FDA deems silicone breast implants safe
The Food and Drug Administration (FDA) recently released a statement confirming that new medical studies have demonstrated the general safety of silicone breast implants. The studies were performed by Johnson & Johnson’s Mentor Unit and Allergan Inc., two well known and long standing breast implant manufacturers.
Silicone breast implants were removed from the market in 1992 by the FDA on the grounds that the product’s manufacturers had not demonstrated the safety of the implants. From 1992 until 2006 saline implants dominated the market. Saline breast implants consist of a bio-compatible pouch filled with a non-toxic saline solution. While they look and feel somewhat like silicone implants and are well known for their safety and reliability, they are generally less sought after due to their watery, less than life-like texture.
During the fourteen year ban on silicone implants in the United States, researchers were unable to link the implants with any long term adverse health effects. Failure to identify any serious negative side effects associated with the implants led to their reintroduction into the market. The FDA asserted, however, that the reintroduction must be accompanied by new studies concerning the long term ramifications of receiving breast implants.
After the ban on silicone implants was lifted, Allergan and Mentor both began independent studies to confirm that their products adhered to the highest health and safety standards. Their studies monitored some forty thousand women who had undergone breast augmentation surgery, and documented the success of the procedures as well as the reliability of the implants at several year intervals after the initial surgery.
While maintaining active, accurate records of as many as forty thousand patients proved to be a complicated and difficult task for both Mentor and Allergan, the studies thus far have delivered some promising results. The FDA’s statement released late last month concluded that silicone breast implants are generally safe, and that only about one in five women experience complications within ten years of an implant procedure.
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