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FDA panel advises restricting breast implants

A Food and Drug Administration panel has recommended restricting silicone gel implants for women seeking breast enlargement for cosmetic reasons. The panel said women needing implants for breast reconstruction would still be able to get them.

If the FDA follows its panel's advice, implants would be allowed only for women who have lost a breast to cancer or have a breast deformity, or for women in tightly controlled clinical trials. Those women currently account for about 20 percent of U.S. women with breast implants.

About 80 percent of U.S. women with breast implants got them for cosmetic reasons, to enlarge their breasts.

Nancy Dubler, a lawyer and one of nine voting members of the 24-person FDA panel, said the recommendation of restrictions "responds to science on the one hand and compassion on the other."

The panel, after three days of hearings, recommended more studies be done on the implants and on the possible effects of the silicone gel on living tissue.

While the recommendations are not binding on the FDA, the agency usually follows the recommendations of such committees. The FDA plans to issue its final decision by April 20.

Dr. Jules Harris, a voting member, said the evidence he has seen this week did not "provide the basis to conclude that silicone gel breast implants are safe and effective."

"I do not find this evidence convincing but it is disturbing," Harris said.

Through their questions and statements over the course of the hearings, the members indicated more sympathy for women needing breast reconstruction than for those who just wanted bigger breasts.

But Dr. Mary McGrath, a non-voting member and a professor of plastic surgery at George Washington University, complained that drawing that kind of distinction was "judgmental and paternalistic."

However, Rita Freedman, a voting member, said women should not jeopardize their health for vanity.

"A woman without breasts is a total woman just as a man who has gone bald and is without hair is a total man," Freedman said.

Earlier, the group's chairman said members did not have the evidence to conclude that leaks from the implants are linked to health problems such as cancer and autoimmune disease.

"We have a possible association, and we need more research," said Dr. Elizabeth Connell, the chairman and a medical school professor.

A majority of panel members agreed there may be a tie between silicone and the development of scleroderma _ a painful tightening and thickening of the skin _ and severe joint and muscle pain.

One who disagreed, Dr. John Sergent, chief of medicine at St. Thomas Hospital in Nashville, Tenn., said, "There is no data implicating any defined or undefined systemic rheumatoid disease with breast implants."

The panel also:

Decided implants should not be relied upon for a lifetime and said women who have them, especially young women, should be prepared for the possibility that the devices may have to be replaced.

The committee did not come up with an expectable lifetime for the implants but urged women to consult their physicians.

Recommended that implant patients with no symptoms of problems not begin having routine mammograms before they normally would, often around the age of 35. The committee said the dangers from repeated radiation outweighed the known risks of the implants.

Urged that women having mammograms seek out centers where radiologists are trained to do the procedure on patients with implants.

Most of the committee members are doctors, who have complained throughout the hearings that most of the material presented to them has been anecdotal rather than scientific.

When they weren't blinking into the bright lights of television cameras, the experts were sitting in the dark, looking at slides. Some were gruesome, showing misshapen breasts, hands and feet mangled by arthritis-like symptoms, and silicone oozing from surgical incisions or open sores.

Doctors treating patients shown on the slides told the panel that they suspected the implants as the cause of the trouble and that, in some cases, when the devices were removed the problems either went away or stabilized.

But the committee also heard the four makers of the devices say their studies did not definitively deal with such questions.

The debate has been a public relations nightmare for the four U.S. manufacturers, especially Dow Corning. Last week, the company complied with an FDA demand to release internal documents that showed a 30-year history of complaints and doubts about the devices' safety and reliability.

Asked Thursday if the company was getting ready to sell its implant business, Robert T. Rylee, chairman of Dow Corning's health care businesses, said:

"That may be an appropriate thing for us to do."

The decision, he said, will be made "fairly soon."

The other three companies that sell implants _ Inamed Corp's McGhan Medical unit, Mentor Corp, and Bioplasty Inc. _ have applied for permission to continue selling the implants, as has Dow Corning.

Manufacturers and surgeons have been honoring the FDA's Jan. 7 request not to implant any more of the devices until the questions over their safety are settled.

_ Information from the Associated Press and Reuters was used in this report.

What the panel decided

Here, at a glance, is what an advisory committee decided Thursday on the issue of silicone gel breast implants. The panel advises the Food and Drug Administration, which plans to issue a final decision within 60 days.

COSMETIC SURGERY: The panel recommended that surgery for purely cosmetic reasons be allowed only under strict controls for the sake of clinical trials. Those controls haven't been written yet.

RECONSTRUCTIVE SURGERY: The committee said women who have had a breast removed because of cancer should be able to use silicone gel implants for reconstructive surgery. The same goes for women who have breasts that are deformed or damaged by accident.

HEALTH CONCERN: The panel said it is concerned about possible adverse health effects of silicone gel breast implants, but it could not determine whether the devices actually caused any of those problems. Testimony before the committee indicated that the silicone gel may be responsible for autoimmune disease and cancer. Much of that evidence was anecdotal, and studies given to the committee said no firm cause-and-effect relationship could be established.

MAMMOGRAMS: The committee said young women with the implants but who have no symptoms of problems should not seek routine mammograms to determine whether their implants are leaking. The panel said the risk from increased exposure to radiation outweighed the possible benefit of finding a leaky implant. However, women who should be getting routine screening anyway for cancer, those age 35 and over, should get the mammograms but only at a center where the technicians are trained to deal with breast implants.


How breast implants are done

The implant is a flexible envelope filled with silicone gel, a saline solution or a combination of both. The surgery for this procedure may be performed in a surgeon's office, in an outpatient surgical center or in a hospital. The cost is estimated at $2,000 to $3,000 or more.

1. Incision site is chosen

Most commonly the surgeon makes the incision in one of three places:

Where the breast meets the chest.

On the lower border of the areola, the dark area surrounding the nipple.

Or in the armpit.

The anesthetic used may be general or a local in combination with a sedative.

2. Implant position is chosen

The surgeon creates a pocket for the implant either directly under the breast tissue (above left) or under the chest wall muscle (above right). This placement depends on the technique used and the patient's anatomy.

3. Finishing the procedure

After surgery, which lasts about two hours, the incisions are closed with a few sutures. A dressing may be applied or the patient may be placed in a surgical bra. Pain, controlled by medication, subsides in a day or two. The sutures are removed within a week of surgery. Scars in most cases fade gradually, becoming barely noticeable.