A government decision not to recommend an immediate ban on silicone breast implants drew criticism from a public advocacy group, which did applaud efforts to educate women better about the procedure.
This week, the Food and Drug Administration's panel on plastic surgery rejected arguments that breast implant surgery be halted immediately because of studies showing silicone gel can cause cancer in laboratory rats.The panel did, however, recommend that all women considering implant surgery undergo a standard patient education program that would provide information about all known health risks. Such a program would have to be completed before patients sign a consent order for surgery.
Dr. Sidney Wolfe, a spokesman for the group Public Citizen, said Wednesday he was upset the panel decided against a ban.
An estimated 2 million American women have received breast implants - about 85 percent to enlarge breasts for cosmetic purposes and the remainder for breast reconstruction after a mastectomy. Currently, 130,000 women a year undergo the operation.
Wolfe noted a chemical engineer who worked for the Dow Corning Corp., a maker of the implants, testified he left the company in 1986 because it started making a more hazardous type of implant.
But Wolfe added, "On the other hand, the panel seems to be taking the issue very seriously and has undertaken steps to obtain written, informed consent from patients."
Instead of imposing an immediate ban on implant surgery as consumer advocates had hoped, the advisory committee voted to take two months to collect more data on the possible health risks of silicone in humans.
The call for an immediate halt to silicone implants was issued earlier this month by Public Citizen's Health Research Group. The group, founded by consumer activist Ralph Nader, charged the FDA and Dow Corning, which makes the slicone gel used in implants, have supressed evidence that the implants may pose a serious health threat.