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


The Axxent FlexiShield Mini was recalled after it was discovered that the devices were defective and left hundreds of tungsten particles inside bodies. Almost 30 women are known to have been affected. Some are even considering having mastectomies to rid their bodies of the tungsten particles, which makes screening for cancer more difficult.

The device, a small pad made of tungsten and silicone, was placed in small incisions in the patient’s breast to protect healthy tissue from radiation during breast cancer therapy.

New York personal injury lawyer David Perecman says that these injuries could have been avoided and wants to know why more testing wasn't done before the company released the product.

The Axxent FlexiShield Mini was cleared in June 2009 through the U.S. Food and Drug Administration (FDA) via its abbreviated 510(K) process.

In April 2010, the Axxent FlexiShield Mini was recalled in a Class I warning — its most serious safety advisory.

New York personal injury lawyer Perecman urges mammography and breast cancer patients to contact their doctors for follow up procedures.

If an individual has been injured by the Axxent FlexiShield Mini or another defective medical device, he or she should contact an experienced New York personal injury lawyer to investigate whether or not they may be entitled to compensation.

According to New York personal injury lawyers at The Perecman Firm following the recall, the Axxent FlexiShield injuries involve having a foreign substance in the body after women undergo radiation therapy for breast cancer.

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