According to the Orange County Register the Food and Drug Administration has approved a new silicone-gel breast implant, making Sientra of Santa Barbara the 3rd company in the nation to market the products. The company says it plans to offer implants in different shapes in addition to the round implants now sold by Irvine-based Allergan and Johnson & Johnson’s Mentor unit, also based in Santa Barbara. Silicone breast implants have been controversial for several years, with critical experts concerned about devices dispensing silicone through leaks or rupturing. Silicone implants were pulled from the market in 1992 but scientists later reported that they ruled out most potential health risks and silicone came back on the market in 2006. Since then manufacturers have been required to track women who get the implants. And last year, the director of the FDA’s Center for Devices and Radiological Health warned that recurrent visits and MRI scans are important for all women who receive breast implants. The FDA also said the majority of women who get the implants will have to have breast implant exchange or undergo additional surgery in 8 to 10 years. “Data on these [Sientra] and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health, said in a news release today. He added, ”It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.” Dr. Kim like most plastic surgeons welcomes the idea of another alternative for FDA approved silicone cohesive gel implants. Breast augmentation patients including those who need a combined breast lift theoretically will be served better with more options. This could translate into better savings as competition should drive the cost of the breast implants down. Dr. Kim advises patient to be diligent concerning their choices of plastic surgeons to perform the breast augmentation procedure. Although it is a popular procedure it is not”easy”. The overall long-term results are heavily dependent upon the plastic surgeon, his expertise, natural and acquired skills. Dr. Kim provides all of his patients an extensive photo gallery displaying his impressive results.
