WASHINGTON -- The Food and Drug Administration, which is expected to announce within days whether it will allow widely used silicone gel breast implants to remain on the market, said yesterday that the biggest manufacturer of the devices has been giving consumers false and misleading information about the implants' safety.
The FDA warned Dow Corning Wright Co., based in Midland, Mich., to immediately stop disseminating the false information on its toll-free hot line and ordered the company to notify the agency by Thursday of corrective steps it has taken.
"FDA believes that Dow Corning is falsely reassuring women of the safety of breast implants," the agency said in a statement.
Barbara Carmichael, vice president of the parent Dow Corning Corp., also based in Midland, said: "We object strongly to any characterization of the hot line as providing anything other than accurate information."
An estimated 2 million women have the breast implants. Side effects include hardening around the implant caused by the development of scar tissue, leakage of silicone gel from inside the implant, rupture of the device and interference with mammography readings.
In a letter to Dan M. Hayes, president of Dow Corning Wright, the FDA said that "verbal statements have been made . . . which are not factual or have been used in a confusing or misleading context. These statements overstate the safety of breast implants and minimize known or suspected side effects."
The FDA said its own investigators who called the hot line were told that "breast implants are 100 percent safe."
In November, an FDA advisory committee found that the manufacturers had failed to prove that implants are safe. Nevertheless, the committee said, a pressing public health need justified their continued availability.
The FDA is expected to announce by Jan. 6 whether it will permit continued marketing of the devices.