(Reuters) - Health regulators said on Wednesday they have approved a new silicone gel-filled breast implant made by Allergan Inc.
The U.S. Food and Drug Administration said it approved Allergan’s Natrelle 410 implants to increase breast size in women 22 years and older and to rebuild breast tissue in women of any age.
The silicone gel in the Natrelle 410 implant is designed to be firmer than that in Allergan’s previous Natrelle implant.
The FDA requires Allergan to conduct a series of studies after the product is approved to assess the long term safety. It must follow about 3,500 women for five years and conduct a 10-year study of more than 2,000 women receiving the implant.
The agency based its approval on seven years of data from 941 women. Most complications were similar to those found in previous breast implant studies, including tightening of the area around the implant, re-operation, implant removal and infection.
Reporting By Toni Clarke; Editing by Tim Dobbyn