The leading maker of silicone gel breast implants, Dow Corning Corp., promised on Wednesday to carry out 15 more safety tests on the implants and to establish a registry to follow implant patients.
The announcement came at a meeting of an expert panel called by the Food and Drug Administration (FDA) to review the safety and benefits of the implants, which are being used by an estimated 1-million American women.
Dow Corning and three other manufacturers of implants maintained at the hearings Wednesday that they believed implants were safe and that any connection between the implants and health problems in women was coincidental. But company officials acknowledged that there might be some link to disease in what they called hypersensitive women and promised to continue to investigate the effects of implants.
The panel will vote today on a recommendation to FDA commissioner David Kessler on whether to allow use of the implants. He temporarily banned them Jan. 7.
Kessler could keep the implants off the market on the ground that their safety has not been proved, or he could allow their use under a provision of the law that allows the marketing of such devices without proof of safety if they fill a pressing public health need.
But most experts expect a compromise in which the implants remain on the market as "experimental" devices, with those getting implants being closely monitored by researchers.
Keith McKennon, Dow Corning's new chairman and chief executive, told the expert panel on Wednesday that he would make sure the FDA received any information it needed, including that from documents sealed by the courts at the request of Dow Corning when it settled lawsuits with implant recipients.
"And we will go further," he said, "We have arrived at an integrated plan that comprises 30 studies, some already completed, some under way, and some yet to be done."
He also said the company would try to establish an advisory "women's council" after consulting women on both sides of the debate.