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Just before Thanksgiving, the Food and Drug Administration renewed its original safety communication issued in April 2014 to once again warn against the use of laparoscopic power morcellators to remove fibroids and/or the uterus. More specifically, the Administration wants manufacturers to include certain safety statements "in the form of a boxed warning and two contraindications."

Ft. Myers personal injury attorney Randall Spivey previously discussed the issues surrounding the morcellators in his blog, "Senators Urge FDA to Get More Power Morcellators Pulled From the Market." Mr. Spivey noted then that he is well aware that "individuals sustain serious injuries or even die 'as a result of unwittingly using defective medical products and devices, most of which are recommended or prescribed by their physicians and approved by the U.S. Food and Drug Administration (FDA).'" However, the FDA, recently stated "immediately in effect (IIE) guidance, continues to take steps to help lower the risk of spreading unsuspected cancer in women suffering with uterine fibroids.”

What Should the Boxed Warning Say?

The chief scientist at the FDA's Center for Devices and Radiological Health stated that adding a boxed warning to the device's label "will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed." The contraindications that should also be included with the warning will advise the following:

• Laparoscopic power morcellators should not be used to remove uterine tissue that contains suspected fibroids in women who are peri-menopausal or post-menopausal, or in women who are candidates for "en bloc" tissue removal through the vagina or mini-laparotomy incision.
• The morcellators should not be used in gynecologic surgeries in which the tissue to be morcellated is cancerous or suspected to be cancerous.

The IIE will apply to morcellators currently marketed, as well as new devices to be used for general and specific gynecological indications.

Why is This Important?

Your personal injury attorney has seen clients who have been directly impacted by laparoscopic power morcellators. Unfortunately, if a morcellation is performed on a woman who suffers from an unknown uterine sarcoma, there is a great risk that the procedure may spread that cancerous tissue further into the woman's abdomen and pelvis, which can severely lessen the her likelihood of surviving long-term.

The FDA has estimated 1 in 350 women receiving a myomectomy or hysterectomy to treat fibroids suffers from unsuspected uterine sarcoma, or uterine cancer. The Administration notes that there are other treatment options available to women with fibroids, including traditional hysterectomies and laparoscopic hysterectomies and myomectomies that do not use morcellation.

The FDA vows to continue to look for additional ways to lessen the risk of spreading unsuspected cancer via laparoscopic power morcellation by encouraging the use of ground-breaking methods to spot uterine cancer and contain the potentially cancerous tissues.

If you or someone you love has questions or concerns about a procedure involving a laparoscopic power morcellator, or if you believe you have sustained injuries after undergoing a morcellation, contact an attorney with the Spivey Law Firm, Personal Injury Attorneys, P.A. right away to discuss the facts of your case.