Johnson & Johnson announced on Wednesday that it is initiating a worldwide market withdrawal of all of its Ethicon morcellation devices that still remain on the market. The devices include the GYNECARE MORCELLEX Tissue Morcellator, MORCELLEX SIGMA Tissue Morcellator System and the SYNECARE X-TRACT Tissue Morcellator.
In April, the FDA evaluated the use of laparoscopic power morcellation for the removal of the uterus or uterine fibroids and recommended against it because it poses a risk of spreading cancer tissue. After that, Ethicon stopped sales and distribution of its devices.
At the U.S. FDA Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on July 10th and 11th, it was announced that using the devices makes it difficult for physicians to preoperatively diagnose some malignancies, particularly leiomyosarcoma, and that there is a risk that they can spread unsuspected cancer tissue.
"We believe Ethicon morcellation devices perform as intended and that there are patients who can benefit from procedures using laparoscopic power morcellators," Matthew Johnson, director of communications at Ethicon, wrote to DOTmed News in an email. "However, the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain."
The company's decision to withdraw the devices aligns with research regarding morcellation that was published in the Journal of the American Medical Association last Tuesday. Columbia University researchers used a database of over 500 hospitals and identified 232,882 women who had a minimally-invasive hysterectomy from 2006 to 2012.
They found that out of the 36,470 women who underwent morcellation, 99 cases of uterine cancer were identified at the time of the procedure, which equates to 27 out of every 10,000. They also detected other malignancies and precancerous abnormalities.
Ethicon believes that the market withdrawal 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," said Johnson. He added that they will continue to monitor and evaluate the issue.
