WASHINGTON (Reuters) - Silicone breast implants will be widely available in the United States for the first time in 14 years after U.S. health officials approved sales by two companies on Friday.You know, I understand that there are women out there who feel they need this because they don’t feel like women if they don’t have huge tits. Or they want to be actresses and they think they’ll get more jobs this way. But, MAN! The fucking side effects! So not worth it.
Mentor Corp. (NYSE:MNT) and Allergan Inc. (NYSE:AGN) each must study the implant risks in 40,000 women for 10 years, the Food and Drug Administration said. Silicone breast implants were banned for most U.S. women in 1992 after some complained the devices leaked and made them chronically ill.
FDA officials said the companies had provided "reasonable assurance of the benefits and risks" that would enable women to make informed decisions.
"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," said Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health.
Breast pain, hardening of the area around the implant, change in nipple sensation, implant rupture and the need for additional surgery all were reported in the companies' studies, the FDA said. Still, most women said they were happy with the implants.