any lawsuits for that matter . For personal reasons which I will explain , I am very interested in the problem of availability of medical devices . In ten years of private medical practice I cared for many patients ...
Page 35
... litigation . Editor's note : This disclosure statement is in accord with our usual policy but is somewhat more detailed because of the intense public controversy over the health effects of breast implants . known type ) . The mean ( SD ) ...
... litigation . Editor's note : This disclosure statement is in accord with our usual policy but is somewhat more detailed because of the intense public controversy over the health effects of breast implants . known type ) . The mean ( SD ) ...
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Common terms and phrases
advisory agency answer approval autoimmune disease BARRETT believe biomaterials breast augmentation breast cancer breast reconstruction BURLINGTON Chairman clinical cohort committee companies concern CONG CONGRE CONGRESS THE LIBRARY Congressman connective tissue disease connective-tissue disease cosmetic developed documents Dow Corning Drug elastomers evaluation evidence fact FDA's Ganske going GUTKNECHT HAZLETON hearing hydrocephalus implant patients industry issue KESSLER LIBRARY OF CONGRESS litigation look lymphocyte manufacturers MCINTOSH medical devices MERKATZ moratorium MORELLA panel percent plants plastic polyester polyethylene polyurethane polyvinylchloride prepared statement problem PTFE public health question Ransom reconstruction regulatory reported rheumatoid arthritis Rheumatology Russano scientific scleroderma SHANKLIN SHAYS shunt sili silica silicon dioxide silicone breast implants silicone gel silicone gel breast silicone gel implants silicone implants specific subcommittee surgeons surgery symptoms Tara testimony tests Thank tion Traficant women with breast women with implants
Popular passages
Page 92 - Thank you very much. I yield back my time, Mr. Chairman. Mr.
Page 95 - ... (B)(i) The Secretary may not enter into an agreement to extend the period in which to take action with respect to an application submitted for a device subject to a regulation promulgated under subsection (b) unless he finds that the continued availability of the device is necessary for the public health. (ii) An order approving an application for a device may require as a condition to such approval that the sale and distribution of the device be restricted but only to the extent that the sale...
Page 34 - Massachusetts Medical Society Registry on Continuing Medical Education To obtain information on continuing medical education courses in the New England area, call between 9:00 am and 12:00 noon, Monday through Friday, (617) 893-4610 or in Massachusetts 1-800-322-2303, ext. 1342.
Page 9 - Chairman, for this hearing, and look forward to hearing the testimony of the witnesses.
Page 2 - I ask unanimous consent that all members of the subcommittee be permitted to place an opening statement in the record and the record remain open for 3 days for that purpose.
Page 131 - J, Colditz GA, Karlson EW et al. Silicone breast implants and the risk of connective-tissue diseases and symptoms.
Page 1 - The subcommittee met, pursuant to notice, at 10 am, in room 2247, Rayburn House Office Building, Hon. Christopher Shays (chairman of the subcommittee) presiding. Present: Representatives Shays, Pappas, Towns, and Kucinich.
Page 170 - Corning have had the vision to innovate new products and materials that sometimes make the difference between life and death for hundreds of thousands of people.
Page 28 - I yield back my time. [The prepared statement of Hon. Greg Ganske follows:] PREPARED STATEMENT OF HON. GREG GANSKE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF IOWA Thank you, Mr. Chairman. I want to join my colleagues in expressing my appreciation for your leadership in addressing the issue of FDA Reform.