Safety Inquiry Begins on Saline Breast Implants

WASHINGTON — The Food and Drug Administration on Thursday opened its inquiry into the safety of saline breast implants, provoking the same intensely emotional debate that surrounded the agency’s decision two years ago to sharply curtail the availability of silicone breast implants.

A hearing, sponsored by the FDA, was called to hear views about when manufacturers should be required to submit safety data to the agency. But it quickly turned into a public opinion forum on the implants themselves.

“I’m alive and happy with my body again,” said breast cancer patient Susan Yuriditsky of Washington. “I’m happy saline implants were available to me at my time of need.”

But Mary Spieker, a Florida woman who has suffered life-threatening infections she is convinced were caused by implants she received for cosmetic augmentation, implored: “Women can live without saline implants.”

The controversy over silicone implants, which ultimately resulted in their virtual removal from the market, pitted women against women over the freedom of choice to use the implants and raised soul-searching questions about the values of a society so conscious of women’s breasts.

About 80% of those who undergo implant surgery do so for cosmetic reasons. The remaining 20% seeks implants for reconstruction, usually after breast cancer surgery.

Saline implants, which are the only breast implants still widely available, generally are considered safer than silicone, although their long-term safety has not been established.

It is unclear how many women have saline implants, although one manufacturer said that his company has sold enough implants for about 1,500 women a month. A second firm estimated it had sold implants for about 125,000 women since 1986.

Saline implants, which are filled with salt water, can leak or rupture, requiring further surgery to remove or replace them.

Other known risks include infection, capsular contracture--which is the hardening of scar tissue around an implant--interference with mammography, and altered breast sensation.

Officials from the two companies that manufacture saline implants, McGhan Medical Corp. and Mentor Corp., both of Santa Barbara, said that they have safety studies under way but do not expect results for several years.

Based on preliminary data, however, they said the saline implants could continue to be used safely and urged that they remain available.

McGhan said that results from its first two years of research show only 3% of the nearly 500 patients studied had experienced capsular contracture, 2% had suffered deflation of the device, 0.2% had developed infections and less than 1% had developed breast disease or immune system disorders.

The early results indicate that “there would be no immediate health concerns associated with continued marketing,” the company said.

Implants have been on the market for more than three decades but escaped strict regulation until recent years because they were introduced before passage of legislation in 1976 that gave the FDA authority to regulate medical devices.

Like other devices grandfathered under that law, implants were allowed to remain in use with the understanding that the agency would later require manufacturers to submit evidence of product safety and effectiveness.

Many women had blamed silicone implants for connective tissue diseases and other immune system disorders, although the association has not yet been proven scientifically.

In April, 1992, the FDA banned almost all cosmetic uses of the silicone implants--except for specific and closely monitored research purposes--and restricted their use to breast cancer patients and those with other valid medical needs.

Today, all women who receive silicone gel implants, including for the purposes of reconstruction, must agree to participate in an overall research program to evaluate their long-term effects.

In January, 1993, the FDA announced that it would require manufacturers of saline implants to begin the process of proving their safety.

The agency is expected to call for data later this year. It will then be evaluated, probably by an advisory committee of outside experts who will recommend whether to allow the implants to remain on the market, or what restrictions--if any--should be placed on them. The process could take a year or longer.

“Women should be allowed to make their own choices based on the information available,” said Cindy K. Wofford, a Texas woman who underwent reconstruction after breast cancer surgery. “My feelings of self-confidence in my body have been restored.”

But Spieker, the Florida woman, said that the implants totally disabled her. She attributed her health problems to a faulty valve design that caused contamination with a fungus that spread throughout her body.

She said that she suffered severe pain, chronic fatigue, memory loss so severe that “it took me three hours to get dressed in the morning because I could not put the right clothes together,” allergies to all drugs, and other chronic ailments.

She was at the hearing, she said, because she felt the panel needed to know “how difficult it is to live my life.”