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US to reconsider breast implant safety
Silicone breast implants, banned for most U.S. women since 1992 due to health concerns, will come under scrutiny again starting on Monday as a panel of health experts weighs whether new data shows they are safe enough to be widely marketed. A three-day meeting will open with nearly 12 hours of public testimony from patients, doctors and interest groups both supporting and opposing the implants made by Inamed Corp. and rival Mentor Corp.
Many women and plastic surgeons say the silicone gel-filled devices, which are widely available in other countries, have a more natural look and feel than saline-filled breast implants.
But some patients are convinced that leaking silicone can cause sickness, although studies have failed to find a link to cancer, lupus or other chronic diseases.
In October 2003, an advisory panel said Inamed's silicone implants were safe enough to be sold, but the agency rejected the application and asked all makers to collect more data on when and how often the devices break.
The FDA panel of outside experts will review the new data at this week's meeting.
Both Inamed and Mentor have said the silicone implants they make now are sturdier than the ones popular in the 1970s and 1980s, adding that the gel is stickier and less likely to migrate.
Inamed is being bought by Medicis Pharmaceutical Corp.
FDA staff reviewers last week questioned new submissions from both companies, which they said failed to shed light on how likely the devices are to break.
Inamed's analysis assumes "the implant does not age" so that the number of broken devices is the same each year, the reviewers said.
FDA staff cited estimates that anywhere from 21 to 74 percent of the silicone devices could break 10 years after implantation.
Breast cancer survivors and others needing breast reconstruction or implant replacements have been able to get silicone implants since the 1992 ban, but only through clinical trials.
Between 25,000 and 30,000 U.S. women have been getting silicone implants each year as part of the trials, Inamed officials have said.
According to the American Society of Plastic Surgeons, more than 264,000 cosmetic implant procedures, and nearly 63,000 breast reconstructions, were performed in 2004.
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