FDA Issues Warning Over Truclear Ultra Morcellator
Medical device manufacturer Smith & Nephew has received a warning letter from the U.S. Food and Drug Administration (FDA) concerning the company’s Truclear Ultra laparoscopic power morcellator.
Morcellators Distributed Despite Shipment Hold
According to MassDevice, the warning letter addresses problems found during inspections at a Smith & Nephew plant located in Andover, Massachusetts.
The letter states that Smith & Nephew continued to distribute Truclear Ultra 4.0 morcellators despite a shipment hold being placed on the products in August 2012. The hold was placed on the products due to complaints concerning loss of visualization and undersized sluff chambers.
A spokesperson for Smith & Nephew confirmed that the hold is still in place as federal regulators assess the morcellator problems and reviews preventive actions put in place by the manufacturer. It is speculated that a full review will be completed by January 2016.
The FDA has not yet called for the recall of Truclear Ultra 4.0 morecellators distributed after the 2012 shipment hold.
Morcellators Facing Additional Scrutiny
Power morcellators similar to the Truclear Ultra have become points of controversy following reports that the use of such devices during hysterectomies can result in the spread of undetected cancers.
Such concerns led to the FDA calling for a black box warning to be added to hysterscopic morcellators in Novemeber of 2014.
It is estimated that between up to 100,000 women undergo power morcellator procedures every year. Further, reports estimate 250 women develop late-cancer every year due to morcellator procedures.