J&J Suspends Sale of Surgical Device
Johnson & Johnson has suspended the sale of a medical device used in fibroid surgery due to concerns over its potential to spread undetected cancer beyond the uterus.
Laparoscopic Power Morcellation
According to a April 30 release by Reuters, Johnson & Johnson notified the medical community that it would be suspending the sale of its power morcellators accross the globe until their role in fibroid treatment is better understood.
J&J’s announcement came after an advisory notice by the U.S. Food and Drug Administration (FDA) which discouraged doctors from using laparoscopic power morcellators to remove fibroids, citing that such procedure could result in the worsening of often-hidden cancer.
Laparoscopic power morcellation is one of several treatments currently available for uterine fibroids – non-cancerous growths that originate from the smooth muscle tissue in the uterine walls.
In the procedure, doctors use a medical device to divide the uterine tissue into smaller fragments so it can be extracted through a small incision in the abdomen.
Details of the FDA Notification
On April 17, the FDA issued a communication notice discouraging the use of laparoscopic power morcellation for hysterectomy and myomectomy, claiming a risk that the procedure could lead to the spread of unsuspected cancerous tissue.
The agency estimates that 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have a uterine cancer called uterine sarcoma. Laparoscopic power morcellation can potentially spread the cancerous tissue within the pelvis and abdomen, significantly worsening the patient’s chances of long-term survival.
Further, as uterine fibroid do not cause life-threatening problems, the risk of the procedure may out-weigh the benefits.
Women are advised to discuss the risk and benefits of laparoscopic power morcellation as well as alternative treatments with their doctors.