Power Morcellator Lawsuits See New Aggressive FDA Medical Device Draft Guidance

January 07, 2016 – – Banville Law reports on recent announcements by the U.S. Food and Drug Administration indicating their new plans to issue more aggressive safety communications earlier than they have done in the past. This decision follows an ever-increasing amount of lawsuits filed against several medical devices and products, including laparoscopic power morcellator tools, of which the Ethicon brand are the subject of multidistrict litigation number 2652 in the U.S. District of Kansas.

A statement released by the FDA showed that they felt a great need “…to notify the public about emerging signals that the agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the agency does not yet have specific recommendations.” They noted that this type of aggressive communication would hopefully reduce or limit “… the number of patients exposed to the potential risk while the issue is being further evaluated.”

The U.S. Food and Drug Administration released this statement on Wednesday, indicating that from this point forward they plan on being much more aggressive when it comes to reporting potentially dangerous medical devices to the public. The message was well received by many plaintiffs across the nation who are currently involved in various medical device lawsuits.

One device that has seen a recent surge of lawsuits is the laparoscopic power morcellator tool, which is used during gynecological surgeries on uterine fibroids. These tools have recently been surrounded by much controversy, and many people across the U.S. have stepped forward filing lawsuits against the surgical tools’ manufacturers, and alleging that the device uncovered and spread cancer cells within their body, creating an aggressive and advanced cancer that often proves untreatable and fatal.

In 2014, the FDA issued a safety warning regarding the use of laparoscopic power morcellation to remove uterine fibroids, and indicating that women should refrain from undergoing these procedures due to the risk of spreading previously undetected cancer, and the impact that it could have on their life-expectancy.

As this announcement indicates, the FDA does currently have a safety warning system in place. However, in new draft guidance, the FDA indicated that their current system was just not enough, and that there was an important need for change moving forward.

In the meantime, plaintiffs across the U.S. fight for justice. While those involved in power morcellation litigation await trial, the attorneys at Banville law are working to ensure that anyone who has undergone laparoscopic power morcellation and who was later diagnosed with cancer will be able to fully explore their legal rights. These women could be entitled to significant compensation. Currently, the attorneys at Banville Law are offering free legal consultations for affected individuals.

To request more information on power morcellation, or to ask questions, please contact the attorneys at Banville Law by calling (888) 997-3792.

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Contact Banville Law:

Laurence Banville, Esq.
888-997-3792
info@banvillelaw.com
165 West End Avenue, #1H
New York, NY 10023
United States (US)

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