Printer Friendly

SALINE BREAST IMPLANTS -- CALL FOR DATA

 WASHINGTON, Jan. 5 /PRNewswire/ -- The Food and Drug Administration (FDA) today announced a proposal that manufacturers of saline breast implants be required to submit evidence of their safety and effectiveness to keep them on the market.
 Saline breast implants designed for augmentation or reconstruction have been on the market for about 20 years. Introduced as an alternative to silicone gel implants, they have been used by about 10 percent of the 1 million women estimated to have breast implants. These implants are made using silicone rubber shells inflated to the desired size with sterile saline solution (salt water) before or after implantation surgery.
 "We are proposing that manufacturers collect and present all relevant data in support of the safety and efficacy of these implants," said FDA Commissioner David A. Kessler, M.D. "In the meantime, women should carefully read the patient information sheets that accompany the implants and discuss the risks with their doctors before undergoing implant surgery."
 Among the issues to be addressed by manufacturers are infection, capsular contracture and interference with mammography. The implants can also rupture and rapidly deflate, requiring further surgery. FDA has received numerous reports of rupture, leakage and deflation associated with saline implants.
 FDA is relying on physicians to provide patients with the manufacturers' information sheets on the known risks and unanswered questions concerning breast implants so that women who are considering implant surgery can weigh their risks and benefits.
 These devices were on the market prior to the Medical Device Amendments of 1976, which gave FDA regulatory authority over devices. Like other pre-amendments devices, saline implants were allowed, under the law, to remain on the market with the understanding that FDA would later require manufacturers to demonstrate their safety and effectiveness.
 Although the safety and effectiveness of the saline implants have not been proven, leakage or rupture would release only salt water, which is not thought to be harmful. Nevertheless, like silicone gel- filled implants, saline implants have a silicone rubber envelope and therefore may not be entirely without risk. Although scientific evidence is not available to establish a risk of immune-related diseases or cancer related to the silicone envelope of saline implants, these dangers cannot be ruled out.
 In 1991, FDA published regulations requiring manufacturers to submit safety and effectiveness data for silicone gel-filled breast implants. These implants are still under study to answer questions about the effects of silicone gel in the body due to gel bleed, rupture and migration of the gel.
 When today's proposal becomes final, manufacturers planning to continue the marketing of the saline implants will be required to submit Premarket Approval Applications demonstrating the safety and effectiveness of these devices as a condition of keeping them on the market.
 The proposal, which will be published in the Jan. 8, 1993, Federal Register, provides for a 60-day comment period. Comments may be submitted to Dockets Management Branch, HFA-305, Rm 1-23, 12420 Parklawn Drive, Rockville, Md. 20857.
 -0- 1/5/93
 /NOTE: TV broadcasters, please use open caption for the hearing impaired./
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-3285 or, after hours, 301-926-7081/


CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:

MH -- DC019 -- 1956 01/05/93 18:11 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 5, 1993
Words:538
Previous Article:EDMISTEN GETS SETTLEMENT FROM SALOMON BROTHERS TO HELP FUND NATIONAL AWARENESS PROGRAM
Next Article:NORTHWEST AIRLINES WOULD NEED APPROVAL FROM UNION WORKERS FOR MAJOR BUSINESS DECISIONS UNDER PROPOSED BAIL-OUT DEAL
Topics:


Related Articles
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
MENTOR CORP. OFFERS SALINE-FILLED BREAST IMPLANTS AS ALTERNATIVE TO SILICONE
MENTOR CORP. OFFERS SALINE-FILLED BREAST IMPLANTS AS ALTERNATIVE TO SILICONE
FDA COMMISSIONER ISSUES STATEMENT ON SALINE BREAST IMPLANTS
FDA PROPOSES CALLING FOR DATA ON TESTICULAR IMPLANTS
PLASTIC SURGEONS' SOCIETY TO TELL FDA WHAT IT KNOWS ABOUT SALINE IMPLANTS
Saline Breast Implants.
FDA panel conditionally backs silicone implants: breast augmentation and reconstruction.

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