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...

Feds Crack Down on Insurance Fraud Scheme
Compounding Center Officials Accused of Second-Degree Murder
Chief Financial Officer Pleads Guilty to Soliciting and Receiving Kickbacks for Referrals
Joan Rivers Clinic Outlines Required Improvement Plan
What Caused Hot Dog Electric Blanket to Overheat?
Sex, Drugs and Hot Water for Prominent Surgeon
Nurse Anesthetist Accused of Stealing Drugs So He Could Have Sex

 
Have an account? Please log in:
Email Address:
  Remember my login on this computer

DID YOU SEE THIS?
Infection Control

Kimberly-Clark Health Care Is Now Halyard Health

advertiser banner

Other Articles That May Interest You

Feds Crack Down on Insurance Fraud Scheme

Florida biller's Ohio ASC scammed millions from private payors.

Legal Update: Price Your Physician Buy-Ins With Care

3 lessons learned from a $5M whistleblower settlement.

Wrongly Connected Tubing a Major Concern, Says Joint Commission

Sentinel Event Alert cites 117 cases, 21 deaths.