Allergan has obtained approval from the US Food and Drug Administration (FDA) for 28 additional styles of Natrelle 410 silicone-filled breast implants.
The approval has been granted for 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 implants for use in breast reconstruction, augmentation and revision surgery.
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.
The complete 12 style matrix comprises three heights and four projection styles, including a 7.1cm option, claimed to be the highest projecting implant available in the US.
The additional gel implant styles approval was based on three-year data from a study of over 350 women who had breast reconstruction, augmentation or revision surgery with the previously approved range of Natrelle 410 breast implants.
These implants can be used for breast augmentation for women of at least 22 years old, which includes primary breast augmentation to increase the breast size and revision surgery to correct or improve the result of a primary breast augmentation surgery.
In addition, implants are used for breast reconstruction that includes primary reconstruction to replace breast tissue, which was removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality.
It also comprises revision surgery to correct or improve the result of a primary breast reconstruction surgery.