Healthcare Business News

Reports to FDA over laparoscopic devices spur inquiry

By Jaimy Lee
Posted: July 8, 2014 - 3:45 pm ET

The Food and Drug Administration has received reports of 17 adverse events regarding laparoscopic power morcellators and the resulting spread or upstaging of uterine sarcoma, which has prompted an advisory committee meeting this week to discuss how the devices are used.

The FDA in April issued a communication discouraging morcellation for hysterectomies or the removal of uterine fibroids because of the risk of spreading unsuspected uterine sarcoma.

“The dissemination of unsuspected malignant uterine tissue within the intraperitoneal cavity during laparoscopic surgery for presumed fibroids represents a serious concern,” the FDA said in meeting documents posted July 7 to its website.

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The morcellators, which have been on the market since the 1990s, are commonly used in gynecologic surgeries. Morcellators are used during minimally invasive surgeries to cut the tissue into pieces to remove it. But the devices are under scrutiny over recent cases during which patients undergoing a hysterectomy or fibroid removal have had cancer spread by use of the technology.

About one in 350 women who has a hysterectomy or fibroid removal surgery has a type of cancer called uterine sarcoma, which can be spread if a morcellator is used during surgery. Uterine fibroids are the most common type of pelvic tumors in women and are more likely to affect African-American women as well as women in their 50s or with a family history. About 20% of the nearly 500,000 hysterectomies performed each year in the U.S. are done using minimally invasive laparoscopic procedures, which includes surgeries using morcellators.

“Recent discussions within the patient and clinical communities as well as the peer-reviewed literature have raised awareness of the risk of spreading unsuspected cancerous tissue beyond the uterus when LPMs are used during surgeries intended to treat benign fibroids,” the FDA said.

One question that the committee is expected to address is whether the devices should be reclassified as high-risk medical devices. If subject to reclassification, the manufacturers that make morcellators would have to seek the more stringent premarket approval.

Another issue is the utilization of what are called specimen bags during some surgeries using morcellators. The bags are used to gather the tissue so it does not spread in the body.

Six manufacturers make morcellators that have been marketed in the U.S. in the past year. They are Johnson & Johnson, Karl Storz, Richard Wolf, Lina Medical, Trokamed and Gyrus. Johnson & Johnson in April suspended sales and distribution of its morcellation devices “while the role of morcellation with symptomatic fibroid disease is redefined by the FDA and the medical community,” the company said in an April 30 statement on its website.

The advisory committee plans to discuss how laparoscopic power morcellators are used to treat uterine fibroids and whether new labeling about the possible spread of cancer should be required. The meeting is expected to take place Thursday and Friday.

Follow Jaimy Lee on Twitter: @MHjlee

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