Boston Scientific recalls device after pieces broke off in patients – Boston Business Journal

The Marlborough-based medical device giant said the recall is voluntary, but that the Food and Drug Administration has classified it as Class 1, the most serious type.

Source: Boston Scientific recalls device after pieces broke off in patients – Boston Business Journal

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FDA warning on uterine device draws opposition from doctors | Newsday

Nearly 50 doctors across the United States sent an open letter to the U.S. Food and Drug Administration on Monday calling on the agency to “revise or rescind” its position on a controversial device that had been used on more than 50,000 women annually until the agency cautioned against it last year.

The device, known as a laparoscopic power morcellator, had been widely used to remove benign growths known as fibroid tumors from the uterus or to completely remove the uterus itself in a hysterectomy.

Serious concerns arose, however, when deadly cancer cells harbored in the fibroids of some women were dispersed throughout the abdomen once shredded by the blades. Some fibroids hide rare and dangerous leiomyosarcomas, an aggressive cancer that can prove difficult to treat.

Source: FDA warning on uterine device draws opposition from doctors | Newsday