|Johnson & Johnson's Ethicon division's power morcellation device--Courtesy of Johnson & Johnson|
Amid growing safety concerns over the use of power morcellator tools in gynecological procedures, new research shows that a significant number of women undergoing laparoscopic surgery with the device have increased levels of undetected cancer.
As The Wall Street Journal reports, Columbia University physicians looked at a database of insurance information to identify more than 36,000 women treated with power morcellators at 500 U.S. hospitals between 2006 and 2012. The doctors found that one in 370 women who underwent a hysterectomy with the device have hidden uterine cancer, and that morcellator tools could spread a wider range of cancers than previously expected, according to results published Tuesday in the Journal of the American Medical Association.
Lead study author Jason Wright told the WSJ that the physicians decided to conduct the study due to recent publicity surrounding the device. Last week, the FDA convened a two-day advisory panel to discuss the risks and potential benefits of using power morcellator tools in laparoscopic procedures. The agency's Obstetrics and Gynecology Devices panel recommended upgrading the labeling for power morcellators and advising patients about risks prior to surgery, although its suggestions are nonbinding.
The panel's findings build on earlier regulatory action, as the FDA issued an advisory in April warning against using the devices in minimally invasive surgeries to remove uterine fibroids. The agency said that women undergoing the procedures carried a one-in-350 risk of uterine sarcoma, and that the tools could cause cancerous tissue to spread. Before the advisory warning, the device was used in an estimated 50,000 U.S. uterine surgeries each year, according to the WSJ story.
The industry heeded the agency's warning and responded with measured sales and more conservative product estimates. Weeks after the FDA issued its advisory, Johnson & Johnson ($JNJ) temporarily suspended sales of morcellator devices made by its Ethicon subsidiary. In April, Intuitive Surgical ($ISRG) cut 2014 growth projections for its da Vinci surgical robot from as much as 12% to as little as 2%, citing power morcellator safety concerns as one reason behind its lowered guidance.
Other companies are taking a different approach and rolling out alternatives to the controversial devices. In May, Boston Scientific ($BSX) laid down $65 million to purchase a large stake in IoGyn, a company that develops products for minimally invasive gynecological surgery. Through the deal, the device giant gains access to IoGyn's Symphion System, an innovative tool for hysteroscopic intrauterine tissue removal that resects growth within the uterus. Earlier this month, Redwood, CA-based Gynesonics raised an additional $6 million in financing to support development of its next-generation transcervical treatment for uterine fibroids, a device the company markets as less invasive than traditional morcellator tools.