Investigation Finds FDA Delayed Warnings Against Power Morcellators
Posted by PKSD Law Firm on February 24, 2017 in Defective Medical Devices
A new federal report has revealed that the Federal U.S. Food and Drug Administration (FDA) knew about the link between power morcellators and uterine cancer for 23 years before the administration warned the public.
The Government Accountability Office (GAO) began investigating the FDA’s knowledge of power morcellators link to cancer in 2015 after a group of bi-partisan Representatives raised concern over the FDA’s handling of power morcellators.
The GAO’s investigation revealed on Feb. 7, 2017 that the FDA delayed reporting the adverse side effects of using power morcellators in gynecological surgeries and that the administration was aware of the device’s ability to spread cancer when it was first released in 1991.
Power morcellators are used during gynecological procedures to cut cancerous tissue into small pieces which makes it easier to remove via laparoscopy.
However, morcellators can spread or worsen uterine cancer in patients with fibroids or who are undergoing a hysterectomy by shredding cancerous tissue and causing the cancer to metastasize.
The FDA asserts that the first report it received of a power morcellator spreading undiagnosed cancer was in 2013.
The FDA claimed that when power morcellators were first reviewed, it was believed that the device was similar to other surgical tools that had a low-risk associated with spreading cancerous cells, and were therefore not intensely examined.
The initial reports conducted by the FDA in 1991 stated that power morcellators had between a one in 500 chance and a one in 10,000 chance of spreading cancer.
When the FDA further reviewed power morcellators in 2013, its findings revealed that patients had a 1 in 350 chance of developing advanced uterine cancer.
In 2014, the FDA issued a safety warning advising against using morcellators in most women due to the threat of dispersing cancer cells. The administration also issued a “black box” label, its most severe warning for consumers, on all power morcellator packages.
After the FDA’s warnings, manufacturers of power morcellators like Johnson & Johnson removed the device from the market. Hospitals also banned the use of power morcellators in surgeries and several insurance companies refuse to cover surgeries involving the use of the device.
Prior to the FDA’s 2014 warning, doctors and hospitals did not report uterine cancer since the morcellators were functioning well. Therefore, health regulators did not see any reports.
The FDA has released a statement revealing it agrees with the GAO findings and morcellators should on be used rarely.
If you have been diagnosed with cancer after a surgical procedure where a power morcellator was used, you could be entitled to compensation through a power morcellator lawsuit. Contact the power morcellator lawyers at PKSD and find out how you can receive the justice you deserve. We do not charge any legal fees unless you are awarded compensation and will provide a free, no obligation consultation to determine if you can take legal action.
Call 877-877-2228 to learn more about qualifying for a lawsuit.