Breast Implants / Breast Augmentation - WARNINGS AND PRECAUTIONS - Saline Filled Breast Implant Breast augmentation and augmentation mammoplasty are plastic surgery terms for the breast-implant and the fat-graft mammoplasty approaches used to increase the size, change the shape, and alter the texture of the breasts of a woman. As a primary reconstruction, augmentation mammoplasty is applied to effect a post-mastectomy breast reconstruction, the repair of the chest wound consequent to the removal of a cancerous breast; to correct congenital defects of the breast(s); and to correct congenital defects of the chest wall. As an elective, cosmetic surgery, primary augmentation changes the aesthetics - of size, shape, and texture - of healthy breasts. The surgical implantation approach effects the global augmentation of the breast hemisphere using a breast implant, either an implant filled with saline-solution, or an implant filled with silicone-gel; moreover, the surgical augmentation approach can include the application of transplanted autologous skin flaps harvested from the woman's body. The fat-graft transfer approach augments the size and corrects contour defects of the breast hemisphere with grafts of autologous adipocyte fat tissue, drawn from the woman's body. Summary of Safety and Effectiveness Data (Ssed) - PMA P120011: FDA Summary of Safety and Effectiveness Data. The IDEAL IMPLANT is a round, smooth-surface, saline-filled breast implant that is supplied sterile in a dual tray packaging system with two disposable fill tubes and reflux valves. It was developed to provide women and surgeons with another option in addition to the current saline-filled implants or silicone gel-filled implants. While the currently available, FDA-approved saline-filled implants have a single lumen within a single shell made from cross-linked silicone elastomer, the IDEAL IMPLANT has two lumens within two nested shells that are attached at the patch on the back of the implant. The inner lumen within the inner shell is filled through a valve in the patch. The outer lumen within the outer shell and surrounding the inner shell is filled through a valve on the front. Unattached and floating within the outer lumen is a baffle structure designed to restrict movement of the saline in the outer lumen. Table 1 below shows that the amount of material required for the baffle structure is proportionate to the size of the implant and the fill volume in the outer lumen. This baffle structure is comprised of one to three nested baffle shells that are perforated with slits so the saline is free to move through the slits, as well as around and between the shells.