Sept. 21, 2005 -- The FDA has taken a forward step in the approval process for a maker of silicone gel-filled breast implants. The agency issued an "approvable letter" to Inamed Corporation to market the implants in the U.S.
It's the second time in two months that the FDA has issued an approvable letter for silicone gel-filled implants. In July, another implant maker, Mentor Corp., got an FDA approvable letter.
However, those implants can't go on the market yet.
"An approvable letter is one of several intermediate steps in the FDA review process of new products," states an FDA news release.
Implant's Maker Responds
"We respect the thoroughness of the FDA review process and are pleased with this decision," states Inamed president and CEO Nick Teti, in an Inamed news release.
According to the news release, the approvable letter "stipulates a number of conditions that Inamed must comply with in order to receive FDA approval to market and sell responsive silicone gel-filled breast implants in the United States."
The terms spelled out in the approvable letter weren't announced, due to federal laws and regulations.
The conditions "are generally in line with our expectations" and with FDA panel discussions, states Teti.
In April, an FDA advisory panel voted five to four not to approve Inamed's premarket application for silicone gel-filled breast implants. At the time, the panel cited a lack of long-term safety data.
Since then, Inamed has given the FDA more information about the main safety concerns mentioned by the panel. Inamed has also promised to drop an implant that had raised particular safety issues with the panel, states the FDA.
Partial Ban Has Lasted 15 Years
Breast implants filled with silicone gel have been partially banned in the U.S. for 13 years. Controversy surrounded health concerns if the implants ruptured and leaked.
In 1992, the FDA moved to make silicone implants available only if saline-filled implants weren't an option. The silicone implants were not totally banned.
The FDA's 1992 investigation didn't conclude that silicone implants posed a health risk, but that implant manufacturers had not provided enough data to confirm the absolute safety of the devices.