Printer Friendly

FDA CALLS FOR A UNITED STATES MORATORIUM ON SILICONE GEL-FILLED BREAST IMPLANTS

 FDA CALLS FOR A UNITED STATES MORATORIUM ON
 SILICONE GEL-FILLED BREAST IMPLANTS
 ST. PAUL, Minn., Jan. 6 /PRNewswire/ -- Bioplasty, Inc. (NASDAQ: BIOP) announced today that it was genuinely disappointed that the Food and Drug Administration (FDA) rejected the recommendation of its own Advisory Panel. On Nov. 14, 1991, the Panel recommended to the FDA that silicone gel-filled breast implants should remain on the market in the United States citing a public health need.
 Bioplasty's CEO, Arthur A. Beisang, stated that the moratorium decision by the FDA is likely to cause unnecessary confusion and apprehension among the two million women who have received silicone gel-filled implants. Beisang further stated that the company will comply with the moratorium called by the FDA on silicone gel-filled breast implants.
 The FDA stated the reason for calling for the moratorium was to allow the Advisory Panel to review new safety data. The FDA has collected information from selected rheumatologist to review the possible links between silicone gel and connective tissue diseases. This information has been characterized as non-scientific, statistically non-significant and non-peer reviewed. Additional new information has surfaced relating to silicone gel-filled implants manufactured prior to 1985. Bioplasty did not start manufacturing and marketing breast implants until 1988.
 Although Bioplasty is genuinely disappointed with the ruling, this decision does not eliminate continued commercial availability of silicone gel-filled breast implants outside the United States. The majority of the company's current revenues occur outside the United States. If the moratorium on silicone gel-filled breast implants were made permanent, it would have a significant negative impact on the profitability of the company.
 Bioplasty has developed and recently received a patent on a breast implant with an alternative non-silicone filling material named MISTI GOLD(TM) Bio-Oncotic(TM) Gel. The company will re-enter clinical trials with this breast implant as soon as possible. Bioplasty is diligently working to obtain full market approval for the MISTI GOLD Bio-Oncotic Gel Prosthesis.
 Bioplasty, Inc. has more than twenty years of experience in the development, manufacturing and marketing of plastic surgery products worldwide. Bioplasty's stock is currently traded on the NASDAQ National Market System under the symbol "BIOP."
 -0- 1/06/92
 /CONTACT: Arthur A. Beisang, CEO, or Timothy P. Lawin, president, 612-636-4112, both of Bioplasty/
 (BIOP) CO: Bioplasty, Inc. ST: Minnesota IN: MTC SU:


AL -- MN010 -- 7007 01/06/92 15:32 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 6, 1992
Words:390
Previous Article:MINNESOTA TECHNOLOGY SUBMITS TECHNOLOGY POLICY RECOMMENDATIONS TO GOVERNOR, LEGISLATURE
Next Article:DELTA AIR LINES REPORTS DECEMBER TRAFFIC
Topics:


Related Articles
FDA PANEL RECOMMENDS SILICONE BREAST IMPLANTS REMAIN ON THE MARKET
SILICONE BREAST IMPLANTS: THE FDA BANS THEIR USE. NOW WHAT?
FDA CALLS FOR TEMPORARY MORATORIUM ON SILICONE GEL BREAST IMPLANTS
PLASTIC SURGEONS PLEDGE COOPERATION WITH IMPLANT MORATORIUM; DEMAND RELEASE OF NEW INFORMATION
CALIFORNIA PLASTIC SURGEON LAUDS UNITED KINGDOM DOCTOR'S STANCE ON BREAST IMPLANTS
AESTHETIC PLASTIC SURGEONS SAY FDA PANEL RECOMMENDATIONS WILL LEAVE WOMEN CONFUSED AND CONCERNED
AESTHETIC PLASTIC SURGEONS SAY FDA DECISION ON SILICONE GEL IMPLANTS IS 'TOO LITTLE, TOO LATE'
SALINE BREAST IMPLANTS -- CALL FOR DATA
FDA ANNOUNCES MEDICAL DEVICE TRACKING REQUIREMENTS
WOMEN'S IMPLANT INFORMATION NETWORKHAILS LIFTING OF FRENCH MORATORIUM ON SILICONE GEL IMPLANTS

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