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Pennsylvania Law Firm Urges FDA Action On Power Morcellators
Date:7/16/2014

tended to give the agency a clearer idea of the risks of the device and the best course of action. While the advisory panel failed to reach a consensus, there were signals from many participants that a future halt on usage might be in the offing, with the majority opinion that morcellators should be banned or at the very least limited. This insight came after a set of hearings in which doctors spoke on the matter and people affected by a surgery gone wrong shared their plight.

Levy Baldante Finney Baldante Rubenstein & Cohen is asking the FDA to follow the lead of those advisory panel members who recognized the inherent danger posed by these uterine surgery devices. They ask that the FDA ban the further sale and usage of morcellators for uterine surgery.

The New Jersey and Pennsylvania personal injury law firm’s medical device liability branch has taken an active interest in the subject and is working to assist people who have been negatively impacted by these products. Martin G. Rubenstein, the firm’s lead on Drug and Medical Device litigation, had this to say:

“Early word out of the morcellator advisory panel is encouraging,” said Mr. Rubenstein, “but in the past, I’ve seen various instances where the FDA’s final decision does not align with what concerned panel members have urged. It’s more important than ever that the FDA take a look at the facts and come to a wise decision regarding the usage of these devices.

“In order to offer the highest degree of protection to citizens, the FDA should move to put an end to the sale of morcellators and initiate an immediate recall on the items. At the very least, new usage guidelines must be put in place that prevent the products’ continued usage except in extreme cases where immediate medical intervention is necessary and a doctor has been able to rule out the presence of uterine sarcomas. In such instances, a patient must be made well aware of the potential dangers.”

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