Receive our newsletter – data, insights and analysis delivered to you
  1. News
August 6, 2015

FDA clears 28 additional styles of Allergan’s Natrelle breast implants

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.

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.

"Natrelle 410 breast implants are the most selected shaped gel implants in the United States."

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.

Content from our partners
The added value of Qarad’s multilingual freephone service to their eIFU solution
Small and simple: how medical device manufacturers select materials
Precision wire: The future of bespoke medical treatment

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU