Surgeons see lingering fear over silicone-gel implants

April 17, 1992|By Jonathan Bor | Jonathan Bor,Staff Writer

Despite a federal ruling that makes silicone gel implants widely available to women losing a breast to cancer, the lingering fear left by months of rancorous debate will probably cause most patients to choose other methods of breast reconstruction.

That is the view of many plastic surgeons who said yesterday that they doubted the Food and Drug Administration's decision to give cancer patients the right to choose silicone gel would ease fears over the implants' safety.

The FDA ruling, announced yesterday, gives cancer patients access to silicone gel implants as long as they enter studies designed to answer safety questions.

Some surgeons predicted that most breast-reconstruction patients would choose either saline implants or a technique in which surgeons use a flap of tissue from the patient's abdomen to reconstruct the breast. Both have grown in popularity since the FDA called for a voluntary moratorium on silicone implants Jan. 6.

"I think that people are still leery about silicone, which has had such a pounding from the press," said Dr. Bernard McGibbon, a plastic surgeon at the Greater Baltimore Medical Center who maintains that the implants are safe.

"They will still have some doubt in the back of their mind. I suspect there may be a slow swing of the pendulum back to silicone over a period of time. But it's going to take some time before people feel comfortable again," he said.

Dr. Paul Manson, a plastic surgeon at the Johns Hopkins Hospital, said he will offer silicone as an option to his reconstruction patients but expects most to choose the other methods.

"I think most would feel safer with saline, and many are choosing their own tissue," Dr. Manson said. "It's a difficult issue. The studies that need to be done essentially haven't been done."

Yesterday, FDA Commissioner David Kessler lifted his four-month moratorium on silicone breast implants -- declaring that the implants would be widely available to women facing reconstructive surgery because of mastectomies, birth defects and serious injuries such as burns.

However, their doctors would have to first certify that saline implants were not a satisfactory alternative for the patients' well-being.

Also, the women would have to agree to participate in strictly controlled research studies aimed at answering safety concerns: How frequently do they rupture? Does leaking silicone cause diseases such as lupus and rheumatoid arthritis? And do implants interfere with mammography, making it difficult to diagnose cancers in time to save lives?

The studies, sponsored by the implant manufacturers, will be open to practically all reconstruction patients who want them -- although possibly not for a few months while procedures are being set up.

In the meantime, silicone-gel implants will be immediately available to women whose implants have ruptured -- and to others who received a temporary tissue expander before the moratorium was imposed and now await a permanent implant.

In contrast, the scientific studies would be open to a relatively small number of healthy women wanting breast augmentation. Because of limited enrollment for the studies, the annual average of 80,000 women who obtained silicone implants for cosmetic purposes would drop to "hundreds, maybe a couple thousand," Dr. Kessler said.

"I am highly conscious that some women need these implants for reconstruction after cancer surgery or traumatic injury, or for certain congenital disorders," Dr. Kessler said at a news briefing yesterday.

"Our primary goal is to put in place a process to obtain adequate information about the safety of these devices."

Like many plastic surgeons, Dr. James Paskert of Cockeysville said the FDA sent a "mixed message" that says the implants are safe enough for cancer patients who have already faced a life-threatening disease and the possibility of recurrence, but not safe enough for women wanting augmentation.

"They took what appears to me to be an uncourageous way out: the way that would stir up the very fewest people but answer the fewest questions," Dr. Paskert said. "Are you trying to help one group but not the other? It doesn't make any sense, not at all."

Despite that, Dr. Paskert said he decided over a year ago to offer only saline to his patients because he believed that the controversy might generate doubts and regrets among patients getting silicone. He said the FDA ruling gives him no reason to change. "They are happy they have gone that route," he said.

While the silicone debate was fueled by patients who said leaking silicone had caused painful illnesses, other women argued that patients should have the right to weigh the evidence and choose for themselves.

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