Printer Friendly

DOW CORNING WELCOMES FDA REVIEW OF ADDITIONAL INFORMATION CONCERNING SILICONE BREAST IMPLANTS

 DOW CORNING WELCOMES FDA REVIEW OF ADDITIONAL INFORMATION
 CONCERNING SILICONE BREAST IMPLANTS
 MIDLAND, Mich., Dec. 24 /PRNewswire/ -- Dow Corning said today that it is pleased to respond to the requests for additional information made by the U.S. Food and Drug Administration regarding silicone breast implants.
 In Washington today, the FDA began to review various files it requested of Dow Corning that pertain to silicone breast implants.
 "We have an excellent relationship with the FDA, and hope that by providing then with the additional information they request, the debate over silicone breast implants can be based not on innuendo and anecdotal information but true science," said Dan M. Hayes Jr., president and chief executive officer of Dow Corning Wright, the Dow Corning subsidiary that manufactures silicone breast implants.
 "We hope that by providing this additional data, there will be no doubt about our willingness to provide to the agency with those files that they say are necessary for their review of the product," Hayes said.
 The FDA requests for additional information follow the submission to the agency by Dow Corning this past July of more than 30,000 pages of data that comprise the company's Pre-Market Approval Application. At that time, the company took the unprecedented step of releasing its safety data not only to the agency but to the public at large.
 Hayes went on to say that as early as 1988, Dow Corning and Dow Corning Wright invited the FDA to examine its files concerning silicone breast implants.
 "Since the commissioner of the FDA will be ruling on the future availability of silicone breast implants in early January, we hope that the agency's review of our files will lead them to conclude that breast implants should remain widely available to women in this country for augmentation as well as for reconstruction after breast cancer surgery," Hayes said. "This would be consistent with the findings of the FDA Advisory Panel that in November voted to keep breast implants available while additional studies are conducted." Hayes added that he hoped the FDA's review of additional data will affirm the safety and efficacy of silicone breast implants.
 -0- 12/24/91
 /CONTACT: Barbara Carmichael of Dow Corning, 517-496-6470, or 517-631-8072 (home)/ CO: Dow Corning Corporation; Dow Corning Wright ST: Michigan IN: MTC CHM SU:


JG-KK -- DE008 -- 5200 12/24/91 17:03 EST
COPYRIGHT 1991 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1991 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Dec 24, 1991
Words:392
Previous Article:JOCKEYS' GUILD FILES MULTI-MILLION DOLLAR CIVIL ACTION AGAINST NORTH AMERICAN RACETRACKS AND THOROUGHBRED RACING ASSOCIATIONS INC.
Next Article:SALVATION ARMY SERVES CHRISTMAS MEAL SPONSORED BY PIC 'N' SAVE
Topics:


Related Articles
DOW CORNING STRONGLY DISAGREES WITH FDA PANEL FINDING ON SILICONE BREAST IMPLANTS; PROTESTS INABILITY TO PRESENT ALL OF ITS DATA
DOW CORNING AND ITS EMPLOYEES CALL SAN FRANCISCO JURY AWARD REGARDING BREAST IMPLANTS 'OUTRAGEOUS'
DOW CORNING CALLS SID WOLFE CLAIMS '11TH HOUR SHADOWBOXING'
DOW CORNING WILL CONTINUE TO PROVIDE IMPLANT INFORMATION PACKAGE; TEMPORARILY SUSPENDS HOTLINE DISCUSSIONS
DOW CORNING WRIGHT DISAGREES WITH FDA ANNOUNCEMENT; URGES AGENCY TO MOVE REGULATORY PROCESS AWAY FROM POLITICS, BACK TO SCIENCE
DOW CORNING CALLS UPON KESSLER TO IDENTIFY 'NEW INFORMATION' ECHOES ASPRS RECOMMENDATION OF NEW EXPERT PANEL
DOW CORNING GLAD THAT FDA FINALLY IDENTIFIES WHAT CONSTITUTES NEW INFORMATION CONCERNING BREAST IMPLANTS
DOW CORNING RETAINS JUDGE GRIFFIN BELL TO CONDUCT INTERNAL INVESTIGATION OF SILICONE BREAST IMPLANTS
ASAPS STATEMENT ON RELEASE OF STUDIES & INTERNAL DOCUMENTS RELATED TO SILICONE-GEL BREAST IMPLANTS BY DOW CORNING
FIRST AND FINAL ADD TO DOW CORNING BREAST IMPLANTS.

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters