Just recently, the US Food and Drug Administration has approved a new brand of silicone breast implant; the device, which is made by California-based Sientra, can be used in breast reconstruction following cancer surgery, and cosmetic breast augmentation.
Dr. Tarick Smaili, one of the leading Los Angeles plastic surgeons, believes the FDA’s approval clearly shows the “reasonable safety of silicone breast implants, despite potential risks such as implant failure and hardening of the tissue or capsular contracture.”
“Any type of breast implant does not guaranty to last a lifetime, although modern designs can accommodate greater force and are quite resistant to the elements that are causing natural wear and tear,” Smaili said.
The plastic surgeon added that implant from Sientra is just like other brands already sold in the US market, thereby patients who will choose the new silicone implant are “technically choosing a technology that has been tried and tested for many years.”
“In fact, silicone breast implants have been subjected to the most rigorous, comprehensive clinical trials and surveys that would allow patients to make a good decision and understand the potential risks and limits of the devices,” he said.
Meanwhile, the plastic surgeon believes that Sientra breast implant is neither inferior nor superior to other brands manufactured by Mentor and Allergan, which used to be the only two companies allowed by the FDA to sell silicone and saline breast implants.
In 1992, silicone breast implants were banned in the US over concerns that they may increase the risk of cancer and many forms of systemic disease. But in 2006, the FDA has lifted the moratorium based on facts that no study has proven the link between the devices and serious illnesses.
After the lifting of the 14-year ban, silicone breast implants are increasingly becoming more popular than saline implants because they provide a natural feel and look. In addition, many doctors believe they are less likely to fail because the cohesive gel filling prevents wrinkling, a problem that can eventually lead to shell failure.
By contrast, saline implants—which are filled with a sterile mixture of salt and water—are relatively prone to “folds” that may rub each other, thereby increasing the risk of implant failure.