FDA Nod for Sientra’s Low Plus Profile Projection Breast Implant

The U.S. Food and Drug Administration (FDA) approved Sientra’s Low Plus Profile Projection Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breast reconstruction.

This product will be commercially available for board-certified and board-eligible plastic surgeons in the United States in late July 2022.

“I am excited that I will now have this new FDA-approved Sientra implant option for my patients, as it fills a formerly unmet need between the low profile and moderate profile implants Sientra already offers,” says Bradley M. Calobrace, MD, a KY-based board-certified plastic surgeon, in a news release. “Now when I utilize Sientra’s new Low Plus Profile Projection Breast Implant, my patients will get the natural look with the upper pole fullness they desire.”

Sientra will be the first and only implant maker within the United States to offer 80cc and 110cc gel implants. These two new sizes will bring more options to surgeons and their patients.

“With this new FDA approval, Sientra offers its most comprehensive product portfolio to date. This offering expands our addressable market in breast augmentation and reconstruction and will accelerate our market share in 2022 and beyond,” adds Sientra President and CEO Ron Menezes. “We have long been committed to matching Sientra’s unrivaled safety profile3 and best-in-industry, Sientra Platinum 20™, warranty with a strong R&D pipeline, bringing surgeons and their patients a broader selection for creating their ideal outcomes.”