FDA Warns Against Procedure Used in Removing Fibroids

Image: JAMA, ©AMA

Image: JAMA, ©AMA

The US Food and Drug Administration (FDA) is discouraging the use of a surgical technique often used during minimally invasive surgery to treat uterine fibroids because it poses a risk of inadvertently spreading cancer cells from an undetected uterine tumor.

The focus of the agency’s concern is the use of medical devices called electric or power morcellators during laparoscopic (minimally invasive) surgery to remove the uterus or fibroids, noncancerous growths that develop from the muscular tissue of the uterus. The morcellator is used to cut uterine tissue into fragments that can be removed through the small incisions used in laparoscopic surgery. But in a safety communication released today, the FDA said that, based on its analysis of currently available data, 1 in 350 women who are treated for fibroids with surgery—a hysterectomy or myomectomy (fibroid removal)—is found to have an unsuspected uterine sarcoma, such as a leiomyosarcoma.

“If power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the FDA said. “For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

As a JAMA news feature published earlier this year noted, in recent months, some critics of the procedure have said that use of the technique may be too risky, whereas others said that more research on risks was needed before banning it outright. The Society of Gynecologic Oncology issued a statement in December about the potential risks and the concern that no reliable methods exist to distinguish benign growths from cancers before they are removed. Some prominent US medical centers, including Brigham and Women’s Hospital, Massachusetts General Hospital, and the Cleveland Clinic issued statements stressing the importance of counseling patients about the procedure and potential risks.

An estimated 600 000 hysterectomies are performed annually in the United States. According to the National Institutes of Health, more than 200 000 hysterectomies are performed each year for uterine fibroids.

Various therapies, including drugs, surgical removal of individual fibroids, and hysterectomy, are used to treat symptoms caused by fibroids, which may include heavy or prolonged menstrual bleeding or pelvic pressure or pain. “Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids,” the FDA said.

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For more information:

Critics of Fibroid Removal Procedure Question Risks It May Pose for Women With Undetected Uterine Cancer. Hampton, T. JAMA. 2014;311(9):891-893.

Evaluating the Risks of Electric Uterine Morcellation. Kho, KA and Nezhat, CH. JAMA. 2014;311(9):905-906.

 

 

 

 

 

 

 

 

 

 

 

Patients Coinfected With HIV and HCV More Likely to Experience Severe Worsening of Liver Disease

People infected with both hepatitis C virus (HCV) and HIV are more likely than people infected only with HCV to experience a severe worsening of liver disease, even if they are receiving anti-HIV drugs. (Image: RapidEye/iStockphoto.com)

Washington, DC—Even when they are receiving anti-HIV drugs, people who are infected with both HIV and hepatitis C virus (HCV) are more likely than people who are infected only with HCV to experience a severe worsening of HCV-related liver disease and death, according to research reported here at the International AIDS Conference.

About one-quarter of individuals who are infected with HIV also have HCV infection. According to the US Centers for Disease Control and Prevention, HIV coinfection more than triples the risk for liver disease, liver failure, and liver-related death from HCV. Continue reading

New Trials Will Determine If Vaginal Ring With Anti-AIDS Drug Can Protect Women Against HIV

Two major trials are under way to study whether a vaginal ring designed to remain in place for a month while it continuously releases a potent anti-AIDS drug will protect women against HIV infection.

Washington, DC—Two large trials are now under way in Africa to test whether a vaginal ring containing a potent antiretroviral drug will prevent HIV infection in women, researchers announced here at the International AIDS Conference.

The ring, a silicone matrix containing the antiretroviral drug dapivirine, is designed to remain in place for a month while it continuously releases the drug to the surrounding vaginal tissue.

The option of a discreet and long-acting HIV prevention method would be especially welcome in sub-Saharan Africa, where the ring is being tested. About half of the more than 34 million people living with HIV worldwide are women; in sub-Saharan Africa, nearly 60% of HIV-infected adults are women. Most acquire the infection through unprotected sex; many have few options to protect themselves when a sexual partner refuses to use a condom. Continue reading

HHS Secretary Announces New HIV/AIDS Initiatives for Patients and Clinicians

Kathleen Sebelius, US Health and Human Services Secretary, announced new initiatives aimed at improving the care of patients with HIV infection.

Washington, DC—In remarks during the opening ceremony at the XIX International AIDS Conference last night, US Secretary of Health and Human Services (HHS) Kathleen Sebelius announced 4 new public-private collaborations to help people living with HIV get care for their illness and to help train clinicians to treat patients with the infection.

The announcement came 3 days after HHS had announced an infusion of nearly $80 million to help low-income patients with the disease obtain medications and care.

One effort, a partnership between HHS and the MAC AIDS Fund, will launch a mobile text-messaging pilot program called UCARE4LIFE to help patients with HIV infection adhere to strict medication regimens and to remain in care for the disease. The program involves developing a message library in English and Spanish for delivering timely reminders for medical appointments and for taking medications as prescribed. Continue reading