FDA Advisory Panel Rejects Inamed Silicone Breast Implants

Inamed narrowly failed to convince a U.S. panel that its silicone breast implants are safe enough to win U.S. approval and end 13-year-old restrictions sparked by concerns over possible illness from leaking silicone.

The advisory committee voted 5-4 against recommending Inamed's implants, with opponents saying they needed more information on how often and why the devices break. The FDA will consider the panel's advice as it decides whether to lift sales restrictions imposed in 1992 amid concerns that leaking implants could cause long-term, disabling diseases such as lupus or rheumatoid arthritis. However, studies have failed to find a connection between silicone implants and chronic illnesses. The implants can cause pain and other local complications, and they can break and require repeat operations to replace them.

An earlier bid by Inamed to sell silicone breast implants was rejected by the FDA in January 2004 despite a 9-6 vote from another panel that urged approval. Currently in the U.S., only breast cancer survivors and others needing reconstruction or implant replacements can receive silicone implants through clinical trials.