Insurance Companies Question Safety of 510(k) Process

Thursday, April 16, 2015

Source: Q Med

America’s Health Insurance Plans (AHIP), a prominent insurance lobbying group representing 1300 insurance companies, is pushing for changes to FDA’s premarket regulatory submission process. AHIP is arguing that the agency’s clearance of products such as laparoscopic power morcellators under the 510(k) pathway point to flaws in its ability to ensure the safety of medical devices.

Once used for roughly half of hysterectomies in the United States, morcellators are thought to unwittingly spread cancer cells throughout the body in some cases. FDA has warned that the vast majority of hysterectomy and myomectomy should not be treated with the devices.

FDA cleared the first power morcellator in 1991 via the 510(k) process. The agency would go on to clear 10 of the devices via that pathway and, over the years, the devices became widely used for a variety of surgical procedures, with five companies marketing the devices on the U.S. market. In April 2014, FDA formally discouraged the use of power morcellators for hysterectomy or removal of uterine fibroids, stating: “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.” It updated its warning in November 2014.

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