FDA reconsidering: As a committee hears testimony, a plastic surgeon says the moratorium was political

By Carey Hamilton

and Elizabeth Neff

The Salt Lake Tribune

Salt Lake Tribune

As federal regulators this week debate whether to lift a ban on silicone-gel breast implants, a Utah plastic surgeon says patients should have the option of choosing them.

The Food and Drug Administration pulled the implants from the market in 1992 amid concerns that leaking silicone was causing serious illnesses.

Since then, only breast cancer patients and other women with special needs have been able to select silicone implants. Women with healthy breasts have had to use implants filled with saline.

An FDA advisory committee heard emotional testimony Monday, as women who blame silicone-gel breast implants for crippling health problems faced women who called them the best option. Committee members are meeting until Wednesday in Gaithersburg, M.D., and will vote on whether the ban should be lifted, as requested by manufacturers Mentor Corp. and Inamed Corp.

The FDA usually follows the recommendations of its advisory panels.

Silicone implants largely have been exonerated of causing such serious or chronic illnesses as cancer or lupus. But breaks and resulting silicone leakage, as well as painful scar tissue and other local complications, continue to raise doubts about the safety of the implants.

Stephan Ralston, a plastic surgeon in Ogden, says about 75 percent of the enlargements he does are with saline implants; the remainder are silicone. He believes "the moratorium was more political rather than scientific" and spurred by widespread class-action lawsuits.

"Women should be able to have the opportunity to make their own decision with informed consent," he said. "The government shouldn't make their decisions for them.

"I've done this for 25 years. I've done thousands of augmentations with silicone, and I've never had anyone who has had a documented illness related to silicone-gel implants."

Lisa Obray, of Ogden, who now works for Ralston, received her silicone implants from him 18 years ago when she was 23, because she had different sized A-cup breasts.

"Women should have a choice," Obray said. "There are those young girls who like the fake Pamela Anderson look, and then there are those women who want the before-we-had-children look. The silicone implants look and feel more natural, and you don't have the rippling on the sides."

But Salt Lake City attorney Ruth Lybbert, who represented hundreds of Utah women suing the makers of silicone breast implants in the early 1990s, is surprised the FDA would reconsider.

"Why are we revisiting the issue?" she asked. "The only thing I can see that's truly changed are studies by the industry, and I don't think they are neutral studies."

Lybbert called the timing of the Maryland hearings "bewildering," because they are occurring just as many of her clients who filed claims against Dow Corning are receiving their settlement money. A bankruptcy plan for Dow Corning, which included paying more than 300,000 women about $3.2 billion to settle claims, became effective June 1.

"The FDA has pressures and considerations other than the effectiveness and safety of medical devices," Lybbert said. "People's opinions [on silicone breast implants] now are where they were . . . it's a very polarized issue."

Breast augmentations in the United States are a $300 million annual business. The American Society of Plastic Surgeons estimates that 264,000 women received implants in 2004.

While the U.S. Institute of Medicine issued a report in 1999 that found no link between silicone breast implants and connective-tissue diseases, the FDA projects 22,500 women might experience ruptures each year with silicone implants.

In testimony before the panel Monday, a tearful Brenna Dowd, of Boise, Idaho, said: ''They poisoned my mother. I have never known a healthy mother.''

Susan Helman, of Florida, described autoimmune diseases that she attributes to platinum left in her body when her implants broke apart. ''I don't want anybody else to suffer this way,'' she said.

Others contended that consumers should be free to choose.

''We have a right to decide what is right for our own bodies,'' said Virginia Silverman, of Orange County, Calif. She initially chose saltwater-filled implants for reconstruction after breast cancer surgery, but found them so hard that she replaced them in 2001 with silicone-gel implants that she finds more comfortable.

''We are neither ignorant nor shallow,'' said Arlene Nicole Cummings, who runs a pro-gel implant Web site. ''Women along with their surgeons should be allowed to choose silicone or saline.''

New Jersey plastic surgeon Caroline Glicksman said she has implanted thousands of the silicone-gel version. ''No medical device lasts a lifetime,'' she said, adding the FDA's decision should be based ''on facts, not politics and emotion.''

Just 15 months ago, the FDA told manufacturers that it wouldn't lift restrictions on the implants' sale until questions about breakage in particular are settled.

Inamed and Mentor filed studies with the FDA suggesting that over three to four years, anywhere from roughly 1 percent to 20 percent of implants rupture, requiring patients to undergo additional surgery to remove or replace them.

But those studies tracked small numbers of women for a short time, FDA scientists cautioned in preliminary analyses posted on the agency's Web site last week. One FDA estimate suggested that up to three-quarters of the devices might rupture within 10 years of implantation.

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