FDA panel approves one make of silicone breast implant in the US
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《英国医生杂志》
A panel of advisers to the US Food and Drug Administration last week unexpectedly recommended approving silicone breast implants made by Mentor Corporation, just one day after rejecting a similar product from a competing firm.
In a seven-two vote last Wednesday, the panel recommended approving silicone breast implants but attached nine conditions. The conditions included more rigorous monitoring of safety issues, including the effects on pregnant women; mandatory education for doctors and patients; and setting up a national register of recipients. On Tuesday, however, the panel had voted five-four against approving silicone implants made by a competitor, Inamed Corporation, because of a lack of convincing evidence of safety.
A silicone breast implant has been recommended for use in the US, 13 years after such implants were effectively taken off the US market
Credit: KLAUS GULBRANDSEN/SPL
Both companies have been trying to overturn a ban imposed more than 10 years ago. Silicone breast implants were effectively taken off the market in 1992 in the United States. This was because of wide-spread public concern about a range of health effects, including localised effects of implants rupturing and the potential for more serious illness, including connective tissue diseases.
In the past decade, implants have been available to women only for breast reconstruction after cancer and only within the context of long term trials. Some of these trials were designed to run for 10 years.
Three years' data from these trials presented at the FDA advisory hearings by Mentor showed that rates of rupture with their implants were less than 1%. Two panel members argued strongly that the evidence was too preliminary to support approval, however. Amy Newburger said that it was "still too soon" to know about the safety of either company's implants. And Brent Blumenstein argued that there was "too much uncertainty" in the evidence, highlighting data that showed that implants may increase the risk of symptoms of connective tissue diseases.(Ray Moynihan)
In a seven-two vote last Wednesday, the panel recommended approving silicone breast implants but attached nine conditions. The conditions included more rigorous monitoring of safety issues, including the effects on pregnant women; mandatory education for doctors and patients; and setting up a national register of recipients. On Tuesday, however, the panel had voted five-four against approving silicone implants made by a competitor, Inamed Corporation, because of a lack of convincing evidence of safety.
A silicone breast implant has been recommended for use in the US, 13 years after such implants were effectively taken off the US market
Credit: KLAUS GULBRANDSEN/SPL
Both companies have been trying to overturn a ban imposed more than 10 years ago. Silicone breast implants were effectively taken off the market in 1992 in the United States. This was because of wide-spread public concern about a range of health effects, including localised effects of implants rupturing and the potential for more serious illness, including connective tissue diseases.
In the past decade, implants have been available to women only for breast reconstruction after cancer and only within the context of long term trials. Some of these trials were designed to run for 10 years.
Three years' data from these trials presented at the FDA advisory hearings by Mentor showed that rates of rupture with their implants were less than 1%. Two panel members argued strongly that the evidence was too preliminary to support approval, however. Amy Newburger said that it was "still too soon" to know about the safety of either company's implants. And Brent Blumenstein argued that there was "too much uncertainty" in the evidence, highlighting data that showed that implants may increase the risk of symptoms of connective tissue diseases.(Ray Moynihan)