The US Food and Drug Administration (FDA) has granted approval for US-based pharmaceutical firm Allergan to market its Natrelle Inspira round gel-filled smooth breast implants.
Compared to available breast implant styles, Allergan’s Natrelle Inspira line has a higher fill ratio that provides an additional breast shaping option for women undergoing reconstruction, augmentation or revision surgery.
With approval, the Natrelle Inspira round gel-filled smooth breast implants are now added to the broad portfolio of currently available Natrelle products, which include the Natrelle 410 anatomically shaped implants, classic round gel implants and saline implants.
The Natrelle breast implants are available with 243 size options and a variety of projection styles.
Allergan executive vice-president Research and Development Scott Whitcup said: "The FDA approval of Natrelle Inspira round gel-filled implants exemplifies our commitment to scientific innovation, and to meeting the dynamic needs of plastic surgeons and their patients.
"In the past two years, Allergan has received FDA approval for three new and important breast implant options, which represent the latest advancements in Allergan’s growing product portfolio."
According to the company, the Natrelle product line allows plastic surgeons to provide a tailored fit based on a patient’s desired look and individual size and dimensions.
The Jewell District Medical Spa and Plastic Surgery Center founder Mark Jewell said: "The FDA approval of NATRELLE INSPIRA breast implants heralds a major advancement in the art and science of aesthetic and reconstructive breast implant surgery in the US.
"The Natrelle Inspira breast implants provide women seeking breast augmentation the option of fullness in breast shaping that can become lost after pregnancy.
"Additionally, this implant will provide a great revision option to the millions of women in America who have ageing saline or silicone breast implants."
The new breast implants are developed for breast augmentation of women at least 22 years old, and it includes primary breast augmentation to increase breast size and revision surgery to correct or improve the result of a primary breast augmentation surgery.
They will also be used for breast reconstruction, which includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma, or that has failed to develop properly due to a severe breast abnormality.