Santa Barbara, CA-based Inamed said that it will amend its silicone gel breast implants PMA submission after the FDA panel rejected the company’s original application in April.
As part of its revised application, the company has provided the FDA with three years of post-market data and additional imaging information.
It has also halted clinical studies of its Style 153 model breast implant, for which it had originally sought approval. Instead, the company will seek approval for its BioDimensional Style 410 Matrix implant, which the FDA is currently studying.
Inamed’s silicone gel breast implants have been widely available outside the U.S. for approximately 10 years. They are currently not allowed for cosmetic use in the U.S. because of a FDA ban.
In April the agency panel narrowly rejected Inamed’s application while approving rival Mentor’s silicone-gel breast implant under strict limitations.
The FDA banned silicone gel-filled breast implants in 1992 after some women reported health problems including migraines, fibromyalgia and chronic pain.
Inamed is a maker of facial aesthetic and obesity reduction products in addition to breast implants.
Inamed Supplements Data To Gain Approval for Implant
Published July 20, 2005
blog comments powered by Disqus