#FDA #Approves #Sientra #Profile #Projection #Breast
SANTA BARBARA, Calif., July 6, 2022 (GLOBE NEWSWIRE) — Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the low-plus-profile projection breast implant for breast augmentation in women ages 22 and older all age groups undergoing breast reconstruction. This product will be commercially available in the United States in late July 2022 to board-certified and board-licensed plastic surgeons.
More than 500,0001 Women in the US made the choice to have breast augmentation or revision surgery last year, and according to the latest statistics from the American Society for Aesthetic Plastic Surgery, breast augmentation including revision surgery increased 41 percent from 2020 to 20211making it the top-grossing procedure for plastic surgeons.2 Providing plastic surgeons with a wide range of implant sizes and profiles allows them to use their artistry and individualize each patient’s outcomes to meet their unique goals and preferences.
“I am pleased to now have this new FDA-cleared Sientra implant option for my patients as it fills a previously unmet need between the low-profile and moderate implants already offered by Sientra,” said Bradley M .Calobrace, MD, a KY-based board-certified plastic surgeon. “Now, when I use Sientra’s new low profile plus projection breast implant, my patients get the natural look with upper pole fullness that they desire.”
Sientra will be the first and only implant manufacturer in the United States to offer 80cc and 110cc gel implants. These two new sizes give surgeons and their patients more options.
“With this new FDA approval, Sientra offers its most comprehensive product portfolio to date. This offering expands our addressable breast augmentation and reconstruction market and will increase our market share in 2022 and beyond,” said Sientra President and CEO Ron…