Back in November 2012, we discussed that Allergan was awaiting approval for their new Gummy Bear Implants, and that like all implants the style 410 has its pros and cons. As I mentioned, I strongly believe that the Natrelle® 410 highly cohesive implant will help women that are in need of reconstruction and hopefully improve the capsule rate dramatically.
The time has arrived. Effective late last week, Allergan, Inc. (NYSE: AGN) announced that they have received approval from the U.S. Food and Drug Administration(FDA) to market the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery. Below is the information released by Allergan, Inc.:
IRVINE, Calif.–(BUSINESS WIRE)– Allergan, Inc. (NYSE: AGN) today announced that the company has received approval from the U.S. Food and Drug Administration(FDA) to market the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.
“The FDA approval of Natrelle® 410 shaped gel implants provides an important new alternative to traditional round implants for women considering breast augmentation, reconstruction or revision surgery,” said David E.I. Pyott, Allergan’s Chairman of the Board, President and Chief Executive Officer. “The Natrelle® 410 is the most selected shaped gel implant in markets where the product is already available, such as Europe and Canada. We are pleased that the FDA has recognized the benefits and safety of the Natrelle® 410, and has now made the product available as an additional option for women in the United States.”
The Natrelle® 410 shaped gel implant is designed to mimic the slope of the breast and is filled with a highly cohesive silicone gel, which is intended to enable the implant to hold its shape over time while remaining soft to the touch.
The FDA approval of the Natrelle® 410 shaped gel implants was based on an extensive review of various studies and data, including pre-clinical device testing and clinical data from Allergan’s 10-year prospective, multi-center pivotal study, involving nearly 1,000 women who have undergone breast reconstruction, augmentation or revision surgery.