FDA to Begin Breast Implant Hearings : Health: Some blame the devices for illness. Others say they boost self-esteem. The agency plans to make a decision by early 1992.
Sheila Berkman, who was found to have breast cancer on her 50th birthday last year, replaced the breast she lost 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 when 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. 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 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 now have them. About 150,000 women undergo the surgery every year--80% of them for cosmetic reasons, the rest for reconstruction after breast cancer surgery.
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 as yet unproved, including cancer and autoimmune disease. Women have blamed the implants for such conditions as arthritis and lupus. There are as yet no reliable estimates on how widespread the problems are; the evidence is largely anecdotal.
Since implants were introduced before the 1976 legislation that gave the Food and Drug Administration the authority to regulate medical devices, manufacturers were not required to prove that the devices were safe. But the law also provided that such proof might eventually be required.
Today, the FDA will begin three days of hearings to determine whether the implants are safe enough to remain on the market.
An FDA advisory committee will first decide whether current research is sufficient to establish their 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, 1992.
What has made the debate especially compelling are the strong and often emotional voices of women on both sides: those, like Berkman of Los Angeles, who have breast implants and speak eloquently of the profound difference they have made in their lives, and others, like Reid, who 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.
“On the one hand, we must take action against these products if their manufacturers cannot demonstrate that they are safe and effective,” Kessler said. “On the other hand, we would certainly hesitate to remove a product from the market if that action could jeopardize the well-being of patients.”
The lobbying has been extremely heavy by both camps. Plastic surgeons, who have used the devices for years, insist that they are safe and claim that only a “vocal minority” of patients has generated the negative attention. Moreover, implant manufacturers have submitted thousands of pages of data to the FDA supporting their contention that the devices pose no serious health dangers.
“We can say to women emphatically that we are confident in the safety of silicone implants,” says Robert Grupp, a spokesman for Dow Corning Corp., one of the largest manufacturers of silicone implants. “There are risks and they are well known. But the science shows no link between implants and serious illness. We have done more than 300 studies during the last 30 years, all of which support the general safety of the device.”
Medical ethicist Arthur Caplan, director of the bioethics center at the University of Minnesota, believes that the FDA’s only obligation is to evaluate whether the benefits outweigh the risks and to make a decision based only on that ratio.
“If somebody wants to have big breasts for aesthetic reasons, I think the level of risk that the government should tolerate is relatively low,” he says. “If someone wants to have breasts replaced because they feel mutilated, I think the level of risk the government could accept would be higher.”
But those who support the continued availability of the implants argue that women should be able to maintain their right to choose.
“This society, unfortunately, focuses on breasts,” Berkman said. “It is so tied to our sense of sexuality and our self-esteem. That will not change. Women should not be denied the opportunity to make an informed choice. That should not be taken away from us.”
But Caplan and others believe that freedom of choice is a weak argument in the context of whether a product is hazardous.
“The argument about the right to choose in the mouths of cosmetic surgeons and implant manufacturers has about as much force as the right-to-choose rhetoric of tobacco companies when they talk about smoking,” Caplan said. “You never hear rights of consumers invoked so much as when a doctor wants to sell them something.”
Kessler said that FDA regulations do not permit the choice issue as a statutory standard. “The law requires us to conclude that they are safe,” he said.
The National Women’s Health Network, a public interest organization that concentrates on women’s health issues, will urge the FDA during the hearings this week to impose a moratorium on the market availability of silicone implants if the FDA panel concludes that more studies are needed to evaluate their safety.
The panel should “create a situation of informed choice by acting upon the evidence at hand, rather than a well-orchestrated public relations campaign,” said Cynthia Pearson, a spokeswoman for the network.
