Letter to Chairmen Upton, Pitts and Stearns, October 12, 2011
Congress Urge Hearing on DePuy Metal-on Metal Hip ImplantNovember 5, 2011
Congressmen Urge Hearing on DePuy Metal-On-Metal Hip Implant
Bloomberg Businessweek reports that a group of concerned Congressmen have written to the chairpersons of several committees, requesting hearings on the safety of Johnson & Johnson’s DePuy metal-on-metal hip implants and Boston Scientific brain stents.
The DePuy ASR metal-on-metal hip implant, which was approved under the FDA’s 510(k) approval process, in which a device can be cleared for market if it is “substantially equivalent” to devices already on the market, is known to release small metal particles into patients’ bloodstreams, potentially damaging nearby bone and tissue and necessitating painful correctional surgery. The Congressmen note that the FDA has already received over 5,000 complaints since January 2011. However, the United States does not have a registry to track medical device failure and it is possible that the number of failed devices is higher than 5,000 and will continue to rise in the coming years. The high failure rate and lack of a reliable tracking registry led the FDA “to order 20 manufactureres of these devices to submit a plan to the FDA to study how frequently they were failing and to examine the health implications of device failures.”
The Congressmen hope that hearings on the DePuy metal-on-metal hip implants will serve as a foundation to “provide important lessons about the device clearance and approval process as well as the adequacy of our postmarketing safety system.” In the past few years, Congressional “hearings on medical devices have examined claims about delays in FDA approval and overregulation,” but the letter writers believe Congress should be wary of underregulation and should examine “evidence as to whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices.”
The Depuy Hip Replacement Helpline Applauds this and is waiting, watching and hopeful that dangerous drugs and medical devices get more and better regulations. Our callers are suffering and have been thru hell with revision surgeries, rehabiltiation, and a downturn in their qualityb of life. Our seniors need protection. The FDA has failed us and we are hopeful for reform. If you or a lovwd on has been unjured by a defective recalled hip implant call the Helpline today and speak to our medical social worker and a hip replacement recall lawyer.
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