Mentor Worldwide has received approval from the US Food and Drug Administration (FDA) for four new styles of the MENTOR MemoryShape Silicone Breast Implants.
The implants have been developed for breast augmentation and reconstruction in women of above 22 years age.
The approval was based on clinical studies, including a core study of 955 patients implanted with MemoryShape Implant Style MM and a study of all five MemoryShape Implant styles, comprising 3,637 patients.
The core study demonstrated that patients with MemoryShape Implants expressed better satisfaction with their breast appearance and around 97% reported they would make the same decision again to have breast implant surgery, according to the company.
MENTOR MemoryShape Breast Implants, which have been approved a decade ago outside the US, includes a teardrop shape and are filled with a uniquely formulated cohesive gel that enables shape retention.
Mentor Worldwide president David Wilson said the product line demonstrates firm’s commitment to meet the needs of plastic surgeons and their patients with an expanded range of shaped styles and sizes of implants that have demonstrated better patient satisfaction and safety in long-term study.
"Our growing portfolio can now more effectively meet the needs of patients undergoing either breast reconstruction or augmentation surgery by allowing a better match between the patient and the implant on height, width and desire for optimal projection," Wilson added.
Image: MENTOR MemoryShape Breast Implant. Photo: courtesy of PRNewsFoto/Mentor Worldwide.