ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Tuesday, December 17, 1996 TAG: 9612170026
SECTION: EDITORIAL PAGE: A-7 EDITION: METRO
SOURCE: SUE MYRICK
WHEN ROSEMARY Locke visited her doctor at the national Naval Medical Center in Bethesda, Md., 11 years ago, she received the news no woman wants to hear. Her doctor had found a cancerous lump in her breast, and there was a chance the cancer would spread.
Like the more than 182,000 American women who are diagnosed with breast cancer each year, Rosemary's life became a nightmare. Although her cancer was in the beginning stages, her options were still bleak.
Doctors explained that she faced two choices: a lumpectomy (removal of the lump itself) or a mastectomy (removal of the entire breast). While a lumpectomy would be less disfiguring, her chances of stopping the cancer from spreading would improve significantly with a mastectomy.
If Rosemary agreed to the mastectomy, her doctors would use a silicone breast implant to restore her figure and help prevent any back or shoulder pain she might suffer from the lopsided effect of a missing breast. While no operation could erase the pain and fear Rosemary had suffered, implant surgery could help her psychologically by ensuring that a deformity would not be a constant, daily reminder of her ordeal.
Rosemary, like many other breast-cancer patients facing these difficult decisions, agonized for days. She concluded that she wanted to make sure all the cancer was removed and that her figure was as fully restored as possible. For these reasons, she chose to have a double mastectomy, have the silicone implants inserted and move forward with her life.
Unfortunately, today's breast-cancer survivors do not have the same choices when it comes to reconstructive surgery. When they choose mastectomies, silicone breast implants no longer are an option except as part of restricted clinical trials.
In 1992, soon after Rosemary's reconstructive surgery, the U.S. Food and Drug Administration imposed a moratorium on silicone breast-implants on the grounds that the devices never had received adequate safety tests.
When a blue-ribbon investigative panel convened by the FDA recommended that the moratorium be lifted, FDA Commissioner David Kessler ignored the recommendation and continued the ban until studies could show conclusively that silicone breast-implants were safe.
Now, four years later, the evidence is in - and it is overwhelming. No less than 17 epidemiological studies conducted on the side effects of silicone breast implants by such prestigious institutions as Harvard, Johns Hopkins, the Mayo Clinic and the University of Michigan have found no link between silicone-gel implants and a wide variety of diseases. Despite those remarkable clean bills of health, the FDA still refuses to allow female breast-cancer victims the option of rebuilding their bodies, their morale - and their lives - with silicone breast implants.
Although I am not a breast-cancer victim, it is beyond my comprehension why breast-cancer survivors should be denied the choice of safe, effective reconstructive surgery. After battling a deadly disease and winning, any human should be free to erase the scars to the fullest extent possible. Why should breast-cancer survivors be any different?
Each year that the FDA's discriminatory ban on silicone breast-implants remains in place, some 91,000 American women with recent mastectomies will be denied the very product that could reconstruct a missing breast and allow them to resume near-normal lives.
By continuing to restrict access to silicone breast-implants, the FDA is allowing trial lawyers to raise false questions about the safety of thousands of other vital medical devices containing silicone. The fear of class-action lawsuits already has forced two major silicone manufacturers to cease production. Smaller companies that have been on the cutting edge of medical device technology say silicone shortages now threaten their businesses.
The negative effect on ailing Americans could reach epidemic proportions in a very short time. Each year in the United States alone there are:
* More than 75,000 babies, children and adults who depend on silicone brain shunts to relieve the debilitating condition known as water on the brain.
* More than 600,000 people who receive artificial limbs, hip joints and other arthoplasty devices fashioned from silicone.
* More than 175,000 people whose hearts continue to beat because of silicone pacemakers and/or heart valves.
As President Clinton ponders a replacement for Kessler at the FDA, I urge him to remember not just the breast cancer survivors, but the millions of other Americans whose access to vital silicone medical-implants is now threatened by the avalanche of baseless lawsuits.
The next FDA commissioner should be someone who fully understands that public-health decisions must always be based on the proof of scientific evidence rather than the wishes of a handful of trial lawyers.
If Clinton chooses wisely, millions of Americans currently at risk will be assured access to implantable medical devices that save lives and enhance living. That, in itself, would be a major and remarkable move toward health reform!
Sue Myrick, former mayor of Charlotte, N.C., is a Republican member of the U.S. House of Representatives.
- Knight-Ridder/Tribune
LENGTH: Medium: 92 linesby CNB