Do Power Morcellators Have a Black Box Warning?
Last fall, the US Food and Drug Administration (FDA) announced that power morcellators would receive a “black box” warning, the strongest caution the agency issues. Power morcellators are used in laparoscopic myomectomy and hysterectomy surgeries, and have been linked to uterine sarcoma (a type of uterine cancer).
“We believe that in the vast majority of women, the procedure[s] should not be performed,” William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health said, according to the Wall Street Journal, following the black box announcement.
Earlier, in the spring of 2004, the FDA released a warning about the devices, which are used thousands of times in surgery each year. According to the FDA, about 1 in 350 women who have undergone fibroid surgery have reported a sarcoma in later testing. The agency recommended that health care providers explain options and risks to the women that need to remove symptomatic uterine fibroids.
Have a Uterine Sarcoma Potential Claim Investigated
If you have undergone one of these procedures and now have uterine cancer, contact an attorney specializing in pharmaceutical and medical product litigation to investigate whether you may have a claim.
A cancer diagnosis is life changing and costly. You should not have to suffer because a manufacturer put a dangerous medical device out in the marketplace. Our firm is currently investigating power morcellator litigation.
Zoll & Kranz, LLC – Defective Medical Drug and Device Lawyers