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Shezad Malik MD JD
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FDA, Black Box Warnings and Morcellator Hysterectomy

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As the number of lawsuits filed against power morcellators increases across the United States, it is worthy to note the US Food and Drug Administration (FDA) response regarding the routine use of power morcellators during minimally invasive laparoscopic removal of uterus fibroids and hysterectomy.

J&J Ethicon Morcellator Cancer AttorneyFDA Black Box Warning for Power Morcellators

The FDA has dinged laparoscopic power morcellators with the strongest warning possible, requiring the morcellator medical devices to have a black box warning concerning the risk of using power morcellators.

FDA Notes Increased Risk of Uterine Cancer Spread

According to the FDA, most women should not undergo a laparoscopic power morcellation hysterectomy because of the risk of spreading undiagnosed uterine cancer.

The FDA issued the black box warning in November 2014, alerting patients, doctors and hospitals about the risk of spreading unsuspected uterine cancer, which can sharply reduce the affected patient’s survival chances.

FDA: Power Morcellator Hysterectomy Contraindications

Contraindications were also included on the warning label, including that the laparoscopic power morcellator should not be used in women who are peri- or post-menopausal or who could have the uterus tissue removed intact, and those women in which the uterus tissue being morcellated is known or suspected to be cancerous.

The FDA stated, “Based on a quantitative analysis of currently available data, the FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma.

If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

Since the black box warning, many doctors and hospitals had stopped using the morcellator. HCA Holdings, a company that runs almost 300 hospitals and medical centers in the US and England, has banned morcellators in its facilities

What is Power Morcellator Hysterectomy?

Power morcellator devices are used in minimally invasive laparoscopic procedures to remove fibroids, benign uterine tumors and during hysterectomies.

What is the problem with Power Morcellator Hysterectomy?

The major problem is that benign fibroids may harbor hidden or undiagnosed uterine sarcoma (a cancer). Morcellators grinds the uterine tissue with powerful blades, so it can be removed. But in that grinding process, the cancerous uterine tissue may spread through the abdomen.

In the case of uterine sarcoma, which cannot be diagnosed prior to surgery, the uterine tissue is a very aggressive cancer, resulting in a spreading of the cancer, which had been previously localized.

The FDA stopped short of an outright ban. The FDA noted that there are other options for women with uterine fibroids, including traditional surgery, laparoscopic hysterectomy and myomectomy without morcellation.

Power Morcellator Litigation

There are at least 22 lawsuits pending across 16 federal courts, alleging personal injury, wrongful death and product liability complaints against several manufacturers of power morcellators. All the plaintiffs claim that the devices caused the spread of uterine cancers during a laparoscopic hysterectomy or myomectomy, removal of benign fibroids.

Plaintiffs are requesting to centralize cases brought in the federal court system before U.S. District Judge Kathryn H. Vratil in the District of Kansas. The major manufacturers all oppose centralization of the litigation into a multidistrict litigation, stating that it would be impracticable and that there are not enough cases to justify it. A hearing is set for October, over whether to grant a power morcellator MDL.