New York, NY (PRWEB) October 24, 2011
By letter dated October 12, 2011, members of the United States House of Representatives Committee on Energy and Commerce—including ranking member Henry A. Waxman of California—opined to committee chairman Fred Upton, Subcommittee on Health chairman Joseph Pitts, and Subcommittee on Oversight and Investigations chairman Cliff Stearns that hearings on FDA regulation of medical devices held in the past year “have not provided a balanced and accurate picture that fully reflects the role [the] FDA plays in reviewing device applications; nor have they spoken to the potential dangers posed to patients if medical devices are not appropriately regulated.” The letter can be viewed in its entirety here.
The authors of the letter urge the committee as a whole to “hold hearings that examine medical devices that have developed serious defects after being implanted in patients. Specifically, 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.”
The authors note that both items are “examples of devices that were found to be associated with major health problems after being approved or cleared by the FDA. As such, we believe they could provide important lessons about the device clearance and approval process as well as the adequacy of our postmarketing safety system.”
The letter notes that several metal-on-metal hip implant devices “were cleared under the 510(k) clearance process, meaning that the devices [sic] had to demonstrate they were ‘substantially equivalent’ to one or more devices already on the market. Although clinical data can be required under this clearance process, many submissions are cleared without such data…. As of December 31, 2010, [the] FDA had cleared for marketing 175 submissions for metal-on-metal hips through the 510(k) process, many of which were components of larger systems.” But metal-on-metal hip implant systems have “unique risks in addition to the general risks of all hip implant systems,” the Representatives remarked, quoting an FDA report. “Because the metal rubs against the metal, ‘tiny metal particles may wear off of the device and… cause damage to the bone or tissue surrounding the implant and joint.’”
The letter authors mention that concerns about the dangers of all-metal hip implants “led [the] FDA to order 20 manufacturers of these devices to submit a plan… to study how frequently [the devices are] failing and to examine the health implications of device failures.” One of those manufacturers is DePuy Orthopaedics, a subsidiary of Johnson & Johnson, which manufactured and sold the recalled ASR hip implant system and which currently sells the embattled Pinnacle system.
The Rottenstein Law Group maintains a website with information about DePuy’s problematic hip implants at http://www.hiprecalllaw.com. The site has features that allow for easy sharing, including links for automatic posting on Facebook and Twitter.
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients hurt by defective medical devices. http://www.rotlaw.com
The Rottenstein Law Group LLP
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