Allergan, Inc. has announced that it has received approval from the U.S. FDA to market two new styles, X and L, of the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.
Background
The Natrelle® 410 X and L styles provide surgeons additional options to customize their patients’ fit by matching the implant’s height and width with the patient’s body type while providing optimal projection, based on the desired aesthetic outcome. The new Natrelle® 410 X styles provide extra full projection, while the new L styles feature low height and low projection. The entire line of Natrelle® 410 shaped gel implants are designed to mimic the slope of the breast and are filled with a highly cohesive silicone gel, which is intended to enable the implants to hold their shape over time while remaining soft to the touch.
The FDA approval of the additional Natrelle® 410 shaped gel implant styles is based on 10-year data from a study of nearly 1,000 women who underwent breast reconstruction, augmentation or revision surgery with the previously approved range of Natrelle® 410 breast implants. Allergan says Natrelle® 410 breast implants are the most selected shaped gel implants in the United States and are one of the most extensively studied shaped gel implants.
Physician comments
“Breast augmentation, revision and reconstruction patients have varying needs when it comes to implants. Having additional implant options, such as the Natrelle® 410 X and L styles, available to me and my patients enables me to provide the aesthetic outcomes they desire,” said Patrick Maxwell, M.D., a board certified plastic surgeon and Founder of Maxwell Aesthetics in Nashville, TN. “Based on my experience with the implants and a decade of safety data available, I feel confident recommending Natrelle® 410 breast implants to my patients.”
Company comments
“The FDA approval of additional Natrelle® 410 shaped gel implants underscores Allergan’s long-standing commitment to innovation and R&D investment in medical aesthetics and plastic surgery,” said David E.I. Pyott, Allergan’s Chairman of the Board and Chief Executive Officer. “The approval provides plastic surgeons with additional implant options enabling them to better meet the individual needs of women considering breast augmentation, reconstruction or revision surgery.”
Source: Allergan, Inc., Business Wire
