Press release
FDA Device Chief Calls for Stricter Guidelines Amid Transvaginal Mesh Lawsuits
Under the current laws, when a new medical device cites a current predicate, the FDA must approve the device unless there is an older version of it that the FDA or a court order removed from the market for safety reasons. Unfortunately, when a dangerous product is voluntarily recalled, the recall does not impact the further approval of the product and the FDA, by law, has to approve a product with a valid predicate despite the fact that the product was voluntarily recalled in the past.
Shuren has indicated that an average of 28 devices each year cite a predicate and are cleared for approval, despite the previous voluntary recalls. Transvaginal mesh devices were among those submitted and approved. Unfortunately, the products were still not safe when submitted for approval and countless women began experiencing side effects, many of which required multiple surgeries to correct.
Jason Byrd and the Byrd Law Firm have represented many women who have experienced side effects in transvaginal mesh lawsuits. Mr. Byrd commends Shuren saying, "It's time someone took action. The FDA is supposed to stop drug companies and medical device manufacturers from putting out dangerous products. Loopholes that allow bad products to be used on patients can cause significant unnecessary pain and suffering."
For details on the tranvsaginal mesh lawsuits brought by the Byrd Law Firm or more information on Jason Byrd's legal work protecting injured victims, visit his site at http://www.txbyrd.com or all 1.888.616.2973.
About Jason Byrd
Jason Byrd defended corporate clients and insurance companies before starting the Byrd Law Firm in 2005. Today, Jason Byrd specializes in defective medical devices, bad drugs and other personal injury cases and represents the interests of plaintiffs. For more information, read about him at www.txbyrd.com.
Jason M. Byrd
The Byrd Law Firm
448 Orleans, Beaumont, TX 77701
409-924-0660
http://www.txbyrd.com
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