Cancer Letter Article on Power Morcellator Uterine Cancer Reports Issues With Previous FDA Evaluations

January 14, 2016 – – Banville Law reports on an article recently published by The Cancer Letter, which highlights some problematic aspects of the FDA’s prior evaluation of medical devices, in wake of the recent power morcellator cancer lawsuit surge.

According to information found within the article, the FDA does not assess the risks potentially posed by a vast majority of medical devices currently used. The article says, in a bulleted statement, “Instead of focusing on risk, FDA’s Class II 510 (k) process clears products for the market based on ‘substantial equivalence’ to comparable devices that are already on the market. The power morcellator is one example where preemptive risk assessment by the agency might have gauged the potential for harm to a subset of women, experts said to The Cancer Letter.”

Plaintiffs involved in lawsuits against the device commonly discuss this 510(k) approval process and the issues that could lie within it. Power morcellator tools were approved through this process, so their approval was fast-tracked, skipping much of the rigorous testing due to the fact that they were similar to devices which had already been approved and released to the public.

Another interesting point that The Cancer Letter article brings up is that, although there are stipulations currently in place which require hospitals and manufacturers to “self-report” adverse outcomes directly to the U.S. Food and Drug Administration, the FDA does not “actively look for those” who neglect to report.

As these issues are brought to light, they continue to draw concern. Currently, lawsuits filed against various manufacturers of power morcellator devices continue to add up, and those filed against Ethicon morcellators have been consolidated by the JPML in multidistrict litigation number 2652. These cases will be heard in the United States District of Kansas and overseen by Judge Kathryn H. Vratil. Plaintiffs involved all similarly agree that when women undergo laparoscopic power morcellation during gynecological surgeries, they are putting themselves at increased risk for the spreading of uterine cancer cells they may be completely unaware of.

The attorneys at Banville Law are dedicated to helping ensure that all women who have experienced a serious cancer diagnosis after undergoing power morcellation to remove uterine fibroids will have the opportunity to explore their legal rights. These women may be entitled to legal action and compensation. Banville Law is offering complimentary consultations to those involved.

To request more information regarding power morcellators, or 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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