FDA Safety Release Reinforces Concern Over Link Between Morcellator Use And Uterine Cancer

Banville Law reports on new concern over power morcellation as cases consolidated in MDL No. 2652 move forward. This new worry is spurred by a recent change in policy announcement from the U.S. Food and Drug Administration (FDA) regarding several medical devices, including the laparoscopic power morcellator. The notification was released in order to properly inform the public that the FDA had made a decision to allow earlier public notification of the safety issues they are evaluating as concerns are raised about certain medical devices. The FDA hopes that by announcing concerns earlier to the public, they can save lives. They no longer see the need to wait to inform the public until further investigations are completed, and rather feel that the public has the right to know as soon as the safety of a product comes into question.

This recent decision, announced just before the new year, follows a surge of lawsuits discussing power morcellation and its potential link to the spreading and accelerating of previously undiscovered cancer cells during women’s gynecological surgeries. At this time, even 12 members of congress have requested a complete investigation into the tools. Various power morcellator manufacturers from across the nation are facing these cancer-related product lawsuits, some of which allege wrongful death. Lawsuits filed against morcellator manufacturer Ethicon (a subdivision of Johnson & Johnson corporation) have been consolidated to form multidistrict litigation in a single court.

This new FDA policy update is known as draft guidance and was aptly titled, “Public Notification of Emerging Postmarket Medical Device Signals (‘Emerging Signals’).” In details of the release, the U.S. Food and Drug Administration explains what the term “emerging signals” constitutes to them as an organization, and discusses change in policy, which helps the agency to take a proactive rather than reactive approach to providing the public with safety warnings.

Power morcellator lawsuits consolidated in MDL No. 2652, which name defendant Ethicon, continue to increase in number today. The cases are being overseen by Judge Kathryn H. Vratil in the U.S. District of Kansas, who recently made history by forming MDL No. 2652 into the first women-majority MDL. The issue at hand, a potential link to cancer spreading during gynecological surgeries, is one of the largest women’s legal issues in recent years.

The attorneys at Banville Law understand how devastating a cancer diagnosis can be, and are now working to ensure that women who have undergone gynecological power morcellation and who have later been diagnosed with cancer will have the important opportunity to fully explore their legal rights. To help attain justice for these women, Banville Law is currently offering free legal consultations to those affected. These women and their families may be entitled to legal action and substantial compensation.

To request more information, or to ask questions regarding the topics discussed in this release, please contact Banville Law by calling 888-997-3792.