Bill to Allow FDA to Block Medical Devices Linked to Safety Recalls

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A bill introduced by House Democrats this month, if passed, will allow federal regulators to block medical devices tied to safety recalls such as the transvaginal mesh implants that are manufactured by companies including C.R. Bard Inc. and Johnson & Johnson. According to a Bloomberg news report, the bill would close a loophole that allows medical devices to get the stamp of approval from the U.S. Food and Drug Administration (FDA) even when they are similar to an unsafe product that has been already pulled from the market.

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Hewlett-Packard to Pay Civil Penalty for Defective Batteries

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Hewlett-Packard has been instructed to pay a civil penalty of $425,000 for failing to report issues with their lithium-ion battery packs that posed burn hazards. According to an article in the Consumer Reports, HP apparently knew of 22 incidents regarding their defective products but failed to immediately report the situation to the Consumer Product Safety Commission (CPSC). Those incidents resulted in injuries to at least two consumers. HP reportedly conducted studies between March and April of 2007 and failed to notify the CPSC of their findings until July of 2008 by which time there were reports of 31 faulty battery packs.

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FDA Asks Transvaginal Mesh Implant Makers to Conduct Three-Year Safety Trials

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The Food and Drug Administration (FDA) has sent out a letter to Johnson & Johnson, C.R. Bard, and 31 other manufacturers of transvaginal mesh products saying that they must study rates of organ damage and other complications linked to these mesh implants. According to a Bloomberg News report, the FDA is asking mesh implant manufacturers to conduct three years of trials on the safety and effectiveness of these mesh products, after finding a five-fold increase in deaths, injuries, or malfunctions linked to these implants.

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