The recommendation smacked of Solomon. Breast implants have not been proven safe, said the panel. But neither are they clearly harmful. Therefore, the panel suggested that only women with clear medical needs should be automatically eligible for the implants. Women undergoing reconstructive surgery after mastectomies belong to this group; so do those disfigured due to medical trauma or birth defects. All others would take their chances on admission into clinical trial programs. This includes those who want cosmetic breast enlargement, currently perhaps 120,000 American women a year. The FDA commissioner, Dr. David Kessler, will likely make a final decision within 60 days.
The panel reached its conclusion on admittedly insufficient data. Certain problems with implants are acknowledged even by the manufacturers: rupture, gel leakage, inflammation and hardening of surrounding breast tissue. But the committee judged that a possible link between implants and a variety of more serious health conditions, such as arthritis, lupus and scleroderma, needs further study. Meanwhile, the panel said women seeking implants should be given some vital information:
Implants deteriorate as they age and won’t last a lifetime.
All the devices “bleed”-that is, some components of the silicone leak through the enclosing sac.
Estimates of rupture rates vary. Dow Corning, the largest manufacturer of the products, claims that less than 1 percent of implants rupture. The FDA cites figures as high as 14 percent.
Young women with implants need not start their mammograms early, but the procedure should be done by a radiologist experienced with implants.
Because of gaps and loopholes in regulatory laws, breast implants have only recently come under FDA scrutiny. Last month Kessler called for a voluntary moratorium on their use, which will continue until he announces his final regulatory decision sometime in the next two months.
The FDA advises women with implants to watch for symptoms of rupture (pain, swelling, a change in the shape of the breast) or of more serious “autoimmune” diseases (such as arthritis and lupus), in which the body attacks its own tissues. Those symptoms include fever, weakness, joint pain and skin rashes. In the absence of problems, implants don’t need to be removed but should be regularly checked.
Despite reassurances, many women are anxious. Five weeks ago Medic Alert Foundation International of California established a centralized nonprofit registry for women with implants; so far, it has received more than 18,000 calls. The women expressed “anger, stress and frustration” toward the government, the medical community and the media, says company vice president Donald Nichols. Of some 1,200 who enrolled 1,000 reported significant health problems they believed were caused by the devices. Testifying before the FDA panel, Maryland state legislator Joan Pitkin declared: “True informed consent in [early implant] cases did not take place because the information was not there.”
Dow Corning spokesmen last week insisted that their products were safe. But plagued by dozens of lawsuits alleging implant failure, there was also the possibility that Dow would get out of the business altogether. Most insurance companies now cover insertion of postsurgery implants and removal of any devices for medical reasons, but many plan to review their policies when the FDA decision is final.
Breast augmentation and liposuction are the two most popular cosmetic operations in America. If women can’t get silicone-gel implants, they will probably resort to other options. Saline-filled implants are still available, although they produce a less cosmetically desirable result. Implants filled with peanut oil are also being developed. The desire for bigger breasts isn’t easily deflected, but if women are sensible, they will add to their wish list a product that not only makes them feel more attractive but also makes them feel safe.
title: “A Vote Of No Confidence” ShowToc: true date: “2022-12-29” author: “Lynette Bennett”
The recommendation smacked of Solomon. Breast implants have not been proven safe, said the panel. But neither are they clearly harmful. Therefore, the panel suggested that only women with clear medical needs should be automatically eligible for the implants. Women undergoing reconstructive surgery after mastectomies belong to this group; so do those disfigured due to medical trauma or birth defects. All others would take their chances on admission into clinical trial programs. This includes those who want cosmetic breast enlargement, currently perhaps 120,000 American women a year. The FDA commissioner, Dr. David Kessler, will likely make a final decision within 60 days.
The panel reached its conclusion on admittedly insufficient data. Certain problems with implants are acknowledged even by the manufacturers: rupture, gel leakage, inflammation and hardening of surrounding breast tissue. But the committee judged that a possible link between implants and a variety of more serious health conditions, such as arthritis, lupus and scleroderma, needs further study. Meanwhile, the panel said women seeking implants should be given some vital information:
Implants deteriorate as they age and won’t last a lifetime.
All the devices “bleed”-that is, some components of the silicone leak through the enclosing sac.
Estimates of rupture rates vary. Dow Corning, the largest manufacturer of the products, claims that less than 1 percent of implants rupture. The FDA cites figures as high as 14 percent.
Young women with implants need not start their mammograms early, but the procedure should be done by a radiologist experienced with implants.
Because of gaps and loopholes in regulatory laws, breast implants have only recently come under FDA scrutiny. Last month Kessler called for a voluntary moratorium on their use, which will continue until he announces his final regulatory decision sometime in the next two months.
The FDA advises women with implants to watch for symptoms of rupture (pain, swelling, a change in the shape of the breast) or of more serious “autoimmune” diseases (such as arthritis and lupus), in which the body attacks its own tissues. Those symptoms include fever, weakness, joint pain and skin rashes. In the absence of problems, implants don’t need to be removed but should be regularly checked.
Despite reassurances, many women are anxious. Five weeks ago Medic Alert Foundation International of California established a centralized nonprofit registry for women with implants; so far, it has received more than 18,000 calls. The women expressed “anger, stress and frustration” toward the government, the medical community and the media, says company vice president Donald Nichols. Of some 1,200 who enrolled 1,000 reported significant health problems they believed were caused by the devices. Testifying before the FDA panel, Maryland state legislator Joan Pitkin declared: “True informed consent in [early implant] cases did not take place because the information was not there.”
Dow Corning spokesmen last week insisted that their products were safe. But plagued by dozens of lawsuits alleging implant failure, there was also the possibility that Dow would get out of the business altogether. Most insurance companies now cover insertion of postsurgery implants and removal of any devices for medical reasons, but many plan to review their policies when the FDA decision is final.
Breast augmentation and liposuction are the two most popular cosmetic operations in America. If women can’t get silicone-gel implants, they will probably resort to other options. Saline-filled implants are still available, although they produce a less cosmetically desirable result. Implants filled with peanut oil are also being developed. The desire for bigger breasts isn’t easily deflected, but if women are sensible, they will add to their wish list a product that not only makes them feel more attractive but also makes them feel safe.
