Senators Urge FDA Action on Hysterectomy Machines - Should You Be Concerned?

Wednesday, October 29, 2014

This month, Senator Robert Casey Jr. from Pennsylvania became the latest member of Congress to draft a letter to the FDA expressing concern about the continued use of power morcellators for hysterectomies and fibroid removal surgeries.

The oversight is a welcome sign after a year in which the machines have been linked to spreading deadly uterine cancer in numerous patients. However, Senator Casey is only the third member to take the initiative to protect the public in this way.

Casey’s letter. Sent October 6th to FDA Commissioner Margaret Hamburg, urges the agency to "swiftly and closely evaluate the concerns that have been raised, and take any additional action necessary that is appropriate to safeguard the health of the public."

The correspondence follows a joint letter to the FDA this August from New York Democratic senators Kirsten Gillibrand and Chuck Schumer.

Power morcellator surgical devices, used to perform hysterectomies and myomectomies with smaller incisions, have been under fire since the FDA raised concerns in April, estimating that 1 in 350 women could have undetected uterine cancer spread by the devices.

Morcellators use narrow, high-speed blades to mince tissue so that it can be extracted through smaller openings. However, in doing so, it can spread cancer very quickly to nearby organs. Before this year, they were used in over 50,000 procedures annually.

The leading manufacturer of the machines, Johnson & Johnson’s Ethicon division, announced on April 30th that they would stop sales to allow for more investigation. Also, many leading surgical centers have chosen to halt their use.

In July, the FDA gathered an investigatory panel to review growing concerns. They recommended that patients be given additional warnings before undergoing the procedures, having both patients and doctors sign consent forms, or instituting a total ban of the machines.

While the panel’s recommendations were furnished to the FDA, the agency has yet to issue a decision.

In the meantime, companies that sold morcellation devices without warning patients or doctors face an increasing number of lawsuits from those injured. Lawyers are reviewing cases and considering a consolidation of cases into a special court.

DrugNews will continue to monitor the safety of these surgical devices, as well as any action taken by the FDA. For more information, or to talk with a lawyer about a claim, contact us today.

 

Sources:

Singer, P. Another Senator Gets On FDA About Morcellation. Democrat and Chronicle. (October 10, 2014). Retrieved from http://www.democratandchronicle.com/story/all-about-health/2014/10/10/another-senator-gets-on-fda-about-morcellation/17032975/

 

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