Breast implants create a furor as debate opens

November 12, 1991|By Barbara Murphy | Barbara Murphy,Los Angeles Daily News

DIANE CHRISS of Calabasas, Calif., lost a breast to cancer last year and chose to reconstruct it with a silicone-filled implant, just months before she opted to augment her remaining breast with another implant.

"It was important to me that I look good not only in clothes with a bra, but not in clothes and not in a bra," she said. "I've got all of that now. I'm really happy."

But Chriss said her self-esteem would be undermined if a federal probe on the safety of implants result in their removal from the market.

"I can't be sure that my implants will last forever," said Chriss, a 45-year-old social worker. "If implants were taken off the market and [I developed problems with mine], I think it would be like having a mastectomy all over again."

Chriss and thousands of women nationwide are speaking out -- for and against implants -- as the U.S. Food and Drug Administration prepares to decide the future of the silicone-filled devices. Many carried the debate to Maryland today for the start of a three-day FDA advisory panel hearing about breast implant safety.

Available to women for three decades but never put through scientific regulatory tests, implants are being scrutinized for the first time because of complaints they might be linked to a variety of diseases, might make it difficult to get accurate mammography results, or, at the very least, might cause pain and require additional surgeries.

The debate over the safety of the implants, argued in many cases by women but fueled by plastic surgeons whose livelihood depends, in part, on fitting women with the devices, has turned ** what once was a private issue into something very public.

"I didn't want the whole world to know I had cancer, but I couldn't live with the thought of other women being harmed like I was," said Sybil Goldrich, 52, of Beverly Hills, Calif., who with a Kentucky woman formed Command Trust Network as an information clearing house on breast implants.

Goldrich got breast implants eight years ago following a double mastectomy. The implants hardened, lost their shape, moved and at one point almost passed through her weakened skin, she said.

She underwent five operations in 10 months before she had the implants removed. When she had a hysterectomy six years later, Goldrich said, doctors found silicone in her uterus, ovaries and liver.

"I'm eight years post-cancer but I'm never going to be post-silicone," she said. "There's no way they can wash it out."

Officials say 2 million American women have had breast implants since they were introduced in the early 1960s. Eighty percent of the women opt for the surgery for cosmetic reasons, while the remainder use an implant for reconstruction following breast cancer.

The implants have avoided government study because they already were on the market when the FDA was given authority to regulate medical devices in 1976. Following a number of complaints from women, however, the FDA put implant manufacturers on notice in June 1988 that they needed to collect scientific data on the safety and effectiveness of the silicone devices.

Seven manufacturers submitted their data to the FDA in July of this year and three were rejected in their applications for approval. Devices by Dr. Joseph F. Cavon of Santa Ana, Calif.; Surgitek, a subsidiary of Bristol-Myers Squibb in Paso Robles, Calif.; and Bioplasty Inc. of St. Paul, Minn., are being removed from the market, but FDA officials stress that does not mean they are unsafe.

It means only that the information they supplied the FDA was insufficient to evaluate the safety of the implants, the officials said.

An FDA advisory panel began three days of hearings today at the Holiday Inn in Gaithersburg, Md., to gather information about implants made by the four companies whose applications for review were accepted. Following the hearings the panel will make its recommendation to the FDA, which will announce in January whether the implants can stay on the market.

The possibility that the implants may be removed from the market has prompted the American Society of Plastic and Reconstructive Surgeons to start a lobbying and public relations campaign to encourage women who are happy with their implants to speak up.

Dr. Norman Cole of Louisville, Ky., president of ASPRS, said the effort is being funded by a three-year $1,050 assessment on each of the group's 4,000 members. The money has been used to fly satisfied implant patients to Washington to meet with members of Congress and to run newspaper advertisements in a handful of cities.

Command Trust Network, formed in March 1989, has received complaints from 12,000 women who have had problems with their implants, Goldrich said. Cruzan said the FDA has received 3,172 complaints from women who have had problems with their silicone implants.

(Saline-filled breast implants will be the subject of a later FDA study, Cruzan said. The agency has received almost 3,000 complaints to date about those devices, she said.)

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