The FDA hasissued an "approvable letter" to Mentor Corp. for the company's application for silicone gel-filled breast implants.
"This letter does not mean that the device is approved for marketing in the United States at this time," states an FDA news release.
Federal law and regulations prohibit the government from discussing the letter's specific contents. However, an approvable letter is one of several intermediate steps in the FDA's review process for new products, says the FDA.
The FDA's news release only mentions Mentor's product, not silicone implants from other makers.
Then and Now
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.
Fast forward to April 13, 2005. That's when an FDA expert panel voted 7-2 that Mentor's application was "approvable with conditions," states the FDA news release.
One day earlier, the same FDA committee narrowly rejected another company's bid to market silicone breast implants.
"The approvable letter stipulates a number of conditions which Mentor must satisfy in order to receive FDA approval to market and sell silicone gel-filled breast implants in the United States," states a Mentor news release.
"We are very encouraged by this communication from the FDA, and view this letter as a positive sign for women and their surgeons that another option will soon be available," says Joshua H. Levine, Mentor's president and CEO, in the news release.
"For more than a decade, choices for women seeking breast augmentation and reconstruction have been limited," says Levine. "If ultimately approved by the FDA, Mentor's Memory Gel breast implants will be a significant additional option for these women. Mentor is committed to making these important products available to women and will continue working with the FDA to address the approvable conditions."
Plastic Surgeon's Comment
"We are pleased that the FDA supports its advisory panel's decision to allow women the choice of silicone breast implants provided the manufacturer meets certain conditions," says Richard D'Amico, MD, in a news release from the American Society for Aesthetic Plastic Surgery (ASAPS).
D'Amico chairs the Breast Implant Task Force of the ASAPS/American Society of Plastic Surgeons (ASPS).
SOURCES: News release, FDA. News release, Mentor Corp. WebMD Medical News: "Panel OKs Lifting Silicone Breast Implant Ban." WebMD Medical News: "FDA Rejects Silicone Implants."