FDA’s approval of silicone breast implants doesn’t mean they are risk-free. US Food and Drug Administration (FDA) officials have this month approved the sales of silicone breast implants for the first time in 14 years. Revelations that have led to widespread scepticism as to whether it is too soon for silicone to be back on the cosmetic market.
Following the four-year review of an extensive amount of data from clinical trials, the FDA has deemed the marketing of silicone breast implants from two companies, Mentor and Allergan, to be safe and effective for women over the age of 22 years old.
The agency says nothing it approves carries definitive proof that it’s absolutely safe for all people. And the silicone implants will carry warnings about possible problems.
But given the implants’ troubled history and the studies still to come on their safety, women considering them should weigh whether they’re truly worth the risk.