The U.S. Food and Drug Administration has approved a controversial new surgical tool. The device is called the PK Morcellator. It is an electrical tool used for gynecological procedures.
Power morcellators have been a serious safety concern in recent years. The FDA announced in 2014 that they had the potential to spread cancers in the body. Studies show that 1 in 350 women have a risk of having tumors that cannot be detected before the device is used. The operation has the potential to spread these tumors throughout the body in a way that can be fatal.
The FDA gave its strongest warning for the product, the black-box warning, and told healthcare providers to avoid using the tool for most hysterectomies. As a result, Johnson & Johnson faced numerous lawsuits for the product. It settled roughly 70 different cases, with damages as high as $1 million dollars. The company eventually decided to take its morcellator products off the market.
Should the FDA Have Approved this Surgical Tool?
The new version, made by Olympus America Inc., was approved under a new FDA rule, where new iterations of old products do not require human testing if the maker can prove they are effectively similar to an earlier version.
The new device claims a few improvements, including different grip options for doctors. These are intended to make it easier for them to perform the operation safely. Olympus has also added what is called a PneumoLiner containment device. This is intended to serve as a shield between the areas the doctor is operating on and other tissues. The hope is that this can minimize accidental damages.
Olympus has noted that the new product is intended for women who doctors believe are at low risk of suffering from the potential negative effects of the operation.
What Will the New Product Mean?
There are roughly 600,000 hysterectomies performed in the United States every year. More than half involve the kind of the non-invasive surgery that this tool uses. Before the FDA’s safety warning in 2014, most of these operations used these devices.
Only time will tell to what extent power morcellators will remain in popular use. Let’s hope that the companies behind these products are not putting patients in danger by repeating their mistakes.