Silicone breast implants are gel filled medical devices implanted in the breast tissue or beneath the chest muscle to increase or reconstruct the breast. These implants have an outer smooth or textured silicone gel-filled and comes in different sizes. Breast reconstruction replaces the breast tissue 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 result of a primary breast reconstruction surgery. Breast augmentation includes primary breast extension to enlarge the size of the breasts and the surgery review to correct or improve the result of a primary breast augmentation surgery. With this new approval, include three gel silicone implants approved by FDA in the U.S. manufactured by Allergan , Mentor and Sientra . "Research on these and other silicone breast implants filled with gel approved continue to demonstrate reasonable assurance of safety and efficacy," said William Maisel, MD, MPH, deputy director for science at the Center the FDA for Devices and Radiological Health. "It is important to remember that breast implants are not lifetime devices.
Women should fully understand the risks associated with breast implants before considering the increase or reconstructive surgery, and recognize that the long-term monitoring is essential. "said Maisel. The FDA based its approval to Sientra three years of data in clinical trials among 1.788 participants. The complications and the results reflect those found in previous studies of breast implants and others include hardening of the area around the implant (capsular contracture), reoperation, implant removal, uneven appearance (asymmetry), and infection. Source: FDA.gov
