Recipients of gel implants mixed on FDA's action

January 07, 1992|By Jonathan Bor

Lucille Bodke of Glen Burnie blames her stiff joints, "rock-hard" breasts and inability to stretch without searing pain to leakage of the silicone breast implants she received 13 years ago after having both breasts removed due to a cyst disorder.

The 58-year-old woman has nothing good to say about the implants. But she declared yesterday "one of the greatest days" of her life after hearing that FDA Commissioner David Kessler had asked plastic surgeons to stop inserting the gel implants until he could resolve concerns about their safety.

"To me, today is the greatest day since Maryland passed a law requiring doctors to give information to patients about the risks of silicone implants," Mrs. Bodke said. That law took effect in 1988.

But in Arnold, 30-year-old Mary Romano called the commissioner's decision "an overreaction," saying the implant she received last year after losing a breast to cancer has brought her nothing but satisfaction.

"I've been thrilled," said Mrs. Romano, 30. "I had no idea how happy I'd be. It's comfortable, it's attractive, it's so real life and so convenient. I used to stand in my closet for 20 minutes every morning deciding what to wear and how to wear it. Now I can wear anything."

As for risks, she had this to say: "People are allowed to smoke cigarettes in this country, and the risks [of silicone implants] aren't nearly as great."

Before yesterday's announcement, participants in one of the most heated medical debates in years could agree on one thing: Whatever Dr. Kessler decided, the controversy would not die. They were right.

Not surprisingly, women who believe their implants have caused them medical hardships applauded the commissioner's decision, while those who have enjoyed good health and like the cosmetic results criticized him for overreacting.

Most plastic surgeons voiced disappointment, but said alternatives such as the saline implant will leave women wanting augmentation or reconstructive surgery with a cosmetically appealing option.

Dr. Norman Anderson, a Johns Hopkins physician who sat on the expert panel that advised Dr. Kessler, applauded the decision.

Last November, he joined the panel in recommending that Dr. Kessler leave the gel implants on the market pending further review of their safety. But on Dec. 12, he told Dr. Kessler in a letter that the implants should be removed from the public marketplace because documents produced in four lawsuits against the Dow Corning Corp. had raised questions of scientific fraud.

"There is additional information that has not been covered to this point by the press that requires further investigation," he said yesterday, refusing to provide details. "It deals with scientific fraud and other important concerns."

Dr. Anderson said he believes the implants should remain available only to women taking part in a clinical trial aimed at judging the implants' safety once and for all.

His greatest concern is what happens when the implants rupture or leak into the surrounding tissues.

"There's no doubt in my mind that I've seen patients where the silicone has migrated through the armpit to the elbow, trapping the arteries and nerves and placing the patient at enormous risk of impaired use of the extremities," he said.

But Dr. Bernard McGiven, chief of plastic surgery at the Greater Baltimore Medical Center, said he was "bitterly disappointed" in the FDA action, insisting he has used silicone implants since 1977 without ever observing serious side effects.

He said the breast sometimes harden due to the natural scarring that takes place after implant surgery -- a response that can be prevented or minimized with daily exercise.

But he said there was no proof that implants caused the serious problems, including the immune disorders claimed by Ms. Hopkins and other plaintiffs.

Dr. James Paskert, a Cockeysville plastic surgeon, said he stopped using the gel implants last year because he wanted to spare women the worry many would feel in the emotionally charged atmosphere of the FDA debate.

"But I don't have any feelings that it's harmful in causing autoimmune problems," he said.

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