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HOW SAFE ARE BREAST IMPLANTS? REPORTS OF LEAKAGE, BLEEDING ARE RAISING QUESTIONS

WOMEN WITH breast implants are becoming increasingly concerned that the implants may cause problems rather than solve them.

The implant is an artificial breast form that is most frequently made of silicone, a synthetic substance. Most implants have a silicone shell with a rubbery consistency that generally contains silicone, saline fluid or both.

The health complications connected to the implants include hardening of the breast, difficulty with cancer detection, scarring, infection, bleeding, and leakage of silicone gel.

The concern has reached Congress as well as the television airwaves. Some popular shows have taken up the issue, which concerns women who have had implants following surgery for breast cancer or for cosmetic reasons.

Graphic accounts of poor health and disfigurement were given last month by four women on "Face to Face With Connie Chung," a CBS television program.

One woman told of developing flulike symptoms, including swollen glands and joint pain that lasted five years. After some doctors said it was caused by a virus, she found a doctor who identified it as a silicone-associated disease and related it to rupturing of the implant.

A nurse who was initially pleased with the implants said that within six months she suffered extreme fatigue, mouth ulcers, chest pain and hair loss, and was diagnosed as having lupus.

Since the airing of Chung's report, women have testified before Congress asking for fuller disclosure by manufacturers and physicians and closer monitoring of the implants by the Food and Drug Administration.

Although 2 million women have received implants in the past 30 years, the FDA has never ruled on their safety or effectiveness.

When 1976 amendments to the Food, Drug and Cosmetic Act required regulation of medical devices, breast implants were not covered by the law and did not have to meet the specifications required of new products.

Reportedly, the federal agency has received reports of 2,017 cases of adverse reactions from silicone implants.

Lockport resident Barbara Johnston says women should be fully informed of potential dangers. Later this month she will appear on "The Sally Jessy Raphael Show" to campaign for New York State legislation that would force doctors to give women written information before implant surgery.

A bill before the state Legislature would require physicians to furnish patients, before surgery, a standardized booklet on possible risks and complications.

Maryland is the only state that requires physicians to provide that information, and it started the practice just last year, Mrs. Johnston said.

An 18-page booklet, "Breast Reconstruction: What You Need to Know About Breast Implants," prepared by the Maryland Department of Health and Mental Hygiene, is given to surgical candidates in that state.

"Women get more information when they buy a car battery than when they have a breast implant," said Mrs. Johnston. "All I'm saying is that I want women to know the risks and complications so they can make an informed decision."

Mrs. Johnston, who had implants inserted after a double mastectomy in 1984, said she had 24 procedures, including several operations, that have left her in worse shape than if she had never had the implants.

Eventually she had both implants removed, but before she did, she had an implant that ruptured and recurring tumors. She is scheduled to have a tumor on her chest wall removed this week, and she has another that she calls a "silicone tumor" on her lung.

"Right now I think the story about implants is coming out all one-sided," said Dr. Bruce Cuzens, a local plastic surgeon, who plans to write to his patients to encourage them to call him if they have questions about their implants.

"Certainly there is concern to be made over anything implanted in the human body. But silicone implants have been used for more than 20 years and are in 2 million women," said Cuzens.

"There have been problems with them just like any device that's been used in the body over the years. But according to all statistics, they have a very safe track record. Women should not be walking around paranoid about this."

The American Society of Plastic and Reconstructive Surgeons says most women who have had implants are satisfied. The group's recently completed survey of 600 women showed that 92.5 percent were satisfied, and 82 percent said that "without a doubt" they would choose to have the surgery again. Their implants had been in place an average of eight years, and 65 percent of them had implant surgery for cosmetic reasons.

In the survey, 14 percent reported appearance-related problems; 12 percent complained of pain or numbness, and 10 percent said they had experienced infection or implant leaks.

Dr. Takuma Nemoto, a breast surgeon who is on the staff of the Breast Care Center at Sisters Hospital, said that in his experience most women do quite well with implants.

"There will always be the rare occasion of patients who have problems," he said.

And statistics show that women continue to want them.

In 1988, there were 71,720 enlargements and 34,210 reconstruction procedures done in this country, according to the society.

The Erie County unit of the American Cancer Society offers no recommendations regarding implants, according to its executive director.

"I always refer people back to their physicians," said Constance M. Schweitzer. "I'd call the physician who did the procedure to see if he has information."

Sandy Liebler of Reach-for-Recovery, an organization for mastectomy patients, said she hasn't had any difficulty with her implants and is pleased that she had the operation.

"For me, it was such a simple procedure and I've been very glad that I did it," she said. "I've had no problems. What I always say to women is that they don't have to make decisions right now."

That's the advice that Maggie Fredrickson followed.

A year ago when the 47-year-old teacher had a mastectomy, her doctor encouraged her to heal both physically and emotionally before making a decision about implants, which can be inserted at the time of the mastectomy or years later.

"I was in a state of shock, and I think if he had pushed me to have the implant, I might have decided to do it," she said. Instead, she has worn a prosthesis since the operation and plans to continue.

An information packet about the benefits and risks of implants is available by sending a postcard to Breast Implants, FDA (HFZ-210), 5600 Fishers Lane, Rockville, Md. 20857.

Women who have significant problems can write to U.S. Pharmacopeia (USP), Problem Reporting Program, 12601 Twinbrook Parkway, Rockville, Md. 20852.

Mrs. Johnston will also provide an informational flier on implants; her address is P.O. Box 1513, Lockport, N.Y. 14095.

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