Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: WEDNESDAY, March 4, 1992 TAG: 9203040294 SECTION: EDITORIAL PAGE: A-6 EDITION: METRO SOURCE: DATELINE: LENGTH: Medium
These women assumed the federal government would not allow the implants to be on the market if they were unsafe. What is now clear, however, is that the government relied on studies done by manufacturers that fell woefully short of establishing the implants' safety.
To be sure, the evidence presented recently to a panel advising the Food and Drug Administration neither proves nor disproves that the devices are unsafe. The panel heard it argued both ways - by plastic surgeons, cancer specialists, implant makers and implant users.
It heard that many women - particularly those who have had mastectomies - have a compelling psychological need for the implant surgery, that indeed this plays an important role in their recovery. But it also heard of implants that have ruptured or leaked silicone, causing suffering and debilitating conditions.
In an effort to reconcile concerns about potential dangers and the desires of women who want implants for reconstruction purposes, the panel proposed new limits on implant availability but rejected an outright ban. Breast-cancer patients and women who want to correct breast abnormalities would be able to have the implants as participants in extensive research programs that will help determine the medical risks.
Those who want the implants for cosmetic purposes - a bigger bustline is the motivation for about 80 percent of implant recipients - may not be flat out of luck. But they must apply to doctors who'll be conducting the research programs, and - if they can get in - become part of the medical experiments.
It would have been best if the thorough medical research to evaluate risks had been done before 1 million women got the implants. But since that's now just wishful thinking, the panel's proposed limits on availability sound reasonable enough.
Get on with the studies as soon as possible, under a far more watchful eye of the federal government.
Meanwhile, spare us, please, the complaints about discrimination against women who want to improve on what Mother Nature gave them.
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by CNB