A number of consumer advocate groups are asking Congress to investigate the US Food and Drug Administration's decision to allow the return of silicone gel breast implants, the Associated Press report.
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The National Organization for Women and a dozen other women's and health groups contend that the agency is violating its own safety standards in allowing the implants back on the market. The devices were withdrawn 13 years ago over concerns that they could leak and cause chronic illness.
Last year, the FDA told implant makers to provide long-term data on the implants' durability, and on the consequences of silicone leaking into women's bodies, the wire service said. But when the agency last month OK'd Mentor Corp.'s petition to return the devices to the market, it based its decision on a company study that tracked implant recipients for only three years, the AP added.
The consumer groups also are urging the FDA to release details of its criminal investigation of Mentor in the late 1990s. The FDA closed the probe without taking any action against the company, which has denied that it underreported problems with the implants. An agency spokeswoman said the FDA is working on releasing details of the investigation, the wire service reported. – (HealthDayNews)
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