WASHINGTON — A day after rejecting another company's proposal, a Food and Drug Administration advisory panel recommended Wednesday that silicone breast implants made by Mentor Corp. be approved for use in cosmetic surgery.
The 7-2 vote came with nine stipulations attached, including ongoing safety monitoring studies, required follow-up care of patients, special training for surgeons and voluntary tracking of every woman with implants.
But the expert advisors gave a mixed message to the FDA regulators who must make the final decision on marketing the implants: The same panel voted 5-4 on Tuesday to recommend "non-approval" of silicone implants made by another manufacturer, Inamed Corp.
Many observers consider the risks and benefits of the two companies' products to be similar. Both Mentor and Inamed are located in Santa Barbara.
"It was a bizarre and strange decision by a handful of panel members who switched their votes, who [Tuesday] demanded longer-term data and [Wednesday] accepted shorter-term data," said Dan Cohen, Inamed vice president.
Mentor provided two to three years of data on implant ruptures, and Inamed offered three to four years of information from clinical trials.
But Joshua H. Levine, Mentor's chief executive, said the vote showed that "these products are not all created equal." He said he was gratified by the decision, but recognized that "there are still other hurdles to be passed" before his company can offer its implants to women seeking surgery to enhance the shape of their breasts.
"This is a great day for my patients, who will now have access to a better and safer product," said Dr. Scot Glasberg, a New York plastic surgeon and Mentor consultant. "There is no mixed message here. [Inamed's] presentation had problems."
The two companies now divide the $400-million-a-year U.S. breast implant market. Mentor's shares rose 77 cents Wednesday to close at $35.33 on the New York Stock Exchange. In after-hours trading, they rose as high as $39.60. By contrast, Inamed shares fell $2.90 on Nasdaq, closing at $63.51, and dropped to $60.80 after-hours.
The FDA had no immediate comment on the panel's recommendations. The time frame on the agency's decision to agree or disagree with its advisory panel's recommendations ranges from six weeks to several months.
More than 250,000 American women have cosmetic breast surgery every year, but for the last 13 years the FDA has allowed only implants filled with a saline solution.
