FDA hearings on emotional issue of breast implant safety start today

November 12, 1991|By Marlene Cimons | Marlene Cimons,Los Angeles Times

WASHINGTON -- Sheila Berkman, diagnosed with breast cancer on her 50th birthday last year, replaced her lost breast with a silicone gel implant. "It has given me back my life," she said. "I could not have gotten through the trauma of losing a breast without the reconstruction."

Karen Reid, 37, a former finance specialist for the Army, was 25 when she decided to enlarge her small breasts with silicone implants. Three years later, she and her boyfriend were roughhousing; as he pulled her against him, they heard a popping sound. The implant had ruptured.

Months later, she began experiencing burning, stinging, aching joints and muscles and "ice-pick stabbing" throughout her body. Ms. Reid, a Colorado woman who still suffers serious health problems, blames the implants.

"I thought I would be more attractive to men, and now I'm too sick to date," said Ms. Reid, who has filed a lawsuit against the manufacturer. "What price beauty, eh?"

Breast implants have been on the market for three decades, and an estimated 2 million women have them. About 150,000 women undergo the surgery every year, 80 percent of them for cosmetic reasons, the rest for reconstruction following breast cancer surgery.

Today, the Food and Drug Administration will begin three days of hearings to determine whether the implants are safe enough to remain on the market.

There are documented risks associated with the devices. They include hardening, caused by the scar tissue that develops around the implant after the surgery, leakage of silicone gel from the implant and interference with mammography readings.

There are also several suspected dangers, more serious but unproved, including cancer and autoimmune disease.

Women have blamed the implants for such conditions as arthritis and lupus.

There are no reliable estimates of how widespread the problems with the implants are; the evidence is largely anecdotal.

Implants were introduced before the 1976 legislation that gave the FDA the authority to regulate medical devices, so manufacturers were not required then to prove that the devices were safe. But the law also provided that such proof might eventually be required.

An FDA advisory committee will first decide whether current research is sufficient to establish the implants' safety. If such evidence is lacking, the panel, weighing the relative risks and benefits, will decide whether there is still a public health need strong enough to justify their continued use and, if so, under what conditions.

The panel is expected to make a recommendation to the agency Thursday, when the hearing ends. The FDA intends to announce a final decision by Jan. 6.

What has made the debate especially compelling are the strong and often emotional voices of women on both sides.

Some, who like Ms. Berkman of Los Angeles have breast implants, speak eloquently of the profound difference they have made in their lives and those of others.

Others, including Ms. Reid, condemn the devices as the source of serious and debilitating pain and injury.

FDA Commissioner David A. Kessler calls the dilemma "one of, if not the most difficult public health decisions" he has faced as head of the agency.

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