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The Tylenol recall led to the temporary closing of a plant owned by the McNeil Consumer Health Care unit, which is the subject of a federal inquiry over its handling of recent recalls of over-the-counter products.
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Hinzugefügt am 09.04.2012 - 04:21:05
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von ekunter39
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This expedited FDA approval process, commonly known as the 510(k) Process, allows medical devices to avoid the rigorous clinical trials if the manufacturer can show that the device is "substantially equivalent" to other medical devices already approved by the FDA. DePuy persuaded the FDA that the ASR XL Hip System was similar to previously approved metal-on-metal hip implants. DePuy claimed that the ASR XL Hip System did not "raise any new issues of safety or effectiveness."
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Patients who need their current implant removed will need to undergo revision surgery and will endure severe pain and physical limitations. DePuy has asked for access to patients' medical records so the company can compensate them for the cost of corrective surgery.
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