FDA
17th July 2014

Laparoscopic Power Morcellator Devices’ Risk Discussed by FDA Panel

Earlier this week, panel members of the Obstetrics and Gynecology Devices Panel of the FDA’S Medical Devices Advisory Committee discussed different methods of mitigating the risk of a device that can spread cancer in women. Overall, panelists’ suggestions ranged from an outright ban of the device to limiting its use among patients.

Laparoscopic Power Morcellator Devices’ Risk Discussed by FDA Panel

Earlier this week, panel members of the Obstetrics and Gynecology Devices Panel of the FDA’S Medical Devices Advisory Committee discussed different methods of mitigating the risk of a device that can spread cancer in women. Overall, panelists’ suggestions ranged from an outright ban of the device to limiting its use among patients.

A laparoscopic power morcellator device is used to cut up common noncancerous uterine growths (fibroids) often in a hysterectomy, so they can be removed from the body through small incisions in the abdomen. However; in rare instances, the device can actually spread a rare but dangerous cancer that has a similar appearance as benign fibroids in physical examination and lab or imaging tests. In April of this year, the FDA had noted that there was a 1 in 350 chance that a woman undergoing the procedure has cancer, and discouraged physicians from using the device for this reason.

Although this method of surgery was designed to be less invasive than traditional open surgery, in these unfortunate instances, it has caused more harm than good. “There is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery,” said Craig Shriver, a surgical oncologist at Walter Reed National Military Medical Center, a supporter of placing a ban on the device.

Several discussion questions were posed to the panel members, including whether the benefits of the device outweigh the risks, whether other lab tests, exams or special imaging would better determine the presence of this rare uterine cancer, and whether there are surgical techniques or intra-operative methods to avoid tissue fragment dissemination from spreading within the abdominal cavity.

The entire panel agreed there is no evidence to show that containment bags used with the device during surgery actually reduce the risk of spreading malignant tissue, and that there is no sure way that gynecologists can distinguish a benign fibroid from a cancerous mass before the actual procedure. 

Amy Reed, a 41-year-old anesthesiologist of the Boston area and mother of six, has emerged as a leading campaigner against the procedure and spoke at the two-day emotionally-packed FDA meeting. In October, Dr. Reed learned that her rare uterine cancer had been worsened by a morcellation procedure, consequently lowering her chances of survival. 

Nonetheless, there are still some who believe the device has the potential to benefit many patients. Keith Isaacson, a Boston-area gynecologist on the panel, suggested the tool could still help young women who want to maintain their fertility. 

It isn’t clear when the FDA will make its final determination about the tool’s use.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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