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Panel advises limiting use of implants Surgery backed in reconstructive cases, special trials Jonathan Bor

THE BALTIMORE SUN

BETHESDA -- Seeking a delicate balance, an advisory panel suggested yesterday that the federal government make silicone breast implants widely available to cancer patients but strictly limit their use by healthy women who simply want larger breasts.

The Food and Drug Administration advisory panel, wrapping up a grueling three-day hearing over the implants' safety, decided it still lacked sufficient evidence to recommend banning the devices outright.

But the nine-member panel unanimously agreed that safety concerns were troubling enough to rule out their wide-scale use by healthy women who want larger breasts to enhance their appearance. Instead, a relatively small number of cosmetic implants would be given to women who enroll in tightly controlled trials aimed at settling the safety question once and for all.

The trials also would include women who want breast reconstruction because of cancer surgery, burns or birth defects. But such women could also get the implants without enrolling in the trials as long as they agreed to many years of monitoring by their doctors.

The panel's recommendation now goes to Food and Drug Commissioner David Kessler, who is expected to issue a final ruling within 60 days.

Supporters of the compromise said this would help resolve long-festering questions about implant safety while making the implants available to the women who need them most: Those who suffer the devastating effects of disfigurement.

"This responds to the science on one hand and compassion on the other," said Nancy Dubler, a lawyer/ethicist from New York who served on the panel.

"To deny mastectomy patients would be inhumane, given what they've been through," said Dr. Sherry Pulaski, a Bethesda radiologist who was a non-voting member.

Besides recommending limited use of implants in the future, the panel issued this advice to women who already have the devices:

* Although there have been reports that the implants pose a risk of "autoimmune" diseases, there is no proven link between the two.

* Some implants rupture. Surgical removal is a decision for the doctor and patient to make.

* While mammograms can detect some "silent ruptures," women under 30 should not undergo routine mammography. This is because X-rays pose a heightened cancer risk to young women.

As they deliberated yesterday, panelists were divided -- in some cases, bitterly -- over how much credibility should be given to new safety reports that emerged at this week's hearing.

They heard two radiologists say that mammograms had found the implants had ruptured in 5 percent to 6 percent of several hundred women who had the silicone devices. Most of the

breaks were "silent," producing neither pain nor a misshapen appearance.

Also, four physicians said they had seen a few hundred implant patients whose immune systems had turned against them, causing debilitating diseases like rheumatoid arthritis, lupus and scleroderma.

Some panelists said they found the reports deeply troubling. But others clung to industry claims that rupture rates occurred in less than 1 percent of implant patients. And they said there was no evidence that the illnesses were caused by silicone spilling or bleeding from the implants.

The decision satisfied many members of the sharply divided audience, which included some women who were happy and others who were furious with the results of their implants.

But others said the compromise didn't solve anything: "The hundreds of women who have become very ill from implants feel the panel sold out," said Lynda Roth, a Colorado woman who said her implants made her weak and caused blurred vision and irritable bowel syndrome.

The panel's balancing act marked a significant reversal from its actions last November, when it argued that reports of the implant hazards were so shaky that it couldn't recommend denying them to any groups. To give greater weight to the needs of reconstruction patients, the panelists decided then, would be to devalue the problems of small-breasted women suffering from low self-esteem.

An estimated 130,000 women every year were getting the implants before Mr. Kessler asked doctors to stop using them last month so he could have time to resolve new questions about their safety. Three-quarters of the operations were cosmetic, according to some estimates, while the rest were for reconstructive purposes.

While the end of the hearing brought relief to participants who had endured three days of emotional and sometimes contentious testimony, many people were troubled by a big unanswered question: How many people wanting purely cosmetic surgery could get the implants if Dr. Kessler accepts the panel's advice?

There were no clear answers. But Dr. Norman M. Cole, president of the American Academy of Plastic and Reconstructive Surgery, said it was likely that the clinical trials would be conducted solely at selected teaching hospitals. Additionally, implants filled with salt water would remain available at any hospital.

The panel seemed headed toward a compromise when officials of embattled Dow Corning, a leading manufacturer of silicone implants, said Wednesday that they would agree to limits that would allow trials to occur. It could take four years of studies to produce significant results, a company scientist said.

FDA officials made it clear that whatever happened, they planned to create a national registry of past and future implant patients. This would allow them to compile data on problems that occur, giving the agency the first large "data bank" on implant safety despite 30 years of their use.

BREAST IMPLANT CHRONOLOGY

* 1962: Silicone breast implants are invented by Dr. Thomas D. Cronin, former chief of plastic surgery at St. Joseph Hospital in Houston, with the help of Dr. Frank Gerow.

1963: Timmie Jean Lindsey of Houston becomes the first

woman to receive a silcone breast implant, made by Dow Corning.

*March 9, 1971: An internal Dow Corning memo reports that a silicone gel breast implant ruptured and leaked inside a New Orleans masectomy patient, inflaming and puncturing her breast.

* 1976: The federal Food and Drug Administration is given the power to regulate breast implants along with other medical devices. Under the law, manufacturers of new devices are required to provide the FDA with full clinical studies, but devices used before 1976 are "grandfathered," meaning they can still be sold without FDA approval. The FDA may seek safety data on grandfathered devices. But with 100,000 products on the market, the agency moves slowly.

Dec. 15, 1977: A Dow Corning employee writes an internal memo detailing reports by four Ohio and Michigan doctors, who found that 52 out of 400 implants had ruptured.

The FDA classifies breast implants as a "significant risk device" and tells manufacturers safety data might be required. Manufacturers and medical supporters appeal.

Amid concerns about implant leakage, the industry switches to a new double-walled implant filled with a silicone "gel" that is less liquid than the previous filling.

The Maryland General Assembly requires surgeons to provide implant patients with a booklet on potential risks.

*1988: The Public Citizen Health Research Group asks the FDA to ban breast implants after obtaining an internal Dow Corning study showing that silicone gel caused malignant fibrosarcoma, a rare cancer, in 23 percent of rats tested.

1990: After nine years of filings and appeals, the FDA asks for safety data on breast implants from manufacturers.

April 1991: A style of implant with a polyurethane coating, designed to prevent the formation of sometimes painful scar tissue inside the breast, is taken off the market by its manufacturer. An FDA panel looking at implant safety recommends they be left on the market.

*Dec. 9, 1991: A federal jury in San Francisco orders Dow Corning, the largest U.S. implant manufacturer, to pay $7.34 million to a woman who blamed her crippling immune-system disease on ruptured silicone gel implants.

Dec. 30, 1991: The FDA orders Dow Corning to stop telling consumers using a toll-free hotline that breast implants are "100 percent safe."

*Jan. 6, 1992: Based on previously undisclosed Dow Corning documents that surfaced in four lawsuits, FDA Commissioner David Kessler asks doctors for a 45-day moratorium on the use of silicone gel implants.

Feb. 10, 1992: Under pressure from the FDA, Dow Corning makes public an 800-page collection of confidential documents that, implant critics charged, show the company understated the risks of implants. Within hours, the company replaces its chief executive and chairman.

*Feb. 20, 1992: The FDA advisory panel on breast implants lifts the moratorium, but will tightly restrict silicone gel implants. Within hours, the company replaces its chief executive and chairman.

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