Although the medicine and plastic surgery have evolved so much over the past decades, women still don’t have too many choices when it comes to breast implants. However, the FDA just approved a new silicone gel breast implant, produced by Sientra.
Last week, the Food and Drug Administration (FDA) announced it will approve Sientra’s third new model of silicone gel filed breast implant, if the company manages to bring studies that will consolidate its safety and success rates long term. Sientra’s newly approved silicone gel breast implant adds to the other two such implants approved by the FDA.
According to Sientra, the manufacturer’s new silicone gel breast implant is designed for breast augmentation procedures in patients over 22 years. The producer’s specifications rule it to be appropriate and effective for reconstruction of breast tissue in patients of any age.
For a lot of women today, such as breast cancer patients, rebuilding breast tissue is of huge importance. The silicone gel implants bring better quality and a more natural look, coming in all sort of sizes and shells. Basically, the procedure itself has been developed by skilled surgeons to state of the art. The implants are placed under the patient’s chest muscle.
However, the FDA warns that despite the state of the art technology and high quality surgeon work, patients need to remember that “breast implants are not lifetime devices”. William Maisel is a deputy director in the Center for devices and Radiological Health with the FDA. He said: “Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential”.
Also, another point to have in mind, is that being approved by the FDA does not mean each procedure is free from side-effects. For instance, Sientra’s new approved silicone gel breast implants have been approved after FDA investigators compared the results of a three years clinical report.
Based on Sientra’s clinical test and similar reports, the administration ruled that this manufacturer’s breast implant has the same complications and results as others in the market. The complications and side effects include infection, tightening of the skin around the implant, asymmetry and even risks of implant removal or undertaking the procedure once again.