Allergan, plc. (NYSE: AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market 28 additional styles of Natrelle® 410 silicone-filled breast implants, giving surgeons and patients more options to achieve desired outcomes. The FDA approved extra-full projection styles (X), along with additional low projection, low height styles (L) from the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant line, for use in breast reconstruction, augmentation and revision surgery.
Designed to mirror the shape of a woman's breast, the Natrelle® 410 Shaped Gel Breast Implants are filled with a highly cohesive silicone gel which enables the implants to have long-lasting shape over time. The additional projection styles offer surgeons more options to better meet the individual needs of each patient.
"The FDA approval of additional Natrelle® 410 shaped gel implants is further proof of Allergan's long-standing and continued commitment to medical aesthetics and plastic surgery," said David Nicholson, Executive Vice President. "Natrelle® 410 breast implants are the most selected shaped gel implants in the United States."
The approval of the X and L projection styles adds to a wide range of breast reconstruction, augmentation and revision surgical options across the Natrelle® 410 Shaped Gel Breast Implants line. The complete 12 style matrix includes three heights and four projection styles, including a 7.1 cm option – the highest projecting implant available in the U.S., giving surgeons and patients more options to achieve desired outcomes.
The FDA approval of additional Natrelle® 410 shaped gel implant styles is based on 3-year data from a study of over 350 women who underwent breast reconstruction, augmentation or revision surgery with the previously approved range of Natrelle® 410 breast implants.
These additional implant styles will be available to surgeons and patients in October 2015. Allergan requires surgeons to complete a certification program, which includes instruction on surgical techniques and patient selection, before they are able to offer Natrelle® 410 breast implants to their patients.