CTV.ca News Staff

A U.S. Food and Drug Administration advisory panel recommended silicone-gel breast implants return to the market, one day after the same advisers rejected the application of a rival manufacturer.

The advisers voted 7 to 2 to lift the 13-year-old partial ban on Mentor Corp.'s silicone-gel breast implants -- but only if the company follows strict guidelines.

In recent years only women who had mastectomies and some who took part in clinical trials were allowed to have the silicone implants.

On Wednesday, the panel outlined a list of conditions that Mentor Corp. must adhere to if the implants can go back on the market for wider use.

The conditions include:

* making sure women know how the implants may rupture;

* recommending regular and pricey MRI exams to check for breaks;

* limiting implant operations to specially trained plastic surgeons;

* and launching new studies to prove how long implants last.

One day earlier, the panel rejected the sale of rival manufacturer Inamed Corp.'s silicone implants, citing lingering concerns about how long they last and what happens when the silicone oozes.

"Patients can determine whether or not for them it is worth it to have a device that might need to be replaced within a 10-year period of time," Dr. Marilyn Leitch, a cancer surgeon at the University of Texas Southwestern Medical Center told The Associated Press.

But New York dermatologist Dr. Amy Newburger opposed lifting the restrictions, saying Mentor hasn't proved that the implants will last even 10 years.

"I don't have the assurance that it's safe," Newburger said. "My concern was, since hundreds of thousands of patients will be exposed to this, I felt that the urgency (to sell) was not warranted at this time."

Despite the panel's recommendations, the FDA is not bound to act. Fifteen months ago. the FDA overruled a recommendation to bring back gel implants, saying that manufacturers need to provide better research on how long they would last and the potential for silicone leakage. The FDA now has 90 days to decide whether to accept the panel's recommendations.

Still, the recommendation pleased patients who say the silicone-gel implants look and feel more natural than the salt-water filled implants that are currently available.

"If I had the option today, I would choose silicone over saline," Arlene Nicole Cummings, a saline implant recipient who runs a website for women considering breast implants, told the FDA panel.

"Women, along with their surgeons, should be allowed to choose. ... We are neither ignorant nor shallow."

The silicone-gel implants went on the market in 1962, before the FDA required evidence that all medical devices must be safe and effective.

In 1992, the implants were banned amid concerns that silicone leaks were potentially dangerous.

These days, the implants have been cleared of causing serious illnesses such as cancer or lupus.

Yet there is still proof they can cause infection and lead to painful scar tissue.

In a three-year study by Mentor, 400 women were tracked for three years. Researchers found that 1.4 per cent suffered from ruptured implants. In another study of 100 patients who had Mentor implants by a British doctor, 5 per cent of implants broke within nine years of insertion.

FDA scientists have said the Mentor data was too limited and the British study was skewed because it excluded patients at the highest risk of implant rupture; however, the panel said the data suggests the Mentor implants are strong.

Meanwhile, the advisers criticized Mentor's rival Inamed Corp., which had studied about 900 patients for three to four years and found 2 per cent and 10 per cent breakage.

Inamed Vice President Dan Cohen accused the panel of making "bizarre and strange decisions."

More than 260,000 women had their breasts enlarged and more than 60,000 underwent surgery after breast cancer in the United States last year.