WASHINGTON D.C. — On July 10, 2015 the U.S. House of Representatives passed H.R. 6, the 21st Century Cures Act. This broad and far-reaching bill addressed multiple medical device and drug issues and for the most part favored the medical industry. However, one of the provisions in the bill specifically addresses defective medical devices in favor of patients.

Representative Mike Fitzpatrick (R-PA) introduced an amendment that requires for the unique identifiers (such as the make or model number) of a medical device used to treat patients to be include in the patient’s medical record. The purpose of this is to allow for more accurate tracking in the event the device is recalled or found to have caused adverse health problems. Current law does not require electronic health records to include this information. In 2014, the FDA recommended that all medical devices include unique device identifiers and was slowly phasing in the new system. The congressman (a cancer survivor himself) said he was inspired to introduce such an amendment after learning about the dangerous ramifications of using power morcellators and hoped to speed up the process already started by the FDA.

The congressman introduced eight amendments in total that addressed patient safety, and the power morcellator amendment was the only one to unanimously pass. While the congressman ultimately voted against H.R. 6 because it did not go far enough to protect patients from defective devices, there is some consolation that this one piece made it through.

The problem of power morcellators has not been insignificant. In fact, it became so pervasive and deadly the FDA conducted a study on power morcellators and reviewed its device safety warning. It found that 1 in 350 women who had a morcellation procedure for fibroid removal or a hysterectomy were then found to have an unsuspected sarcoma (i.e. cancer). These odds are incredibly high and dangerous so the FDA gave the device its strongest warning and strict recommendations for how/when it should be used.

Despite the risk, many hospitals and medical providers are still using the power morcellator thus putting women across the country in danger of contracting a very deadly form of cancer.

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