A group of congressional democrats from the House Energy & Commerce Committee are urging GOP lawmakers to hold hearings on the safety and regulation of brain stents and metal-on-metal hip implants.
The letter, written by Reps. Henry Waxman (D-Calif.), Frank Pallone (D-N.J.), Diana DeGette (D-Colo.) and John Dingell (D-Mich.) specifically targeted the republican chairmans of three influential House committees.
"We believe that looking further into the ‘metal-on-metal’ hip implants and brain stents, two high-profile devices that appear to have resulted in significant harm to human health, would shed further light on the regulation of medical devices," said the October 12 letter.
Hip replacements are one of the most common procedures in the U.S., and more than 500,000 metal-on-metal implants have been performed thus far, according to the letter.
Due to the natural friction of the hip movement, metal particles can wear off implants and enter the patients’ bloodstream, the FDA said.
Metal-on-metal hip implants complaints have skyrocketed in recent months, numbering more than 5,000 since January, which is more than in the past four years combined.
The growing concern puts metal-on-metal hip replacement devices on track to be the biggest and most expensive medical implant quagmire since Medtronic (NYSE: MDT) recalled its Sprint Fidelis lead in 2007.
"We should also be examining evidence as to whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices," Waxman wrote.
The letter comes right as Cook Medical’s drug-coated Zilver PTX stent gets its day with the federal watchdog agency’s circulatory system devices advisory panel. According to the FDA’s preliminary report, Cook’s stent met safety and efficiency standards in the treatment of peripheral arterial disease.
It is unclear how the proposed hearing would affect devices already in the reviewing process.
"While working to reduce inefficiencies at the FDA, it is critical that we also protect patient safety," said the legislators, adding that the FDA review system needs to be strengthened to ensure all medical devices are safe and effective.
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