Europe’s Most Popular Breast Implant Gets FDA Nod

In short 

Allergan, Inc. has received approval from the U.S. FDA to market the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.

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.

Background

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.

The approval is conditional on Allergan doing quite a few things, including commencing a new 10 year study among others.

For its part, Allergan requires surgeons to complete a certification program, which includes instruction on surgical techniques and patient selection, before they are able to offer the Natrelle® 410 shaped gel implant option to their patients.

Physician comments

“For many patients, round silicone and saline breast implants are good options. For others, they may not provide the aesthetic outcome they desire,” said Scott L. Spear, M.D., FACS, Chairman, Department of Plastic Surgery, Georgetown University School of Medicine. “As well, patients may have minimal breast tissue remaining after the removal of a tumor or have lost breast volume over the years, so the option of a shaped breast implant designed with an anatomical shape that lasts over time is an important one as it may help these patients obtain the aesthetic look they are seeking.”

Company comments

“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.”

Source: Allergan, Inc., Business Wire