14 DAY TRIAL // The Food and Drug Administration has recently announced that they raise the ban on silicone gel breast implants temporarily, while they are deeply looking into the risks, effectiveness and safety of such plastic surgery. Throughout time, the FDA cautioned that resorting to plastic surgery for cosmetic purposes is severely restricted, therefore women who wanted to enlarge their breasts through silicone implants should not be very enthusiast when hearing the news.
The US watchdog allowed for a short period of time silicone breast implants, but mainly for breast reconstruction, consequently only for functional plastic surgery, for women who have lost a breast to serious conditions such as breast cancer.
Since 1992, sales of silicone breast implants for both cosmetic and functional purposes have been forbidden. Yesterday, 17th of November 2006, after a 14-year ban, US officials have announced that women who want to resort to plastic surgery in order to enlarge or reconstruct their breasts are legally free to do it.
Nevertheless, both Mentor Corp. and Allergan Inc. companies who have been greenlighted by the FDA to sell silicone breast implants after a 14-year ban will have to check on the safety and effectiveness of the particular implants for 10 years from now on in 40,000 women. In 1992, the US watchdog has declared silicone breast implants illegal due to a large number of complaints about the devices leaking and causing chronic health disorders.
Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health stated: "We now have a good understanding of what complications can occur and at what rates. We also know that women who get these devices will probably need to have additional breast implant surgery at least once."
Dr Scott Spear, head of plastic surgery at Georgetown University Hospital, told the Associated Press: "It's a hugely positive piece of news for plastic surgeons and for patients... because it really allows us to turn a page and to work with what we have believed for a long time is a better technology and better device."