Important Safety Information
alloClae Structural Adipose Tissue
IMPORTANT SAFETY INFORMATION: alloClae is intended to be applied subcutaneously in localized areas of the body to provide cushioning and support to the patient's body where adipose tissue naturally exists. alloClae does not contain viable cells, and has no systemic effect, and is not dependent upon the metabolic activity of living cells for its primary function. This allograft is intended for single patient use only. Human tissue shall not be offered or dispensed for veterinary use. alloClae should not be used on patients with severe allergen sensitivities, a history of anaphylaxis, or in the presence of active infection. Like all procedures of this type there is a possibility of complications, although not everyone experiences them. Those potential complications include cystic or nodule formations, pain or infection, hematoma, anaphylaxis or other allergic or immune responses, or discoloration of the skin at the procedure site.
Sientra Silicone Gel Breast Implants
IMPORTANT SAFETY INFORMATION: Sientra’s Silicone Gel Breast Implants are indicated for breast augmentation in women at least 22 years old and for breast reconstruction. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery. Breast implant surgery is contraindicated in women with active infection anywhere in their bodies, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions and, who are pregnant or nursing. Key complications include capsular contracture, implant removal, rupture and reoperation. For more detailed information about the risks and benefits of Sientra breast implants, please visit sientra.com/resources or call Sientra at 888.708.0808. Sientra breast implants with high-strength cohesive silicone gel are only available through board-certified or board-eligible plastic surgeons.
The sale and distribution of this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Sientra, Inc.
Viality Lipoaspirate Wash System
IMPORTANT SAFETY INFORMATION: The Viality Lipoaspirate Wash System is to be used to filter and wash aspirated, harvested autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation. The Viality Lipoaspirate Wash System may be used in processing harvested adipose tissue obtained in surgical specialties, including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. The Viality Lipoaspirate Wash System is not intended to process autologous adipose tissue other than for aesthetic body contouring uses.
