A Medical Device Daily
Inamed (Santa Barbara, California) reported receiving a letter from the FDA concerning its Style 410 cohesive gel-filled breast implants premarket approval (PMA) application.
Inamed said that the letter outlines the additional information that Inamed must provide before the agency can complete its review of the Style 410 PMA. It added that the additional information is necessary in order for the FDA to determine whether there is reasonable assurance that the Style 410 breast implants are safe and effective for their intended use.
Inamed calls the Style 410 its next generation gel-filled breast implant, designed for memory and shape retention. It is marketed internationally as the Bio-Dimensional Cohesive Gel Matrix (Style 410). And it says the Style 410 breast implants "are the preferred choice of breast implants by physicians and patients in countries where they are commercially available."
The company said that the Style 410 breast implants are not part of its PMA application to be considered at the FDA's Medical Devices Advisory Committee meeting on April 11-13, and that the letter has no impact "on the timing or substance" of the issues considered at that meeting.
Nick Teti, president, CEO and chairman of Inamed, said, "We acknowledge and appreciate the review to date . . . . As has been our ongoing practice, we intend to work closely and cooperatively with the FDA in providing the additional information that will allow it to complete the review of our Style 410 PMA."
Inamed's products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the LAP-BAND System for morbid obesity.