Company’s Breast Implant Data Faulted
A Food and Drug Administration advisory committee concluded overwhelmingly Wednesday that safety data gathered by Dow Corning fails to show the company’s silicone-gel breast implants are safe.
The panel is to consider and recommend to the FDA this week whether the implants should be allowed to remain on the market while more safety studies are conducted and under what conditions.
Committee members expressed concerns about the lack of information on how long the implants will last before deteriorating or rupturing, whether the implants are associated with cancer or immune disorders and whether they interfere with mammograms in detecting breast tumors.
“I didn’t see sufficient scientific data to conclude these implants are safe,” said Mary Davis, associate professor in the Department of Pharmacology and Toxicology at West Virginia University.
Sheryl Ruzek, associate professor of health education at Temple University, said she believes that “a woman has the right to freedom of choice and to make her own decision.” But, she said, women “can only take these risks when they know what they are.”
The vote was 9 to 1 to not recommend approval of Dow Corning’s implants. E. James Potchen, chairman of radiology at Michigan State University, was the only person to say he believes there is reasonable assurance the devices are safe.
He said his major concern related to breast cancer. If implants are not available, he said, women who suspected breast cancer might not seek care because of fear they would lose their breast.
This is a bigger concern, he said, than fears that mammography is impaired with implants, which he believes are unfounded.
The committee is also considering silicone implants made by three other companies. Its meeting was to continue today.
During the daylong meeting, officials of the company defended its products and maintained that the more than 33,000 pages of data it has submitted show the implants are safe and effective and have few complications.
“It is of vast importance that FDA allow this product to remain on the market for all women,” Robert R. LeVier, technical director of Dow Corning’s Health Care Businesses, told reporters during a break at the meeting. “To do anything else would make victims of these women.”
But an FDA official told the panel that the data the company has submitted is inadequate in several respects, though they “do not show a hazardous device posing a major threat to the health of the user.”
“However, questions remain as to the presence of long-term risk, the accurate measurement of the incidents of complications and the effects of the implants on mammography,” said Daniel McGunagle, an FDA scientist.
