New Silicone-Gel Breast Implant Approved by FDA
A new silicone-gel breast implant for women 22 years and older has been approved by the U.S. Food and Drug Administration.
The agency said that Allergan's Natrelle 410 implant contains silicone gel that is firmer than the company's older Natrelle models, the Associated Press reported.
The approval was based on data from 941 women collected over seven years. Allergan's studies did not compare the safety of the new implant with that of the older models.
"The data we reviewed showed a reasonable assurance of safety and effectiveness," said Dr. Jeffrey Shuren, the FDA's medical device director, the AP reported. "We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness."
Silicone-gel implants were banned by the FDA in 1992 due to fears they could cause illnesses such as cancer and lupus. But the ban was lifted in 2006 after research ruled out most of the health concerns.
Copyright © 2012 HealthDay. All rights reserved.