advertiser banner advertiser banner advertiser banner
Digital Issues

Home >  News >  June, 2014

FDA Says More Decisions on Morcellation Coming

The agency will hold a public meeting in July.

Published: June 12, 2014

Will morcellation devices used to laparoscopically remove uterine fibroids be recalled or banned? The FDA is convening a meeting next month to take up the topic.

The agency issued an advisory in April, discouraging their use because the devices can spread cancerous tissue in women with undetected uterine sarcomas, a condition the agency says may affect as many as 1 in every 350 women.

However, proponents of morcellation say the proportion of women with undetected sarcomas is likely closer to 1 in 1,000; that the prognosis is already bleak for those women; and that for everyone else, the alternatives are typically much more dangerous and invasive.

The FDA's Medical Devices Advisory Committee will hold a public meeting on July 10 and 11 and plans to "make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations" for morcellators.

One stock analyst, Greg Chodaaczek of Sterne Agee, says the meeting is likely to result in a so-called black-box warning, saying he doesn't think there's enough data to warrant a recall or ban.

Jim Burger

Also in the News...

Surgeon Operated on Wrong Part of Brain
Widow Sues Olympus and Custom Ultrasonics Over Husband's Superbug Death
Surgeons Reach Peak Performance Between 35 and 50 Years Old
Results From Head-to-Head Comparison of Exparel and Conventional Bupivacaine
Forbes: Punitive Ban on Physician-Owned Hospitals Imposed by the Affordable Care Act Has to Go
'Post-Hospital Syndrome' Is a Risk Factor in Elective Surgery
FDA Approval of Sugammadex Appears Imminent

Have an account? Please log in:
Email Address:


advertiser banner

Other Articles That May Interest You

N.J. Revokes License of Spine Surgery Anesthesiologist

Calif. Doc Behind Bars for Supply Theft

$25K Kaiser heist brings new charges for repeat offender.

New Law Tightens Regulation of California Surgical Centers

Legislation calls for unannounced accreditation inspections, mandatory 2-year physician peer reviews and more sharing of information.