Printer Friendly

PLASTIC SURGEONS DISAPPOINTED IN FDA PANEL'S RECOMMENDATION TO RESTRICT IMPLANT ACCESS; CLAIM DECISION CONTRADICTS HEARING DISCUSSION

PLASTIC SURGEONS DISAPPOINTED IN FDA PANEL'S RECOMMENDATION TO RESTRICT
 IMPLANT ACCESS; CLAIM DECISION CONTRADICTS HEARING DISCUSSION
 BETHESDA, Md., Feb. 21 /PRNewswire/ -- While it is relieved that the Food and Drug Administration's advisory panel has recommended preservation of women's access to silicone-gel implants for breast reconstruction, the American Society of Plastic and Reconstructive Surgeons (ASPRS) is disappointed that the group chose to discriminate against the more than 100,000 individuals who seek the devices for other reasons that are often equally important to their self-image.
 Further, restricting access to the implants to specific research studies would likely label gel filled devices as 'experimental' in the eyes of insurers, depriving many women of coverage for what most believe to be the preferred form of breast reconstruction. Insurance coverage would also be threatened for any woman with an implant who develops breast disease -- regardless of whether it is related to the device.
 "The panel's recommendation to restrict use of gel implants to limited research studies for augmentation, and to a broader protocol for reconstruction, does not reflect the scientific conclusions that emerged during the hearing," ASPRS President Norman Cole, MD, said Thursday. "If Commissioner (David) Kessler 'rubber stamps' this proposal, a large group of patients will be deprived of a very important right to make their own health care decisions -- forcing them to choose what for many women is a less-than-ideal alternative.
 Although saline-filled breast implants would continue to remain available -- at least for now -- many plastic surgeons and their patients have found that they produce less-than-satisfactory results, particularly in women who have little natural breast tissue.
 Cole noted that the panel's recommendation seems particularly illogical when contrasted with the discussion of advice for patients, which took place among the group's expert consultants just hours before.
 "The majority of the FDA's hand-picked experts concluded from all of the testimony presented during the previous two days that there is absolutely no clear link between silicone-gel, breast implants and any serious health risks," Cole said. "Plastic surgeons agree that more research is needed to settle the theoretical speculation on the potential risks. We wholeheartedly support the plan to establish a registry for patient tracking, and to standardize disclosure to patients. However, this need for more information does not warrant an action that would deprive many women of the right to choose silicone-gel breast implants. We urge Commissioner Kessler to review the testimony carefully, and to seek additional expert advice, before making a final ruling."
 -0- 2/21/92
 /CONTACT: Pam Rasmussen or Anne Gorman, 708/228-9900, of Porter/Novelli Omnicom PR Network for ASPRS/ CO: American Society of Plastic and Reconstructive Surgeons ST: Maryland IN: HEA SU: SM -- NY036 -- 1400 02/21/92 12:54 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:Feb 21, 1992
Words:451
Previous Article:VETERANS' COMMITTEE REJECTS ADMINISTRATION BUDGET; ADDS $2.3 BILLION TO IMPROVE AILING SERVICES, BRACE FOR MILITARY DRAWDOWN
Next Article:TOTAL SYSTEM SERVICES ANNOUNCES REORGANIZATION
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
PLASTIC SURGEONS PLEDGE COOPERATION WITH IMPLANT MORATORIUM; DEMAND RELEASE OF NEW INFORMATION
CALIFORNIA PLASTIC SURGEONS TAKE SECOND LOOK AT FDA ACTION REGARDING SILICONE GEL BREAST IMPLANTS
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
FDA ANNOUNCES SILICONE BREAST IMPLANT DECISION
AESTHETIC PLASTIC SURGEONS SAY FDA DECISION ON SILICONE GEL IMPLANTS IS 'TOO LITTLE, TOO LATE'

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