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(Reuters) - Women who get silicone breast implants are likely to need additional surgery within 10 years to address complications such as rupturing of the device, U.S. health regulators said on Wednesday.
The FDA approved silicone gel-filled breast implants sold by Allergan and Johnson & Johnson's Mentor unit in 2006. It had banned silicone implants for most U.S. women in 1992 after some complained that the devices leaked and made them chronically ill.
As a condition of taking the devices to market, both companies were required to conduct post-approval studies of 40,000 women for 10 years, as well as extend smaller pre-approval studies. The FDA considered the companies' results, as well as reports of negative events and scientific literature.
The report also found a small correlation between implants and anaplastic large-cell lymphoma, a form of cancer that affects about 3,000 Americans a year.
From 1997 to 2010, there were about 60 cases of ALCL reported for women worldwide out of about 5 million to 10 million women who had breast implants, Shuren said.
"If there's a true association between that cancer and implants, it's very, very rare," he said.
The FDA said most long-term studies confirmed initial results, and that most risks of implants were well known.
"Most women reported high levels of satisfaction with their body image and the shape, feel and size of their implants," the FDA report said, adding that they should monitor their breasts for the rest of their lives.
http://www.reuters.com/article/2011/06/22/us-fda-implants-idUSTRE75L3NA20110622
The FDA approved silicone gel-filled breast implants sold by Allergan and Johnson & Johnson's Mentor unit in 2006. It had banned silicone implants for most U.S. women in 1992 after some complained that the devices leaked and made them chronically ill.
As a condition of taking the devices to market, both companies were required to conduct post-approval studies of 40,000 women for 10 years, as well as extend smaller pre-approval studies. The FDA considered the companies' results, as well as reports of negative events and scientific literature.
The report also found a small correlation between implants and anaplastic large-cell lymphoma, a form of cancer that affects about 3,000 Americans a year.
From 1997 to 2010, there were about 60 cases of ALCL reported for women worldwide out of about 5 million to 10 million women who had breast implants, Shuren said.
"If there's a true association between that cancer and implants, it's very, very rare," he said.
The FDA said most long-term studies confirmed initial results, and that most risks of implants were well known.
"Most women reported high levels of satisfaction with their body image and the shape, feel and size of their implants," the FDA report said, adding that they should monitor their breasts for the rest of their lives.
http://www.reuters.com/article/2011/06/22/us-fda-implants-idUSTRE75L3NA20110622
