|Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson|
Amid regulatory and industry backlash surrounding the use of laparoscopic surgical tools in gynecological procedures, Johnson & Johnson ($JNJ) is pulling its related device from the global market.
The company's Ethicon unit will issue a worldwide letter to customers to return power morcellator tools, which slice up uterine tissue into smaller pieces so it can be removed in minimally invasive surgery, The Wall Street Journal reports. In April, Johnson & Johnson suspended sales of its morcellator devices following an FDA advisory warning that discouraged physicians from using the tools in surgical procedures. Approximately one in 350 women with fibroids also has uterine sarcoma, the agency said in its report, and power morcellators could spread tumorous cells in the abdomen and pelvis.
Before the advisory warning, the device was used in an estimated 50,000 U.S. uterine surgeries each year, according to the WSJ. European device outfits Karl Storz GmbH, Richard Wolf GmbH and LiNA Medical also make power morcellators, but declined to comment to the WSJ.
Matthew Johnson, a, Ethicon spokesman, told Bloomberg that the company's decision was influenced by a two-day FDA panel meeting earlier this month that examined the device's risks and potential benefits in laparoscopic surgical procedures. The agency's Obstetrics and Gynecology Devices panel recommended upgrading the labeling for power morcellators and advising patients about risks prior to surgery, but its suggestions are nonbinding.
"Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk," Johnson said (as quoted by Bloomberg).
The company's decision also comes in the wake of troubling data, as a recent study by Columbia University physicians found that a significant number of women undergoing laparoscopic surgery with the device have increased levels of undetected cancer. Doctors surveyed a database of insurance information to identify more than 36,000 women treated with power morcellators at U.S. hospitals between 2006 and 2007, and determined that one in 370 women who underwent a hysterectomy with the device have hidden uterine cancer, according to results published in the Journal of the American Medical Association. The tools could also spread a wider range of cancers than previously expected, physicians noted in the study.
Johnson & Johnson is not the only company facing pushback for its power morcellator devices. In April, Intuitive Surgical ($ISRG) cut 2014 growth projections for its da Vinci surgical system from as much as 12% to as little as 2%, citing power morcellator safety concerns as one of the factors in its lowered guidance. The company issued a recall of 1,300 of its da Vinci arms in November.
Other companies are taking a different approach, and creating minimally invasive products that provide an alternative to traditional power morcellator devices. In May, Boston Scientific ($BSX) shelled out $65 million for a larger stake in IoGyn, a California startup that develops products for minimally-invasive gynecological surgery. Earlier this month, California-based Gynesonics raised an additional $6 million to support development for its next-generation ultrasound treatment for uterine fibroids.