The US Food and Drug Administration (FDA) has authorised Allergan to market 28 additional styles of its Natrelle 410 cohesive anatomically shaped silicone-filled breast implants.
Based on three-year data from a study, the authority approved extra-full projection styles (X), along with additional low projection and height styles (L) from the Natrelle 410 breast implant line, for use in breast reconstruction, augmentation and revision surgery.
The study featured more than 350 women who underwent breast reconstruction, augmentation or revision surgery with the previously approved range of Natrelle 410 breast implants.
Allergan executive vice-president David Nicholson said: “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.
“Natrelle 410 breast implants are the most selected shaped gel implants in the United States.”
The complete 12 style matrix includes three heights and four projection styles, including a 7.1cm option, which is claimed to be the highest projecting implant available in the US, giving surgeons and patients more options to achieve desired outcomes.
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 that enables the implants to have long-lasting shape over time.
Additional implant styles will be available to surgeons and patients in October this year.
Surgeons are being asked by the company to complete a certification programme, which includes instruction on surgical techniques and patient selection, before they are able to offer Natrelle 410 breast implants to their patients.