Overview: This document provides information on
pectoral implants, which are medical devices restricted to sale by or on the order of a physician. These implants are not intended for use as
breast implants, and their safety and effectiveness for breast augmentation, reconstruction, or revision have not been established.
Purpose: Pectoral implants are designed for the surgical repair of deficiencies such as congenital pectoral aplasia. They are used to enhance the appearance of patients with underdeveloped or disproportionate chests. The implants have a textured surface and come in various sizes.
Surgical Procedure: The incision for implant insertion is made in the axillary region and should be approximately 5 cm wide. The pocket for the implant is created beneath the largest pectoral muscle, ensuring not to remove it from the smaller pectoral muscle. The undermining should stop 1 to 2 cm below the areola to avoid a low implant position, which could result in a feminine appearance. The pocket must be inspected for any remaining muscle fibers. The implant is inserted using long tongs, ensuring it is positioned correctly between the two pectoral muscles.
Device Features: The implants contain a polyester reinforcement to aid in the insertion process. They are supplied in different shapes for the left and right sides to ensure symmetry.
Dimensions and Reference: The document provides a table with dimensions and volume for different implant sizes, including specific references for right and left side implants.
Contact Information: Sientra, located in Santa Barbara, CA, provides contact details including phone numbers and a website for further information.
See more