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Lawmakers Seek Probe Of Metal Hip Implants, Brain Stents

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House Energy & Commerce Committee Democrats are asking Republican lawmakers to probe metal hip implant and brain stent safety and regulation. In a letter authored by Democratic representatives Henry Waxman (California), Frank Pallone (New Jersey), Diana DeGette (Colorado), and John Dingell (Michigan) the Republican chairs of three key House committees were targeted.

“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 representatives in their letter dated October 12, said Mass Device. Mass Device noted that hip replacement surgery is among the most popular surgery in the United States, with over 500,000 performed, to date, according to the letter.

As the U.S. Food and Drug Administration has long noted, hip movement friction causes metal pieces to shed from the devices into the patient’s body, noted Mass Device. “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 in the letter, said Mass Device.

The FDA has received an increasing number of Adverse Event Reports (AERS) concerning DePuy Orthopaedics’ all metal Pinnacle hip implant. Its ASR devices have also long made news for their unusually high failure rates. When hip implants fail, revision surgery is required to remove the faulty device and implant the patient with a new device. The surgery is typically more complex and riskier than original the original surgery.

According to Mass Device, the metal-on-metal hip replacement device debacle is expected to be the most expensive in years, second only to 2007’s Medtronic Sprint Fidelis lead recall. DePuy, a unit of Johnson & Johnson, will likely end up costing its parent company $1 billion, noted Mass Device.

Regarding brain stents,a study recently published in the New England Journal of Medicine found that Patients who undergo aggressive medical therapy with no stent implant actually tend to fare better when compared to patients who undergo medical therapy with a brain stent implant, according to the study. As a matter-of-fact, a clinical trial reviewing the FDA-approved Gateway-Wingspan device had to be halted when data revealed that stent patients died more frequently and suffered more strokes versus patients who underwent only therapy. Annually, some 90,000 Americans suffer the type of stroke the Gateway-Wingspan was developed to prevent.

Mass Device said that it remains unclear how the potential hearing would impact devices currently under review. “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 consistent medical device safety and efficacy, said Mass Device.

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