In April Johnson & Johnson, the largest maker of devices used in a popular uterine surgery, suspended sales of the tools amid concerns that their use may spread a rare but deadly cancer. The health-care giant said it was halting world-wide sales, distribution and promotion of the tools, called power morcellators, but was not permanently pulling them from the market.
The action follows a Food and Drug Administration advisory on April 17 discouraging doctors from using the devices to remove fibroids, a common uterine growths, because of a risk of worsening an often-hidden cancer. Fibroids account for about 40% of the roughly 500,000 hysterectomies performed annually in the U.S. Morcellators typically use long, tube-shaped blades to cut and remove the growths through tiny incisions, helping patients avoid open abdominal surgery and the long scars reducing recovery time.
In some cases the fibroids can be caused by an undetected cancer known as a uterine carcoma. The risk of spreading this cancer with morcellators has been the subject of a recent debate. After a Boston hospital acknowledged that the use of morcellation may have worsened uterine cancer in a 41-year-old mother of 6 post-hysterectomy, the FDA took more notice.
The FDA has said it plans an advisory committee meeting this summer to examine the tools' use more deeply. J&J wrote in a letter to customers that it is waiting for the FDA and the medical community to further clarify the role of morcellation in fibroid treatment. "We believe that suspending the commercialization of these products until their role is better understood and redefined by the medical community is the appropriate course of action at this time," J&J told customers.
Written by James P. Nevin