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Frequently Asked Questions About Morcellators

Laparoscopic power morcellators are medical devices used during minimally invasive laparoscopic surgeries. Morcellation is the division of tissue into smaller pieces. Power morcellators are devices with blades that help remove tissue through small incision sites. They were very common until recently when it became clear that power morcellators could actually spread cancer cells.

Below are answers to frequently asked questions we’ve been asked about morcellators.

 

Why are power morcellators dangerous?

What are uterine fibroids?

Why do people choose laparoscopic hysterectomy or myomectomy?

What are the risks of power morcellators?

Did the FDA issue warnings about Morcellator?

Was there a recall?

 


 

Q: Why are power morcellators dangerous?

A: Morcellation has recently come under scrutiny after patients reported serious complications linked to the procedure. In April 2014, the U.S. Food and Drug Administration (FDA) issued a warning to consumers that power morcellation could spread cancerous tissue into other parts of the body.

The FDA cautioned that if power morcellation is performed on a woman with uterine sarcoma, a type of cancer in the uterus, the cancerous tissue may get broken up and spread. This could have devastating health consequences for patients.

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Q: What are uterine fibroids?

A: Uterine fibroids are noncancerous growths that can develop from the muscular tissue of the uterus. Most women develop uterine fibroids known as leiomyomas and suffer no consequences from the growth.

Some women experience symptoms such as increased menstrual bleeding, pelvic pressure, and frequent urination.

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Q: Why do people choose laparoscopic hysterectomy or myomectomy?

A: Women with symptoms related to their uterine fibroids often choose hysterectomy or myomectomy. These procedures are relatively simple with less recovery time and a reduced risk of infection. However, there are risks involved when these laparoscopic procedures are performed with a power morcellator.

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Q: What are the risks of power morcellators?

A: If a woman with uterine fibroids undergoes hysterectomy or myomectomy treatment and she has an unsuspected uterine sarcoma, there is a chance that the procedure will spread the cancerous tissue. The cancer can spread to the abdomen and pelvis, which can significantly alter the patient’s chances of survival.

Women with a uterine sarcoma should absolutely not have surgery with power morcellation. However, uterine sarcoma is a form of cancer that is commonly overlooked and misdiagnosed. So, it is not always clear if a patient is a viable candidate for morcellation.

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Q: Did the FDA issue warnings about Morcellator?

A: There were two warnings issued by the FDA in the year 2014.

  • In April, the FDA warned patients and doctors to avoid morcellation specifically for treatment of uterine fibroids in cases involving suspected malignancy.
  • In November 2014, the FDA expanded their warning to the majority of women and required the manufacturer to add a black box warning on all power morcellator packages.

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Q: Was there a recall?

A: Shortly after the FDA issued the first warning, Johnson & Johnson stopped selling its power morcellator models. Later, they issued a voluntary market recall. In July of 2014, the manufacturer asked doctors to return their power morcellators over fears that they spread cancer.

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Contact a Morcellator Compensation Lawyer

If you have suffered harm because of a surgery you had performed, do not hesitate to research your legal rights and options. Call a surgical device injury lawyer at Farah & Farah at (800) 533-3555 for more information about your legal rights.


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Who We Are

The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

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