Maker of Morcellator Receives FDA Warning Letter

Morcellator cancer attorneys note that Smith & Nephew, Inc., maker of the TRUCLEAR ULTRA Reciprocating Morcellator 4.0, received a warning letter from the Food and Drug Administration (FDA) alleging numerous violations and concerns with the product. The morcellator, a surgical instrument commonly used by gynecologists to remove masses of tissue, has been linked to the spread of cancer during fibroid removal, which has raised concerns for its use in hysterectomies and other uterine surgeries.

If you or a loved one developed cancer after a procedure involving a morcellator, contact Attorney Group today. We can answer your questions without cost or obligation on your part, and if you choose to pursue a claim, we can connect you with an affiliated morcellator lawsuit attorney. You may be entitled to compensation resulting from your or a loved one’s injury, but the time to pursue a claim is limited, so contact us today.

Alleged Violations By the Device-Maker

In the FDA’s letter to Smith & Nephew dated April 30, 2015, numerous violations regarding the product were outlined following an inspection of the company’s Advanced Surgical Devices facility in Massachusetts. The FDA warning letter alleges that the manufacturer failed to respond to initial complaints regarding its morcellators, and that they failed to properly establish, implement, and document procedures ensuring the safe use of the TRUCLEAR ULTRA Reciprocating Morcellator 4.0 device.

The letter further alleges that the device maker failed to comply with numerous other requests for documentation of product corrections and new device designs, and that they also failed to properly establish quality audits to ensure the product’s safe use and provide a description of the actions taken to ensure its safety.

Patients Injured by Medical Devices May Be Entitled for Compensation

Those who are injured by a medical device such as a morcellator may be entitled to compensation for their injuries. Compensation can be based on medical expenses, loss of income or ability to work, pain and suffering and mental anguish. If a person is killed as a result of a medical device, family members may be able to pursue claims for wrongful death damages, which can be based on medical expenses attributable to the injury, mental anguish and pain and suffering from losing a loved one, loss of financial support, and conscious pain and suffering of a loved one prior to death.

Contact Us to Discuss Your Claim Today

If you or someone you love developed cancer after a procedure in which a morcellator was used, contact Attorney Group today. We offer free consultations in which we can answer your questions, and there is no obligation on your part. If you choose to pursue a claim against a medical device manufacturer, we can connect you with an affiliated morcellator cancer attorney. The time to pursue a claim is limited, so contact us today.

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