Recalled medical devices received fast-track FDA approval, says New York Personal Injury Lawyer


Women are at risk of life-threatening injuries from a device meant to protect the body from stray radiation during cancer treatment. The medical device, called the Axxent FlexiShield Mini, has been classified by the U.S. Food and Drug Administration (FDA) as the most serious type of recall.

“Unsurprisingly, the shield was approved by the FDA via an abbreviated process used for devices that are considered substantially similar to products already on the market," said New York personal injury lawyer David Perecman, founder of the New York personal injury law firm, The Perecman Firm. "This process, known as 510(K), allows a manufacturer to obtain market approval with little clinical testing and no required testing on humans.”

According to the FDA, recalls of this level involve “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

New York personal injury lawyer Perecman understands the device was flawed and left hundreds of tiny particles of tungsten in woman's breasts. These heavy metal particles could pose significant health risks for these women in the future.

About 30 women were affected. According to the New York Times, at least one woman, fearing that the metal could cause cancer or another illness, is considering having her breast and its underlying tissue removed in a radical and disfiguring operation.

Individuals who have been injured by a defective medical device, including the the Axxent FlexiShield Mini, should contact an experienced New York personal injury lawyer at The Perecman Firm.

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