GAO Asked to Investigate FDA Over Morcellator Claims

GAO Asked to Investigate FDA Over Morcellator Claims

Posted By Golomb & Honik, P.C. || 4-Sep-2015

The U.S. Government Accountability Office has been asked by twelve members of Congress to investigate claims relating to power morcellators. The GAO investigates how American tax dollars are spent and is often known as the “congressional watchdog.” Specifically, the GAO has been charged with determining why the devices were marketed for two decades prior to safety warnings being issued by the FDA.

What is a Power Morcellator?

The power morcellator is a small electrical instrument with sharp, rotating blades. The morcellator breaks large tissue masses apart during a hysterectomy, myomectomy or during the removal of fibroid tumors. Once those tissues are shredded, they are vacuumed out of the woman’s body. In theory, the morcellator allows surgeons to perform the procedure with a much smaller incision, avoiding large cuts into the surrounding stomach muscles. The smaller incision allows patients to heal much more quickly, with fewer complications. Unfortunately, as the tissue shreds are removed from the body, they can be deposited into other areas. If a woman had undetected uterine cancer, the use of a power morcellator can inadvertently scatter cancerous tissue, leading to serious or even deadly consequences.

Two Doctors Campaign for a Ban on Power Morcellators

Anesthesiologist Amy Reed underwent a hysterectomy using a power morcellator in October 2013. Soon after, Reed was diagnosed with leiomyosarcoma, a rare, very aggressive uterine cancer. Reed’s husband, Hooman Noorchashm, a heart surgeon, joined with Reed following her diagnosis, to launch a campaign which would have banned the use of power morcellators. After about a year in apparent remission, Reed recently suffered a recurrence of the cancer following a move by Reed, Noorchashm and their six children to Philadelphia.

The campaign spearheaded by the two doctors did result in an FDA review as well as a sharp decline in the use of power morcellators. According to the FDA, one in 350 women who undergo a procedure such as a hysterectomy, myomectomy or fibroid removal could have a hidden cancer which the morcellator could spread. When the power morcellator was first marketed in 1993, gynecologists placed that risk at one in 10,000. The letter sent by the twelve Congress members asks the question “How did they get it wrong for so long?”

Lead signer, Representative Mike Fitzpatrick, is pushing for sweeping changes in the FDA’s approval process for medical devices. Spokesman for the Government Accountability Organization, Chuck Young, stated a variety of factors would be considered in in their determination of whether an investigation is warranted. Those factors include the level of available data as well as potential legal obstacles involved.

FDA Considers it “Premature” to Discuss Potential Actions for Power Morcellators

Following the safety advisory issued by the FDA regarding the use of power morcellators, Johnson & Johnson suspended worldwide sales of its own power morcellator. At the time the safety advisory was issued, the FDA deemed it premature to discuss potential actions associated with power morcellator use. Noorchashm disagrees with this assessment passionately. Leiomyosarcoma, the type of cancer his wife developed following a procedure using a power morcellator, is very aggressive. Spreading it throughout the body can make a less-than-positive prognosis even bleaker.

Noorchashm believes the FDA is well within its purview to ban the use of power morcellators. Two key groups—the American College of Obstetricians and Gynecologists and the AAGL—disagree, saying power morcellators have a valuable role in patient care. Of the more than 400,000 hysterectomies performed each year across the nation, nearly 12 percent use a power morcellator. This means approximately 46,000 women who could have an undetected uterine cancer could be subjected to having that aggressive cancer spread throughout their body. Both groups advocate using the power morcellator with an isolation bag which contains uterine tissues—but brings certain technical problems.

While the FDA has the power to ban a device which offers significant risks of illness or injury, the agency rarely exercises that power. Until the GAO determines whether the issue warrants investigation, patients undergoing hysterectomies, myomectomies or fibroid removal should ask their doctor whether a power morcellator will be used, and should discuss the risks associated with morcellators thoroughly.

National Dangerous Drug Lawyers

If you or someone you love has been diagnosed with advanced stage uterine cancer after your physician used a morcellator during your hysterectomy, you may be able to file a lawsuit. To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb & Honik today at 215-278-4449 or fill out our confidential contact form.

The national product liability lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

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