Printer Friendly

FDA AUTHORIZES USE OF McGHAN BIODIMENSIONAL BREAST IMPLANTS UNDER URGENT NEED EXEMPTION

 FDA AUTHORIZES USE OF McGHAN BIODIMENSIONAL BREAST IMPLANTS
 UNDER URGENT NEED EXEMPTION
 SANTA BARBARA, Calif., Oct. 29 /PRNewswire/ -- INAMED Corp. (NASDAQ: IMDC), headquartered in Santa Barbara, today reported that the Food and Drug Administration (FDA) has authorized limited distribution of the Style 153 BioCell(R) Anatomical Reconstructive silicone gel-filled breast implant (BioDimensional(TM)) manufactured by its McGhan Medical Corp. subsidiary. The implant is used to replace McGhan's temporary tissue expander when reconstruction is accomplished through a two-step procedure following mastectomy.
 This agreement is an interim measure, taken under the urgent need provisions of FDA's April 16, 1992, policy on silicone gel-filled breast implants.
 McGhan may distribute the BioDimensional Style 153 under the following conditions:
 -- McGhan may distribute only existing stock of the BioDimensional Style 153;
 -- The BioDimensional Style may be used only by women who have McGhan temporary tissue expanders in place and whose physicians have determined that they cannot have satisfactory reconstruction with any other implant;
 -- All devices will undergo additional inspection and testing before distribution; and
 -- All patients must be informed as to the special circumstances of the distribution and the detailed informed consent form.
 Because of the limited number of implants available at this time, it is McGhan's responsibility to work with physicians and patients to assure a fair, priority-based allocation system. This system will assign highest priority to patients with the greatest need, taking into consideration those who have had tissue expanders in place the longest. Distribution of the implants is expected to begin in mid- November.
 The urgent need exemption will apply until the current limited supply of BioDimensional Style 153 implants has been exhausted. McGhan does not warrant that there will be sufficient supply of the BioDimensional Style 153 to cover all known or unknown patients needs.
 McGhan will continue to work with the FDA to bring its manufacturing process into compliance with Good Manufacturing Practices (GMPs) so that production of implants may resume in the future.
 Physicians who implant gel-filled devices under the urgent need provision are required to use a special consent form approved for this purpose, certify on the consent form that the patient meets the criteria for urgent need patients as defined above, and notify the manufacturer of all devices implanted and provide information needed for a patient registry.
 The company must maintain records of the number of devices used under the urgent need provision and the names and addresses of the physicians who implanted the devices under this provision. These records will be made available to the FDA upon request. In addition, information on the patient will be entered into the breast implant registry when it becomes available.
 INAMED Corp. is a medical device company with 14 operating subsidiaries in the United States and Europe. The company develops, manufactures and markets medical devices for the plastic and reconstructive, bariatric and general surgery markets. The company reported sales of more than $42.2 million for calendar/fiscal 1991.
 -0- 10/29/92
 /CONTACT: Michael D. Farney, CEO of INAMED, 702-791-3388; or Jimmy Caplan of Market Makers, 805-569-0076, for INAMED/
 (IMDC) CO: INAMED Corp.; McGhan Medical Corp. ST: California IN: MTC SU: PDT


JB-KJ -- LA003 -- 6419 10/29/92 09:05 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:Oct 29, 1992
Words:531
Previous Article:ALBARA ANNOUNCES PROPOSED PUBLIC OFFERING
Next Article:BELL ATLANTIC TEAMS WITH GANDALF AND SUN MICROSYSTEMS ON ISDN APPLICATIONS FOR COLLEGES AND UNIVERSITIES
Topics:


Related Articles
FDA PANEL RECOMMENDS 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
FDA CALLS FOR A UNITED STATES MORATORIUM ON SILICONE GEL-FILLED BREAST IMPLANTS
AESTHETIC PLASTIC SURGEONS SAY FDA PANEL RECOMMENDATIONS WILL LEAVE WOMEN CONFUSED AND CONCERNED
FDA ANNOUNCES SILICONE BREAST IMPLANT DECISION
AESTHETIC PLASTIC SURGEONS SAY FDA DECISION ON SILICONE GEL IMPLANTS IS 'TOO LITTLE, TOO LATE'
SALINE BREAST IMPLANTS -- CALL FOR DATA
FDA Refuses to Put More Silicone Breast Implants on the Market
Saline Breast Implants.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters