Johnson & Johnson Recalls Power Morcellator

Johnson & Johnson Recalls Power Morcellator

Posted By Golomb & Honik, P.C. || 19-Aug-2014

In the wake of mounting evidence that the devices can promote the spread of cancer, Johnson & Johnson has issued a worldwide recall of three laparoscopic power morcellators. In April 2014, the U.S. Food and Drug Administration advised physicians to cease using the device because it could result in the spread of cancerous tissue, and Johnson & Johnson suspended sale and distribution of the device. The medical mogul's Ethicon division stated the recall was the next logical step.

However, the company defended its product to healthcare providers, stating it believes the device functions properly and could potentially benefit many patients although its role in fibroid removal during hysterectomy and myomectomy is yet to be determined.

Morcellators Used for Hysterectomies and Fibroid Removal

Used for a variety of surgical procedures, such as hysterectomies and myomectomies, a morcellator is a laparoscopic instrument designed for the removal of fibroids and benign tumors. Morcellation devices also offer a less-invasive alternative for certain renal and spleen surgeries.

The device is inserted through a small incision on the abdomen to tear apart fibroids for easier removal. However, some masses which were determined to be benign in earlier tests, are later discovered to be malignant, and the rotating action of the morcellator's blades could potentially spread the cancerous tissue, prompting the onset of advanced-stage malignant growths.

Cancer Risks with Morcellator Use

The proportion of device risks to its benefits are not yet entirely clear. However, in light of concern over adverse medical conditions linked to use of the device, the call was made to finally remove the device from the market at the conclusion of July's FDA Medical Devices Advisory Committee meeting.

As of yet, healthcare providers are still searching for an effective preoperative test to identify certain malignancies, including leiomyosarcoma. Unfortunately, indications of some of the most aggressive forms of cancer frequently elude detection with current preoperative screenings.

Currently, doctors do not have a means of minimizing the risks of morcellated tissue being spread throughout the abdominal cavity. While some doctors maintain that power morcellation is a valid treatment, the FDA surmises the chance of the procedure dispersing cancer is 1 in 350.

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