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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

Source: http://www.wsj.com/articles/fda-adds-new-warning-to-labels-for-laparoscopic-power-morcellator-1416842439

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Michelle L. Kranz

Michelle is a founding partner of Zoll & Kranz, located in Toledo, Ohio. Michelle has been a plaintiff’s lawyer for the entirety of her practice – over 32 years. She devotes the majority of her time to complex consolidated litigation and class action including advocating for people injured by medical devices, prescription medications, or corporate negligence.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Zoll & Kranz, LLC and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio injury lawyer, Michelle L. Kranz, you can do so here.

Zoll & Kranz, LLC does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.

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You can learn more about this topic by visiting any of our Morcellator Lawsuits pages listed below:
Are Johnson & Johnson Morcellator Devices Safe?
Are Laparoscopic Power Morcellators Safe?
Do Power Morcellators Spread Cancer?
Have You Had a Hysterectomy or Removal of Uterine Fibroids? Morcellator Device Withdrawn From Market Due To Cancer Risk
Risks of the Power Morcellator and FDA’s Safety Update
The Senate and Victims of the Power Morcellator Are Waiting for Answers
Tissue Containment System for Laparoscopic Power Morcellators Approved by the FDA
What Are the Problems with a Laparoscopic Power Morcellator?
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